Regeneron Pharmaceuticals Inc (REGN)

On May 15, 2026, Regeneron issued a press release disclosing that "results from the Phase 3 trial evaluating two dose levels of fianlimab (LAG-3 inhibitor) in combination with cemiplimab (PD-1 inhibitor) as a first-line treatment for patients with unresectable locally advanced or metastatic melanoma" "did not each statistical significance for the primary endpoint of improvement in progression-free survival (PFS) compared to pembrolizumab (PD-1 inhibitor) monotherapy." Following this news, Regeneron's stock price dropped $68.57 per share, or 9.82%, to close at $629.68 on May 16, 2026.

WHAT YOU CAN DO NOW: If you are a long-term Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) shareholder, you are encouraged to visit https://grabarlaw.com/the-latest/regeneron-shareholder-investigation/

Regeneron slides after melanoma study misses key endpoint (REGN)May 18, 2026 6:19 AM
IH Market News Regeneron Pharmaceuticals (NASDAQ:REGN) shares tumbled nearly 12% in premarket trading on Monday after the biotechnology company announced that its phase 3 melanoma study involving fianlimab failed to meet its main clinical objective. Phase 3 trial misses primary goal The company said the study in metastatic melanoma patients did not reach statistical significance for its primary endpoint, which was improvement in progression-free survival.Despite missing the main target, Regeneron reported that the high-dose fianlimab combination demonstrated a numerical improvement of 5.1 months in median progression-free survival compared with pembrolizumab used as a standalone therapy.Regeneron also noted that a separate phase 3 head-to-head study comparing the high-dose fianlimab combination against Opdualag, the combination treatment of nivolumab and relatlimab-rmbw, is still underway. Analysts cut ratings and price targets Following the trial results, Citi downgraded Regeneron shares to neutral from buy and reduced its price target to $700 from $900.Analyst Geoffrey Meacham said the downgrade was driven by the disappointing phase 3 findings for fianlimab in metastatic melanoma.Meacham added that he expects continued pressure on the stock after the trial outcome.BMO analyst Evan David Seigerman also lowered his target price on the shares by nearly 20% in response to the update.“This was to be the defining catalyst of 1H26, with share sentiment inextricably tied to this release,” he said.Regeneron Pharmaceuticals stock price Original: Regeneron slides after melanoma study misses key endpoint (REGN)

Regeneron (REGN) Dupixent Phase 4 Trial Results Show Improved Esophageal Function in EoEMay 5, 2026 10:14 AM
IH Market News New clinical data reinforce Dupixent’s role in treating eosinophilic esophagitis and may support its long-term positioning in the indication.Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) reported Dupixent Phase 4 trial results showing significant improvements in esophageal function and structural disease markers in eosinophilic esophagitis (EoE). The data, presented at Digestive Disease Week 2026, may strengthen confidence in Dupixent’s clinical profile and durability as a leading treatment in this chronic condition. Key Investor Takeaways Regeneron (NASDAQ:REGN) and partner Sanofi reported positive Phase 4 data, reinforcing Dupixent’s efficacy in EoE. The trial showed statistically significant improvements in esophageal function and disease structure versus placebo. High histological remission rates (59% vs. 4%) could support continued adoption in clinical practice. Dupixent remains the only approved biologic for EoE, strengthening its competitive positioning. Longer-term data and real-world adoption may influence the commercial trajectory in this indication. Press Release Overview The REMODEL Phase 4 trial evaluated Dupixent in 69 adults with eosinophilic esophagitis, comparing weekly 300 mg dosing (n=46) to placebo (n=23) over 24 weeks.Key findings included: A 1.28 mm improvement in esophageal distensibility versus a slight decline in the placebo group, meeting the primary endpoint (p

Regeneron Tops Q1 Estimates on Dupixent MomentumApril 29, 2026 8:53 AM
IH Market News
Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) reported first-quarter results that exceeded expectations, supported by strong growth from its collaboration with Sanofi on Dupixent.Adjusted earnings per share came in at $9.47, ahead of the analyst consensus of $8.97 by $0.50. Revenue reached $3.6 billion, up 19% year over year from $3.0 billion and above the $3.48 billion estimate. Shares rose 1.4% following the announcement.Global net sales of Dupixent, recorded by Sanofi, climbed 33% to $4.9 billion, driving a 36% increase in collaboration revenue to $1.6 billion.In contrast, combined U.S. net sales of EYLEA HD and EYLEA declined 10% to $941 million. EYLEA HD sales rose 52% to $468 million, while legacy EYLEA revenue dropped 36% to $473 million due to competitive pressures and ongoing patient transitions to the newer formulation.“In the first quarter of this year, we were able to achieve strong double-digit growth on both the top and bottom line while continuing to invest significant resources in our portfolio of nearly 50 product candidates in clinical development,” said Leonard S. Schleifer.The company’s GAAP gross margin on net product sales declined to 76%, down from 81% a year earlier, primarily due to unabsorbed manufacturing costs and higher inventory write-offs linked to a temporary production disruption at its Limerick, Ireland facility.Production resumed in the second quarter, although Regeneron expects margin pressure to persist until operations return to normal levels by the end of the quarter.The company lowered its full-year 2026 GAAP gross margin guidance to 77%–78%, compared with the previous range of 79%–80%, reflecting the impact of the disruption.Regeneron repurchased $803 million of shares during the quarter and approved a new $3.0 billion share buyback program in April.Regeneron Pharmaceuticals stock price

Original: Regeneron Tops Q1 Estimates on Dupixent Momentum

Markets Steady Ahead of Fed Decision and Key Tech Earnings: Dow Jones, S&P, Nasdaq, Wall Street FuturesApril 29, 2026 5:16 AM
IH Market News
U.S. equity futures were slightly higher on Wednesday but remained close to flat, as investors braced for a wave of major announcements that could influence market direction. The Federal Reserve is widely expected to leave interest rates unchanged, though reports suggest it may adopt a more hawkish tone in its policy statement. At the same time, several mega-cap technology firms are set to report earnings, with particular focus on their spending around artificial intelligence. In Europe, a heavy slate of corporate results is also underway, while Donald Trump has reportedly instructed aides to prepare for a prolonged blockade of Iranian ports.



Futures Tick Slightly Higher



U.S. stock futures moved modestly higher early in the session, ahead of what is shaping up to be one of the busiest trading days of the year.As of 03:26 ET, Dow futures were up 47 points, or 0.1%, S&P 500 futures gained 5 points, or 0.1%, and Nasdaq 100 futures rose 85 points, or 0.3%.Wall Street’s main indices declined in the previous session, largely due to concerns about the financial health of OpenAI after a report from The Wall Street Journal indicated the company had missed certain revenue and user targets. Stocks linked to OpenAI, either through partnerships or investments, also came under pressure.Meanwhile, ongoing tensions between the U.S. and Iran continued to weigh on sentiment, with stalled negotiations delaying any reopening of the Strait of Hormuz, which has effectively been shut to shipping for weeks. Oil prices have risen as a result, raising concerns about inflation and global growth.Despite these headwinds, corporate earnings have shown resilience. According to Reuters, just over one-third of S&P 500 sectors have reported results so far, with 81% of companies exceeding expectations.



Fed Decision in Focus



The Federal Reserve is expected to keep its benchmark interest rate unchanged within a range of 3.5% to 3.75% at the conclusion of its two-day meeting, as policymakers assess the inflationary impact of geopolitical tensions.Reports from the The Wall Street Journal suggest the Fed could adjust its forward guidance in a more hawkish direction by removing references to potential rate cuts in 2026.The meeting may also mark one of the final press conferences by Fed Chair Jerome Powell, whose term is set to expire in May.“Powell’s (supposedly) final press conference shouldn’t rock the boat, but he could err a bit on the hawkish side given the lack of progress in the Gulf,” analysts at ING Group said in a note.Former Fed Governor Kevin Warsh has been nominated by Trump as Powell’s successor, with the Senate Banking Committee expected to vote on his confirmation this week.



Tech Earnings Take Center Stage



Investors are also closely watching a wave of earnings reports, particularly from major technology firms whose heavy investment in AI has fueled recent market gains.Alphabet Inc. (NASDAQ:GOOG), Microsoft (NASDAQ:MSFT), Amazon (NASDAQ:AMZN), and Meta Platforms (NASDAQ:META) are all scheduled to release results after the close.Following the negative sentiment sparked by the OpenAI report, these earnings will serve as a key test for confidence in the AI-driven market rally.“[P]articipants will be looking not only for the classic ‘beat and raise’ from these ‘Magnificent Seven’ names, but also for clarity as to the scale of capital expenditure over coming quarters, the source of that expenditure, and the timeframe over which a return on said investment is likely to be achieved,” said Michael Brown.“With the sector coming into earnings, essentially, at record highs, we are to a degree ‘priced for perfection’, leaving little room for disappointment, and with the market hence likely to punish any sub-par reports.”Beyond tech, companies including AbbVie (NYSE:ABBV), Regeneron Pharmaceuticals (NASDAQ:REGN), and Phillips 66 (NYSE:PSX) are also due to report.



European Earnings Flood Markets



Amid the ongoing geopolitical uncertainty, several major European companies released results earlier in the day.Adidas AG saw its shares jump more than 7% after reporting stronger-than-expected first-quarter operating profit, despite a “very volatile and heavily discounted” retail environment.UBS Group AG rose after posting an 80% increase in quarterly profit, supported by strong trading and client activity linked to market volatility.STMicroelectronics advanced to its highest level since 2024 following better-than-expected results.Airbus SE edged higher after reaffirming its annual delivery targets, even as it faces supply challenges from Pratt & Whitney.Mercedes-Benz Group AG posted modest gains despite weaker revenue, while Banco Santander hovered near flat after reporting a 12.5% rise in underlying profit.



Trump Prepares for Extended Iran Blockade



Donald Trump has instructed his team to prepare for a prolonged blockade of Iran, according to a report by the The Wall Street Journal.Citing U.S. officials, the report said the strategy would focus on intensifying pressure on Iran’s oil exports and restricting shipping access, with a blockade seen as a lower-risk option compared to renewed large-scale military action or rapid diplomatic efforts.This approach follows a ceasefire in April that halted a major bombing campaign but left regional tensions unresolved.According to the report, Trump recently rejected a three-step proposal from Iran that would have allowed an early reopening of the Strait of Hormuz while postponing nuclear negotiations, considering it insufficient to meet U.S. demands.The report added that Trump remains firm on requiring Iran to suspend uranium enrichment for at least 20 years and accept additional long-term restrictions.Alphabet stock priceMicrosoft stock priceAmazon stock priceMeta stock priceAbbVie stock priceRegeneron Pharmaceuticals stock pricePhillips 66 stock price

Original: Markets Steady Ahead of Fed Decision and Key Tech Earnings: Dow Jones, S&P, Nasdaq, Wall Street Futures

$REGN: Getting a deal with White House today.................

Word is out there.... added 300 shares here at $760


LFG !


GO $REGN

Regeneron, Telix strike radiopharmaceutical cancer deal worth up to $2.1bnApril 13, 2026 10:01 AM
IH Market News
Regeneron Pharmaceuticals (NASDAQ:REGN) has entered into a strategic collaboration with Telix Pharmaceuticals (NASDAQ:TLX) to develop and commercialize radiopharmaceutical therapies targeting cancer.As part of the agreement, Telix will receive an initial $40 million payment covering four early-stage therapeutic programs. Both companies will jointly fund development and split any resulting profits equally, while Telix will retain co-promotion rights for selected products. Regeneron also holds the option to extend the partnership to include four additional programs, which would trigger further upfront payments.If Telix opts out of co-funding any specific program, it would instead be eligible for milestone payments of up to $535 million tied to development and commercialization, along with low double-digit royalties on net sales. Across all programs, total potential milestone payments could reach $2.1 billion.The partnership brings together Regeneron’s expertise in antibody discovery and oncology with Telix’s capabilities in radiopharmaceutical development and manufacturing. The initial focus will be on multiple solid tumor targets derived from Regeneron’s antibody pipeline, including those developed using its VelocImmune platform.In addition to therapeutics, the companies plan to co-develop diagnostic imaging tools to support patient selection and monitor treatment response. Telix will lead the commercialization of these diagnostic products, while Regeneron will receive a share of the associated profits.“Targeted radiopharmaceuticals represent a rapidly emerging frontier in oncology and an exciting opportunity to bring new treatment options to patients in need,” said John Lin, Senior Vice President of Oncology & Antibody Technology Research at Regeneron.The collaboration also provides Regeneron with the opportunity to explore combining radiopharmaceutical approaches with its existing immunotherapy portfolio, particularly in indications such as lung cancer, where its PD-1 inhibitor is already established as a standard-of-care treatment.Regeneron Pharmaceuticals stock priceTelix Pharmaceuticals stock price

Original: Regeneron, Telix strike radiopharmaceutical cancer deal worth up to $2.1bn

TriNetX collabore avec Regeneron pour accéder aux dossiers de santé électroniques anonymisés de 300 millions de patients afin de stimuler la recherche et le développement de produits en sciences de la vie et en solutions de santé numériquesApril 4, 2026 10:14 PM
PR Newswire (Canada)

Regeneron a l'opportunité exclusive de connecter des cohortes de données génomiques et protéomiques à grande échelle au réseau mondial de données de dossiers de santé électroniques de TriNetXLa collaboration élargira la base de données génomique et protéomique liée aux DSE de RegeneronLa base de données continuera de stimuler la découverte et le développement de médicaments et de soutenir les algorithmes de formation de l'IA pour offrir les solutions de santé numériques de demain aux consommateurs, aux patients et aux prestatairesTARRYTOWN, New York et CAMBRIDGE, Massachusetts, le 4 avril 2026 /CNW/ -- TriNetX® et Regeneron Pharmaceuticals, Inc. (NASDAQ : REGN) annoncent aujourd'hui une collaboration stratégique pour soutenir les capacités de Regeneron en matière de découverte et de développement de médicaments, ainsi que de nouvelles initiatives pour offrir les solutions de santé numériques de demain aux consommateurs, aux patients et aux prestataires. Regeneron obtient l'occasion exclusive de connecter des cohortes de données génomiques et protéomiques à grande échelle au réseau de données phénotypiques de TriNetX, qui compte environ 300 millions de patients anonymisés. Cette collaboration permettra l'expansion de la base de données génomique et protéomique liée aux dossiers de santé électroniques (DSE) de Regeneron, un catalyseur clé de la filière thérapeutique de pointe de l'entreprise.
Dans le cadre de cette collaboration, TriNetX fournira à Regeneron un accès sécurisé aux données de santé anonymisées actuelles et futures de TriNetX d'environ 300 millions de personnes (dont 170 millions aux États-Unis), provenant directement de son réseau mondial de partenaires du système de santé. Grâce à des méthodes de protection de la vie privée, Regeneron sera en mesure de mettre en correspondance une partie des données anonymisées de TriNetX aux données génomiques et protéomiques générées par le Regeneron Genetics Center® (RGC®). Cette mise en correspondance sera effectuée conformément à toutes les lois applicables en matière de confidentialité des données, y compris la loi HIPAA et le RGPD.Le RGC a mis au point des approches de séquençage et de protéomique de l'ADN à haut débit et rentables pour constituer la plus grande base de données de séquençage et de protéomique couplées aux DSE au monde, en collaboration avec plus de 150 collaborateurs des sciences de la vie et des soins de santé dans le monde. La collaboration avec TriNetX aidera Regeneron à élargir considérablement cet ensemble de données de calibre mondial afin de continuer à stimuler la découverte et le développement de médicaments, tout en soutenant les algorithmes de formation de l'intelligence artificielle (IA) pour offrir les solutions de santé numériques de demain.« Nous sommes ravis de travailler avec Regeneron, et plus particulièrement avec l'équipe du Regeneron Genetics Center, pour faire avancer la santé humaine grâce à l'utilisation de technologies de l'information axées sur l'intelligence et alimentées par nos données de confiance », déclare Jeff Margolis, président exécutif de TriNetX. « Notre équipe est heureuse d'avoir été choisie par Regeneron pour donner accès à l'étendue et à la profondeur uniques de données prêtes pour la recherche de TriNetX, à travers notre vaste réseau mondial fédéré de centres médicaux universitaires et d'autres sites de recherche de premier plan dans le domaine des soins de santé. »« Il s'agit d'un jalon important pour le RGC et d'une nouvelle voie puissante pour accomplir notre mission : bâtir la plus grande et la plus riche base de données sur la santé humaine au monde pour stimuler le développement de médicaments et les solutions de santé numériques pionnières pour les consommateurs, les patients et les prestataires », déclare Aris Baras, M.D., vice-président principal, chef du RGC et co-chef de Regeneron Genetic Medicines. « TriNetX a construit une plateforme de calibre mondial qui a fait ses preuves en matière de recherche à grande échelle. Le RGC a passé plus d'une décennie à produire des données génomiques et maintenant protéomiques et à intégrer ces données moléculaires aux dossiers de santé longitudinaux à grande échelle. La combinaison de ces plateformes rassemble de puissantes bases de données sur la santé humaine avec des capacités d'analyse et d'IA pour aider à découvrir et à développer des médicaments novateurs pour les maladies dévastatrices et créer des solutions de santé numériques qui, nous l'espérons, transformeront notre capacité à prédire, prévenir et gérer les maladies. »« Nous nous réjouissons à la perspective de travailler avec l'équipe de TriNetX », déclare Andrew Deubler, vice-président principal, responsable commercial et administratif du RGC. « Les investissements stratégiques du RGC catalysent l'innovation, stimulent les progrès dans les technologies de pointe qui accélèrent la découverte et le développement de médicaments, et nous aident à développer des solutions numériques novatrices en matière de santé. Cette entente représente la plus récente et l'une de nos plus importantes collaborations, et nous nous réjouissons à l'idée de continuer à élargir notre réseau de partenaires de premier plan dans la poursuite de notre mission. »Dans le cadre de cette collaboration, Regeneron investira jusqu'à 200 millions de dollars dans TriNetX.À propos de TriNetX, LLC
TriNetX est le moteur de vérité au service d'une meilleure santé humaine (Global Truth Engine for Better Human Health™) qui facilite l'utilisation de données complexes et concrètes sur la santé. Les données proviennent directement de notre réseau mondial croissant de plus de 11 000 prestataires de soins de santé. Les clients de TriNetX choisissent la source, les types et l'étendue des données dont ils ont besoin, les méthodes d'accès qu'ils souhaitent utiliser et les types de logiciels et d'intelligence humaine et machine qu'ils souhaitent mettre en œuvre, et les combinent pour atteindre leurs objectifs commerciaux. Visitez TriNetX à www.trinetx.com ou suivez TriNetX sur LinkedIn pour en savoir plus.À propos de Regeneron
Regeneron (NASDAQ : REGN) est une biotech de premier plan qui invente, développe et commercialise des médicaments qui transforment la vie des personnes atteintes de maladies graves. Fondée et dirigée par des médecins-scientifiques, la société a la capacité unique de traduire la science en médicaments de façon répétée et constante, ce qui a donné lieu à de nombreux traitements et produits candidats, dont la plupart ont été élaborés dans nos laboratoires. Nos médicaments et nos médicaments émergents sont conçus pour aider les patients atteints de maladies oculaires, de maladies allergiques et inflammatoires, de cancer, de maladies cardiovasculaires et métaboliques, de maladies neurologiques, de maladies hématologiques, de maladies infectieuses et de maladies rares.Regeneron repousse les limites de la découverte scientifique et accélère le développement de médicaments en utilisant des technologies exclusives, comme VelociSuite®, qui produit des anticorps entièrement humains optimisés et de nouvelles classes d'anticorps bispécifiques. Nous façonnons la prochaine frontière de la médecine grâce à des renseignements fondés sur des données provenant du Regeneron Genetics Center® et à des plateformes de médecine génétique pionnière, ce qui nous permet d'identifier des cibles novatrices et des approches complémentaires pour potentiellement traiter ou guérir des maladies.Pour de plus amples renseignements, visitez www.Regeneron.com ou suivez Regeneron sur LinkedIn, Instagram, Facebook, YouTube ou X.À propos du Regeneron Genetics Center
Le Regeneron Genetics Center® (RGC®) est une initiative de recherche en génomique et une filiale en propriété exclusive de Regeneron. Depuis plus d'une décennie, nous exploitons la puissance de la génétique humaine pour découvrir de nouveaux médicaments importants, valider les programmes de recherche existants et optimiser les essais cliniques. Nous puisons dans notre base de données croissante de plus de trois millions d'exomes séquencés et d'informations dépersonnalisées sur la santé grâce à l'analyse de données exclusives, à la technologie et à l'ingéniosité humaine pour faire des découvertes biologiques significatives à grande échelle et à grande vitesse. Notre modèle intégré met l'accent sur la participation avec nos collaborateurs pour créer un ensemble de données comportant des cohortes significatives. Nous utilisons des technologies novatrices, comme l'apprentissage automatique, pour séquencer les exomes, assurer l'alignement avec les informations de santé et effectuer des analyses à grande échelle pour établir des associations pertinentes entre les gènes et les maladies. Nous appliquons nos connaissances pour orienter les efforts de découverte et de développement de médicaments de Regeneron.Énoncés prospectifs de Regeneron et utilisation des médias numériques
Le présent communiqué de presse comprend des énoncés prospectifs qui comportent des risques et des incertitudes liés à des événements futurs et à la performance future de Regeneron Pharmaceuticals, Inc. (« Regeneron » ou la « société »), et les événements ou résultats réels peuvent différer sensiblement de ces énoncés prospectifs. Des mots comme « anticiper », « s'attendre à », « avoir l'intention », « planifier », « croire », « chercher », « estimer », des variations de ces mots et des expressions semblables visent à identifier de tels énoncés prospectifs, bien que tous les énoncés prospectifs ne contiennent pas ces mots identificateurs. Ces déclarations concernent, et ces risques et incertitudes comprennent, entre autres, la nature, le calendrier et le succès possible ainsi que les applications thérapeutiques des produits commercialisés ou autrement mis sur le marché par Regeneron et/ou ses collaborateurs ou titulaires de licence (collectivement, les « produits de Regeneron ») et des produits candidats en cours de développement par Regeneron et/ou ses collaborateurs ou titulaires de licence (collectivement, les « produits candidats de Regeneron »), les programmes de recherche et cliniques en cours ou prévus, ainsi que l'utilisation de la génétique humaine dans les programmes de recherche de Regeneron ; la probabilité, le calendrier et la portée de la réalisation des jalons anticipés décrits dans le présent communiqué de presse ; la mesure dans laquelle les résultats des programmes de recherche et de développement menés par Regeneron et/ou ses collaborateurs ou titulaires de licence (y compris ceux pouvant résulter de la collaboration de Regeneron avec TriNetX mentionnée dans le présent communiqué de presse) peuvent être reproduits dans d'autres études et/ou conduire à l'avancement des produits candidats vers des essais cliniques, des applications thérapeutiques ou une approbation réglementaire ; les obligations réglementaires continues et la surveillance ayant un impact sur les produits de Regeneron, les programmes de recherche et cliniques et les activités de la société, y compris celles liées à la confidentialité des patients ; la probabilité, le calendrier et la portée d'une éventuelle approbation réglementaire et du lancement commercial des produits candidats de Regeneron ainsi que de nouvelles indications pour les produits de Regeneron ; l'incertitude quant à l'utilisation, à l'acceptation du marché et au succès commercial des produits de Regeneron et des produits candidats de Regeneron, ainsi que l'impact des études (qu'elles soient menées par Regeneron ou par des tiers, et qu'elles soient obligatoires ou volontaires) sur ce qui précède ; la capacité des collaborateurs, titulaires de licence, fournisseurs ou autres tiers de Regeneron (le cas échéant) à assurer la fabrication, le remplissage, la finition, l'emballage, l'étiquetage, la distribution et d'autres étapes liées aux produits de Regeneron et aux produits candidats de Regeneron ; la capacité de Regeneron à gérer les chaînes d'approvisionnement pour plusieurs produits et produits candidats, ainsi que les risques associés aux droits de douane et autres restrictions commerciales ; les problèmes de sécurité résultant de l'administration des produits de Regeneron et des produits candidats de Regeneron chez les patients, y compris les complications graves ou les effets secondaires liés à leur utilisation dans les essais cliniques ; les décisions des autorités gouvernementales réglementaires et administratives susceptibles de retarder ou de restreindre la capacité de Regeneron à continuer à développer ou commercialiser ses produits et produits candidats ; la disponibilité et l'étendue du remboursement ou de l'assistance aux copaiements pour les produits de Regeneron par des payeurs tiers et autres entités, y compris les programmes privés d'assurance maladie, les organismes de gestion de soins de santé, les sociétés de gestion des prestations pharmaceutiques et les programmes gouvernementaux tels que Medicare et Medicaid ; les décisions de couverture et de remboursement prises par ces payeurs et autres tiers, ainsi que les nouvelles politiques et procédures adoptées par ceux-ci ; les modifications de la réglementation et des exigences en matière de prix des médicaments et la stratégie de tarification de Regeneron ; d'autres changements dans les lois, réglementations et politiques affectant le secteur de la santé ; les produits concurrents et produits candidats (y compris les biosimilaires) pouvant être supérieurs ou plus rentables que les produits de Regeneron et ses produits candidats ; les dépenses imprévues ; les coûts de développement, de production et de commercialisation des produits ; la capacité de Regeneron à atteindre ses prévisions financières ou ses orientations, ainsi que les modifications des hypothèses sous-jacentes ; la possibilité que tout accord de licence, de collaboration ou d'approvisionnement, y compris les accords de Regeneron avec Sanofi et Bayer (ou leurs sociétés affiliées respectives, le cas échéant), ainsi que la collaboration avec TriNetX mentionnée dans le présent communiqué de presse, soit annulé ou résilié ; l'impact des flambées de santé publique, des épidémies ou des pandémies sur les activités de Regeneron ; et les risques liés aux litiges et autres procédures ainsi qu'aux enquêtes gouvernementales concernant la société et/ou ses activités (y compris les procédures civiles en cours engagées ou rejointes par le département de la Justice des États-Unis et le bureau du procureur des États-Unis pour le district du Massachusetts), les risques liés à la propriété intellectuelle de tiers et aux litiges en cours ou futurs y afférents (y compris, sans limitation, les litiges en matière de brevets et autres procédures connexes relatifs à EYLEA® (aflibercept) Injection), l'issue finale de ces procédures et enquêtes, et l'impact de tout ce qui précède sur les activités, les perspectives, les résultats d'exploitation et la situation financière de Regeneron. Une description plus complète de ces risques et d'autres risques importants se trouve dans les documents déposés par Regeneron auprès de la Securities and Exchange Commission des États-Unis, y compris sur son formulaire 10-K pour l'exercice clos le 31 décembre 2025. Les énoncés prospectifs sont formulés en fonction des croyances et du jugement actuels de la direction, et le lecteur est invité à ne pas se fier indûment aux énoncés prospectifs de Regeneron. Regeneron ne s'engage pas à mettre à jour (publiquement ou autrement) les énoncés prospectifs, y compris, sans s'y limiter, toute projection ou directive financière, que ce soit à la suite de nouveaux renseignements, d'événements futurs ou autrement.Regeneron utilise son site Web de relations avec les médias et les investisseurs ainsi que les médias sociaux pour publier des renseignements importants sur la société, y compris des renseignements qui peuvent être considérés comme importants pour les investisseurs. Les renseignements financiers et autres sur Regeneron sont affichés régulièrement et sont accessibles sur le site Web de Regeneron sur les relations avec les médias et les investisseurs (https://investor.regeneron.com) et sa page LinkedIn (https://www.linkedin.com/company/regeneron-pharmaceuticals).Regeneron
Médias :
Ella Campbell
Courriel : ella.campbell@regeneron.comInvestisseurs :
Vesna Tosic
Courriel : vesna.tosic@regeneron.comTriNetX
Karen Tunks
Courriel : Karen.Tunks@TriNetX.comLogo - https://mma.prnewswire.com/media/542641/TriNetX_Logo.jpgSOURCE TriNetX, LLC.

Original: TriNetX collabore avec Regeneron pour accéder aux dossiers de santé électroniques anonymisés de 300 millions de patients afin de stimuler la recherche et le développement de produits en sciences de la vie et en solutions de santé numériques

TriNetX Collaborates with Regeneron to Access De-Identified Electronic Health Records of 300 Million Patients to Drive Research and Product Development in Life Sciences and Digital Health SolutionsApril 2, 2026 4:30 PM
PR Newswire (US)

Regeneron has exclusive opportunity to connect large-scale genomic and proteomic data cohorts to TriNetX's industry-leading global network of electronic health record dataCollaboration will expand Regeneron's world-leading genomic and proteomic EHR-linked database Growing database will continue to drive drug discovery and development and empower AI training algorithms to deliver digital health solutions of the future for consumers, patients and providersTARRYTOWN, N.Y. and CAMBRIDGE, Mass., April 2, 2026 /PRNewswire/ -- TriNetX® and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced a strategic collaboration to support Regeneron's capabilities in drug discovery and development, as well as new initiatives to deliver digital health solutions of the future for consumers, patients and providers. Regeneron gains the exclusive opportunity to connect large-scale genomic and proteomic data cohorts to TriNetX's industry-leading phenotypic data network of approximately 300 million de-identified and anonymized patients. This collaboration will enable expansion of Regeneron's world-leading genomic and proteomic Electronic Health Record (EHR)-linked database, a key driver of the company's industry-leading therapeutics pipeline.







Under the collaboration, TriNetX will provide Regeneron with secure, licensed access to TriNetX's current and future de-identified health data from approximately 300 million individuals (170 million of whom are in the United States), sourced directly from its global network of health system partners. With privacy-preserving methods, Regeneron will have the capability to match a portion of TriNetX's de-identified/anonymized data to genomic and proteomic data generated by the Regeneron Genetics Center® (RGC®). Such matching will be conducted in accordance with all applicable data privacy laws, including HIPAA and GDPR.The RGC has developed high-throughput and cost-efficient DNA sequencing and proteomics approaches to build the world's largest database of EHR-linked sequencing and proteomics data, in collaboration with over 150 life sciences and healthcare collaborators around the world. The collaboration with TriNetX will help Regeneron dramatically expand this already world-leading dataset to continue to drive drug discovery and development, while also empowering artificial intelligence (AI) training algorithms to deliver digital health solutions of the future."We are delighted to work with Regeneron, and specifically the Regeneron Genetics Center team, to advance human health through the application of intelligence-driven information technology, powered by our trusted data," said Jeff Margolis, TriNetX Executive Chairman. "Our team is gratified to be selected by Regeneron to provide access to TriNetX's unique breadth and depth of research-ready data, across our extensive federated global network of academic medical centers and other leading healthcare research sites.""This is a major milestone for the RGC and a powerful new pathway to achieve our core mission: building the world's largest and richest human health database to drive drug development and pioneer digital health solutions for consumers, patients and providers," said Aris Baras, M.D., Senior Vice President, Head of RGC and Co-head of Regeneron Genetic Medicines. "TriNetX has built a world-leading platform with a proven track record of enabling research at scale. The RGC has spent over a decade generating genomic and now proteomic data and integrating these molecular data with longitudinal health records at large-scale. Combining these platforms brings together powerful human health databases with analytical and AI capabilities to help discover and develop innovative medicines for devastating diseases and create digital health solutions that we hope will transform our ability to predict, prevent and manage disease.""We are looking forward to working with the TriNetX team," said Andrew Deubler, Senior Vice President, RGC Chief Business and Administrative Officer. "Our RGC strategic investments catalyze innovation, driving advancements in cutting-edge technologies that accelerate drug discovery and development, as well as help us develop innovative digital health solutions. This deal represents the latest and one of our most significant collaborations, and we look forward to continuing to expand our network of top-tier partners as we pursue our mission."As part of the collaboration, Regeneron will invest up to $200 million in TriNetX.About TriNetX, LLC 
TriNetX is the Global Truth Engine for Better Human Health™ that makes complex, real-world health data easy to use. Data is sourced directly from our growing global network of over 11,000 healthcare provider locations. TriNetX customers select the data source, types, and breadth of data they need; the data access methods they desire; and the types of software, human and machine intelligence they wish to apply – and combine these to solve their business objectives. Visit TriNetX at www.trinetx.com or follow TriNetX on LinkedIn to learn more.About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and?product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook, YouTube or X.About the Regeneron Genetics Center
The Regeneron Genetics Center® (RGC®) is a genomic research initiative and a wholly owned subsidiary of Regeneron. For over a decade, we have harnessed the power of human genetics to discover important new medicines, validate existing research programs and optimize clinical trials. We tap into our growing database of more than 3 million sequenced exomes and de-identified health information using proprietary data analytics, technology and human ingenuity to make meaningful biological discoveries at speed and scale. Our high-touch integrated model focuses on working closely with our collaborators to build a dataset with meaningful cohorts. We use innovative technologies, such as machine learning, to sequence exomes, align with health information and perform large-scale analyses to make meaningful associations between genes and diseases. We apply our insights to guide Regeneron's broader drug discovery and development efforts.Regeneron Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates"), research and clinical programs now underway or planned, and the use of human genetics in Regeneron's research programs; the likelihood, timing, and scope of achieving any of the anticipated milestones described in this press release; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees (such as those that may result from Regeneron's collaboration with TriNetX discussed in this press release) may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on any of the foregoing; the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; the availability and extent of reimbursement or copay assistance for Regeneron's Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron's pricing strategy; other changes in laws, regulations, and policies affecting the healthcare industry; competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) as well as the collaboration with TriNetX discussed in this press release, to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2025. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals).Regeneron
Media:
Ella Campbell
Email: ella.campbell@regeneron.comInvestors:
Vesna Tosic
Email: vesna.tosic@regeneron.comTriNetX
Karen Tunks
Email: Karen.Tunks@TriNetX.com



View original content to download multimedia:https://www.prnewswire.com/news-releases/trinetx-collaborates-with-regeneron-to-access-de-identified-electronic-health-records-of-300-million-patients-to-drive-research-and-product-development-in-life-sciences-and-digital-health-solutions-302733225.htmlSOURCE TriNetX, LLC.

Original: TriNetX Collaborates with Regeneron to Access De-Identified Electronic Health Records of 300 Million Patients to Drive Research and Product Development in Life Sciences and Digital Health Solutions

Regeneron reports 19% weight loss in China Phase 3 trial of olatorepatideMarch 9, 2026 11:12 AM
IH Market News
Regeneron Pharmaceuticals (NASDAQ:REGN) said Monday that partner Hansoh Pharmaceutical Group Company Limited reported positive results from a Phase 3 clinical trial evaluating olatorepatide in Chinese patients with obesity or who are overweight. The announcement comes as the $78 billion biotechnology company trades near its 52-week high, with shares up 59% from their lowest level over the past year and gaining 37% in the last six months.The randomized, double-blind, placebo-controlled study enrolled 604 adult participants across 33 clinical sites in mainland China. The trial compared once-weekly doses of olatorepatide with placebo over a 48-week period, testing three treatment groups receiving 5 mg, 10 mg, or 15 mg doses alongside a placebo group.The study achieved its co-primary endpoints, showing that patients receiving olatorepatide experienced statistically significant reductions in body weight compared with placebo. A significantly higher percentage of participants in the treatment groups also achieved at least 5% weight loss by week 48.According to the company, patients treated with olatorepatide achieved mean weight reductions of up to 19% from baseline after 48 weeks. Additional analyses indicated that as many as 97% of participants reached at least 5% weight loss by the end of the study period.The trial also reported relatively low rates of gastrointestinal side effects and treatment discontinuation compared with other published Phase 3 studies involving dual incretin therapies. The average rate of nausea was below 10%, while vomiting occurred in fewer than 5% of participants on average.Olatorepatide is a dual GLP-1/GIP receptor agonist. Under a strategic licensing agreement with Hansoh, Regeneron holds exclusive rights for clinical development and commercialization outside mainland China, Hong Kong, and Macau.Regeneron said its global Phase 3 registrational program for the therapy is expected to begin later this year, and more detailed data from the study will be presented at an upcoming medical conference.The safety and effectiveness of olatorepatide have not yet been reviewed by any regulatory authority.



Other recent developments



Regeneron has also seen several notable updates in recent weeks. Guggenheim raised its price target for the company to $975 while maintaining a Buy rating, citing continued strong sales growth for Dupixent, which increased 26% year over year to $17.8 billion.Barclays recently initiated coverage on Regeneron with an Overweight rating, highlighting the growth potential of Dupixent and forecasting that the company’s broader portfolio will help offset pressures related to its Eylea franchise.Meanwhile, RBC Capital lifted its price target to $765 while maintaining a Sector Perform rating following encouraging data from a melanoma study involving fianlimab and Libtayo.In addition, the U.S. Food and Drug Administration has accepted Regeneron’s Biologics License Application for priority review of garetosmab, a potential treatment for fibrodysplasia ossificans progressiva. A regulatory decision is expected by August 2026.Regeneron is also preparing to present Phase 3 clinical data on new allergy antibody treatments at an upcoming scientific conference, where the therapies have shown promising results in reducing allergy symptoms.Regeneron Pharmaceuticals stock price

Original: Regeneron reports 19% weight loss in China Phase 3 trial of olatorepatide

Fed Chair Speculation, Apple Results and Shutdown Deal Shape Market Moves: Dow Jones, S&P, Nasdaq, Wall Street FuturesJanuary 30, 2026 5:24 AM
IH Market News
U.S. equity futures edged lower on Friday as investors assessed growing speculation that Kevin Warsh could be named the next chair of the U.S. Federal Reserve. Corporate news provided some support, led by a strong earnings update from Apple, while precious metals pulled back from record highs. Meanwhile, political risk eased after signs emerged that a U.S. government shutdown has likely been avoided.



Apple delivers standout quarter and upbeat outlook



Apple (NASDAQ:AAPL) reported results that comfortably exceeded expectations for both revenue and profit in its fiscal first quarter, which includes the key holiday period. The group posted its strongest quarterly iPhone sales growth in more than four years, with iPhone revenue surging 23.3% year on year to $85.27bn, the largest increase since the fourth quarter of 2021.Demand has been particularly strong for the latest iPhone 17 range, especially higher-end Pro models, helping Apple lift its global smartphone market share to around 20% in 2025 from 18% a year earlier. The company also surprised on guidance, forecasting revenue growth of up to 16% for the March quarter, driven by sustained iPhone demand, a sharp recovery in China and accelerating momentum in India. Operating expenses are expected to come in between $18.4bn and $18.7bn, slightly higher than in the first quarter.Despite the strong performance, Apple acknowledged ongoing supply-side challenges. “We’re currently constrained. And at this point, it’s difficult to predict when supply and demand will balance,” CEO Tim Cook said, adding, “we’re seeing less flexibility in supply chains than normal, partly because of our increased demand that I just spoke about.” The company, like many peers, continues to face tight availability of memory chips, which is weighing on production.



U.S. futures slip as investors turn cautious



U.S. stock futures traded lower as risk appetite softened ahead of the expected Fed announcement. By 03:25 ET, S&P 500 futures were down 55 points, or 0.8%, Nasdaq 100 futures had fallen 240 points, or 0.9%, and Dow futures were lower by around 400 points, or 0.8%.Wall Street ended Thursday’s session mixed. The S&P 500 and the Nasdaq Composite closed lower, dragged down by weakness in technology stocks following earnings-related losses at Microsoft (NASDAQ:MSFT), while the Dow Jones Industrial Average edged modestly higher. For the week so far, the S&P 500 and Nasdaq are both up close to 0.8%, while the Dow is slightly negative.Attention is also turning to another busy earnings day, with results due from Exxon Mobil (NYSE:XOM), Chevron (NYSE:CVX), American Express (NYSE:AXP), Verizon (NYSE:VZ), Regeneron Pharmaceuticals (NASDAQ:REGN) and Aon (NYSE:AON).



Kevin Warsh emerges as leading Fed contender



President Donald Trump said late Thursday that he will unveil his nominee to succeed Jerome Powell as Federal Reserve chair later in the session, fuelling speculation that former Fed governor Kevin Warsh is the frontrunner. “A lot of people think that this is somebody that could have been there a few years ago,” Trump said. “It’s going to be somebody that is very respected, somebody that’s known to everybody in the financial world.”Those remarks have been widely interpreted as pointing to Warsh, who lost out to Powell for the role in 2017 during Trump’s first term. Reports from Reuters said Warsh visited the White House on Thursday, while both the Wall Street Journal and Bloomberg indicated the administration is preparing to nominate him.Warsh is generally viewed as supportive of lower interest rates, aligning more closely with Trump’s policy preferences, but is also seen as a relatively moderate choice compared with some other names floated for the role. Trump has repeatedly criticised Powell for not cutting rates as aggressively as he wanted, a dispute that has raised concerns about central bank independence. Those concerns intensified earlier this month when Powell suggested that a criminal investigation into a Fed renovation project was politically motivated.



Shutdown risk eases after last-minute deal



Political uncertainty also eased after lawmakers reached a late-night agreement to prevent another U.S. government shutdown. The White House and Senate Democrats agreed to advance a large package of spending bills, while splitting out the Department of Homeland Security budget and funding that agency at current levels for an additional two weeks.Saturday had been the deadline to pass five spending bills required to keep much of the government operating. The Trump administration previously endured a 43-day shutdown last autumn. Democrats had resisted backing DHS funding without changes to immigration enforcement tied to Trump’s mass deportation programme. The compromise is seen as buying time for further negotiations, particularly following renewed scrutiny of enforcement policies after the deaths of U.S. citizens Alex Pretti and Renee Good in Minneapolis.



Gold, silver and oil pull back from recent peaks



Precious metals retreated sharply after reaching record levels, as expectations of a less dovish Fed chair candidate boosted the U.S. dollar. Spot gold fell 3.1% to $5,184.26 an ounce, while April gold futures dropped 4.1% to $5,151.24 per ounce. Even after the pullback, gold remains up more than 20% so far in January, on track for a sixth consecutive monthly gain and its strongest monthly rise since 1982.Other metals also cooled after a volatile week. Spot silver slid 7.3% to $106.073 an ounce after hitting a record high on Thursday, while platinum dropped 8.5% to $2,394.98 an ounce.Oil prices eased following a three-day rally, though both benchmarks remained on course for strong weekly gains amid concerns that potential U.S. military action against Iran could disrupt supplies. Brent crude slipped 1.8% to $68.36 a barrel, while U.S. West Texas Intermediate fell 1.8% to $64.24. Both were still set to rise by more than 5% on the week.OPEC and its allies, known as OPEC+, are due to meet on Sunday. Recent reports suggest the group is likely to keep output unchanged, having paused monthly production increases from January after raising supply by around 2.9 million barrels per day through 2025, a move that had previously weighed heavily on oil prices amid fears of oversupply and softer global demand.Apple stock priceExxonMobil stock priceChevron stock priceAmerican Express stock priceVerizon Communications stock priceRegeneron Pharmaceuticals stock priceAon stock price

Original: Fed Chair Speculation, Apple Results and Shutdown Deal Shape Market Moves: Dow Jones, S&P, Nasdaq, Wall Street Futures

🌱 Chronic Pain (Non-Cancer)
Cannabis: Patients turn to cannabis for neuropathic pain, migraines, and fibromyalgia, valuing its natural profile.

Pharma/Biotech: Opioids, gabapentin, and lab-engineered pain modulators are the standard.

Competition: Cannabis is marketed as “nature’s painkiller,” while pharma stresses controlled dosing and patent-protected molecules. $REGN $TLRY $WEED $CGC

$REGN"CRISPR as if playing GOD with a gene editing adulterated and contaminated bio weapon passed off as a “vaccine” wasn’t enough" CRISPR

as if playing GOD with a gene editing adulterated and contaminated bio weapon passed off as a “vaccine” wasn’t enough

Let me offer you a solution to your vaxinjury

CRISPR

Their solution to the DOD fuck up of deploying a bioweapon and injecting billions of people with… pic.twitter.com/BivVv2miWz— Lyndsey, RN 💜🐭 (@HouseLyndseyRN) March 19, 2025

REGN creeping higher
Yeah,sure
REGN
Regeneron Pharmaceuticals Inc
499.455
-105.935 (-17.50%)

REGN creeping higher

The FDA has already approved two BCMAxCD3 bispecifics: Johnson & Johnson’s Tecvayli and Pfizer’s Elrexfio.
Could be the reason why they balked at the manufacturing plus both companies have multiple drugs for cancer in the pipeline.

All is good. A temporary delay with way more upside.

$REGN $1,081 cha Ching. Starting put position on spy for elections

REGN new 52 week high

$REGN $994 we are so close bust it!!!!

REGN new 52 week high

$REGN $940 we hit a thousand and I’ll start buying puts on spy

REGN new 52 week high

REGN new 52 week high

Posted new 52 week high yesterday
I had it on my list of new highs but didn’t post
I am lazy these days
2024 in my view will be bullish for the very broad healthcare sector
I am talking close to 700 public traded companies
Not all will grow market capitalization
There will still be plenty of failures
I usually spend the weekends viewing charts of healthcare stocks from the Barchart website
Since I have free membership I can use the site’s flip chart feature
It’s tedious but it tells me where the institutional money is heading

I wonder when will REGN buyout NWBO... this will catapult them to be the Leader in oncology sector, finally beating out Merck!

REGN $881.70 can I get a thousand???

REGN new 52 week high

REGN Regeneron brings its antibody chops to gene editing's biggest problem, aiming to 'change the field'
By Andrew Dunn, Biopharma Correspondent for Endpoints In Focus
September 18, 2023 10:00

TARRYTOWN, NY — For over three decades, Regeneron has been synonymous with one thing in the drug industry: antibodies. Blockbusters like Dupixent, Eylea, and Covid-19 antibodies have transformed what started as a scrappy startup into one of biotech’s biggest names.

But the billionaire co-founders who still run the $91 billion giant, CEO Leonard Schleifer and CSO George Yancopoulos, have spent nearly the last decade working on the company’s next act. They have partnered, built, and bought their way into genetic medicine, going beyond antibodies into CRISPR, RNA interference, and other technologies that manipulate the genetic code of life.

It’s an audacious bet on the future of the drug industry. And even though Regeneron’s success has come from antibodies, its leaders believe new therapies may dominate its next age.

Not only is the biotech co-developing the most clinically advanced in vivo CRISPR therapy with Intellia Therapeutics and an Alzheimer’s RNA interference drug candidate with Alnylam Pharmaceuticals, it’s also quietly working on — and increasingly excited about — some earlier, less heralded research that could change the field. Its leaders believe it can crack the delivery problem that holds back the entire space. Doing so would bring genetic medicines beyond the liver to reach more parts of the body, in the process greatly expanding the medical — and commercial — possibilities of the technology.

“While everybody else was so hyped and giving Nobel Prizes for CRISPR and all that, we realized those weren’t really the limitations,” Yancopoulos, Regeneron’s chief scientific officer, told Endpoints News during an interview at the company’s Tarrytown headquarters. “The limitations were really delivery.”

Regeneron is tapping its decades-long expertise in antibodies, attaching these proteins to standard viral vectors so they hunt for specific types of cells in the body. Research is early, with no timetable on reaching the clinic, but results in mice and non-human primates have emboldened the company’s scientific leaders on the promise of the idea. If it works, Regeneron could crack the delivery challenge that has held the entire field back for years, ultimately bringing technological breakthroughs like CRISPR and RNAi to far more diseases.

“We believe we’ve become leaders in that space,” Yancopoulos said of the delivery idea. “We will hopefully be announcing programs where we’re using biologicals to deliver genetic payloads, which we think has the chance to really continue to change the field.”

There’s still a long journey ahead into making this reality. Academics first tried the idea of attaching antibodies to viral vectors in the 1990s with moderate success, but challenges in making such a complex product have deterred industry interest. Before this idea reaches the clinic, Regeneron will need to convince regulators it has the manufacturing chops to attach these antibodies to viruses in a consistent way so batches look the same. Gene therapy experts said scaling up will be a key challenge.

Still, Regeneron carries unique credibility with its deep pockets and decades of antibody experience.

“Regeneron has certainly been the leader in designing and producing specific antibodies that could be used for this purpose,” said Barry Byrne, director of the University of Florida’s gene therapy center. “They’re the ones who will probably make this work.”

Whether using a hollowed-out virus or a lipid nanoparticle, delivering genetic cargo in the body is frustratingly hard. These carriers predominantly wind up in the liver, the body’s clearinghouse organ.

While that can address diseases caused by genes expressed in liver cells, that’s not most illnesses. The brute force approach, upping doses to try to reach other organs, comes at the expense of the liver, leading to patient deaths in some gene therapy clinical studies.

Christos Kyratsous
“You have to give so much vector that you’re overwhelming your liver, and your liver enzymes go crazy,” said Christos Kyratsous, co-head of Regeneron’s genetic medicines team. “That becomes the major limitation for delivering the interesting payloads.”

The delivery problem has caused the field to crowd into the same liver-based targets, such as PCSK9, to slash cholesterol. Other efforts, like the sickle cell CRISPR gene-editing program now being reviewed by the FDA, avoid delivery altogether by using an ex vivo process closer to arduous transplant surgery than a typical drug.

The delivery work is one part of a sprawling genetics strategy at Regeneron, which started in 2014 with the launch of its Regeneron Genetics Center. That has become one of the world’s largest DNA-reading efforts, having sequenced 2 million genomes and counting, leading to over 10 new genetic targets tied to diseases like obesity or liver disease.

Walking around the RGC, sequencing machines tower over and outnumber white-coated scientists toiling at lab benches. It’s far more common for its 170 employees to log on remotely to check experiments or let robotic systems whiz around to handle routine tasks like pipetting.

Regeneron has inked collaborations with Decibel Therapeutics and Alnylam over the past few years, respectively working on CRISPR gene editing, gene therapy, and RNA interference to advance that RGC research. In August, Regeneron made an extraordinarily rare M&A move, agreeing to buy Decibel and its gene therapy work.

Regeneron now has six genetic medicines in its pipeline and more than 30 preclinical programs. But even as the field has generated excitement with the first US approvals for gene therapies, RNAi drugs, and mRNA vaccines all since 2017, its potential still dwarfs its current impact. The pesky delivery problem looms over the entire field.

Regeneron hopes its antibody idea can reach more organs, starting with the muscle and the brain. Preclinical data are encouraging, independent experts told Endpoints.

Regeneron’s most advanced program attaches an antibody targeting a protein found in muscle cells called CACNG1 to a viral vector. Mice and non-human primate studies showed massive boosts in reaching muscle cells, alongside big drops in entering the liver and heart compared to an unmodified version of the virus, according to data presented at this year’s American Society of Gene & Cell Therapy meeting.

“This is unlocking an entirely new space in terms of delivery and what you can actually do with all these genetic medicines,” Kyratsous said.

Christina Pacak, a University of Minnesota gene therapy researcher, called the data exciting, adding she’s hopeful for the approach.

“If we can increase safety, reduce costs, and just lower what patients are exposed to, that’s an enormous advantage,” said Pacak, who’s not involved with Regeneron’s research.

***

For Regeneron’s early results, other experts said they are encouraging but not industry-shaking.

“Super-beautiful data. It’s impressive,” said Nicole Paulk, CEO of the gene therapy startup Siren Biotechnology. “But it doesn’t look different magnitude-wise on either purposeful targeting or detargeting to any of the novel capsids. Competitive, but not different.”

Startups like Dyno Therapeutics, Solid Biosciences, Capsida Biotherapeutics, and Apertura Gene Therapy are all tinkering with AAVs, or adeno-associated viruses, to get beyond the liver. (Paulk sits on Dyno’s scientific advisory board.) Outside of AAVs, other startups focused on delivery include Aera Therapeutics, Ensoma, and ReCode Therapeutics.

Even as more startups take on delivery, Regeneron stands alone with its antibody idea. In a sign of its progress, its AAV-focused team has grown from the single digits about seven years ago to now several hundred people.

Outside experts repeatedly mentioned scaling up production as the key challenge to watch. Siren’s Paulk said manufacturing challenges have limited the idea’s potential for decades, as attaching antibodies can be inconsistent and finicky. Paulk said Regeneron would need to have a production trick up its sleeve to address those challenges.

“Every lot becomes a snowflake, and that becomes a challenge for the FDA,” Paulk said. “I don’t see a way this moves forward. I hope I’m dead wrong.”

David Schaffer, a bioengineering researcher at UC Berkeley, called Regeneron’s results “interesting” but noted in an email it may be “technically challenging to scale reproducibly and robustly.”

Regeneron’s leaders said they are confident in meeting that challenge. Kyratsous said they are advancing two methods of attaching antibodies to viruses, adding they’ve seen consistent results in scaling both ideas so far.

“We don’t want to over-engineer something and make something that is very cool on paper or works very well in small animal models, and you cannot scale it up for human use,” he added.

Regeneron’s leaders pointed to their experience in mass-producing antibodies and the expanding AAV team.

“We’re moving toward clinical-scale virus production,” said Leah Sabin, executive director of Regeneron’s genetic medicines unit.

Sabin said they are debating what muscle diseases to prioritize for the clinic, while a brain-targeting program is now being tested in non-human primates. The team is already mulling what tissues to target next.

“The current capsids are not good enough,” Sabin said. “They’re fine, but what would be industry-altering is having this completely new, way more efficient way to get them there.”

AUTHOR
Andrew Dunn
Biopharma Correspondent
adunn@endpointsnews.com

REGN clearly states in their filing that the competition is fierce and they are happy to steal any and all information to make a couple billion now and worry about settling in court for a few million later. They have a history of this.

anyone on this board know anything about regn possibly working with enzolytics pharmaceuticals on a treatment and a cure for hiv and aids. ?

Anyone watching or interested in the revised EUA from FDA tomorrow for REGEN-COV? I saw calls were getting some decent action last week.

Heard on the street,
FREQ would fit nicely in REGN 's growth plans.

CEO on CNBC now

DeSantis Office: Over Half Of Those Seeking Lifesaving COVID-19 Treatment In South Florida Fully Vaccinated

https://www.zerohedge.com/covid-19/desantis-office-over-half-those-seeking-lifesaving-covid-19-treatment-south-florida-fully?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+zerohedge%2Ffeed+%28zero+hedge+-+on+a+long+enough+timeline%2C+the+survival+rate+for+everyone+drops+to+zero%29

Just read the drug can no longer be purchased directly from REGN - it will only be distributed by the Government....allocated state by state

We are no long living in a free country

CORRCTION; FLORIDA - RED STATE - Now I understand their agender.

Why I said NJ is a mystery to me. Sorry

PS: new delivery

barnyarddog: Heard yesterday that Biden cut off supply to NJ, after promising them this life saving drug. (and to think NJ is even a blue State)

Hopefully the Governor could buy it directly from REGN.

It makes you wonder what the Dems agenda is really all about.

Dr. Rand Paul ~ Monoclonal Antibodies Can Save Lives

Panzer: Actually I got back into AMZN. Still have my REGN. I wouldn't recommend selling AMZN at this time. Try to find the money some where else if u can. JMO

Pfizer is 38% effective versus Delta ie worthless

Way better than ineffective "vaccines"

Actually looking to do the exact same thing.

Hearing some great things about this company.

No Vaxx for Panzer

...Monoclonal antibodies work by targeting the coronavirus spike protein, blocking the virus from entering your body’s cells, and stopping the infection from spreading, according to the Health and Human Services website...

REGN-COV2

...The treatments, that the federal government pays for and makes free to patients, have been shown to sharply reduce hospitalizations and deaths when given to patients within a 10-day window of experiencing symptoms, via intravenous infusion or injections. That’s the timeframe in which they have been shown to cut rates of hospitalization and death by roughly 70 percent, according to DeSantis, who says he has “heavily researched and read data” on the virus and treatment options...

Texas Doctor Warns Florida and Others: Feds May Ration Monoclonal Antibodies

Thursday, Sep 09, 2021
https://www.zerohedge.com/covid-19/texas-doctor-warns-florida-and-others-feds-may-ration-monoclonal-antibodies?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+zerohedge%2Ffeed+%28zero+hedge+-+on+a+long+enough+timeline%2C+the+survival+rate+for+everyone+drops+to+zero%29

love the company - sold my AMZN and put it into REGN - don't think I'll regret it

$3.50 spread

Japan Becomes First Country to Approve Regeneron Antibody Cocktail (casirivimab and imdevimab) for the Treatment of Mild to M...
July 20 2021 - 01:00AM
PR Newswire (US)
Alert
Print
Share On Facebook
TARRYTOWN, N.Y., July 20, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Regeneron's casirivimab and imdevimab antibody cocktail to treat patients with mild to moderate COVID-19. This marks the first time the antibody cocktail, known as REGEN-COVTM in the U.S. and Ronapreve™ in other countries, has received a full approval to treat COVID-19. Emergency or temporary pandemic use authorizations are currently in place in more than 20 countries, including in the U.S., European Union, India, Switzerland and Canada.

"After a record-speed discovery and development program, we are pleased that our COVID-19 antibody cocktail continues to reach even more people around the globe," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "Unfortunately, this virus continues to spread despite increasing rates of vaccination, and there will be an important continued need for treatments that remain active against the variants of concern."

In Japan, the antibody cocktail was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. The approval was based on results from a Phase 3 trial in high-risk non-hospitalized patients, which showed the antibody cocktail reduced the risk of hospitalization or death by 70%, as well as results from a Phase 1 trial that examined the safety, tolerability and pharmacokinetics in Japanese people.

Regeneron invented REGEN-COV and is collaborating with Roche to increase global supply of the antibody cocktail, with Roche primarily responsible for development and distribution outside the U.S. In December 2020, Chugai obtained development and exclusive commercialization rights in Japan from Roche, and is working with the Japanese government to ensure an appropriate and timely supply of the antibody cocktail.

The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.

About the REGEN-COV Antibody Cocktail
REGEN-COV (casirivimab and imdevimab) is a cocktail of two monoclonal antibodies that was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19, using Regeneron's proprietary VelocImmune® and VelociSuite® technologies. The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.

Over the past few months Regeneron has announced results from multiple Phase 3 trials demonstrating the ability of REGEN-COV to reduce the burden of COVID-19, from prevention through to hospitalization. This includes trials assessing the ability of REGEN-COV to treat outpatients already infected with SARS-COV-2 (including symptomatic outpatients and recently infected asymptomatic patients) and in certain hospitalized patients, including the RECOVERY trial.

Multiple analyses, including a recent publication in Cell, have shown that REGEN-COV retains potency against the main variants of concern circulating within the U.S.; consequently, REGEN-COV remains available for use in all 50 states. REGEN-COV retains potency against variants including Delta (B.1.162.2; first identified in India), Gamma (P.1; first identified in Brazil), Beta (B.1.351; first identified in South Africa).

REGEN-COV is available throughout the U.S. – information on availability in your area is available from the Department of Health and Human Services and the National Infusion Center Association. REGEN-COV has not been approved by the U.S. Food and Drug Administration (FDA), but is currently authorized in the U.S. under an Emergency Use Authorization (EUA) to treat mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing ≥40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. REGEN-COV is not authorized for use in patients who are hospitalized due to COVID-19 or require oxygen therapy, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19.

In the U.S., REGEN-COV can be administered by intravenous infusion (as short as 20 minutes) or by subcutaneous injection (4 injections), which is an alternative when intravenous infusion is not feasible and would lead to a delay in treatment. It is now authorized as a co-formulated single vial, or in individual vials to be administered together.

Regeneron and Roche share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.

About Regeneron's VelocImmune Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately a quarter of all original, FDA-approved fully human monoclonal antibodies currently available. This includes REGEN-COV (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab and odesivimab-ebgn).

AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION
REGEN-COV, (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. [see Limitations of Authorized Use]

REGEN-COV has not been approved, but has been authorized for emergency use by FDA
This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of REGEN-COV and mandatory requirements of the EUA and must comply with the requirements of the EUA. The FDA Letter of Authorization is available for reference, as well as the Dear Healthcare Provider Letter and Patient Fact Sheet
Limitations of Authorized Use

REGEN-COV (casirivimab and imdevimab) is not authorized for use in patients:
who are hospitalized due to COVID-19, OR
who require oxygen therapy due to COVID-19, OR
who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity
Benefit of treatment with REGEN-COV has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as REGEN-COV, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation
Definition of High Risk Patients
The following medical conditions or other factors may place adults and pediatric patients (age 12-17 years and weighing at least 40 kg) at higher risk for progression to severe COVID-19:

Older age (for example, age ≥65 years of age)
Obesity or being overweight (for example, BMI >25 kg/m2, or if age 12-17, have BMI ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm)
Pregnancy
Chronic kidney disease
Diabetes
Immunosuppressive disease or immunosuppressive treatment
Cardiovascular disease (including congenital heart disease) or hypertension
Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
Sickle cell disease
Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID 19))
Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19 and authorization of REGEN-COV under the EUA is not limited to the medical conditions or factors listed above.

For additional information on medical conditions and factors associated with increased risk for progression to severe COVID, see the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Healthcare providers should consider the benefit-risk for an individual patient.

Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies. Healthcare providers should review the Antiviral Resistance information in Section 15 of the Fact Sheet for details regarding specific variants and resistance, and refer to the CDC website (https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant-cases.html) as well as information from state and local health authorities regarding reports of viral variants of importance in their region to guide treatment decisions.

Important Safety Information
REGEN-COV (casirivimab and imdevimab) is an unapproved investigational therapy, and there are limited clinical data available. Serious and unexpected adverse events may occur that have not been previously reported with REGEN-COV use

Warnings and Precautions:
Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions: Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of REGEN-COV. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive therapy. Hypersensitivity reactions occurring more than 24 hours after the infusion have also been reported with the use of REGEN-COV under EUA. Infusion-related reactions, occurring during the infusion and up to 24 hours after the infusion, have been observed with administration of REGEN-COV. These reactions may be severe or life threatening
Signs and symptoms of infusion-related reactions may include: fever, difficulty breathing, reduced oxygen saturation, chills, nausea, arrythmia (e.g., atrial fibrillation, tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g., pre-syncope, syncope), dizziness, fatigue and diaphoresis. Consider slowing or stopping the infusion and administer appropriate medications and/or supportive care if an infusion-related reaction occurs
Clinical Worsening After REGEN-COV Administration: Clinical worsening of COVID-19 after administration of REGEN-COV has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrythmia (e.g., atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to REGEN-COV use or were due to progression of COVID-19
Limitations of Benefit and Potential for Risk in Patients with Severe COVID-19: Benefit of treatment with REGEN-COV has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as REGEN-COV, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation. Therefore, REGEN-COV is not authorized for use in patients who are hospitalized due to COVID-19, OR who require oxygen therapy due to COVID-19, OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19–related comorbidity
Adverse Reactions:
In a pooled phase 1/2/3 analysis of COV-2067, infusion-related reactions (adverse event assessed as causally related by the investigator) of grade 2 or higher severity have been observed in 10/4,206 (0.2%) of those who received REGEN-COV at the authorized dose or a higher dose
Overall, in Phase 1/2/3, three subjects receiving the 8,000 mg dose of REGEN-COV, and one subject receiving the 1,200 mg casirivimab and 1,200 mg imdevimab, had infusion-related reactions (urticaria, pruritus, flushing, pyrexia, shortness of breath, chest tightness, nausea, vomiting, rash) which resulted in permanent discontinuation of the infusion. All events resolved
Anaphylactic reactions have been reported in the clinical program in subjects receiving REGEN-COV. The events began within 1 hour of completion of the infusion, and in at least one case required treatment including epinephrine. The events resolved
The safety with subcutaneous administration is based on analysis from HV-2093, a randomized double-blind, placebo-controlled trial evaluating the safety and pharmacokinetic profile in healthy volunteer adult subjects. Subjects were randomized 3:1 to REGEN-COV (n=729) or placebo (n=240). Injection site reactions were observed in 12% and 4% of subjects following single dose administration in the casirivimab and imdevimab, and placebo arms respectively; the remaining safety findings with subcutaneous administration in the casirivimab and imdevimab arm were similar to the safety findings observed with intravenous administration in COV-2067
Patient Monitoring Recommendations: Clinically monitor patients during infusion and observe patients for at least 1 hour after intravenous infusion or subcutaneous dosing is complete

Use in Specific Populations:
Pregnancy: There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. REGEN-COV should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus
Lactation: There are no available data on the presence of casirivimab and/or imdevimab in human milk or animal milk, the effects on the breastfed infant, or the effects of the drug on milk production. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for REGEN-COV and any potential adverse effects on the breastfed child from REGEN-COV or from the underlying maternal condition
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron's business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron's and its collaborators' ability to continue to conduct research and clinical programs, Regeneron's ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators (collectively, "Regeneron's Products"), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron's Products and product candidates being developed by Regeneron and/or its collaborators (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation the development program relating to Regeneron's casirivimab and imdevimab antibody cocktail known as REGEN-COVTM in the United States and RonapreveTM in other countries; how long the Emergency Use Authorization ("EUA") granted by the U.S. Food and Drug Administration (the "FDA") for REGEN-COV will remain in effect and whether the EUA is revoked by the FDA based on its determination that the underlying health emergency no longer exists or warrants such authorization or other reasons; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates (such as REGEN-COV) and new indications for Regeneron's Products; whether the EUA for REGEN-COV will be expanded for use for appropriate hospitalized patients and/or in the prevention setting; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates, including the impact of recommendations, guidelines, or studies (whether conducted by Regeneron or others and whether mandated or voluntary) on any of the foregoing or any potential regulatory approval of Regeneron's Products and Regeneron's Product Candidates (such as REGEN-COV); the ability of Regeneron's collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates (including REGEN-COV) and the impact of the foregoing on Regeneron's ability to supply Regeneron's Products and Regeneron's Product Candidates (including REGEN-COV); the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates (such as REGEN-COV) in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates, including without limitation REGEN-COV; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron's Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), as well as Regeneron's collaboration with Roche relating to the casirivimab and imdevimab antibody cocktail (known as REGEN-COV in the United States and Ronapreve in other countries), to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection, Dupixent® (dupilumab), Praluent® (alirocumab), and REGEN-COV), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2020 and its Form 10-Q for the quarterly period ended March 31, 2021. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).

Contacts:



Media Relations

Sarah Cornhill

media@regeneron.com

Investor Relations

Vesna Tosic

investor@regeneron.com

Cision View original content:https://www.prnewswire.com/news-releases/japan-becomes-first-country-to-approve-regeneron-antibody-cocktail-casirivimab-and-imdevimab-for-the-treatment-of-mild-to-moderate-covid-19-301336962.html

SOURCE Regeneron Pharmaceuticals, Inc.


Copyright 2021 PR Newswire

coming right up