iHub News
3週前
Roivant Shares Climb on Earnings Beat Despite Revenue Shortfall (ROIV)May 20, 2026 8:45 AM
IH Market News On Wednesday, Roivant Sciences Ltd. (NASDAQ:ROIV) posted fourth-quarter adjusted earnings per share of $0.28, far surpassing analyst expectations of a $0.29 loss per share. However, quarterly revenue came in at $2.52 million, missing the consensus forecast of $3.76 million.The biotech company’s stock jumped 9.89% in pre-market trading after investors reacted positively to the stronger-than-expected earnings results and upbeat clinical developments. Litigation Settlement Boosts Profitability Roivant’s earnings were largely supported by a $770.2 million gain tied to a litigation settlement with Moderna, although the benefit was partially offset by higher research and development spending. Quarterly revenue declined 67% year over year from $7.57 million in the comparable period last year.The company reported income from continuing operations of $355.7 million, a sharp turnaround from the $252.4 million loss recorded a year earlier. Encouraging Rheumatoid Arthritis Trial Results “The positive Period 1 data from the IMVT-1402 trial in D2T RA demonstrate exciting potential for a new, differentiated mechanism to treat RA patients who have failed multiple prior therapies,” said Matt Gline, CEO of Roivant.Roivant highlighted encouraging data from its IMVT-1402 study in difficult-to-treat rheumatoid arthritis. The trial delivered Week 16 response rates of 72.7% for ACR20, 54.5% for ACR50, and 35.8% for ACR70.The company also announced that the FDA granted Breakthrough Therapy Designation to brepocitinib for cutaneous sarcoidosis following positive Phase 2 trial results. Cash Position and Pipeline Outlook As of March 31, 2026, Roivant held consolidated cash, cash equivalents, and marketable securities totaling $4.3 billion, which management said is expected to support the business through profitability.Looking ahead, the company plans to launch brepocitinib for dermatomyositis by the end of September 2026. Roivant also expects several clinical data readouts during the second half of calendar year 2026.Roivant stock price Original: Roivant Shares Climb on Earnings Beat Despite Revenue Shortfall (ROIV)
Enterprising Investor
2年前
Roivant Announces Positive NEPTUNE Study Results for Brepocitinib in NIU, as well as Board Authorization for up to $1.5 Billion Share Repurchase Program, Including Repurchase of Entire Sumitomo Pharma Stake for $648 Million (4/02/24)
Roivant (Nasdaq: ROIV) and Priovant Therapeutics today announced positive results from the Phase 2 study (NEPTUNE) evaluating brepocitinib in non-anterior non-infectious uveitis (NIU), showing the strongest efficacy data in NIU observed to date. Roivant also announced that its board of directors has authorized a share repurchase program for up to $1.5 billion of the company’s common shares, including the repurchase of all 71.3 million shares held by Sumitomo Pharma at a purchase price of $9.10 per share. The aggregate purchase price for the Sumitomo Pharma transaction is approximately $648.4 million and will reduce Roivant’s shares outstanding as of February 9, 2024 by approximately 9%.
“The striking NIU data underscore Roivant’s continued commitment to developing effective medicines in underserved indications with high unmet need, such as for these patients who are at risk of blindness. We are extremely pleased to share these positive data. We are also pleased to announce our authorized share repurchase program, and our agreed repurchase of all shares owned by Sumitomo Pharma. This transaction along with further potential buybacks reduces shareholder concentration and efficiently retires shares, increasing our continuing shareholders’ exposure to developments in NIU and to the rest of our upcoming clinical data and company progress,” said Matt Gline, CEO of Roivant.
The NEPTUNE study enrolled 26 subjects with active NIU who were randomized 2:1 to brepocitinib 45 mg once daily or brepocitinib 15 mg once daily. Patients, physicians, and the study team were blinded to dose. All subjects received a 60 mg/day prednisone burst at study entry for two weeks and were tapered off prednisone per protocol by week 8 (six-week steroid taper). Subjects were evaluated for Treatment Failure, a registrational composite endpoint comprising multiple measures of ocular inflammation and visual acuity, as well as discontinuation due to intercurrent events or initiation of rescue therapy. The study’s primary efficacy endpoint was the Treatment Failure rate at week 24.
At week 24, 29% (5/17) of subjects in the brepocitinib 45 mg arm and 44% (4/9) of subjects in the brepocitinib 15 mg arm met Treatment Failure criteria, with lower failure rates reflecting greater treatment benefit. The Treatment Failure rate from disease activity (discontinuations censored) was 18% in the brepocitinib 45 mg arm. These observed results represent approximately twice the observed benefit as seen in the corresponding registrational study for the only approved non-steroidal therapy in NIU.
All week 24 secondary efficacy endpoints, including haze grades, visual acuity, and macular thickness, were also positive and dose responsive. Of patients in the brepocitinib 45 mg arm who met the threshold for uveitic macular edema at baseline, 43% achieved resolution of macular edema by week 24. No patients in the brepocitinib 45 mg arm who entered the study without macular edema developed macular edema by week 24.
Safety and tolerability were consistent with prior clinical studies of brepocitinib, with no new safety or tolerability signals identified. Brepocitinib has been dosed in over 1,400 subjects and patients with a safety profile that appears consistent with approved and widely prescribed JAK inhibitors. Additional safety and efficacy data will be presented at a future medical conference.
“Non-infectious uveitis is a devastating disease that can lead to severe visual impairment and contribute to tens of thousands of cases of legal blindness in the United States each year, including many instances of irreversible blindness,” said Quan Dong Nguyen, MD, MSc, FARVO, FASRS, NEPTUNE investigator and Professor of Ophthalmology at the Byers Eye Institute, and Professor of Medicine and Pediatrics at Stanford University School of Medicine. “Current treatment options provide inadequate benefits to many patients; thus, novel pharmacotherapeutic agents with better efficacy and more convenient methods of administration are urgently needed. Brepocitinib’s striking results on multiple endpoints of clinical significance position the drug to become a potentially transformative once-daily oral therapy for this debilitating disease and reinforce the distinctive mechanistic benefits of dual TYK2/JAK1 inhibition for highly inflammatory autoimmune diseases with multiple pathogenic cytokines, such as non-infectious uveitis.”
“The NEPTUNE study was designed to minimize likelihood of false signals of benefit, by tapering patients with active disease from 60 mg/day of prednisone to 0 mg/day in just six weeks, more than twice as fast as steroid tapers in precedent studies,” said Ben Zimmer, CEO of Priovant. “Against that backdrop, we are thrilled to see a failure rate of only 29% in the brepocitinib 45 mg arm, better than any precedent study was able to achieve even with more lenient tapers. The magnitude and consistency of dose-dependent benefit across multiple independent measurements of inflammation, visual acuity, and macular edema give us high confidence heading into Phase 3. The results further point to a potentially highly differentiated product profile for brepocitinib in NIU—an orphan indication with high prevalence, severe morbidity, and few other therapies approved or in development.”
Priovant intends to initiate a Phase 3 program in NIU in the second half of calendar year 2024. The company would like to thank all of the investigators and patients who participated in the NEPTUNE study.
The ongoing Phase 3 study evaluating brepocitinib in dermatomyositis is expected to be fully enrolled in the third calendar quarter of 2024, with data expected in calendar year 2025.
Share Repurchase Program & Sumitomo Pharma Repurchase
Roivant’s board of directors has authorized a common share repurchase program, allowing for repurchases of Roivant common shares in an aggregate amount of up to $1.5 billion. The repurchase program will be funded with available cash and cash equivalents on hand and does not have an expiration date. The timing and total amount of common shares to be repurchased will depend on several factors, including the market price of the company’s common shares, general business, macroeconomic and market conditions, and other investment opportunities. Under the repurchase program, purchases may be conducted through open market transactions, tender offers or privately negotiated transactions, including the use of trading plans under Rule 10b5-1 of the Securities Exchange Act of 1934, as amended.
Pursuant to the share repurchase program, on April 2, 2024, Roivant entered into a share repurchase agreement with Sumitomo Pharma to repurchase all 71,251,083 common shares held by Sumitomo Pharma at a purchase price per share of $9.10, for an aggregate purchase price of approximately $648.4 million. The repurchase transaction with Sumitomo Pharma is expected to close on or about April 4, 2024.
The repurchase program may be suspended or discontinued at any time. There can be no assurances as to how many additional common shares the company will repurchase under the program, if any, or at what prices any purchases will be made.
Investor Call
An investor call and webcast will be held at 8 a.m. EDT on April 2, 2024, to discuss the Phase 2 NEPTUNE study results for brepocitinib in NIU and Roivant’s share repurchase program. To access the conference call by phone, please register online using this registration link. The presentation and webcast details are also available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call.
About Priovant
Priovant Therapeutics is a biotechnology company dedicated to developing novel therapies for autoimmune diseases with high morbidity and few available treatment options. The company’s lead asset is brepocitinib, a dual selective inhibitor of TYK2 and JAK1. Through dual TYK2/JAK1 inhibition, brepocitinib is able to distinctively suppress key cytokines linked to autoimmunity—including type I IFN, type II IFN, IL6, IL12, and IL23—with a single, targeted therapy. Brepocitinib has generated positive data in seven Phase 2 studies with oral once-daily administration. Brepocitinib is currently being evaluated in a Phase 3 program for dermatomyositis and is entering a Phase 3 program for non-infectious uveitis.
About Roivant
Roivant is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Today, Roivant’s pipeline includes VTAMA®, a novel topical approved for the treatment of psoriasis and in development for the treatment of atopic dermatitis; batoclimab and IMVT-1402, fully human monoclonal antibodies targeting the neonatal Fc receptor (“FcRn”) in development across several IgG-mediated autoimmune indications; brepocitinib, a novel TYK2/JAK1 inhibitor in late stage development for dermatomyositis, non-infectious uveitis, and other autoimmune conditions, in addition to other clinical stage molecules. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, www.roivant.com.
Enterprising Investor
2年前
Roche Completes Acquisition of Telavant from Roivant, Including Rights to Novel TL1A Directed Antibody (RVT-3101) for the Treatment of Inflammatory Bowel Disease (12/14/23)
BASEL, Switzerland and LONDON and NEW YORK, Dec. 14, 2023 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) announced today the completion of the previously announced acquisition by Roche (SIX: RO, ROG; OTCQX: RHHBY) of Telavant, for an upfront payment of approximately $7.1 billion. Telavant holds the rights in the US and Japan to RVT-3101, a promising new therapy in development for people suffering from inflammatory bowel disease, including ulcerative colitis and Crohn’s disease. Prior to the closing of the transaction, Roivant owned 75% of the issued and outstanding shares of common stock and preferred stock of Telavant, on an as-converted basis. An additional payment of $150 million in cash is payable upon the completion of a near-term milestone.
“We are pleased to announce the timely completion of the Telavant acquisition, and I am deeply grateful to everyone at Roivant and Telavant who worked tirelessly to develop RVT-3101, prepare for Phase 3, and execute this transaction. We look forward to seeing Roche continue the rapid development of RVT-3101 across multiple indications and ultimately transform the lives of patients with inflammatory and fibrotic diseases,” said Mayukh Sukhatme, M.D., President and Chief Investment Officer at Roivant. “This transaction enables us to continue doing what we do best, at even greater scale: work creatively side by side with our partners on programs that could generate significant impact for patients in areas of high unmet need.”
Additional information on the transaction can be found in the transaction announcement.
Freshfields Bruckhaus Deringer LLP acted as legal counsel to Roivant.
About Roivant
Roivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Today, Roivant’s pipeline includes VTAMA®, a novel topical approved for the treatment of psoriasis and in development for the treatment of atopic dermatitis; batoclimab and IMVT-1402, fully human monoclonal antibodies targeting the neonatal Fc receptor (“FcRn”) in development across several IgG-mediated autoimmune indications; brepocitinib, a novel TYK2/JAK1 inhibitor in late stage development for dermatomyositis and other autoimmune conditions, in addition to other clinical stage molecules. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, visit www.roivant.com.
https://www.globenewswire.com/news-release/2023/12/14/2796336/34323/en/Roche-Completes-Acquisition-of-Telavant-from-Roivant-Including-Rights-to-Novel-TL1A-Directed-Antibody-RVT-3101-for-the-Treatment-of-Inflammatory-Bowel-Disease.html
subslover
3年前
Roivant Announces Positive Initial IMVT-1402 Phase 1 SAD and 300 mg Subcutaneous MAD Results
IMVT-1402 subcutaneous (SC) doses achieved peak Immunoglobulin G (IgG) reductions that are similar to those previously observed with batoclimab
No decrease in serum albumin below baseline or increase in low-density lipoprotein cholesterol (LDL-C) above baseline was observed after 4 weeks of dosing in the 300 mg multiple-ascending dose (MAD) SC cohort
IMVT-1402 is being developed as a simple SC injection
NEW YORK, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced that subcutaneously administered doses of IMVT-1402 produced dose-dependent reductions in IgG in initial data from a Phase 1 clinical trial in healthy adults, with no dose-related changes in serum albumin or LDL-C, bolstering IMVT-1402 as a potential best-in-class neonatal fragment crystallizable receptor (FcRn) inhibitor.
“We are encouraged by the strong pharmacodynamic data observed to date with IMVT-1402,” said Pete Salzmann, M.D., chief executive officer of Immunovant. “These first-in-human results are consistent with those observed in prior non-human primate studies, and we look forward to sharing additional MAD data in November.”
This Phase 1 clinical trial is a randomized, double-blind, placebo-controlled ascending dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMVT-1402 in healthy adults.
In the single-ascending dose (SAD) portion of the study, subcutaneously administered IMVT-1402 demonstrated a consistent reduction in IgG with potency that was similar to or greater than that of batoclimab. The safety data were generally favorable, with all adverse events (AEs) mild or moderate, and no significant reduction from baseline in serum albumin or increase in LDL-C observed at any timepoint measured (all p>0.05).
Immunovant is also pleased to announce that initial MAD study results for the 300 mg cohort were released ahead of schedule today. These data represent all the MAD data currently available. Dosing for the 600 mg cohort has recently begun. After four weekly 300 mg SC doses of IMVT-1402, the mean total IgG reduction from baseline in this MAD cohort was 63%, with no decrease in serum albumin below baseline and no increase in LDL-C above baseline observed. Treatment-emergent adverse events were observed to be mild or moderate in severity. IMVT-1402 was delivered subcutaneously in seconds to participants in this cohort as a simple 2 mL injection at a concentration of 150 mg/mL.
Conference Call & Webcast:
Immunovant will host a conference call with accompanying slides and a simultaneous webcast today, September 26, 2023 at 8:00 a.m. EDT to discuss the initial single-ascending dose and multiple-ascending dose data. To participate in the conference call, please register in advance here. To access the live and archived webcast, please visit Immunovant’s website at https://www.immunovant.com/investors/news-events. The archived webcast will be available for a limited time on the Company’s website.
About IMVT-1402
IMVT-1402 is designed to be a potentially best-in-class anti-FcRn antibody for the treatment of IgG-mediated autoimmune diseases. In the initial results of a Phase 1 clinical trial in healthy volunteers, IMVT-1402 demonstrated favorable pharmacodynamic and safety data. These attributes, combined with a convenient route of administration that may enable patient self-administration, position IMVT-1402 well as a potential treatment for a variety of autoimmune diseases associated with patient unmet need.
About Immunovant, Inc.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit www.immunovant.com.
Forward-Looking Statements
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "can," “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” "intend," and other similar expressions are intended to identify forward-looking statements. Such forward looking statements include Immunovant’s expectations regarding the timing and results of Immunovant’s clinical trials of IMVT-1402; and the potential benefits of IMVT-1402’s unique product attributes and its best-in-class potential. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: initial results or other preliminary analyses or results of early clinical trials may not be predictive final trial results or of the results of later clinical trials; results of animal studies may not be predictive of results in humans; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidates, including the timing of the commencement of additional clinical trials and resumption of current trials; Immunovant’s scientific approach, clinical trial design, indication selection and general development progress; future clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant’s product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of global factors, such as the post-COVID-19 environment, geopolitical tensions, and adverse macroeconomic conditions on Immunovant’s business operations and supply chain, including its clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval and commercialization of batoclimab and IMVT-1402; Immunovant is at an early stage of development for IMVT-1402 and in various stages of clinical development for batoclimab; and Immunovant will require additional capital to fund its operations and advance batoclimab and IMVT-1402 through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s Form 10-Q filed with the SEC on August 10, 2023, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
About Roivant
Roivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Today, Roivant’s pipeline is concentrated in inflammation and immunology and includes VTAMA®, a novel topical approved for the treatment of psoriasis and in development for the treatment of atopic dermatitis; batoclimab and IMVT-1402, fully human monoclonal antibodies targeting the neonatal Fc receptor (“FcRn”) in development across several IgG-mediated autoimmune indications; and RVT-3101, an anti-TL1A antibody in development for ulcerative colitis and Crohn’s disease, in addition to several other therapies in various stages of clinical development. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, visit www.roivant.com.
Roivant Forward-Looking Statements
aries4747
5年前
10/18:ROIV to convert ABUS Preferred to common shares.
Page 44 https://app.quotemedia.com/data/downloadFiling?webmasterId=90423&ref=115698797&type=PDF&symbol=ABUS&companyName=Arbutus+Biopharma+Corporation&formType=10-K&formDescription=Annual+report+pursuant+to+Section+13+or+15%28d%29&dateFiled=2021-03-04&CK=1447028
Quote:
Entities associated with Roivant Sciences Ltd. (“Roivant”) collectively held as a group approximately 23% of our outstanding common shares as of March
1, 2021. In addition, in October 2017, we issued 500,000 Series A participating convertible preferred shares (“Preferred Shares”) to Roivant for gross
proceeds of $50.0 million. We issued a second tranche of 664,000 Preferred Shares to Roivant in January 2018 for gross proceeds of $66.4 million. The
Preferred Shares are non-voting and are convertible into common shares at a conversion price of $7.13 per share (which represents a 15% premium to the
closing price of $6.20 per share on October 16, 2017). The Preferred Shares are currently not convertible into common shares. The purchase price for the
Preferred Shares plus an amount equal to 8.75% per annum, compounded annually, will be subject to mandatory conversion into approximately 23 million
common shares on October 18, 2021 (subject to limited exceptions in the event of certain fundamental corporate transactions relating to our capital
structure or assets, which would permit earlier conversion at
Roivant’s option). Assuming the Preferred Shares were converted as of March 1, 2021, Roivant would have held approximately 39 million common shares,
or, 32%, of our outstanding common shares. Roivant has agreed to a four year lock-up period and standstill period whereby, pursuant to the standstill,
Roivant will not acquire greater than 49.99% of our common shares or securities convertible into common shares. Both the lockup and standstill periods
expire on October 18, 2021. Following the expiration of the standstill period, Roivant will no longer be contractually prohibited from acquiring control of
our company
aries4747
5年前
5/21: ROIV canceled Option to sell Genevant stake
From 10-Q
On December 27, 2019
"Additionally, in connection with the Sumitomo Transaction Agreement, RSL (i) granted Sumitomo options to purchase all, or in the case of Dermavant, 75%, of RSL’s ownership interests in six other subsidiaries (Dermavant, Genevant Sciences Ltd. (“Genevant”), Lysovant Sciences Ltd., Metavant Sciences Ltd., Roivant Asia Cell Therapy Holdings Ltd., and Sinovant Sciences HK Limited (collectively, the “Option Vants”)."
Then:
In May 2021, the Company entered into an Asset Purchase Agreement with Sumitomo and its subsidiary Sumitomo Pharmaceuticals (Suzhou) Co., Ltd. (“SPC”) (the “Asset Purchase Agreement”). The transactions contemplated by the Asset Purchase Agreement closed in June 2021. Pursuant to the Asset Purchase Agreement: (i) Sumitomo terminated all of its existing options to acquire the Company’s equity interests in the Option Vants (the “Sumitomo Options”); (ii) the Company transferred and assigned to SPC all of its intellectual property, development and commercialization rights for (a) lefamulin in Mainland China, Taiwan, Hong Kong, and Macau (collectively “Greater China”), (b) vibegron in Mainland China, (c) rodatristat ethyl in Greater China and South Korea and (d) RVT-802 in Greater China and South Korea; (iii) Sumitomo agreed to pay the Company $5.0 million in cash; and (iv) Sumitomo entered into an agreement with the Company to pursue future collaborations with Genevant. The Company received the cash payment, net of certain withholding taxes, in August 2021. The Company recorded a gain on the termination of the Sumitomo Options of $66.5 million, consisting of the fair value of the Sumitomo Options on the date of termination and the expected cash payment, in the accompanying condensed consolidated statements of operations for the three months ended June 30, 2021
aries4747
5年前
Look what $3 billion bought.....
Check out the recent news below for each Vant. Won't be long before Sumitomo is knocking on Roivant's door to add to the Vants they've already acquired from them, IMO.
"November 1, 2019
Six weeks after Sumitomo Dainippon Pharma agreed a $3 billion deal to license a host of drug candidates developed by companies in Vivek Ramaswamy’s Roivant group, the detail of the transaction has been revealed.
The Japanese drugmaker is taking over Roivant’s stake in five of its subsidiaries, with an option on six more until 2024.
The five companies are women’s health specialist Myovant, urology company Urovant, Enzyvant and Altavant in the rare disease category, and Spirovant, a newly-unveiled company focused on developing innovative gene therapies for cystic fibrosis (CF).
Along with the $3 billion upfront fee to kick off the alliance, Sumitomo will also provide a $350 million loan facility to Myovant to help fund the launch of its late-stage candidate for uterine fibroids – relugolix – if it gets approved for marketing, plus a $200 million loan to Urovant for its overactive bladder drug vibegron.
If Sumitomo takes the option on the other six, it will have effectively bolted on a ready-made pipeline consisting of more than 25 clinical programmes, with multiple potential launches in the 2020 to 2022 timeframe."
Myovant: MYOVANT SCIENCES AND PFIZER ANNOUNCE FDA ACCEPTANCE OF SUPPLEMENTAL NEW DRUG APPLICATION FOR MYFEMBREE® FOR THE MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS
Thursday, September 09, 2021 - 06:58am EST
Filing in endometriosis is supported by data from the Phase 3 SPIRIT program
FDA PDUFA target action date is May 6, 2022
https://www.pfizer.com/news/press-release/press-release-detail/myovant-sciences-and-pfizer-announce-fda-acceptance
Enzyvant: Premature PRV: US FDA Mistakenly Announces Voucher Award For Enzyvant Ahead Of Approval
30 Sep 2021
https://pink.pharmaintelligence.informa.com/PS145021/Premature-PRV-US-FDA-Mistakenly-Announces-Voucher-Award-For-Enzyvant-Ahead-Of-ApprovalNEWS
Altavant: Altavant Sciences Highlights Ongoing Phase 2b ELEVATE 2 Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension at European Respiratory Society Annual Congress
Altavant Sciences logo (PRNewsfoto/Altavant Sciences)
NEWS PROVIDED BY
Altavant Sciences
Sep 13, 2021, 10:06 ET
https://www.prnewswire.com/news-releases/altavant-sciences-highlights-ongoing-phase-2b-elevate-2-study-of-rodatristat-ethyl-in-patients-with-pulmonary-arterial-hypertension-at-european-respiratory-society-annual-congress-301375357.html
Urovant: Urovant Sciences Presents Positive Ambulatory Blood Pressure Data Showing That GEMTESA® (vibegron) 75 mg in Overactive Bladder Was Not Associated with Statistically Significant or Clinically Meaningful Effects on Blood Pressure or Heart Rate
New data from dedicated ambulatory blood pressure study of patients with overactive bladder (OAB) showed once-daily treatment with GEMTESA® was not associated with statistically significant or clinically meaningful effects on blood pressure or heart rate
Phase 3 EMPOWUR trial post-hoc subgroup analyses showed once-daily GEMTESA was associated with significantly reduced daily urgency episodes and micturitions in patients with OAB wet and dry (with and without urge urinary incontinence [UUI] per diary day, respectively) vs. placebo
Presented at the virtual AUA 2021 annual meeting, these data further support safety and efficacy of GEMTESA for treatment of OAB in patients with symptoms of UUI, urgency, and urinary frequency
September 13, 2021 07:30 AM Eastern Daylight Time
https://www.businesswire.com/news/home/20210913005249/en/Urovant-Sciences-Presents-Positive-Ambulatory-Blood-Pressure-Data-Showing-That-GEMTESA®-vibegron-75-mg-in-Overactive-Bladder-Was-Not-Associated-with-Statistically-Significant-or-Clinically-Meaningful-Effects-on-Blood-Pressure-or-Heart-Rate
Spirovant: Spirovant Continues Rapid Growth with New Headquarters and Expanded Leadership
https://www.globenewswire.com/news-release/2021/01/26/2164134/0/en/Spirovant-Continues-Rapid-Growth-with-New-Headquarters-and-Expanded-Leadership.html
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