ErnieBilco
2週前
RenovoRx Announces FDA Orphan Drug Designation Granted: Oxaliplatin for the Treatment of Pancreatic Cancer
Third FDA Orphan Drug Designation Continues to Advance RenovoRx's Therapeutic Oncology Pipeline and Provides Seven Years of Market Exclusivity
MOUNTAIN VIEW, Calif., May 28, 2026 (GLOBE NEWSWIRE) -- RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel, FDA-cleared drug-delivery device, today announced that the U.S. Food and Drug Administration (FDA) recently granted RenovoRx Orphan Drug Designation (ODD) of oxaliplatin for the treatment of pancreatic cancer.
The designation was issued by the FDA’s Office of Orphan Products Development pursuant to Section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb). Oxaliplatin is an approved and commonly used chemotherapy.
As RenovoRx continues to advance its therapeutic pipeline, it is simultaneously expanding commercialization of RenovoCath as a stand-alone device, driving adoption at leading cancer centers and building strategic and clinical collaborations that can support future revenue growth and broader platform use. RenovoCath, a patented FDA-cleared device, employs a dual-balloon infusion catheter for targeted delivery of therapeutic agents directly near a tumor.
This is RenovoRx’s second ODD in pancreatic cancer, and third designation in total, reflecting the Company’s differentiated approach to targeted intra-arterial drug-delivery using RenovoCath. RenovoRx previously received ODD for intra-arterial gemcitabine delivered via RenovoCath (known as IAG) in locally advanced pancreatic cancer (LAPC) and bile duct cancer. This designation for oxaliplatin, a platinum-based chemotherapy widely used in pancreatic cancer treatment, further supports the versatility of RenovoRx's novel approach to delivering multiple therapeutic agents directly near the tumor site.
ODD carries meaningful regulatory and financial benefits, including:
Seven years of market exclusivity: Upon FDA approval of the designated indication (in this case, intra-arterial oxaliplatin for pancreatic cancer via RenovoCath), RenovoRx would be entitled to seven years of exclusive marketing rights, during which the FDA cannot approve the same drug for the same orphan indication by another sponsor.
Federal tax credit: A 25% tax credit on qualified clinical research expenses incurred in connection with the designated drug.
FDA application fee waiver: A waiver of the FDA application filing fee, which currently exceeds several million dollars for applications requiring clinical data.
Eligibility for orphan product development grants: Access to grant funding from the FDA’s Orphan Products Development grants program to support clinical development.
“Receiving a third ODD from the FDA is an important milestone as it provides additional validation of our strategy to build a multi-agent, targeted, drug-delivery oncology pipeline enabled by our patented RenovoCath device,” said Shaun Bagai, Chief Executive Officer of RenovoRx. “Our differentiated technology is designed to deliver therapeutic agents intra-arterially across the arterial wall directly near the tumor site, with potential applications across multiple therapeutic agents and multiple cancer types. The FDA’s ODD of oxaliplatin not only expands our pipeline, but also provides valuable regulatory incentives, including seven years of potential market exclusivity and a waiver of FDA application fees that can total several million dollars. While we are laser focused on finishing our current Phase III clinical trial and advancing commercialization of RenovoCath as a standalone device, we remain committed to advancing our platform and exploring the full potential of targeted oxaliplatin delivery in patients diagnosed with difficult-to-treat cancers.”
Pancreatic cancer remains one of the deadliest malignancies, with an estimated 67,530 new cases and more than 52,740 deaths expected in the United States in 2026, according to the American Cancer Society.[1] Despite advances in oncology, the disease is often diagnosed at a late stage in the majority of patients, and the five-year survival rate remains approximately 13%1, underscoring the profound unmet, yet urgent, medical need for new therapeutic approaches.
Oxaliplatin is a key component of FOLFIRINOX, one of the most widely used chemotherapy regimens for patients with advanced pancreatic cancer. RenovoRx is advancing a differentiated approach by delivering oxaliplatin directly near the tumor site using its RenovoCath device.
“This designation for intra-arterial oxaliplatin highlights the breadth of what RenovoCath may offer to pancreatic cancer patients,” said Leesa Gentry, Chief Clinical Officer of RenovoRx. “Intra-arterial oxaliplatin may broaden the range of pancreatic cancer targets beyond LAPC that could benefit from localized drug-delivery with RenovoCath."
This ODD for intra-arterial oxaliplatin is separate from and in addition to RenovoRx’s existing ODD for IAG in LAPC and bile duct cancer, which also carries seven years of market exclusivity upon NDA approval by the FDA. RenovoRx's TIGeR-PaC Phase III clinical trial evaluating IAG in LAPC continues to advance, with the Company anticipating notification of enrollment closure in June 2026 and final data readout in mid to late 2027.
About RenovoCathBased on its FDA clearance, RenovoCath® is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to select sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use (“IFU”), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.
1https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2026-cancer-facts-figures.html
INV4
3月前
RenovoRx (RNXT) price target increased by 10.66% to $6.88
Story by George Maybach • 2w
RNXT has been revised to $6.88 / share. This is an increase of 10.66% from the prior estimate of $6.22 dated February 1, 2026.
The price target is an average of many targets provided by analysts. The latest targets range from a low of $3.03 to a high of $13.65 / share. The average price target represents an increase of 663.39% from the latest reported closing price of $0.90 / share.
What is the Fund Sentiment?
There are 37 funds or institutions reporting positions in RenovoRx. This is an decrease of 2 owner(s) or 5.13% in the last quarter. Average portfolio weight of all funds dedicated to RNXT is 0.02%, an increase of 24.28%. Total shares owned by institutions decreased in the last three months by 19.94% to 5,940K shares.
What are Other Shareholders Doing?
AIGH Capital Management holds 2,834K shares representing 7.73% ownership of the company. In its prior filing, the firm reported owning 2,615K shares , representing an increase of 7.72%. The firm decreased its portfolio allocation in RNXT by 25.11% over the last quarter.
VTSMX - Vanguard Total Stock Market Index Fund Investor Shares holds 1,057K shares representing 2.88% ownership of the company. No change in the last quarter.
VEXMX - Vanguard Extended Market Index Fund Investor Shares holds 432K shares representing 1.18% ownership of the company. In its prior filing, the firm reported owning 268K shares , representing an increase of 37.95%. The firm increased its portfolio allocation in RNXT by 93.16% over the last quarter.
Geode Capital Management holds 371K shares representing 1.01% ownership of the company. In its prior filing, the firm reported owning 371K shares , representing a decrease of 0.02%. The firm decreased its portfolio allocation in RNXT by 65.90% over the last quarter.
Wealthspire Advisors holds 253K shares representing 0.69% ownership of the company.
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$RNXT 💹
US Market News
4月前
$668B Oncology Surge: 5 Platforms Cracking the Code on GI TumorsJanuary 30, 2026 10:19 AM
PR Newswire (US)
Issued on behalf of Oncolytics Biotech Inc.USANewsGroup.com News CommentaryVANCOUVER, BC, Jan. 30, 2026 /PRNewswire/ -- The global oncology sector is rocketing toward $668 billion in 2034[1], partly fueled by a massive structural pivot toward gastrointestinal cancers where clinical velocity is finally shattering historical benchmarks. With the FDA's 2026 framework explicitly prioritizing accelerated pathways for platforms showing superior objective response rates and durability[2], a select group of innovators is unlocking the immunologically "cold" GI tumors that have baffled researchers for decades. This regulatory tailwind places Oncolytics Biotech Inc. (NASDAQ: ONCY), Pfizer (NYSE: PFE), Verastem Oncology (NASDAQ: VSTM), Perspective Therapeutics (NYSE-A: CATX), and RenovoRx (NASDAQ: RNXT) directly at the intersection of pivotal execution and breakthrough immunotherapy. As the market charges toward a staggering $668 billion valuation by 2034, capital is rotating aggressively toward execution-ready platforms over speculative assets[3]. Fresh FDA guidance issued in December 2025 and January 2026 signals a decisive new era emphasizing overall survival and robust clinical benefit[4]. This shift creates asymmetric upside for companies demonstrating disciplined execution in high-stakes battlegrounds like colorectal, pancreatic, and anal cancers, where targeted immunotherapies are establishing entirely new treatment paradigms.Oncolytics Biotech Inc. (NASDAQ: ONCY) is building out its leadership team as it moves its cancer treatment pelareorep through late-stage clinical trials targeting several gastrointestinal cancers.The company recently announced two key hires: John McAdory as Executive Vice President of Strategy and Operations, and Yujun Wu as Vice President, Head of Biostatistics. McAdory comes from CG Oncology, where he ran late-stage clinical trials for oncolytic virus therapies (cancer-fighting viruses, similar to pelareorep). Wu joins from Morphic Therapeutic, where he led the statistics department through the company's sale to Eli Lilly, and previously designed multiple Phase 3 oncology trials at Takeda. Both bring the specific expertise needed to execute the complex, multi-country registration trials that determine whether a drug gets FDA approval."John's background running complex, late-stage oncology trials makes him exceptionally well-suited to lead Oncolytics' next phase of execution," said Jared Kelly, CEO of Oncolytics Biotech. "As we progress toward pivotal and registration-enabling studies in anal, pancreatic, and colorectal cancers, his experience will be critical to ensuring disciplined execution, speed, and regulatory alignment."These hires complete a significant management upgrade. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024. The company also added three leading cancer specialists from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center to its gastrointestinal tumor scientific advisory board.The clinical data driving this expansion looks compelling. In colorectal cancer, pelareorep combined with chemotherapy and a vascular endothelial growth factor (VEGF) inhibitor achieved a 33% response rate in patients with KRAS mutations (a genetic marker found in about 40% of colorectal cancers). That's three times better than the 6-11% response rate chemotherapy and a VEGF inhibitor typically achieves in these patients. Response rate measures the percentage of patients whose tumors shrink significantly or disappear entirely.In anal cancer, where treatment options are extremely limited after first-line therapy fails, pelareorep is showing even stronger results. Third-line patients (those who've already failed two prior treatments) saw a 29% response rate with responses lasting around 17 months. That nearly triples the historical benchmarks in a setting where no FDA-approved treatments currently exist.In second-line patients, the 30% response rate more than doubled the 13.8% benchmark for the only FDA-approved immunotherapy available, with responses lasting 15.5 months versus 9.5 months for standard treatment.Oncolytics has also secured FDA agreement on its Phase 3 trial design for pancreatic cancer, clearing the way to launch what would be the only immunotherapy registration trial currently planned for this notoriously difficult-to-treat disease.CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/ In other recent industry developments and happenings in the market include:Pfizer (NYSE: PFE) announced positive results from Cohort 3 of the pivotal BREAKWATER trial evaluating BRAFTOVI in combination with cetuximab and FOLFIRI in patients with previously untreated BRAF V600E-mutant metastatic colorectal cancer. The combination achieved a confirmed objective response rate of 64.4% compared to 39.2% with standard-of-care treatment, representing a statistically significant improvement."These data further strengthen the potential utility of BRAFTOVI for patients with BRAF V600E-mutant metastatic colorectal cancer. The significant improvement in response rates reflects the meaningful clinical benefit of this targeted combination therapy regimen for patients," said Jeff Legos, Chief Oncology Officer at Pfizer. "These results underscore the potential of BRAFTOVI as a standard of care for patients with this aggressive cancer."Among patients receiving the treatment regimen, 57.4% on BRAFTOVI plus cetuximab and FOLFIRI maintained response for six months or longer compared to 34.5% with standard therapy. Pfizer continues the BREAKWATER trial with an estimated completion in 2027.Verastem Oncology (NASDAQ: VSTM) announced it will discontinue its RAMP 203 Phase 1/2 trial in advanced KRAS G12C-mutated non-small cell lung cancer (NSCLC) to focus resources on clinical development of VS-7375, an oral KRAS G12D inhibitor. The decision reflects the evolving treatment landscape as next-generation G12C inhibitors establish higher response rate benchmarks."RAMP 203 has provided important insights into treatment strategies and demonstrated proof-of-concept. While avutometinib plus defactinib combined well with a G12C inhibitor to drive early and sustained anti-tumor responses, next generation G12C inhibitors are establishing a new benchmark with higher response rates," said John Hayslip, Chief Medical Officer at Verastem Oncology. "Accordingly, we are prioritizing our clinical development of VS-7375, a potentially best-in-class oral KRAS G12D (ON/OFF) inhibitor, that demonstrated a 69% response rate in advanced KRAS G12D NSCLC."In the doublet combination arm, 30 G12C-inhibitor treatment-naïve patients achieved an overall response rate of 40% with a median progression-free survival of 11.1 months. Verastem Oncology continues advancing RAMP 205, evaluating avutometinib plus defactinib with chemotherapy in first-line metastatic pancreatic cancer.Perspective Therapeutics (NYSE-A: CATX) presented updated interim data from its ongoing Phase 1/2a clinical trial of [212Pb]VMT-a-NET in patients with neuroendocrine tumors at the 2026 ASCO Gastrointestinal Cancers Symposium. The radiopharmaceutical demonstrated a 39% objective response rate in Cohort 2 patients regardless of SSTR2 expression profile, with 76% of patients remaining progression-free and alive."The updated interim results presented at ASCO-GI continue to support VMT-a-NET's compelling overall clinical profile at the 5 mCi dose," said Markus Puhlmann, Chief Medical Officer of Perspective Therapeutics. "With the robust clinical dataset being accrued from strong patient enrollment into our study, we believe we will be able to have meaningful engagement with regulatory agencies during 2026 on proceeding with VMT-a-NET into a registrational trial."The therapy continues to demonstrate favorable tolerability with no dose-limiting toxicities, treatment-related discontinuations, or clinically significant myelosuppression reported across 56 patients. Perspective Therapeutics has completed the Cohort 3 dose-limiting toxicity assessment and is cleared to enroll additional patients at the 6.0 mCi dose level.RenovoRx (NASDAQ: RNXT) announced continued commercial momentum with its RenovoCath FDA-cleared drug-delivery device now integrated at nine active U.S. cancer centers, up from five in September 2025. The company's TAMP therapy platform is designed to deliver chemotherapy near tumor sites, potentially enhancing effectiveness while minimizing systemic side effects associated with traditional intravenous administration."The growing adoption of RenovoCath by esteemed institutions like City of Hope Cancer Center and Moffitt Cancer Center, amongst others, is the driver of our commercial efforts and underscores the clinical need for more targeted oncology tools," said Shaun Bagai, CEO of RenovoRx. "We are encouraged by both the procedural feedback and the strong commercial interest we are seeing."The company generated approximately $900,000 in sales revenue through September 2025 and has strengthened its commercial team to drive growth in 2026. RenovoRx continues enrollment in its Phase III TIGeR-PaC trial evaluating intra-arterial gemcitabine delivery via RenovoCath for locally advanced pancreatic cancer.Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ CONTACT:
USA NEWS GROUP
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.precedenceresearch.com/oncology-markethttps://lumanity.com/perspectives/the-8-fda-regulatory-trends-shaping-2026-and-beyond/https://www.globenewswire.com/news-release/2025/12/02/3198196/0/en/Oncology-Market-Size-Worth-USD-668-26-Billion-by-2034.htmlhttps://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents Logo: https://mma.prnewswire.com/media/2838876/USA_News_Group_Logo.jpg
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Original: $668B Oncology Surge: 5 Platforms Cracking the Code on GI Tumors