Latest news with #RP1
Medscape
14 hours ago
- Business
- Medscape
FDA Declines to Approve New Melanoma Therapy
The FDA has declined to approve a new oncolytic immunotherapy, vusolimogene oderparepvec (RP1), to treat advanced melanoma. The agency recently issued a complete response letter to the company, Replimune Group, rejecting its biologics license application that sought approval for the new agent in combination with nivolumab (Opdivo) to treat adults with advanced melanoma. In the complete response letter, the FDA indicated that it can't approve the biologics license application for vusolimogene oderparepvec because the company's IGNYTE trial 'is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness,' Replimune explained in a press release. According to Replimune, the complete response letter also noted that the trial data 'cannot be adequately interpreted due to the heterogeneity of the patient population,' and that 'there are items related to the confirmatory trial study design which need to be addressed.' 'We are surprised by the FDA decision and disappointed for advanced melanoma patients who have limited treatment options, as highlighted by the granting of breakthrough status at the time we provided the IGNYTE primary data,' stated Sushil Patel, PhD, Replimune's chief executive officer. Vusolimogene oderparepvec is the lead product candidate for the biotech company. Patel further noted that the issues raised in the complete response letter were not 'raised by the agency in mid- and late-cycle reviews.' Additionally, he said, 'we had also aligned on the design of the confirmatory study.' The FDA's response to the biologics license application for the new agent, along with its recently announced policy requiring randomized, controlled trials for approval of COVID vaccines in healthy Americans younger than 65 years, may signal that the agency is taking a tougher stance on new drug approvals. Replimune plans to 'urgently interact with the FDA to find a path forward for the timely accelerated approval of RP1,' according to its statement. Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape Medical News, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at sworcester@ or on X @SW_MedReporter.
Business Insider
2 days ago
- Business
- Business Insider
Why Is Replimune Stock (REPL) Down 75% Today?
Replimune (REPL) stock plummeted on Tuesday after the biotechnology company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). The FDA didn't approve the Biologics License Application (BLA) for RP1 in combination with nivolumab as a treatment for advanced melanoma. Advanced melanoma occurs when the cancer spreads beyond the skin, such as to the lymph nodes, distant organs, or bones. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Replimune CEO Sushil Patel said, 'We are surprised by this FDA decision and disappointed for advanced melanoma patients who have limited treatment options as highlighted by the granting of breakthrough status at the time we provided the IGNYTE primary data.' Replimune intends to request a Type A meeting with the FDA to seek a timely and accelerated approval of RP1. It expects this meeting to be granted within the next 30 days. Replimune Stock Movement Today Replimune stock was down 76.88% in pre-market trading on Tuesday, following a 1.94% rally yesterday. The company's shares have rallied 1.78% year-to-date and 22.76% over the past 12 months. Today's drop came with heavy trading, as some 10 million shares changed hands, compared to a three-month daily average trading volume of 1.63 million shares. Is Replimune Stock a Buy, Sell, or Hold? Turning to Wall Street, the analysts' consensus rating for Replimune is Strong Buy, based on nine Buy ratings over the past three months. With that comes an average REPL stock price target of $22.43, representing a potential 81.99% upside for the shares.
Business Insider
2 days ago
- Business
- Business Insider
Replimune double downgraded to Underperform from Outperform at BMO Capital
BMO Capital double downgraded Replimune (REPL) to Underperform from Outperform with a price target of $2, down from $27. While the firm continues to think that RP1 represents a 'real drug,' the simple reality is that Replimune will likely need to re-run its clinical studies to get to approval and may not have enough cash on its books to get there, the analyst tells investors in a research note. The firm added that it believes more clarity on a path forward and significant restructuring are needed, while Replimune will likely underperform its peer group in the interim. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Business Wire
2 days ago
- Business
- Business Wire
REPL BREAKING NEWS: Replimune Group, Inc. Stock Plummets 75% after FDA Response Letter – BFA Law Announces Securities Fraud Investigation and Urges Investors to Contact the Firm
NEW YORK--(BUSINESS WIRE)--Leading securities law firm Bleichmar Fonti & Auld LLP announces an investigation into Replimune Group, Inc. (NASDAQ: REPL) for potential violations of the federal securities laws. Leading securities law firm Bleichmar Fonti & Auld LLP announces an investigation into Replimune Group, Inc. (NASDAQ: REPL) for potential violations of the federal securities laws. Share If you invested in Replimune, you are encouraged to obtain additional information by visiting: Why is Replimune being Investigated? Replimune is a clinical-stage biotechnology company focused on developing and commercializing oncolytic immunotherapies for the treatment of cancer. Replimune's lead product candidate is RP1, a treatment for melanoma. On June 6, 2024, the Company announced positive top line results from its IGNYTE Phase 1/2 clinical trial for RP1 in combination with the immunotherapy drug nivolumab. On November 21, 2024, Replimune announced that it had submitted a biologics license application ('BLA') to the FDA for RP1 on the strength of the results of the IGNYTE Phase 1/2 trial. During the relevant period, the Company repeatedly touted the results of the IGNYTE Phase 1/2 trial. In truth, the IGNYTE Phase 1/2 trial design was not adequate to produce reliable results. The Stock Declines as the Truth is Revealed On July 22, 2025, Replimune announced that it received a Complete Response Letter from the FDA regarding the BLA for RP1. According to the Company, '[t]he FDA has indicated that the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.' More specifically, 'the FDA said the trial cannot be adequately interpreted due to the heterogeneity of the patient population.' On this news, the price of Replimune stock fell more than 75% on July 22, 2025. Click here for more information: What Can You Do? If you invested in Replimune you may have legal options and are encouraged to submit your information to the firm. All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses. Submit your information by visiting: Why Bleichmar Fonti & Auld LLP? BFA is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It has been named a top plaintiff law firm by Chambers USA, The Legal 500, and ISS SCAS, and its attorneys have been named 'Elite Trial Lawyers' by the National Law Journal, among the top '500 Leading Plaintiff Financial Lawyers' by Lawdragon, 'Titans of the Plaintiffs' Bar' by Law360 and 'SuperLawyers' by Thomson Reuters. Among its recent notable successes, BFA recovered over $900 million in value from Tesla, Inc.'s Board of Directors, as well as $420 million from Teva Pharmaceutical Ind. Ltd. For more information about BFA and its attorneys, please visit Attorney advertising. Past results do not guarantee future outcomes.
Newsweek
09-07-2025
- Health
- Newsweek
Herpes Virus Could Help Treat Advanced Cancer
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. While it may give billions of people worldwide painful cold sores, a common virus could be harnessed to provide a much-need new cancer treatment. This is the conclusion of a study by researchers with Keck Medicine at the University of Southern California, who have shown in early clinical trials that a genetically modified version of herpes simplex virus type 1 (HSV-1) can be used against advanced melanoma. Melanoma is a form of skin cancer that originates in the cells that give our skin its pigment. In its advanced form, however, it spreads to other sites in the body. "These findings are very encouraging because melanoma is the fifth most common cancer for adults—and about half of all advanced melanoma cases cannot be managed with currently available immunotherapy treatments," said paper author and oncologist Dr. Gino Kim In of Keck Medicine in a statement. "The survival rate of untreatable advanced melanoma is only a few years, so this new therapy offers hope to patients who may have run out of options to fight the cancer." Stock image of a doctor inspecting a patient's mole for skin cancer, Stock image of a doctor inspecting a patient's mole for skin cancer, Wavebreakmedia/iStock / Getty Images Plus In their study, In and colleagues recruited 140 patients with advanced melanoma that either did not respond—or was no longer responding—to immunotherapy. Each participant had multiple tumors, some of which were "superficial," in that they were located on or just beneath the skin, while others were located deeper in the body, such as in organs like the liver or lungs. "Unlike other immunotherapy drugs, RP1 is an 'intratumoral' therapy that is injected directly into melanoma tumors," In told Newsweek. Both deep and superficial tumors were treated with a modified version of HSV-1 in combination with the immunotherapy agent, nivolumab (which helps the immune system's T-cells fight tumors), every two weeks for up to 16 weeks in total. If the patients appeared to be responding to the treatment, they then continued receiving nivolumab every four weeks for up to two years. The modified HSV-1 virus used in the study is named "RP1." It is designed to specifically target and destroy cancerous tumors while also stimulating the body's white blood cells to seek and destroy other cancer cells across the entire body. Unlike its natural predecessor, RP1 does not cause herpes. The U.S. Food and Drug Administration approved RP1 for review in patients with advanced melanoma that was not responding to immunotherapy in January this year. By the trial's end, the team found that tumors had shrunk by at least 30 percent in one-third of the patients—while nearly one-in-six saw their tumors disappear completely. "Importantly, RP1 was very well tolerated with approximately 90 percent of patients having only mild side effects, such as fatigue, fever and flu-like symptoms," noted In. An artist's impression of the herpes simplex virus. An artist's impression of the herpes simplex virus. Artur Plawgo/iStock / Getty Images Plus Comparing the outcomes of both tumors that were directly treated and those that were not, the team found that uninjected tumors shrank and/or disappeared just as frequently. "This result suggests that RP1 is effective in targeting cancer throughout the entire body and not just the injected tumor," said In. This, she continued, "expands the potential effectiveness of the drug, because some tumors may be more difficult or impossible to reach." In added that—while it is too early to tell if the positive outcomes stay permanent—she is optimistic about RP1 therapy's potential. She explained: "I believe that oncolytic viruses will open up an important new approach to fighting cancer in some patients in the near future." Stock image of melanoma cells seen through a microscope. Stock image of melanoma cells seen through a microscope. Dlumen/iStock / Getty Images Plus With the first two phases of the clinical trial now complete, the researchers are now moving to confirm their findings in a larger, global population of more than 400 trial patients. Keck Medicine will once again serve as one of the sites for this next trial. Patients interested in participating are encouraged to contact Keck Medicine Oncology Clinical Research Program Manager, Sandy Tran, by email. The clinical trials are being sponsored by the biotechnology company Replimune, which manufactures RP1 as well as other viral-based cancer therapies. As the mechanism of RP1's action is not specific to melanoma, the researchers say that the treatment may also have potential in treating other cancer types. Do you have a tip on a health story that Newsweek should be covering? Do you have a question about melanoma treatment? Let us know via health@ Reference Gino In, Michael Wong, Joseph Sacco, Eva Muñoz Couselo, Dirk Schadendorf, Georgia Beasley, Jiaxin Niu, Bartosz Chmielowski, Trisha Wise-Draper, Mohammed Milhem, Tawnya Bowles, Katy Tsai, Celeste Lebbe, Caroline Gaudy-Marqueste, Adel Samson, Junhong Zhu, Marcus Viana, Jeannie Hou, & Caroline Robert. (2025). Response analysis for injected and non-injected lesions and of the safety and efficacy of superficial and deep/visceral RP1 injection in the registrational cohort of anti–PD-1–failed melanoma patients of the IGNYTE trial. 2025 ASCO Annual Meeting.
