Replimune: Second CRL May Have Sealed RP1's Fate - It's Hard To See Positives

Edmund InghamInvesting Group LeaderFollow5ShareSavePlay(13min)Comments(3)SummaryReplimune Group, Inc. suffered a second FDA rejection for RP1 in anti-PD-1 failed melanoma, causing a sharp stock decline and casting doubt on its near-term prospects.The FDA apparently cited inadequate evidence of effectiveness and trial design flaws, finding the IGNYTE study too heterogeneous and the confirmatory study insufficient.REPL’s cash runway may not extend beyond 12 months, and the company may need to restructure or reprioritize resources, with RP2 in metastatic uveal melanoma as a possible focus.Given persistent regulatory hurdles and uncertain funding, this does not appear to be a "buy the dip" opportunity for REPL.Looking for a helping hand in the market? Members of Haggerston BioHealth get exclusive ideas and guidance to navigate any climate. Learn More » mohd izzuan/iStock via Getty Images News is breaking today that Replimune Group, Inc.'s (REPL) Biologics License Application ("BLA") requesting approval for its drug candidate RP1 (vusolimogene oderparepvec) in the indication of anti-PD-1 failed melanoma has been rejected by the FDA - the second timeThis article was written byEdmund Ingham14.85K FollowersFollowEdmund Ingham is a biotech consultant. He has been covering biotech, healthcare, and pharma for over 5 years, and has put together detailed reports of over 1,000 companies. He leads the investing group Haggerston BioHealth. The group is for both novice and experienced biotech investors. It provides catalysts to look out for and buy and sell ratings. It also provides product sales and forecasts for all the Big Pharmas, forecasting, integrated financial statements, discounted cash flow analysis and market by market analysis. Learn more.Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.