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Investing.com - H.C. Wainwright has reiterated its Neutral rating on Replimune Group (NASDAQ:REPL), which has seen its stock plummet nearly 40% in the past week, following the company’s Type A meeting with the FDA regarding the Complete Response Letter (CRL) for its RP1 therapy. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 6.94, though its overall financial health score is rated as WEAK.
The CRL, issued for Replimune’s Biologics License Application (BLA) for RP1 plus Opdivo in anti-PD1 failed melanoma patients, cited four main concerns with the application. The FDA did not view the IGNYTE trial as providing substantial evidence of effectiveness and noted issues with patient population heterogeneity affecting result interpretation. With the stock trading significantly below its InvestingPro Fair Value, investors seeking deeper insights can access comprehensive analysis and 15 additional ProTips through InvestingPro’s detailed research reports.
Additional FDA concerns included inadequate confirmatory trial design to show component contributions and insufficient data supporting the statistical assumption of a six-month improvement in overall survival, the primary endpoint.
H.C. Wainwright noted that Replimune is currently evaluating the FDA’s feedback to determine next steps, though "at this time, a path forward under the accelerated approval pathway has not been determined."
The research firm maintained that Replimune will likely need to conduct another clinical trial for RP1 to have an opportunity to enter the U.S. market, reiterating its Neutral rating without specifying a price target.
In other recent news, Replimune Group has faced several significant developments. The company recently completed a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss a complete response letter related to its Biologics License Application for RP1 in combination with nivolumab for advanced melanoma treatment. Following this meeting, Replimune announced that a clear path forward under the accelerated approval pathway has not been determined. This regulatory uncertainty has led JPMorgan to downgrade Replimune’s stock rating from Neutral to Underweight, citing regulatory concerns despite acknowledging compelling data for the RP1 treatment. Additionally, Jefferies has lowered its price target for Replimune from $10 to $8, maintaining a Buy rating. Meanwhile, H.C. Wainwright has reiterated its Neutral rating on Replimune after the company submitted a briefing book to the FDA addressing concerns from the complete response letter. The briefing book covers key issues such as patient population agreements and criteria for PD-1 resistance. These developments have kept investors closely watching the company’s next steps regarding its melanoma treatment.
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