On Monday, Replimune Group (NASDAQ:REPL) shares received a reiterated Buy rating and a $17.00 price target from Roth/MKM, following a positive pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA). The meeting is a significant step towards the submission of a BLA for RP1, Replimune's therapeutic candidate, slated for the second half of 2024.
The positive outcome of the meeting with the FDA suggests that RP1 is on track for accelerated approval, particularly for the treatment of melanoma patients who have not responded to anti-PD1 therapies. The analyst expressed optimism about the potential for RP1 to gain approval and launch successfully in late 2025, citing a similar precedent set by Iovance's Lifileucel, which received FDA accelerated approval in February 2024.
Lifileucel, a tumor infiltrating lymphocyte therapy, was approved for adults with certain types of melanoma. However, it is primarily suited for younger patients who can undergo the rigorous treatment process. Roth/MKM highlighted that there remains a significant unmet need for treatments among older, less fit patients who have failed anti-PD1 therapies. RP1 could potentially fill this gap in the market.
Replimune's RP1 is being positioned as a treatment option for this demographic, to be used in combination with nivolumab. The anticipation for RP1's market entry is high, as it could provide an alternative for those unable to tolerate existing treatments like Lifileucel.
The reaffirmation of the $17.00 price target and Buy rating reflects Roth/MKM's confidence in Replimune's strategic progress and the commercial potential of RP1. The company's trajectory toward a BLA submission and potential accelerated approval could mark a significant advancement in the treatment options available for melanoma patients with limited alternatives.
In other recent news, Replimune has seen changes in its leadership, with the appointment of Madhavan Balachandran to its Board of Directors. Balachandran's four decades of experience in the life sciences sector is expected to aid the company's progress.
At the company's Annual Meeting of Stockholders, key decisions were made, including the election of three Class III directors and the ratification of PricewaterhouseCoopers LLP as the company's independent registered public accounting firm for the fiscal year ending March 31, 2025.
In the financial sector, other firms such as H.C. Wainwright, BMO Capital, and Barclays (LON:BARC) have also maintained their positive ratings for the company. These are recent developments in Replimune's ongoing efforts.
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