Replimune holds FDA meeting to discuss melanoma drug rejection

WOBURN, Mass. - Replimune Group, Inc. (NASDAQ:REPL), a biotechnology company with a market capitalization of $272 million, completed a Type A meeting with the U.S. Food and Drug Administration on September 16 to discuss the complete response letter for its melanoma treatment candidate. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 6.94, though it’s currently experiencing rapid cash burn.

The clinical-stage biotechnology company is currently evaluating feedback from the FDA regarding its Biologics License Application for RP1 in combination with nivolumab for advanced melanoma treatment. According to the company, a path forward under the accelerated approval pathway has not yet been determined. The stock has faced significant pressure, declining over 50% in the past six months, though analysis suggests the stock may be undervalued at current levels.

"The feedback from the melanoma community, including patients and physicians, clearly highlights the unmet need in advanced melanoma and the compelling risk-benefit profile of RP1 observed in the IGNYTE trial," said Sushil Patel, Ph.D., CEO of Replimune.

RP1, also known as vusolimogene oderparepvec, is the company’s lead product candidate based on a proprietary strain of herpes simplex virus engineered with proteins intended to enhance tumor killing and activate anti-tumor immune responses.

The Type A meeting follows the FDA’s previous complete response letter, which rejected the company’s application. Replimune stated it remains committed to working with the FDA to determine an expeditious path forward for the treatment.

Founded in 2015, Replimune focuses on developing novel oncolytic immunotherapies through its proprietary RPx platform, which is designed to be compatible with various cancer treatment modalities.

This information is based on a company press release statement.

In other recent news, Replimune Group has faced significant developments concerning its RP1 treatment for melanoma. The company received a Complete Response Letter (CRL) from the FDA, leading to a series of analyst actions. Cantor Fitzgerald has upgraded Replimune’s stock rating from Neutral to Overweight following a leadership change at the FDA’s Center for Biologics Evaluation and Research. In contrast, BMO Capital downgraded the stock from Outperform to Underperform, drastically reducing its price target to $2.00 from $27.00. Jefferies also adjusted its price target for Replimune, lowering it to $8.00 from $10.00, but maintained a Buy rating. H.C. Wainwright reiterated its Neutral rating on the company after Replimune submitted a briefing book to the FDA addressing concerns raised in the CRL. The briefing book aims to resolve issues related to the Biologics License Application for RP1 in combination with Opdivo for melanoma patients. Additionally, reports indicate that a senior FDA official’s intervention was pivotal in the last-minute denial of the therapy, despite internal support within the agency. These developments have created a complex landscape for Replimune as it navigates regulatory and market challenges.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.