In the most recent trading session, shares of Replimune Group, Inc. (NASDAQ: REPL) saw a significant increase, closing 18.89% higher at $3.335. The increase came after investors responded to the FDA’s Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for Replimune’s lead immunotherapy candidate, RP1 (vusolimogene oderparepvec), in combination with nivolumab for advanced melanoma.
FDA Voices Concerns About Study Design and Efficacy
Concerns with the IGNYTE trial, which the FDA does not consider to be a “adequate and well-controlled” research capable of showing effectiveness, prevented the FDA from approving the current BLA, according to the CRL. The FDA pointed out that interpreting the data was made more difficult by the trial’s diverse patient mix.
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The CRL also identified problems with the study design of the confirmatory trial, such as a lack of clarity regarding the role of each combination therapy component. Interestingly, the FDA had no worries about RP1’s safety.
Replimune Requests Immediate Communication with Regulators
Replimune responded by announcing that the company will seek a Type A meeting with the FDA, hoping to be granted one in the upcoming 30 days. The business underlined how urgent it is to address regulatory issues in order to facilitate RP1’s expedited clearance process, which it maintains is a vital treatment option for patients with advanced melanoma who have few other options. Replimune expressed concern that development may not be sustainable without accelerated approval.
Company Stands by RP1’s Potential
Replimune stressed that the FDA had not previously raised these issues during mid- and late-cycle review phases and noted that the design of the confirmatory trial had been agreed upon. The company reaffirmed its confidence in RP1’s clinical benefit.
RP1 is based on a genetically engineered strain of herpes simplex virus, incorporating the fusogenic protein GALV-GP R- and GM-CSF to enhance tumor cell destruction and provoke systemic anti-tumor immune responses. Replimune continues to advocate for RP1’s potential in addressing critical unmet needs in oncology.
