Tumor Destroyer's Regulatory Route Clouded, Leading to Replimune's Collapse
In a surprising turn of events, the Food and Drug Administration (FDA) has rejected Replimune's investigational cancer therapy RP1, also known as vusolimogene oderparepvec. The decision, announced on Thursday, has sent shockwaves through the biotech industry, with Replimune's stock taking a significant hit.
Replimune, a Massachusetts-based biotech company, reported a 32.9% confirmed objective response rate for RP1 in the Phase III IGNYTE trial, including a 15% complete response rate. However, the FDA's complete response letter in July did not provide a clear path forward for RP1, according to Replimune.
The FDA argued that the IGNYTE trial was not an "adequate and well-controlled clinical investigation." This contention has been met with criticism from the researchers behind IGNYTE, alongside other experts in the field, who argue that the heterogeneity of IGNYTE's population more accurately reflects RP1's real-world patient population.
Following the rejection, a group of 22 scientists penned an open letter to the FDA, urging the agency to re-review RP1's application. Replimune's CEO, Suhil Patel, expressed surprise and disappointment in a statement following the rejection.
The news about RP1's regulatory pathway was not well-received by BMO Capital Markets, who expressed further pause and concern for the long-term viability of the RP1 program. The lack of reassurance from Replimune about the RP1 program's future paints a bleak picture, according to BMO Capital Markets.
On September 16, Replimune met with the FDA for a Type A meeting regarding the regulatory pathway of RP1. No new information about the path forward for RP1 under the accelerated approval pathway was provided in this meeting.
As of Thursday, Replimune's stock closed at $3.46, a decrease of nearly 40% from the previous day's closing price of $5.71. The hopes for restructuring the RP1 program or using existing data for future approval do not appear to be supported, according to BMO Capital Markets.
The rejection of RP1 has been linked to the new FDA leader, Robert F. Kennedy Jr., who has been criticised in connection with the decision. As the situation unfolds, the future of RP1 remains uncertain.
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