How is Vinay Prasad's resignation affecting Replimune Group's stock?
7/31/2025 08:31pm
Vinay Prasad's resignation from the FDA's Center for Biologics Evaluation and Research (CBER) has had a significant impact on Replimune Group's stock. Here are the key effects:
1. **Stock Surge**: Following Prasad's resignation, Replimune Group's stock (NASDAQ:REPL) surged by over 100% on July 30, 2025, closing at $7.55. This dramatic increase was fueled by the perception that the FDA's stance on Replimune's lead drug, RP1, has shifted in a favorable direction.
2. **Analyst Upgrades**: Cantor Fitzgerald analyst Li Watsek upgraded Replimune's stock from Hold to Buy, citing the improved chances of RP1 gaining accelerated approval. This upgrade contributed to the stock's positive momentum.
3. **Potential FDA U-Turn**: The market is hopeful that the FDA will reconsider its Complete Response Letter (CRL) issued on July 22, 2025, for RP1 in combination with nivolumab. The CRL had rejected RP1 on the grounds of a lack of rigor in the Ignyte Phase 1/2 trial. With Prasad out of the picture, analysts believe there is a greater chance that this decision could be overturned.
4. **Long-Term Outlook**: While the stock has seen a significant rebound, it remains down 37% year-to-date. The long-term impact on Replimune's stock will depend on the actual outcome of the FDA's review process and the company's ability to navigate the regulatory landscape.
In summary, Vinay Prasad's resignation has had a profoundly positive short-term effect on Replimune Group's stock, driven by optimism around a potential FDA approval reversal. However, the company's stock and prospects will ultimately depend on the results of the FDA review process.