As previously reported, Cantor Fitzgerald downgraded Replimune (REPL) to Neutral from Overweight. The firm noted the FDA has issued a second complete response letter for RP1 plus nivolumab in advanced melanoma, not only reaffirming but also expanding upon prior concerns from the July 2025 CRL on the adequacy and interpretability of the clinical data package for the biologics license application re-submission. Cantor Fitzgerald had hoped for a more lenient FDA with Vinay Prasad’s pending departure, but today’s news suggests this is not the case, the firm told investors in a research note.
Claim 55% Off TipRanks
- Unlock hedge fund-level data and powerful investing tools for smarter, sharper decisions
- Discover top-performing stock ideas and upgrade to a portfolio of market leaders with Smart Investor Picks
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on REPL:
- Replimune says FDA’s CRL for RP1 ‘disappointing’
- Replimune says FDA ‘appears to have contradicted their positions’ in CRL
- Replimune downgraded to Neutral from Overweight at Cantor Fitzgerald
- Replimune downgraded to Neutral at Piper Sandler after second CRL
- Replimune downgraded to Neutral from Overweight at Piper Sandler
