Oppenheimer raised the firm’s price target on Savara (SVRA) to $6 from $5 and keeps an Outperform rating on the shares following quarterly results and business update. Following a Type A meeting with the FDA, management announced alignment on CMC information required to resubmit the BLA for MOLBREEVI in aPAP, now planned for December 2025, with FUJIFILM as the new drug substance manufacturer. With the sole deficiency around CMC addressed, Savara is on track for a potential August 2026 approval, if granted Priority Review. Given the unmet need for therapies in aPAP and the robust Phase 3 IMPALA-2 data, the firm continues to view MOLBREEVI as well-positioned for commercial success, with about 1,000 patients in line of sight at the time of launch.
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