Savara (SVRA) announced that it has received the Day 74 Letter from the FDA which indicated that an Advisory Committee meeting is not planned for the MOLBREEVI Biologics License Application and the review is ongoing with a Prescription Drug User Fee Act target action date of August 22, 2026. Additionally, the company recently submitted the MAA to the EMA for MOLBREEVI for the treatment of autoimmune PAP and is on track to submit the MAA to the U.K.’s MHRA by the end of Q1 2026.
Meet Samuel – Your Personal Investing Prophet
- Start a conversation with TipRanks’ trusted, data-backed investment intelligence
- Ask Samuel about stocks, your portfolio, or the market and get instant, personalized insights in seconds
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on SVRA:
- Savara says FDA files BLA for Molbreevi
- Savara announces BLA for Molbreevi filed for review by FDA
- Savara Advances Pediatric aPAP Trial With Inhaled Molgramostim, Extending Its Rare Lung Disease Reach
- Savara Enters New Material Definitive Agreement and Obligation
- Savara (SVRA): Advancing MOLBREEVI Toward Likely FDA Approval and Blockbuster Rare Disease Potential