Suji Jeong

Edward Marks

Josh Schimmer

Liisa Bayko

- Savara is preparing to **resubmit its Biologics License Application (BLA) for Molbrivi in the United States in December**, with an anticipated PDUFA date in **Q3 2026**.  **[1160308_tx_380195_2]**  The company has aligned with the FDA on **Fujifilm** as the drug substance manufacturer, addressing a previous issue.  **[1160308_tx_380195_7]** 
- A recent claims database analysis revealed an expanded market opportunity, identifying approximately **5,500 patients** with autoimmune PAP (aPAP) in the United States, a **50% increase** from prior estimates.  **[1160308_tx_380195_3]** **[1160308_tx_380195_4]**  The company has confirmed approximately **750 patients** through direct physician contact.  **[1160308_tx_380195_4]** 
- Savara projects a US pricing corridor for Molbrivi between **$400,000 and $500,000 per patient per year**.  **[1160308_tx_380195_4]** 
- The company reports a cash runway into **2027**, with approximately **$146 million** in cash as of the end of Q2.  **[1160308_tx_380195_4]**

Savara Provides Update on Molbrivi Regulatory Pathway and Expanded Market Opportunity

- Savara Inc. reported **positive Phase 3 results** for MOLBREEVI in autoimmune PAP, demonstrating **clinically meaningful benefits** and a **well-tolerated profile**.  **[1160308_0001193125-25-193507_d12513dex991.htm:4]** **[1160308_0001193125-25-193507_d12513dex991.htm:5]** **[1160308_0001193125-25-193507_d12513dex991.htm:6]** 
- The company plans to **resubmit its Biologics License Application (BLA)** for MOLBREEVI in **December 2025**.  **[1160308_0001193125-25-193507_d12513dex991.htm:4]** **[1160308_0001193125-25-193507_d12513dex991.htm:8]** 
- The estimated U.S. autoimmune PAP market is **~50% larger than previously projected**, with approximately **5,542 patients**, representing a potential U.S. total addressable market of **over $2 billion**.  **[1160308_0001193125-25-193507_d12513dex991.htm:10]** **[1160308_0001193125-25-193507_d12513dex991.htm:12]** 
- Savara Inc. has a **cash runway into Q1 2027**, with **~$146 million in cash and short-term investments** as of **June 30, 2025**.  **[1160308_0001193125-25-193507_d12513dex991.htm:12]**

Savara (SVRA)