Suji Jeong

Edward Marks

Josh Schimmer

Liisa Bayko

- A class action lawsuit has been filed against Savara Inc. and certain officers for alleged violations of federal securities laws, covering securities purchased between **March 7, 2024, and May 23, 2025**.  **[1160308_20250923DC80150:0]** 
- The lawsuit alleges that Savara made materially false and misleading statements regarding its MOLBREEVI Biologics License Application (BLA).  **[1160308_20250923DC80150:1]** 
- On **May 27, 2025**, the FDA issued a **refusal to file letter** for the MOLBREEVI BLA, citing insufficient Chemistry, Manufacturing, and Controls (CMC) data.  **[1160308_20250923DC80150:1]** 
- Following this news, Savara's stock price **fell 31.69%** to **$1.94 per share** on May 27, 2025.  **[1160308_20250923DC80150:1]** 
- Savara now plans to resubmit the MOLBREEVI BLA in **December 2025**, a delay from its previously stated target of completing submission by the first quarter of 2025.  **[1160308_20250923DC80150:1]**

Savara Inc. Faces Class Action Lawsuit Over MOLBREEVI BLA

- A **class action lawsuit** has been filed against Savara Inc. and certain officers for alleged materially false and misleading statements regarding the MOLBREEVI Biologics License Application (BLA) during the period of **March 7, 2024, to May 23, 2025**.  **[1160308_20250918DC75021:0]** **[1160308_20250918DC75021:1]** 
- The lawsuit follows the FDA's **refusal to file** Savara's MOLBREEVI BLA on **May 27, 2025**, due to insufficient Chemistry, Manufacturing, and Controls (CMC) data.  **[1160308_20250918DC75021:1]** 
- Savara's stock price **fell 31.69%** to **$1.94 per share** on **May 27, 2025**, after the FDA's decision.  **[1160308_20250918DC75021:1]** 
- The company now plans to **resubmit the MOLBREEVI BLA in December 2025**, a delay that could push the market launch to early 2027 and necessitate raising additional capital.  **[1160308_20250918DC75021:1]**

Savara Inc. Faces Class Action Lawsuit Following FDA Refusal to File MOLBREEVI BLA

- The Portnoy Law Firm has announced a class action lawsuit against Savara, Inc. on behalf of investors who purchased securities between **March 7, 2024, and May 23, 2025**.  **[1160308_59fac0ce3a2f404e8dd71c5e7be852d2_0]** 
- The lawsuit alleges that Savara made false and/or misleading statements regarding its **MOLBREEVI Biologics License Application (BLA)**, specifically concerning insufficient chemistry, manufacturing, and controls (CMC) data, which made FDA approval unlikely.  **[1160308_59fac0ce3a2f404e8dd71c5e7be852d2_0]** 
- On **May 27, 2025**, Savara announced receiving a **refusal to file (RTF) letter from the FDA** for the MOLBREEVI BLA, citing that it was not sufficiently complete and requested additional CMC data.  **[1160308_59fac0ce3a2f404e8dd71c5e7be852d2_0]** 
- Following the FDA's RTF letter, Savara's share price **fell by more than 31%**.  **[1160308_59fac0ce3a2f404e8dd71c5e7be852d2_0]** 
- Investors have until **November 7, 2025**, to file a lead plaintiff motion.  **[1160308_59fac0ce3a2f404e8dd71c5e7be852d2_0]**

Savara Faces Class Action Lawsuit Following FDA Refusal to File MOLBREEVI BLA

- 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)