Suji Jeong

Edward Marks

Josh Schimmer

Liisa Bayko

- A class action lawsuit has been filed against **Savara Inc. (SVRA)** and its officers, covering the period from **March 7, 2024, to May 23, 2025**, alleging materially false and misleading statements regarding the MOLBREEVI Biologics License Application (BLA).  **[1160308_5cb6642cef1f42d28678ad254e4922d7_0]** **[1160308_5cb6642cef1f42d28678ad254e4922d7_1]** 
- The lawsuit follows the **FDA's refusal to file** Savara's MOLBREEVI BLA on **May 27, 2025**, citing insufficient Chemistry, Manufacturing, and Controls (CMC) data.  **[1160308_5cb6642cef1f42d28678ad254e4922d7_1]** 
- On the news of the FDA's refusal, Savara's stock price **fell $0.90 per share, or 31.69%**, closing at **$1.94 per share** on May 27, 2025.  **[1160308_5cb6642cef1f42d28678ad254e4922d7_2]** 
- Savara now anticipates resubmitting the MOLBREEVI BLA in **December 2025**, a delay from its prior expectation of completing the submission in the first quarter of 2025.  **[1160308_5cb6642cef1f42d28678ad254e4922d7_2]**

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

- **Bragar Eagel & Squire, P.C.** has filed a class action lawsuit against **Savara Inc. (SVRA)** on behalf of investors who purchased securities between **March 7, 2024, and May 23, 2025**.  **[1160308_89f34a80555a440b97c14808eee3bb24_0]** 
- The lawsuit alleges that Savara failed to disclose critical deficiencies in the **MOLBREEVI Biologics License Application (BLA)**, specifically regarding chemistry, manufacturing, and/or controls, which made FDA approval unlikely and increased the probability of needing additional capital.  **[1160308_89f34a80555a440b97c14808eee3bb24_0]** 
- Following the announcement on **May 27, 2025**, that the FDA issued a refusal to file (RTF) letter for the MOLBREEVI BLA, Savara's stock price declined by **$0.90 per share, or 31.69%**, closing at **$1.94 per share**.  **[1160308_89f34a80555a440b97c14808eee3bb24_0]** 
- The deadline for investors to apply to be appointed as lead plaintiff in this lawsuit is **November 7, 2025**.  **[1160308_89f34a80555a440b97c14808eee3bb24_0]**

Savara Faces Class Action Lawsuit Over MOLBREEVI BLA Issues

- Pomerantz LLP has filed a **class action lawsuit** against Savara Inc. and certain officers, covering the period between **March 7, 2024, and May 23, 2025**.  **[1160308_20251013DC96237:0]** 
- The lawsuit alleges that Savara made materially false and misleading statements regarding the **MOLBREEVI BLA**, specifically concerning the sufficiency of Chemistry, Manufacturing, and Controls (CMC) information.  **[1160308_20251013DC96237:1]** 
- On **May 27, 2025**, Savara announced it received a **refusal to file letter from the FDA** for the MOLBREEVI BLA due to insufficient CMC data, which led to a **31.69% drop** in the company's stock price.  **[1160308_20251013DC96237:1]** 
- Savara now plans to **resubmit the MOLBREEVI BLA in December 2025**, a delay from the previously expected completion in the first quarter of 2025.  **[1160308_20251013DC96237:1]** 
- Guggenheim revised its price target for Savara to **$8.00 from $9.00**, anticipating profitability no sooner than 2028 and the potential need for additional capital raises.  **[1160308_20251013DC96237:1]**

Savara Faces Class Action Lawsuit Over MOLBREEVI BLA and FDA Refusal

- Pomerantz LLP has filed a class action lawsuit against **Savara Inc. (SVRA)** and its officers, covering the period from **March 7, 2024, to May 23, 2025**, alleging false and misleading statements regarding the MOLBREEVI BLA.  **[1160308_20251008DC93552:0]** **[1160308_20251008DC93552:1]** 
- The lawsuit was prompted by the FDA's **refusal to file** Savara's MOLBREEVI Biologics License Application (BLA) on **May 27, 2025**, due to insufficient Chemistry, Manufacturing, and Controls (CMC) data.  **[1160308_20251008DC93552:1]** 
- Following the FDA's decision, Savara's stock price **fell 31.69%** to **$1.94 per share** on May 27, 2025.  **[1160308_20251008DC93552:1]** 
- Savara, which had previously stated it expected to complete the BLA submission by Q1 2025, now plans to **resubmit the MOLBREEVI BLA in December 2025**.  **[1160308_20251008DC93552:0]** **[1160308_20251008DC93552:1]** 
- Analysts anticipate a delayed market launch for MOLBREEVI until **early 2027** and foresee the company needing to raise additional capital, potentially through a dilutive stock offering, with profitability not expected until **2028**.  **[1160308_20251008DC93552:1]**

Pomerantz LLP Files Class Action Lawsuit Against Savara Inc. Over MOLBREEVI BLA

- A class action lawsuit has been filed against Savara Inc. and certain officers, covering the **Class Period from March 7, 2024, to May 23, 2025**, alleging false and misleading statements regarding the MOLBREEVI BLA.  **[1160308_20251003DC87780:0]** **[1160308_20251003DC87780:1]** 
- The FDA issued a **refusal to file letter** for Savara's MOLBREEVI BLA on **May 27, 2025**, due to insufficient Chemistry, Manufacturing, and Controls (CMC) data.  **[1160308_20251003DC87780:1]** 
- Following this news, Savara's stock price **fell $0.90 per share, or 31.69%**, to close at **$1.94 per share** on May 27, 2025.  **[1160308_20251003DC87780:1]** 
- Savara now plans to **resubmit the MOLBREEVI BLA in December 2025**, a delay from its earlier Q1 2025 target.  **[1160308_20251003DC87780:1]** 
- Analysts anticipate that the company may need to **raise additional capital** and that the market launch for MOLBREEVI could be delayed until early 2027.  **[1160308_20251003DC87780:1]**

Savara Inc. Faces Class Action Lawsuit Over MOLBREEVI BLA

- Pomerantz LLP has filed a class action lawsuit against **Savara Inc.** and certain officers, on behalf of investors who purchased Savara securities between **March 7, 2024, and May 23, 2025**.  **[1160308_20250928DC83428:0]** 
- The lawsuit alleges that Savara made materially false and misleading statements regarding its lead product candidate, **MOLBREEVI**, specifically concerning the sufficiency of its chemistry, manufacturing, and controls (CMC) information for the Biologics License Application (BLA).  **[1160308_20250928DC83428:1]** 
- On **May 27, 2025**, the FDA issued a **refusal to file letter** for the MOLBREEVI BLA, determining it was not sufficiently complete due to requested additional CMC data.  **[1160308_20250928DC83428:1]** 
- Following this news, Savara's stock price fell **$0.90 per share, or 31.69%**, to close at **$1.94 per share** on May 27, 2025.  **[1160308_20250928DC83428:1]**  Savara now plans to resubmit the MOLBREEVI BLA in **December 2025**, contrary to earlier expectations of completing submission by Q1 2025.  **[1160308_20250928DC83428:1]**

Savara Faces Class Action Lawsuit Over MOLBREEVI BLA

- 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]**

- 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]**

- 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 (SVRA)