MOLBREEVI for aPAP - MOLBREEVI demonstrated statistically significant improvement in DLCO% (primary endpoint) at Week 24 (p=0.0007) and Week 48 (p=0.0008) compared to placebo[37] - MOLBREEVI showed nominally significant improvement in Exercise Capacity (Peak METs) at Week 48 (p=0.0234) compared to placebo[37] - MOLBREEVI significantly reduced pulmonary surfactant burden, as shown by Ground Glass Opacity (GGO) score at Week 24 (p=0.0004)[66] - 100% of patients who completed the double-blind period enrolled into the open-label period[37] - The treatment discontinuation rate in the double-blind period was low at 3%, with none due to drug-related adverse events[37] aPAP Disease and Market - Autoimmune PAP (aPAP) is a rare lung disease with no approved drugs in the U S or Europe, and the only treatment option is an invasive procedure[15] - Analysis of U S claims data identified approximately 3,600 aPAP patients[108] - Market development team of ~25 people will be responsible for profiling accounts to gain line of sight into currently diagnosed patients[117] - U S pulmonologists show overwhelming support for MOLBREEVI, with 83% likely to prescribe it regardless of disease severity[113] - The potential U S market opportunity for aPAP is estimated to be >$1 billion[135] Regulatory and Financial - Savara plans to resubmit the BLA for MOLBREEVI in Q4 2025[31] - The company has ~$172.5 million in cash and short-term investments as of March 31, 2025, and non-dilutive debt financing for up to $200 million[133]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Savara Inc. and its officers or directors, following a significant stock price drop after negative FDA news [1][3]. Group 1: Investigation Details - Pomerantz LLP is representing investors of Savara Inc. and is looking into claims of securities fraud or other unlawful business practices [1]. - Investors are encouraged to contact Pomerantz LLP for more information regarding the investigation [1]. Group 2: Stock Performance - On May 27, 2025, Savara announced it received a refusal to file letter from the FDA regarding its Biologics License Application for MOLBREEVI, leading to a stock price decline of $0.90 per share, or 31.69%, closing at $1.94 per share [3].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Savara Inc. and its officers or directors following a significant stock price drop after an FDA refusal letter [1][3]. Group 1: Company Overview - Savara Inc. is a publicly traded company on NASDAQ under the ticker SVRA [1]. - The company recently announced it received a refusal to file letter from the FDA regarding its Biologics License Application for MOLBREEVI, a therapy aimed at treating autoimmune PAP [3]. Group 2: Stock Performance - Following the FDA news, Savara's stock price decreased by $0.90 per share, representing a decline of 31.69%, closing at $1.94 per share on May 27, 2025 [3]. Group 3: Legal Investigation - Pomerantz LLP, a prominent firm in corporate and securities class litigation, is leading the investigation into Savara's potential misconduct [1][4]. - The firm has a history of recovering significant damages for victims of securities fraud and corporate misconduct [4].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Savara Inc. following a significant stock price drop after the FDA's refusal to file letter regarding its drug application [1][3]. Company Summary - Savara Inc. received a refusal to file letter from the FDA for its Biologics License Application for MOLBREEVI, intended to treat autoimmune PAP [3]. - Following this announcement, Savara's stock price decreased by $0.90, representing a 31.69% decline, closing at $1.94 per share on May 27, 2025 [3]. Legal Investigation - Pomerantz LLP is representing investors of Savara and is looking into claims of securities fraud or other unlawful practices by the company and its officers or directors [1].

ATLANTA, May 27, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Savara Inc. (“Savara” or the “Company”) (NASDAQ: SVRA) complied with federal securities laws. On May 27, 2025, Savara announced that it had received a refusal to file letter from the FDA for the Biologics License Application of MOLBREEVI as a therapy to treat patients with autoimmune pulmonary alveolar proteinosis. Following this news, the price of the Company’s stock dropped.  If you purchased Savara stock and suffered  ...

Savara Inc. SVRA on Tuesday announced that it received a U.S. Food And Drug Administration (FDA) refusal To File (RTF)) letter regarding the Biologic license application (BLA) for Molbreevi, a therapy for treating patients with autoimmune Pulmonary Alveolar Proteinosis (PAP).Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the lungs’ alveoli.Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent th ...

BOSTON, May 27, 2025 (GLOBE NEWSWIRE) -- Block & Leviton is investigating Savara Inc. (Nasdaq: SVRA) for potential securities law violations. Investors who have lost money in their Savara Inc. investment should contact the firm to learn more about how they might recover those losses. For more details, visit https://blockleviton.com/cases/svra. What is this all about? Shares of Savara fell over 30% in intraday trading on May 27, 2025, after the company announced that the FDA issued a Refusal to File letter f ...