NEW YORK, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the Eastern District of Pennsylvania on behalf of all persons or entities who purchased or otherwise acquired Savara Inc. (“Savara” or the “Company”) (NASDAQ: SVRA) securities between March 7, 2024 and May 23, 2025, inclusive (the “Class Period”). The Complaint alleges that Defendants made false and/or misleading statements and/or fail ...

NEW YORK--(BUSINESS WIRE)--The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed on behalf of investors who acquired Savara Inc. ("Savara†or the "Company†) (NASDAQ:SVRA) securities during the period of March 7, 2024 through May 23, 2025, inclusive ("the Class Period†). If you suffered a loss on your Savara investments, you have until November 7, 2025 to request lead plaintiff appointment. Follow the link below for more information: [CONTACT THE FIRM IF YOU SU. ...

ATLANTA, Sept. 09, 2025 (GLOBE NEWSWIRE) -- A shareholder class action lawsuit has been filed against Savara Inc. (“Savara” or the “Company”) (NASDAQ: SVRA). The lawsuit alleges that Defendants made materially false and/or misleading statements and/or failed to disclose material adverse information, including allegations that: (i) the MOLBREEVI biologics license application (“BLA”) lacked sufficient information regarding MOLBREEVI’s chemistry, manufacturing, and/or controls; (ii) accordingly, the FDA was un ...

Accessibility StatementSkip Navigation SAN DIEGO, Sept. 8, 2025 /PRNewswire/ -- Robbins LLPÂ informs stockholders that a class action was filed on behalf of persons and entities that purchased or otherwise acquired Savara Inc. (NASAQ: SVRA) securities between March 7, 2024 and May 23, 2025. Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. The Company's lead product candidate is MOLBREEVI (also referred to as "molgramostim"), an inhaled granulocyte-macrophage colony- ...

Savara (SVRA) FY 2025 Conference September 03, 2025 04:30 PM ET Speaker0All right. I think we'll get started. Welcome, everyone. Thanks for joining. I'm Dan Kim with the Wells Fargo Biotech Research team and really happy to have with me here Savara.Giving today's presentation will be Matt Pauls, Chair and CEO. Following the presentation, we'll reserve some time for Q and A. So ask that you hold any questions before the end. And with that, I'm pleased to turn over the mic to Matt.Speaker1Thank you very much. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 Savara Inc. (Exact name of registrant as specified in its charter) Delaware 84-1318182 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 1717 Langhorne Newtown Road, Suite 300 Langhorne, Pennsylvania 19047 (Address of principal execut ...

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].

Savara Inc (SVRA) 2025 Conference Summary Company Overview - Savara Inc is a biotech company focused on orphan rare diseases, specifically in the rare pulmonary space with a single asset, Molgrimostum inhalation solution, branded as Molbrevi [6][7] Key Points and Arguments Clinical Development - Positive phase three data for IMPALA two trial was reported, involving 164 patients with autoimmune pulmonary alveolar proteinosis (APAP) [7] - The trial showed positive results on the primary endpoint of DLCO and all key secondary endpoints at 24 and 48 weeks [7] - A Biologics License Application (BLA) resubmission is planned for Q4 2025, with a potential PDUFA date in mid-2026 [8][48] Market Opportunity - Estimated 3,600 diagnosed APAP patients in the U.S., with a potential market size of approximately 7,300 when including undiagnosed patients [10][12] - Pricing research indicates a price range of $300,000 to $500,000 per patient per year, suggesting significant pricing power [13] Treatment Insights - Molbrevi is expected to be a first-line chronic therapy for APAP, addressing the pathophysiology of the disease [14][16] - The drug is administered once daily using a proprietary nebulizer, contrasting with alternatives that require twice-daily administration [50] Regulatory Challenges - The recent refusal to file (RTF) was due to the need for additional Chemistry, Manufacturing, and Controls (CMC) data, not related to clinical trials or safety concerns [21][22] - The company is working with two drug substance partners, GEMA and Fujifilm, to ensure compliance and readiness for the BLA resubmission [31][39] Future Plans - A type A meeting with the FDA is scheduled within 30 days of the RTF, with meeting minutes expected within 90 days [30][31] - European and UK regulatory filings are on track for year-end 2025 [46] Additional Important Information - The company is preparing for an Advisory Committee (AdCom) meeting, considering it the first therapeutic for this orphan rare disease [45] - There is an ongoing Early Access Program (EAP) for patients awaiting approval of Molbrevi [57] - Approximately 10% of patients in previous trials underwent lung lavages, indicating a need for chronic therapeutic options [60] - The company is scaling up its ILD clinic pilot to identify undiagnosed APAP patients using an antibody test [61] This summary encapsulates the critical insights and developments regarding Savara Inc and its lead product, Molbrevi, as discussed in the conference.

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].