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Savara Inc

2.41

+0.12005.24%

Post-market: 2.420.0107+0.44%19:16 EDT

Volume:1.44M

Turnover:3.42M

Market Cap:416.54M

PE:-4.87

High:2.42

Open:2.29

Low:2.28

Close:2.29

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Overview Company News Filings

Savara Inc. Announces New Inducement Awards for Employees Under 2021 Equity Incentive Plan

Master Tec Group Enters MoU With Senari Synergy Sdn. Bhd

INDIA STOCKS-Indian markets set for muted open as Middle East tensions spur caution

INDIA STOCKS-Indian benchmarks dip as Trump's Tehran evacuation call unsettles investors

Savara Inc. Conducted Annual Stockholders Meeting

Oppenheimer Adjusts Price Target on Savara to $5 From $15, Maintains Outperform Rating

MT Newswires Live

HC Wainwright Downgrades Savara to Neutral From Buy, Adjusts Price Target to $2 From $6

MT Newswires Live

Analysts Have Conflicting Sentiments on These Healthcare Companies: Savara (SVRA) and Intellia Therapeutics (NTLA)

Savara downgraded to Neutral from Buy at H.C. Wainwright

Savara Is Maintained at Overweight by Wells Fargo

Wells Fargo Reaffirms Their Buy Rating on Savara (SVRA)

Savara Inc. Unveils Presentation on New Therapies for Rare Respiratory Diseases

Savara Shares Down 25.3% at $2.12 After FDA Refuses to Accept Co's Application for Lung Disease Therapy

THOMSON REUTERS

Savara Shares Slide After FDA Declines Drug Application

Savara Shares Down 34.1% at $1.89 Premarket After FDA Refuses to Accept Co's Application for Lung Disease Therapy

THOMSON REUTERS

Savara Inc. Receives FDA Refusal to File Letter for MOLBREEVI BLA, Plans to Resubmit in Q4 2025

Savara Inc - FDA Requests Additional Cmc Data for Molbreevi Bla

THOMSON REUTERS

Savara Inc - to Request Type a Meeting With FDA Within 30 Days

THOMSON REUTERS

Savara Inc: Expects to Resubmit Our Bla in Q4 of 2025

THOMSON REUTERS

Savara Receives Refusal to File (Rtf) Letter From the U.S. Food and Drug Administration (FDA) for the Biologics License Application (Bla) for Molbreevi* to Treat Patients With Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune Pap)

THOMSON REUTERS

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Announces New Inducement Awards for Employees Under 2021 Equity Incentive Plan","url":"https://stock-news.laohu8.com/highlight/detail?id=2552974564","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2552974564?lang=en_us&edition=fundamental","pubTime":"2025-07-19 04:05","pubTimestamp":1752869111,"startTime":"0","endTime":"0","summary":"Savara Inc., a clinical stage biopharmaceutical company specializing in rare respiratory diseases, has announced the issuance of inducement awards to two newly hired employees. As of July 15, 2025, these awards include options to purchase a total of 20,000 shares of Savara's common stock, with an exercise price of $2.29 per share, and restricted stock units  for an additional 20,000 shares. These awards are part of the Savara Inc. 2021 Inducement Equity Incentive Plan and are granted under NASDAQ Listing Rules. The stock options have a term of 10 years and vest quarterly over four years, while the RSUs will fully vest on the two-year anniversary of employment, contingent upon the employees' continued tenure with the company.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as fin","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250718:nNDL6b9yLh:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["SVRA","BK4139"],"gpt_icon":0},{"id":"2551616868","title":"Master Tec Group Enters MoU With Senari Synergy Sdn. 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BHD*MOU FOR FEASIBILITY STUDY ON JOINTLY SETTING UP OF CABLE MANUFACTURING FACILITY IN SAR","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250715:nRSD2JwdfL:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"corporation","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["SVRA","BK4139"],"gpt_icon":0},{"id":"2544115993","title":"INDIA STOCKS-Indian markets set for muted open as Middle East tensions spur caution","url":"https://stock-news.laohu8.com/highlight/detail?id=2544115993","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2544115993?lang=en_us&edition=fundamental","pubTime":"2025-06-20 10:20","pubTimestamp":1750386001,"startTime":"0","endTime":"0","summary":"INDIA STOCKS-Indian markets set for muted open as Middle East tensions spur caution June 20 (Reuters) - India's equity benchmarks are poised for a subdued start on Friday, in line with broader Asian m","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250620:nL4N3SN03T:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["SVRA","BK4139"],"gpt_icon":0},{"id":"2544317659","title":"INDIA STOCKS-Indian benchmarks dip as Trump's Tehran evacuation call unsettles investors","url":"https://stock-news.laohu8.com/highlight/detail?id=2544317659","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2544317659?lang=en_us&edition=fundamental","pubTime":"2025-06-17 12:42","pubTimestamp":1750135347,"startTime":"0","endTime":"0","summary":"INDIA STOCKS-Indian benchmarks dip as Trump's Tehran evacuation call unsettles investorsUpdates for morning tradeBy Bharath Rajeswaran. June 17  - India's benchmark indexes edged lower on Tuesday as investors adopted a cautious stance after U.S. President Donald Trump urged Iranians to evacuate Tehran as Israel and Iran attacked each other for a fifth straight day sowing fears of a broader regional conflict.The Nifty 50 .NSEI was down 0.38% to 24,846.80 and the BSE Sensex .BSESN fell 0.39% to 81,474.38 as of 10:10 a.m. IST. Nine of the 13 major sectors logged losses. The broader smallcaps .NIFSMCP100 and midcaps .NIFMDCP100 traded flat.U.S. stock futures slipped, and oil prices rose as markets remained on edge as U.S. President Donald Trump cut short his visit to the Group of Seven summit in Canada amid  U.S. military moving a large number of refueling aircraft to Europe . MKTS/GLOB. A rise in crude prices is a negative for commodity importers such as India, as crude constitutes a sign","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250617:nL4N3SK0BR:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["SVRA","BK4139"],"gpt_icon":0},{"id":"2541296893","title":"Savara Inc. Conducted Annual Stockholders Meeting","url":"https://stock-news.laohu8.com/highlight/detail?id=2541296893","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2541296893?lang=en_us&edition=fundamental","pubTime":"2025-06-07 04:49","pubTimestamp":1749242941,"startTime":"0","endTime":"0","summary":"Savara Inc. held its annual stockholders meeting on June 5, 2025. During the meeting, stockholders elected board members and voted on several proposals. The proposal to ratify the appointment of RSM US LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2025, was approved. Additionally, the advisory vote on the frequency of holding an advisory vote on executive compensation favored a one-year interval.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Savara Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission , on June 06, 2025, and is solely responsi","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250606:nNDLvyjQM:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["SVRA","BK4139"],"gpt_icon":0},{"id":"2540479317","title":"Oppenheimer Adjusts Price Target on Savara to $5 From $15, Maintains Outperform Rating","url":"https://stock-news.laohu8.com/highlight/detail?id=2540479317","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2540479317?lang=en_us&edition=fundamental","pubTime":"2025-06-02 21:04","pubTimestamp":1748869453,"startTime":"0","endTime":"0","summary":"Savara (SVRA) has an average rating of overweight and mean price target of $8.31, according to analysts polled by FactSet.(MT Newswires covers equity, commodity and economic research from major banks ","market":"sh","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["SVRA","OPY"],"gpt_icon":0},{"id":"2539573142","title":"HC Wainwright Downgrades Savara to Neutral From Buy, Adjusts Price Target to $2 From $6","url":"https://stock-news.laohu8.com/highlight/detail?id=2539573142","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2539573142?lang=en_us&edition=fundamental","pubTime":"2025-05-29 19:43","pubTimestamp":1748518987,"startTime":"0","endTime":"0","summary":"Savara (SVRA) has an average rating of overweight and mean price target of $8.31, according to analysts polled by FactSet.(MT Newswires covers equity, commodity and economic research from major banks ","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["SVRA"],"gpt_icon":0},{"id":"2539251158","title":"Analysts Have Conflicting Sentiments on These Healthcare Companies: Savara (SVRA) and Intellia Therapeutics (NTLA)","url":"https://stock-news.laohu8.com/highlight/detail?id=2539251158","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2539251158?lang=en_us&edition=fundamental","pubTime":"2025-05-29 18:30","pubTimestamp":1748514616,"startTime":"0","endTime":"0","summary":"Companies in the Healthcare sector have received a lot of coverage today as analysts weigh in on Savara (SVRA – Research Report) and Intellia Thera...","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/analysts-have-conflicting-sentiments-on-these-healthcare-companies-savara-svra-and-intellia-therapeutics-ntla?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/blurbs/analysts-have-conflicting-sentiments-on-these-healthcare-companies-savara-svra-and-intellia-therapeutics-ntla?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["NTLA","LU1861559042.SGD","LU1861558580.USD","BK4137","HCSG","BK4588","BK4535","BK4139","SVRA","BK4585","BK4556"],"gpt_icon":0},{"id":"2539592682","title":"Savara downgraded to Neutral from Buy at H.C. Wainwright","url":"https://stock-news.laohu8.com/highlight/detail?id=2539592682","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2539592682?lang=en_us&edition=fundamental","pubTime":"2025-05-29 18:16","pubTimestamp":1748513762,"startTime":"0","endTime":"0","summary":"H.C. Wainwright downgraded Savara (SVRA) to Neutral from Buy with a price target of $2, down from $6, after the company received a refusal to file ...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/savara-downgraded-to-neutral-from-buy-at-h-c-wainwright-thefly?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/savara-downgraded-to-neutral-from-buy-at-h-c-wainwright-thefly?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["SVRA","BK4139"],"gpt_icon":0},{"id":"2538247942","title":"Savara Is Maintained at Overweight by Wells Fargo","url":"https://stock-news.laohu8.com/highlight/detail?id=2538247942","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2538247942?lang=en_us&edition=fundamental","pubTime":"2025-05-28 21:17","pubTimestamp":1748438220,"startTime":"0","endTime":"0","summary":"Ratings actions from Benzinga: https://www.benzinga.com/quote/SVRA/analyst-ratings \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  May 28, 2025 09:17 ET (13:17 GMT)","market":"sh","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["SVRA"],"gpt_icon":0},{"id":"2538141344","title":"Wells Fargo Reaffirms Their Buy Rating on Savara (SVRA)","url":"https://stock-news.laohu8.com/highlight/detail?id=2538141344","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2538141344?lang=en_us&edition=fundamental","pubTime":"2025-05-28 10:15","pubTimestamp":1748398524,"startTime":"0","endTime":"0","summary":"In a report released yesterday, Tiago Fauth from Wells Fargo maintained a Buy rating on Savara (SVRA – Research Report), with a price target of $7....","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/wells-fargo-reaffirms-their-buy-rating-on-savara-svra?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/blurbs/wells-fargo-reaffirms-their-buy-rating-on-savara-svra?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["SVRA"],"gpt_icon":0},{"id":"2538498152","title":"Savara Inc. Unveils Presentation on New Therapies for Rare Respiratory Diseases","url":"https://stock-news.laohu8.com/highlight/detail?id=2538498152","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2538498152?lang=en_us&edition=fundamental","pubTime":"2025-05-27 23:31","pubTimestamp":1748359880,"startTime":"0","endTime":"0","summary":"Savara Inc. has released a presentation highlighting its efforts in developing new therapies for rare respiratory diseases, specifically focusing on autoimmune pulmonary alveolar proteinosis . The presentation details the challenges faced by patients with aPAP, a disease characterized by surfactant accumulation in the alveoli due to GM-CSF autoantibodies. The condition can lead to severe respiratory issues, including pulmonary fibrosis and potentially life-threatening respiratory failure, which may necessitate lung transplantation. Currently, there are no approved drugs in the U.S. or Europe for aPAP, and the only available treatment option involves an invasive procedure. The presentation underscores the urgent need for effective therapeutic solutions for this rare disease. You can access the full presentation through the link below.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250527:nNDL8GjvZS:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["SVRA","BK4139"],"gpt_icon":0},{"id":"2538648164","title":"Savara Shares Down 25.3% at $2.12 After FDA Refuses to Accept Co's Application for Lung Disease Therapy","url":"https://stock-news.laohu8.com/highlight/detail?id=2538648164","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2538648164?lang=en_us&edition=fundamental","pubTime":"2025-05-27 21:32","pubTimestamp":1748352728,"startTime":"0","endTime":"0","summary":null,"market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250527:nFWN3RZ13M:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4139","SVRA"],"gpt_icon":0},{"id":"2538469262","title":"Savara Shares Slide After FDA Declines Drug Application","url":"https://stock-news.laohu8.com/highlight/detail?id=2538469262","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2538469262?lang=en_us&edition=fundamental","pubTime":"2025-05-27 20:56","pubTimestamp":1748350560,"startTime":"0","endTime":"0","summary":"Savara shares fell after the Food and Drug Administration said its drug is not ready for a full review.The stock dropped 35% to $1.85 in pre-market trading Tuesday.The Langhorne, Pa., biopharmaceutical company said Tuesday it received a refusal-to-file letter from the FDA for the biologics license application for Molbreevi as a therapy to treat patients with autoimmune pulmonary alveolar proteinosis.The FDA determined the license application, which was submitted in March, was not sufficiently complete and needed additional data on chemistry, manufacturing and controls. The refusal to file was not the result of safety concerns and the FDA did not request additional efficacy studies, Savara said.Savara plans to request a Type A meeting with the FDA within the next 30 days. It is currently generating the data requested by the FDA, and expects to resubmit its application in the fourth quarter of 2025, CHief Executive Matt Pauls said.The letter does not impact previous designations granted ","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":"Savara Shares Slide After FDA Declines Drug Application","news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","SVRA"],"gpt_icon":0},{"id":"2538469841","title":"Savara Shares Down 34.1% at $1.89 Premarket After FDA Refuses to Accept Co's Application for Lung Disease Therapy","url":"https://stock-news.laohu8.com/highlight/detail?id=2538469841","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2538469841?lang=en_us&edition=fundamental","pubTime":"2025-05-27 20:37","pubTimestamp":1748349471,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250527:nFWN3RZ1H6:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4139","SVRA"],"gpt_icon":0},{"id":"2538465020","title":"Savara Inc. Receives FDA Refusal to File Letter for MOLBREEVI BLA, Plans to Resubmit in Q4 2025","url":"https://stock-news.laohu8.com/highlight/detail?id=2538465020","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2538465020?lang=en_us&edition=fundamental","pubTime":"2025-05-27 20:05","pubTimestamp":1748347521,"startTime":"0","endTime":"0","summary":"Savara Inc., a clinical-stage biopharmaceutical company specializing in rare respiratory diseases, announced that the U.S. Food and Drug Administration  has issued a Refusal to File  letter for their Biologics License Application  for MOLBREEVI, a treatment for autoimmune Pulmonary Alveolar Proteinosis . The FDA's decision was based on the need for additional Chemistry, Manufacturing, and Controls  data, not due to safety issues. Savara plans to address the FDA's request and resubmit the BLA by the fourth quarter of 2025. The company has emphasized its confidence in MOLBREEVI's potential, supported by clinical data. Despite the RTF, previous regulatory designations, including Fast Track and Breakthrough Therapy, remain in effect. Savara is also advancing its strategy to establish a redundant supply chain and has made significant progress with its manufacturing processes.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. 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