Savara Submits MOLBREEVI BLA to FDA for Autoimmune PAP Treatment

Reuters

Jan 09

Savara Submits MOLBREEVI BLA to FDA for Autoimmune PAP Treatment

Savara Inc. has submitted a Biologics License Application (BLA) for MOLBREEVI to the U.S. Food and Drug Administration (FDA) in December 2025, seeking approval for the treatment of autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The company has requested Priority Review for the investigational inhaled therapy. If approved, PANTHERx Rare Pharmacy will serve as the exclusive U.S. specialty pharmacy for MOLBREEVI, providing specialized distribution and patient support services.

Disclaimer: This news brief was created by Public Technologies (PUBT) 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 Business Wire (Ref. ID: 20260108735513) on January 08, 2026, and is solely responsible for the information contained therein.

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The company has requested Priority Review for the investigational inhaled therapy. If approved, PANTHERx Rare Pharmacy will serve as the exclusive U.S. specialty pharmacy for MOLBREEVI, providing specialized distribution and patient support services.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) 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 Business Wire (Ref. ID: 20260108735513) on January 08, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"SVRA","symbol_name":"Savara Inc","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260108:nNDL3b6mcC:1","article_id":"2602602318","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2602602318","pubTimestamp":1767906349,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Savara Inc. has submitted a Biologics License Application  for MOLBREEVI to the U.S. Food and Drug Administration  in December 2025, seeking approval for the treatment of autoimmune pulmonary alveolar proteinosis . The company has requested Priority Review for the investigational inhaled therapy. If approved, PANTHERx Rare Pharmacy will serve as the exclusive U.S. specialty pharmacy for MOLBREEVI, providing specialized distribution and patient support services.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. 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If approved, PANTHERx Rare Pharmacy will serve as the exclusive U.S. specialty pharmacy for MOLBREEVI, providing specialized distribution and patient support services.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) 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 Business Wire (Ref. ID: 20260108735513) on January 08, 2026, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"corporation","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}