Savara, Inc. (SVRA)

In March 2025, Savara completed the submission of its Biologics License Application (BLA) to the FDA for MOLBREEVI for aPAP, requesting Priority Review. In May 2025, the FDA issued a Refuse to File (RTF) letter for the MOLBREEVI BLA due to insufficient CMC information, causing a significant stock price drop. Insider purchases were reported in April and June 2025. In August 2025, Savara released its Q1 2025 earnings, reporting an EPS of -$0.14, missing consensus estimates, but the stock gained 4.7% following the announcement, and the company announced plans to resubmit the MOLBREEVI BLA in December 2025. In September 2025, Savara participated in investor healthcare conferences and presented new data from the Phase 3 IMPALA-2 clinical trial of Molgramostim, leading analysts to raise their price targets. In October 2025, the stock reached a new 52-week high following analyst upgrades and positive ratings.

While autoimmune pulmonary alveolar proteinosis (aPAP) is a rare, chronic disease, the broader market for respiratory disease treatments can exhibit seasonality. Respiratory diseases generally show clear predictable seasonal patterns, with primary care visits increasing threefold during winter months due to circulating viral pathogens like influenza and RSV. This general seasonality in respiratory illnesses could indirectly influence the broader healthcare landscape and resource allocation, which might have a tangential effect on companies operating in the respiratory therapeutics space. However, for Savara's specific product candidate, Molgramostim, which targets a chronic rare disease, direct demand seasonality tied to acute respiratory seasons is not explicitly identified in the provided information.

Savara, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for rare respiratory diseases, with its lead product candidate, Molgramostim (MOLBREEVI), in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). MOLBREEVI has received several designations from regulatory agencies, including Orphan Drug Designation from the FDA and EMA, as well as Fast Track and Breakthrough Therapy Designations from the FDA, and Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations from the UK's MHRA. Earlier pipeline candidates, AeroVanc and Apulmiq, had their development programs discontinued in 2020.

Savara Inc. is headquartered in Langhorne, Pennsylvania, United States, and was originally established in Austin, Texas. While its primary operational footprint is in the U.S., the company plans for international market expansion and anticipates completing the submission of a Marketing Authorization Application (MAA) for Molgramostim for aPAP in Europe and the United Kingdom in the first quarter of 2026.

Savara's brand reputation has been influenced by positive clinical developments and negative legal challenges in the past year. Positive results from the Phase 3 IMPALA-2 trial for Molgramostim have reinforced the drug's potential, contributing to a "Moderate Buy" consensus rating from analysts. However, the FDA's Refuse to File letter for the MOLBREEVI BLA in May 2025, citing insufficient CMC information, negatively impacted the company's reputation, leading to a stock price decline and class-action lawsuits alleging securities fraud.

Savara Inc. has significant institutional ownership, with 258 institutional owners and shareholders holding a total of 179,037,528 shares. Major institutional owners include NEA Management Company, LLC, Bain Capital Life Sciences Investors, LLC, TCG Crossover Management, LLC, Frazier Life Sciences Management, L.P., Vestal Point Capital, LP, BlackRock, Inc., VR Adviser, LLC, Vanguard Group Inc, Nantahala Capital Management, LLC, and Deerfield Management Company, L.p. (series C). Hedge funds and other institutional investors collectively own a substantial portion of the stock, with some reports indicating as high as 87.93%. Paul Edward Walker is the largest individual shareholder, owning 24.47 million shares, representing 14.16% of the company.