Savara Resubmits MOLBREEVI BLA with Fujifilm as Manufacturer, Requests Priority Review
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 26 2025
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Source: Newsfilter
- Resubmission of Application: Savara Inc. has resubmitted the MOLBREEVI Biologics License Application (BLA) to the FDA, designating Fujifilm as the drug substance manufacturer, aiming to treat autoimmune pulmonary alveolar proteinosis, demonstrating the company's ongoing commitment to rare respiratory diseases.
- Priority Review Request: The application requests Priority Review, indicating Savara's desire to expedite the approval process to provide treatment to patients as soon as possible, reflecting the company's keen awareness of market demand and commitment to patient welfare.
- Multiple Designations: MOLBREEVI has received Fast Track and Breakthrough Therapy designations from the FDA, as well as Orphan Drug designation from the EMA, highlighting its potential in treating autoimmune PAP and possibly presenting significant market opportunities for Savara.
- Clinical Stage Advancement: Currently in Phase 3 development, MOLBREEVI is delivered via the proprietary eFlow® Nebulizer System, indicating Savara's capability in advancing product candidates to market, which may lay the groundwork for future commercialization efforts.
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Analyst Views on SVRA
Wall Street analysts forecast SVRA stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for SVRA is 10.17 USD with a low forecast of 9.00 USD and a high forecast of 11.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 5.610
Low
9.00
Averages
10.17
High
11.00
Current: 5.610
Low
9.00
Averages
10.17
High
11.00
About SVRA
Savara Inc. is a clinical-stage biopharmaceutical company. The Company is focused on rare respiratory diseases. The Company’s lead program, molgramostim inhalation solution (MOLBREEVI or molgramostim), is an inhaled biologic, specifically an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase III development for autoimmune pulmonary alveolar proteinosis (aPAP). MOLBREEVI is an inhaled formulation of recombinant human GM-CSF and is being developed for the treatment of aPAP. MOLBREEVI is administered once daily by inhalation via a high efficiency nebulizer, the eFlow Nebulizer System (PARI Pharma GmbH). Pulmonary alveolar proteinosis (PAP) is a rare lung disease characterized by the accumulation of surfactant in the alveoli (or air sacs) of the lungs. The Company is engaged in the advancement of the MOLBREEVI aPAP program and the Phase III IMPALA-2 clinical trial and outsourcing capital-intensive operations.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Savara Secures $150M Non-Dilutive Capital for MOLBREEVI Launch
- Loan Agreement Amendment: Savara amended its loan agreement with Hercules Capital to access an additional $75 million upon FDA approval of MOLBREEVI, thereby strengthening its liquidity and financial stability.
- Increased Capital Availability: With the addition of the $75 million royalty financing, Savara will have approximately $150 million in non-dilutive capital to support the launch of MOLBREEVI, ensuring a competitive edge in the biopharmaceutical market.
- Market Potential Assessment: A U.S. claims analysis by Savara revealed that the autoimmune pulmonary alveolar proteinosis market is 50% larger than previously estimated, providing a robust foundation for MOLBREEVI's commercialization and expected sales growth.
- Regulatory Application Progress: Savara resubmitted the Biologics License Application for MOLBREEVI in December 2025, and if granted Priority Review, FDA approval could be achieved by Q3 2026, further accelerating the product launch timeline.
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Savara (SVRA) Faces Class Action Lawsuit Over Shareholder Losses
- Legal Investigation Launched: Bragar Eagel & Squire, P.C. is investigating Savara, Inc. (NASDAQ:SVRA) to determine if the board breached fiduciary duties, particularly in light of a class action complaint filed on September 8, 2025.
- Significant Shareholder Losses: On May 27, 2025, Savara announced that its MOLBREEVI Biologics License Application was rejected by the FDA, causing a stock price drop of $0.90, or 31.69%, closing at $1.94, resulting in substantial losses for long-term shareholders.
- Insufficient Disclosure: The complaint alleges that during the class period, Savara failed to disclose critical information regarding the MOLBREEVI BLA, leading to the FDA's unlikely approval in its current form, which adversely affected the company's capital raising plans.
- Next Steps Recommended: Bragar Eagel & Squire encourages long-term shareholders of Savara to contact them to discuss legal rights and potential claims, highlighting the firm's commitment to protecting investor interests.
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