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On Wednesday, Evercore ISI made adjustments to its financial outlook on Savara (NASDAQ:SVRA), reducing the price target to $2.00 from the previous $3.00. The firm kept its In Line rating for the biopharmaceutical company’s stock. According to InvestingPro data, the stock has fallen over 33% in the past week, with the current price of $1.94 trading near its 52-week low of $1.89. The RSI indicator suggests the stock is currently in oversold territory. The adjustment follows challenges related to the Chemistry, Manufacturing, and Controls (CMC) section of Savara’s Biologics License Application (BLA) for Molbreevi in the treatment of autoimmune pulmonary alveolar proteinosis (aPAP).
The analyst at Evercore ISI noted that the issues with the BLA were anticipated and have led to a 30% reduction in the valuation of the company. Despite this setback, there is an expectation that Savara may be able to resubmit the BLA in the fourth quarter of this year. The company maintains a strong financial position, with InvestingPro analysis showing more cash than debt on its balance sheet and a healthy current ratio of 14.91x, indicating robust short-term liquidity. This could potentially result in a Prescription Drug User Fee Act (PDUFA) date in the third quarter of 2026, provided the application is granted priority review status.
The timeline for the potential commercial launch of Molbreevi has been adjusted in light of the recent developments. Evercore ISI now anticipates that the launch could take place in January 2027. This projection is based on the assumption that the company will receive approval, which the firm estimates has a 60% likelihood. This probability assessment takes into account the need for more information regarding the Refuse to File (RTF) response and the technical transfer processes.
The analyst’s statement clarified the rationale behind the revised price target, stating, "As such, our price target goes to $2." This reflects the updated expectations and the impact of the delay in the BLA process on the company’s market valuation.
Savara’s focus remains on advancing its pipeline of unique therapies aimed at treating rare respiratory diseases. The company’s progress in addressing the regulatory requirements for Molbreevi will be closely watched by investors and analysts alike as it seeks to overcome the hurdles that have impacted its application with the U.S. Food and Drug Administration (FDA). With a market capitalization of approximately $409 million, InvestingPro analysis indicates the stock is currently undervalued. Subscribers can access 12 additional ProTips and a comprehensive Pro Research Report for deeper insights into Savara’s financial health and growth potential.
In other recent news, Savara Inc. has encountered a regulatory challenge as the U.S. Food and Drug Administration (FDA) issued a Refuse to File (RTF) letter for the company’s Biologics License Application (BLA) for MOLBREEVI. The FDA’s decision was based on insufficient Chemistry, Manufacturing, and Controls data, although no safety concerns were raised. Savara plans to meet with the FDA to discuss the requirements for resubmission, expected in late 2025. Meanwhile, JMP Securities has maintained its Market Outperform rating on Savara, with a price target of $10, expressing optimism about MOLBREEVI’s approval prospects due to its Breakthrough Therapy designation and positive Phase 3 trial results.
Additionally, H.C. Wainwright has upheld a Buy rating with a $6 price target, highlighting the potential for a Priority Review that could expedite MOLBREEVI’s market introduction by early 2026. In another development, Savara has terminated its sales agreement with Evercore Group, ending their arrangement for at-the-market offerings of common stock. The company has not sold shares under this agreement since December 2024. Furthermore, Savara is set to present data from a Phase 3 clinical trial of molgramostim, another investigational treatment for autoimmune pulmonary alveolar proteinosis, at medical congresses in Germany and Japan. These presentations will provide insights into the treatment’s effectiveness in improving pulmonary function and quality of life for patients.
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