Savara stock rating upgraded to Buy by H.C. Wainwright on BLA resubmission plans

Investing.com - H.C. Wainwright upgraded Savara (NASDAQ:SVRA) from Neutral to Buy and raised its price target to $5.00 from $2.00 following the company’s alignment with the FDA on Chemistry, Manufacturing, and Controls (CMC) data requirements. The upgrade comes as the stock shows strong momentum, with a 14% return over the past week and trading at $3.08.

The upgrade comes after Savara reached an agreement with the FDA during a Type A meeting regarding the necessary CMC data for resubmitting its Biologics License Application (BLA) for Molbreevi, following a previous Refusal to File letter from the agency. According to InvestingPro data, the company maintains a strong financial position with more cash than debt and a healthy current ratio of 11.08, though it’s currently burning through cash rapidly.

Savara plans to resubmit the BLA in December with Fujifilm Diosynth Biotechnologies as the Drug Substance Manufacturer, replacing the previously considered GEMA biotech, and will request priority review that could result in a PDUFA date around August 2026. Based on InvestingPro’s Fair Value analysis, the stock appears to be trading near its fair value, with analyst targets ranging from $2 to $16.

H.C. Wainwright noted that the extensive data generated from Process Performance Qualification campaigns at Fujifilm, combined with FDA alignment on analytical comparability analysis and CMC data requirements, reduces the risk of the filing being rejected.

The decision to proceed with Fujifilm as the manufacturing partner was a key factor in H.C. Wainwright’s more positive outlook on Savara’s prospects for successful BLA resubmission.

In other recent news, Savara Inc. has been at the center of several significant developments. The company received a Refusal to File (RTF) from the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA) for Molbreevi, requiring additional Chemistry, Manufacturing, and Controls (CMC) data. Despite this setback, Savara plans to resubmit the BLA by December 2025. Oppenheimer has responded by raising its price target for Savara to $6, citing alignment with the FDA on required CMC information. Meanwhile, Guggenheim has adjusted its price target to $8, maintaining a Buy rating, while H.C. Wainwright downgraded the stock to Neutral with a $2 price target due to concerns about the company’s communication with investors and the FDA.

In corporate governance news, Savara held its annual meeting, where stockholders elected six directors and approved key proposals, including the appointment of RSM US LLP as the company’s independent registered public accounting firm. These developments come as the company continues to navigate regulatory challenges and investor sentiment.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.