Voyager Therapeutics Inc. (NASDAQ: VYGR) shares saw a handy gain on Tuesday after the company announced that it received some feedback from the U.S. Food and Drug Administration (FDA) from its Type C meeting.
Based on the written response from the FDA, Voyager continues to plan to submit for review a biologics license application (BLA) for VY-AADC based on the nonclinical and clinical safety and efficacy data from the pivotal program, including plans to submit a BLA based on data from the Phase 2 trial alone, or if needed, from the randomized, placebo-controlled Phase 3 trial.
Additionally, Voyager announced positive interim results from a Phase 1 posterior trajectory trial that achieved enhanced coverage of the putamen, reduced surgical times and improvements in patients’ motor function at six months. As a result, Voyager has determined that the posterior approach will continue to serve as the preferred surgical route of administration and that the pivotal program will use a dose concentration of VY-AADC between those used in Cohorts 2 and 3 from the Phase 1b trial.
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Robert Pietrusko, Pharm.D., senior vice president of regulatory affairs and quality assurance at Voyager, commented:
We are very pleased with feedback from the FDA regarding our pivotal program for VY-AADC that includes the potential to file a BLA based on the safety and efficacy results from the Phase 2 trial, or if needed, from the Phase 3 trial. With the recent RMAT designation for VY-AADC and written feedback from the FDA regarding our Type C meeting questions, we look forward to continuing to work closely with the agency to expedite the development of this potentially important treatment for patients with Parkinson’s disease.
Shares of Voyager were last seen up about 8% at $19.44, with a consensus analyst price target of $32.73 and a 52-week trading range of $8.10 to $31.91.
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