Shares of Canadian specialty pharma Correvio Pharma Corp (NASDAQ: CORV) are retreating in reaction to an adverse FDA verdict.
FDA Goes With Panel Verdict In Rejecting Brinavess
Correvio said it has received a complete response letter, or CRL, from the FDA for its NDA for Brinavess, or vernakalant IV. The decision was along the expected lines.
FDA's Cardiovascular and Renal Drugs Advisory Committee, which met Dec. 10, ruled that the benefit-risk profile of Brinavess wasn't adequate to support approval.
Brinavess is anti-arrhythmic drug that has been approved in several countries outside of the U.S. for the treatment of atrial defibrillation.
Correvio said the FDA determined the NDA cannot be approved in the present form and also provided guidance for resubmission.
Specifically, the FDA had taken exception to the drug's safety profile. The regulatory agency deemed that the company should develop an approach to select patients at low risk of cardiovascular reactions. It also sought data from an additional study to assess Brinavess' cardiovascular risk in the selected population.
Related Link: 10 Biotech M&A Targets Under The Scanner For 2020
Correvio said it will now request a meeting with the FDA at the earliest to discuss the design and specifics of a potential study to address the concerns.
Following the negative FDA panel verdict in early December, Correvio has decided to explore strategic options, including acquisition, merger, business combination or other strategic transaction involving the company or its assets, in a bid to maximize shareholder value.
Correvio shares, which entered penny stock territory in the aftermath of the Dec. 10 Adcom verdict, have not recovered since then.
Although shares jumped 14.57% on Monday in the run up to the FDA decision, the stock was slipping 7.23% to 37 cents Tuesday morning.
See more from Benzinga
- The Daily Biotech Pulse: NewLink Genetics Licenses Ovarian Cancer Dug, Correvio Awaits FDA Verdict
- The Week Ahead In Biotech: Correvio, Intra-Cellular Therapies Await FDA Decisions
- The Daily Biotech Pulse: Axovant Surges On Gene Therapy Study Results, FDA Approves Merck's Ebola Vaccine, Abeona Announces Offering
© 2019 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.