DVAX Plunges On Delay In Approval, FDA Nod For ABBV’s HCV Drug, ABIO On Radar

Today’s Daily Dose brings you news about FDA approval of AbbVie’s new hepatitis C drug; ARCA biopharma’s anticipated milestones; the delay in approval of Dynavax’s experimental hepatitis B vaccine; the approval of the first new chemotherapy advance in the U.S. in more than 40 years for adults with certain types of AML, and the clinical trial catalysts to watch out for in Otonomy.

Read on…

The FDA has approved AbbVie Inc.’s (ABBV) Maviret for the treatment of adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis.

The drug has also been approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both.

Maviret is a fixed-dose combination of two direct acting-antivirals, Glecaprevir and Pibrentasvir, dosed once-daily as three oral tablets. Glecaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (ENTA).

Mavyret is the first treatment of eight weeks duration approved for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated. Standard treatment length was previously 12 weeks or more, the FDA noted.

ABBV closed Thursday’s trading at $70.99, up 0.40%.

ARCA biopharma Inc. (ABIO) has a major event to watch out for this month.

The outcome of the Data and Safety Monitoring Board interim analysis of the Company’s GENETIC-AF trial is slated to be announced this month (August).

GENETIC-AF is a phase 2B/3 double-blind, clinical superiority trial comparing the safety and efficacy of ARCA bio’s investigational drug Gencaro to an approved drug TOPROL-XL for the treatment and prevention of recurrent atrial fibrillation or flutter (AF/AFL) in heart failure patients with reduced left ventricular ejection fraction (HFrEF).

ABIO closed Thursday’s trading at $2.05, up 7.89%.

Shares of Dynavax Technologies Corp. (DVAX) plunged more than 9% in extended trading on Thursday, following FDA’s decision date on Heplisav-B, the Company’s experimental hepatitis B vaccine, being pushed back by 3 months.

The FDA was originally slated to decide on Heplisav-B on August 10, 2017. But with the Company being required to submit additional information related to Heplisav-B, the FDA has postponed the decision to November 10, 2017.

On July 28, 2017, an…

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