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

(RTTNews) - 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 FDA panel voted 12 to 1 (with 3 abstentions) that the safety data for HEPLISAV-B support its approval for active immunization against hepatitis B infection in adults 18 years of age and older while also commenting on the design of Dynavax's proposed post-marketing study for HEPLISAV-B.

DVAX closed Thursday's trading at $17.00, up 5.92%. In after-hours, the stock was down 9.74% to $15.35.

Jazz Pharmaceuticals Public Limited Co. (JAZZ) has secured FDA approval for Vyxeos in the indications of two types of acute myeloid leukemia - newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

According to the Company, Vyxeos represents the first new chemotherapy advance in more than 40 years for adults with certain types of AML.

Vyxeos sports a boxed warning not to interchange Vyxeos with other daunorubicin- and/or cytarabine-containing products. The drug is expected to be commercially available within a week.

JAZZ closed Thursday's trading at $154.41, up 2.66%.

Otonomy Inc. (OTIC) has a couple of catalysts coming its way over the next few months.

The top line data from a phase III trial of OTIVIDEX in Ménière's disease, dubbed AVERTS-1, are expected to be announced in September. The top line data from its second phase III trial of OTIVIDEX in Ménière's disease, dubbed AVERTS-2, are anticipated by the end of 2017.

A phase II study of OTO-311 for the treatment of patients with tinnitus is expected to be initiated by the end of 2017.

OTIC closed Thursday's trading at $17.65, down 2.75%.

An FDA panel of outside experts has voted 10 to 1 to recommend approval of Pfizer Inc.'s (PFE) supplemental new drug applications for XELJANZ and XELJANZ XR for the treatment of adult patients with active psoriatic arthritis.

XELJANZ is an immediate release tablet that releases medication into the bloodstream over the course of several hours, and is taken twice daily. XELJANZ XR is an extended release tablet that releases medication into the bloodstream over the course of a day, and is taken only once a day.

XELJANZ and XELJANZ XR are already approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis. The drugs netted sales of $927 million in 2016, up 77% compared to 2015.

The final FDA decision on whether to approve XELJANZ and XELJANZ XR for the treatment of active psoriatic arthritis is anticipated by December 2017. Although the regulatory agency is not required to follow its panels' recommendations, it usually does.

PFE closed Thursday's trading at $33.43, up 1.55%.

Portola Pharmaceuticals Inc. (PTLA) has resubmitted its Biologics License Application for AndexXa, a reversal agent for Factor Xa inhibitors.

AndexXa was given thumbs down by the FDA last August, and the Company was asked to provide additional information primarily related to manufacturing.

The resubmitted Biologics License Application contains supplemental information primarily related to manufacturing.

PTLA closed Thursday's trading at $61.26, down 2.00%.