DVAX Surges On FDA Panel Vote, CYTR On Watch, EC Approves New HCV Drugs

Today’s Daily Dose brings you news about approval of AbbVie’s Maviret and Gilead’s Vosevi for the treatment of chronic hepatitis C virus by the European Commission; CytRx’s $356 million licensing deal with privately-held NantCell; FDA panel support for Dynavax’s hepatitis B vaccine and the progress of Tenax’s heart drug Levosimendan.

Read on…

AbbVie Inc.’s (ABBV) Maviret for the treatment of all major genotypes (GT1-6) of chronic hepatitis C virus infection has been approved by the European Commission.

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).

The approval of Maviret in the European Union, entitles Enanta to receive a $25 million milestone payment from AbbVie.

In the U.S., Maviret is under FDA review, with a decision expected next month.

ABBV closed Friday’s trading at $70.44, down 1.72%; ENTA closed the day’s trading at $38.04, down 0.05%.

Shares of CytRx Corp. (CYTR) surged over 43% on Friday, following a global strategic license with privately-held NantCell Inc., for Aldoxorubicin.

Aldoxorubicin is CytRx’s lead drug candidate. A phase III clinical trial of Aldoxorubicin as a treatment for patients with relapsed or refractory soft tissue sarcomas, or STS, has been completed by CytRx. The drug candidate is also being explored in other indications like 2nd line small cell lung cancer, Glioblastma multiforme, and Kaposi’s syndrome.

The agreement allows NantCell to expand the development of Aldoxorubicin into multiple tumor types in combination with immuno-oncology and cell-based therapies. In return, CytRx is entitled to receive $13 million in strategic investment wherein NantCell will purchase CytRx common stock at $1.10 per share. CytRx will also receive up to an additional $343 million in milestone payments related to regulatory approvals.

CYTR closed Friday’s trading at $0.82, up 43.61%.

Dynavax Technologies Corp.’s (DVAX) HEPLISAV-B, a vaccine candidate for immunization against hepatitis B infection in adults ages 18 years of age and older, is one step closer to FDA approval.

An FDA panel, on Friday, voted 12 to 1 that the safety data for HEPLISAV-B supports its approval. The panel was not asked to vote on the immunogenicity (efficacy) of the vaccine.

In November 2012, a panel had voted 13 to one that HEPLISAV-B demonstrated immunogenicity, but voted…

Read the full article from the Source…

Leave a Reply

Your email address will not be published. Required fields are marked *