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

(RTTNews) - 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.

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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 eight to five with one abstention that there was insufficient data to support its safety.

HEPLISAV-B has been turned down twice by the FDA, i.e., in February 2013 and November 2016.

It remains to be seen if the third time will be the charm. The FDA usually follows recommendations from its expert panels, although it is not required to do so.

The regulatory agency's final decision is set for August 10, 2017.

DVAX closed Friday's trading at $9.25. In after-hours, the stock was up 80% to $16.65.

The European Commission has granted approval to Gilead Sciences Inc.'s (GILD) Vosevi for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.

Vosevi is a fixed-dose, combination tablet containing two previously approved drugs - Sofosbuvir and Velpatasvir - and a new drug, Voxilaprevir.

In the U.S., Vosevi received FDA approval as recently as July 18, 2017.

The Company also announced that the European Commission has extended the approval of Harvoni for adolescent hepatitis C patients. Harvoni, which is already approved for the treatment of adults with chronic HCV genotype 1, 3, 4, 5 or 6 infection, had annual global sales of $9.08 billion in 2016 compared to $13.86 billion in 2015.

GILD closed Friday's trading at $75.94, up 1.31%.

Haemonetics Corp. (HAE) has received FDA clearance for its NexSys PCS plasmapheresis system.

The NexSys PCS is designed to increase productivity and improve quality and compliance in plasma collection centers, according to the Company.

Haemonetics plans to immediately begin limited production of NexSys PCS devices and intends to pursue further regulatory clearances for additional enhancements to the overall product offering.

The Company is slated to report its first quarter fiscal 2018 financial results on Monday, August 7, 2017.

HAE closed Friday's trading at $42.00, up 6.36%.

The FDA has asked Tenax Therapeutics Inc. (TENX) to conduct an additional clinical trial before it could submit an NDA for Levosimendan.

In the U.S., the Company is developing Levosimendan in two indications - for treatment of patients undergoing coronary artery bypass grafting to reduce the risk of low cardiac output syndrome, and treatment of patients with acute decompensated heart failure for improvement in symptoms.

Outside the US, Levosimendan is approved and marketed under the trade name of Simdax in over 60 countries for use in Acute Decompensated Heart Failure.

Given the size and scope of the additional trial, the Company is reviewing clinical, regulatory and financial options with regard to the Levosimendan program in the U.S. and Canada.

Tenax is reviewing strategic alternatives, which include, but are not limited to a merger, a business combination, a strategic investment into the Company, or a purchase, license or other acquisition of assets.

TENX closed Friday's trading at $0.68, up 2.39%.