Panel Votes For AZN's Gout Drug, MNKD To Dual List, Positive Friday For AMGN

(RTTNews) - Amgen's (AMGN) IMLYGIC, also known as T-Vec, for the proposed treatment of patients with advanced melanoma has received a positive opinion from the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency.

Following this CHMP opinion, Amgen expects a decision on the Marketing Authorization from the European Commission in the coming months.

T-Vec (talimogene laherparepvec) is also under FDA review with a decision scheduled for Oct. 27, 2015. In April of this year, an FDA panel voted 22-1 to recommend approval of T-Vec as a treatment for patients with advanced melanoma.

AMGN closed Friday's trading at $155.75, up 2.26%.

Alexion Pharmaceuticals Inc.'s (ALXN) Strensiq (asfotase alfa), a first-in-class enzyme replacement therapy, for treatment of patients with infantile- and juvenile-onset hypophosphatasia, has been approved by the FDA.

Hypophosphatasia, or HPP, is a genetic, chronic, and progressive ultra-rare metabolic disease in which patients experience devastating effects on multiple systems of the body, leading to debilitating or life-threatening complications.

The FDA approved Strensiq under Priority Review, and had granted Breakthrough Therapy designation for Strensiq. With this approval, the FDA also issued a Rare Pediatric Disease Priority Review Voucher, which confers priority review to a subsequent drug application that would not otherwise qualify for priority review.

Strensiq will become available commercially by October 27, 2015. The drug was approved in Europe last month.

Analysts project peak sales of Strensiq to reach $1 billion.

ALXN closed Friday's trading at $171.16, up 2.64%. In after hours, the stock was up another 1.68% to $174.03.

An FDA panel, on Friday, voted 10-4 recommending approval of AstraZeneca plc's (AZN) Lesinurad 200 mg tablets for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor like Allopurinol or Febuxostat.

The FDA's final decision is set for December 29, 2015. Although the regulatory agency is not bound by the panel's recommendation, it often follows its advice.

Lesinurad came under AstraZeneca's fold following the acquisition of Ardea Biosciences Inc for approximately $1.26 billion in 2012. Bernstein analyst Tim Anderson expects Lesinurad to rake in sales of $582 million by 2020.

Lesinurad is also under regulatory review in the European Union and other territories.

AZN closed Friday's trading at $31.36, up 0.93%.

InVivo Therapeutics Holdings Corp. (NVIV) has reported that there is significant improvement in the first study patient in the ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with complete acute spinal cord injury.

In the time between the 6-month and 12-month post-injury assessments, the patient continued to demonstrate improvement in the American Spinal Injury Association (ASIA) lower extremity motor score with an additional 8 points gained on this 50 point score. The patient demonstrated additional bilateral improvements in the motor function of hip flexors and knee extensors and for the first time bilateral contractions of the ankle dorsiflexors and ankle plantar flexors, the company noted.

NVIV closed Friday's trading at $8.03, up 8.81%.

MannKind Corp.'s (MNKD) common shares have been approved for dual listing on the Tel Aviv Stock Exchange, beginning on October 28, 2015 under the ticker symbol MNKD.

Based on the current market capitalization, MannKind's shares are anticipated to be included in five TASE equity indexes: TASE's TA-75, TA-100, TA-BlueTech, TA-Tech-Elite and TA-Biomed.

Hakan Edstrom, President and CEO of MannKind said, "The new listing also offers an opportunity to expand and diversify our shareholder base by increasing our exposure and improving our accessibility to Israeli investors."

MNKD closed Friday's trading at $3.62, up 4.62%. In after-hours, the stock gained another 2.76% to $3.72.