JAZZ Hits Right Note, ENTA's Purse Set To Fatten, AEZS Put On Notice

(RTTNews) - Aeterna Zentaris Inc. (AEZS) (AEZ.TO) has been notified that it was no longer in compliance with NASDAQ Marketplace Rule 5550(a)(2) as its minimum bid price has fallen below $1.00 for 30 consecutive business days.

The company has time until June 16, 2015, to regain compliance with the minimum bid price requirement.

AEZS closed Friday's trading at $0.61, up 0.41%.

The FDA on Friday approved another new drug to treat chronic HCV infection - AbbVie Inc.'s (ABBV) Viekira Pak to treat patients with chronic HCV genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.

Viekira Pak contains three new drugs - Ombitasvir, Paritaprevir and Dasabuvir -that work together to inhibit the growth of HCV, and an already approved drug Ritonavir, which is used to increase blood levels of Paritaprevir.

Viekira Pak can be used with or without Ribavirin, but it is not recommended for patients whose liver is unable to function properly (decompensated cirrhosis).

Paritaprevir, one of the three direct-acting antivirals in the Viekira Pak regimen, was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals Inc. (ENTA). Therefore, the FDA approval of Viekira Pak triggers a $75 million regulatory approval milestone payment to Enanta from AbbVie.

ENTA closed Friday's trading 3.88% higher at $46.62. In after-hours, the stock gained another 4.65% and was at $48.79.

Jazz Pharmaceuticals plc (JAZZ) has received FDA approval for intravenous Erwinaze as an alternative method of administration to treat patients with acute lymphoblastic leukemia, who have developed an allergy to E. coli derived asparaginase chemotherapy drugs.

Erwinaze is already approved in intramuscular injection formulation by the FDA, and has been available since 2011. Outside of the U.S., Erwinaze is sold under the name Erwinase.

The regulatory approval of the expanded label for Erwinaze offers an alternative option for patients who cannot tolerate intramuscular injections.

Acute lymphoblastic leukemia, or ALL, is a type of cancer in which the bone marrow makes too many lymphocytes, a type of white blood cell. White blood cells help the body fight infection and are formed in the bone marrow. Asparaginase treatment is recommended as an important component of a multi-agent chemotherapy regimen in ALL.

Prior to Erwinaze's approval in 2011, there were two E. coli derived.asparagine specific enzyme products - Elspar (asparaginase injection) and Oncaspar (pegaspargase) - to treat patients with ALL.

JAZZ closed Friday's trading at $169.03, down 0.50%.

Myriad Genetics Inc. (MYGN) has received approval from FDA for BRACAnalysis CDx, an in vitro diagnostic device, to be used as the only companion diagnostic in conjunction with a new drug Lynparza.

AstraZeneca PLC's (AZN) Lynparza, a poly ADP-ribose polymerase (PARP) inhibitor, also received accelerated approval on Friday for the treatment for women with advanced ovarian cancer associated with defective BRCA genes.

BRACAnalysis CDx is Myriad's first FDA-approved companion diagnostic for use with a novel PARP inhibitor.

MYGN closed Friday's trading 2.39% higher at $36.42.

Orexigen Therapeutics Inc.'s (OREX) Mysimba has received positive opinion from European Medicines Agency's Committee for Medicinal Products For Human Use, recommending approval of the drug in the European Union as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults.

A binding decision on granting marketing authorization for Mysimba in the European union is expected in early 2015.

In the United States, the drug has been approved by the FDA and is marketed as Contrave by Orexigen's partner for North America, Takeda Pharmaceuticals since October of this year.

OREX closed Friday's trading at $6.33, up 0.64%.

Vascular Solutions Inc. (VASC) has received FDA clearance for its ZigiWire access support guidewire system, designed to facilitate placement and exchange of catheters during peripheral diagnostic or interventional procedures.

The company plans to launch ZigiWire in the U.S. next month.

VASC closed Friday's trading 2.90% down at $26.77.