AZN Breathes Easy, EXEL Scores FDA Nod, SRPT Disappointed, PETX On The Rise

(RTTNews) - Shares of Aratana Therapeutics Inc. (PETX) were up over 15% in extended trading on Monday, after the company announced a Collaboration, License, Development and Commercialization Agreement with Eli Lilly and Co. (LLY).

Elanco Animal Health, Lilly's animal health division, has been granted rights to develop, manufacture, market and commercialize Aratana's products based on licensed grapiprant rights and technology, including GALLIPRANT, an FDA-approved therapeutic for the control of pain and inflammation associated with osteoarthritis in dogs.

PETX closed Monday's trading at $6.91, down 4.29%. In after hours, the stock was up 15.77% to $8.00.

AbbVie's (ABBV) supplemental New Drug Application for the use of VIEKIRA PAK without ribavirin in patients with genotype 1b chronic hepatitis C virus infection and compensated cirrhosis has been approved by the FDA.

VIEKIRA PAK is a fixed dose formulation of ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets. Paritaprevir is Enanta's lead protease inhibitor identified within the ongoing Enanta-AbbVie collaboration.

VIEKIRA PAK received its first FDA approval in December 2014 to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.

VIEKIRA PAK registered total sales of $1.64 billion in 2015, and is expected to bring in total revenue of $2 billion this year.

ABBV closed Monday's trading at $60.97, down 0.73%.

AstraZeneca plc (AZN) has scored FDA approval for BEVESPI AEROSPHERE inhalation aerosol, which is indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease.

BEVESPI AEROSPHERE is a twice-daily, fixed-dose dual bronchodilator combining glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta-2 agonist (LABA). The product is not indicated to treat asthma or for the relief of acute bronchospasm.

AZN closed Monday's trading at $30.01, down 0.30%. In after hours, the stock was up 1.63% to $30.50.

On May 6, 2016, AveXis Inc. (AVXS) will present data as of April 1, 2016 from the ongoing phase 1 clinical trial of AVXS-101 in Spinal Muscular Atrophy Type 1.

This gene therapy company for neurological diseases went public on the Nasdaq on February 11, 2016, priced at $20 per share.

AVXS closed Monday's trading at $22.71, down 1.35%.

Shares of Exelixis Inc. (EXEL) were up over 6% in extended trading on Monday, following FDA approval for CABOMETYX for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. The FDA approval comes nearly two months ahead of the decision date of Jun 22, 2016.

CABOMETYX is also under accelerated assessment by the EMA and a decision is expected by the end of June 2016.

EXEL closed Monday's trading 5.67% higher at $4.66. In after hours, the stock was up 6.01% to $4.94.

The FDA panel has voted down Sarepta Therapeutics Inc.'s (SRPT) Eteplirsen, proposed for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping.

The advisory committee voted 6-7 against the finding of substantial evidence from adequate and well controlled studies that show that Eteplirsen induces production of dystrophin to a level that is reasonably likely to predict clinical benefit.

In addition, the panel members voted 3 - 7, with three abstentions, against finding substantial evidence based on the clinical results of the single historically controlled study that Eteplirsen is effective for treatment of DMD.

The FDA's final decision is set for May 26, 2016. The FDA usually follows the recommendations of its advisory panels, although it is not mandatory to do so.

SIGA Technologies Inc. (SIGA.OB) has begun enrolling the second and final cohort of healthy subjects for the phase III study of its lead drug candidate, TPOXX, for the treatment of orthopoxvirus.

The initial phase III lead cohort of 40 subjects in the trial has already completed participation without any reports of serious adverse events.

TPOXX is being developed under the FDA "Animal Rule,", and therefore there are no efficacy endpoints in the clinical trial.

SIGA.OB closed Monday's trading at $1.00, up 2.04%.