CPRX Snubbed, PETX On The Move, AERI Rockets, PTLA Gets FDA Date

(RTTNews) - Aratana Therapeutics Inc. (PETX) has filed a Marketing Authorization Application with the European Medicines Agency for Galliprant, intended to treat pain and inflammation in dogs with osteoarthritis. The EMA has started reviewing the submission and Aratana anticipates marketing authorization in 2017.

In the U.S., Galliprant is under FDA review - with a decision date set for March 25, 2016.

PETX closed Wednesday's trading 8.74% higher at $3.36. In after hours, the stock was up another 8.33% to $3.64.

Shares of Aerie Pharmaceuticals Inc. (AERI) were up over 16% in extended trading on Wednesday, following 12-month interim safety results from its second phase III registration trial for Rhopressa.

The study, dubbed Rocket 2, evaluated Rhopressa, a novel once-daily eye drop for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.

The company reported positive efficacy results from the Rocket 2 trial last September. The Rocket 2 trial is expected to be part of Aerie's NDA filing for Rhopressa, which is likely to be submitted to the FDA in the third quarter of 2016.

AERI closed Wednesday's trading at $14.84, up 6.46%. In after hours, the stock was up 16.58% to $17.30.

Shares of Catalyst Pharmaceuticals Inc. (CPRX) plunged 37% on Wednesday after the company's New Drug Application for Firdapse, an investigational drug candidate for the symptomatic treatment of Lambert Eaton myasthenic syndrome and congenital myasthenic syndromes was not accepted for review by the FDA.

In its "Refusal to File" letter, the regulatory agency said that the application, which was submitted in December 2015, was not sufficiently complete, and has sought additional supporting information.

CPRX closed Wednesday's trading at $1.16, down 37.30%.

Seeking to explore the potential of Xiaflex in additional indications, Endo International plc (ENDP) (ENL.TO) has initiated a phase 2b study of Xiaflex for the treatment of edematous fibrosclerotic panniculopathy ("EFP"), commonly known as cellulite.

The phase 2b trial is expected to enroll 350 women aged 18 years or older in the United States. Each subject will receive up to three treatment sessions of Xiaflex or placebo, with each treatment session occurring approximately 21 days apart. Twelve injections will be administered into cellulite dimples during each session across an entire treatment quadrant - left or right buttock or left or right posterior thigh, according to the company.

Xiaflex is a biologic approved in the U.S., EU, Canada, Australia and Japan for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord and in the U.S. and EU for the treatment of adult men with Peyronie's disease (PD) with a palpable plaque and penile curvature deformity of at least 30 degrees at the start of therapy.

The product sales of Xiaflex to Endo in the first nine months of 2015 were $107.92 million.

ENDP closed Wednesday's trading at $52.76, up 2.29%.

Lightlake Therapeutics Inc. (LLTP.OB) has changed its name to Opiant Pharmaceuticals Inc. to better represent its historical core focus of opioid antagonist treatments.

The company's commercial partner Adapt Pharma Ltd. received FDA approval for its ready-to-use, nasal spray version of naloxone hydrochloride, NARCAN Nasal Spray, for the emergency treatment of opioid overdose last September.

LLTP.OB closed Wednesday's trading at $8.65, up 1.14%.

Portola Pharmaceuticals' (PTLA) Biologics License Application for Andexanet alfa has been accepted for priority review by the FDA - with a decision date set for August 17, 2016.

The company is seeking approval of Andexanet alfa for patients treated with a direct or indirect Factor Xa inhibitor when reversal of anticoagulation is needed, such as in life-threatening or uncontrolled bleeding or for emergency surgery and urgent procedures.

Currently, there is no FDA-approved antidote for patients treated with Factor Xa inhibitors. Portola estimates that at present, more than 100,000 U.S. patients may benefit from an antidote. By the year 2020, this number is expected to increase to up to 500,000 patients in the G7 countries.

If approved, Andexanet alfa will become the first universal antidote for Factor Xa inhibitors and the standard of care for managing major bleeding among patients on Factor Xa inhibitors.

PTLA closed Wednesday's trading at $31.42, up 1.35%. In after hours, the stock was up 5% to $32.99.