PETX Has Its Day, AXIM On A High, CPRX Hands Out Pink Slips, CHRS Abuzz

(RTTNews) - Aratana Therapeutics Inc.'s (PETX) Entyce has been approved by the FDA's Center for Veterinary Medicine for appetite stimulation in dogs. The company intends to commercially launch the product in conjunction with the North American Veterinary Conference in February 2017.

Entyce, a ghrelin receptor agonist, is a new chemical entity and is a first-of-its-kind therapeutic to treat inappetence in dogs, says the company.

PETX closed Tuesday's trading at $6.05, down 0.66%. In after-hours, the stock was up 7.44% to $6.50.

AstraZeneca plc (AZN) said that Benralizumab achieved the primary endpoint in two pivotal phase III registrational trials, dubbed SIROCCO and CALIMA, demonstrating significant reductions in the annual asthma exacerbation rate compared to placebo.

The two trials evaluated the efficacy and safety of two dose regimens of Benralizumab as an add-on therapy for severe uncontrolled asthma with eosinophilic inflammation in adults and adolescents 12 years of age and older.

AZN closed Tuesday's trading at $28.79, unchanged from the previous day's close.

Shares of AXIM Biotechnologies Inc. (AXIM.OB) were up over 16% on Tuesday after the company announced that it has begun human clinical trials with AX-1602, the world's first patent-pending formulation containing cannabigerol and other cannabinoids, as a treatment for psoriasis and atopic eczema.

The AXIM AX-1602 ointment will be tested with different concentrations of cannabinoids and will be placebo controlled. Following the successful completion of the clinical trial, AXIM products will be registered as an ointment for various skin disorders, the company noted.

AXIM.OB closed Tuesday's trading at $0.48, up 16.55%.

Seeking to conserve cash, Catalyst Pharmaceuticals Inc. (CPRX) is reducing its workforce by approximately 30%.

The company is working towards NDA submission of Firdapse for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) and congenital myasthenic syndromes (CMS).

Catalyst Pharma's NDA for Firdapse, which was submitted to the FDA, last December, was issued a Refusal to File" letter in February of this year. The U.S. regulatory agency refused to review the NDA saying that it was not sufficiently complete, and requested additional supporting information.

The company continues to believe that its currently available resources will be sufficient to complete the development of and refile an NDA for Firdapse for LEMS and CMS.

CPRX closed Tuesday's trading at $0.55, down 7.28%.

Shares of Coherus Biosciences Inc. (CHRS) rose over 15% on Tuesday after the company received a favorable decision from the Patent Trial and Appeal Board in a case against AbbVie Inc. (ABBV) related to U.S. Patent 8,889,135 of blockbuster autoimmune disease drug Humira.

The U.S. Patent 8,889,135 is directed to a dosing regimen in which 40 mg of Humira is administered subcutaneously every 13 to 15 days to treat rheumatoid arthritis.

Coherus' CHS-1420, a biosimilar version of Humira, is under phase 3 study in psoriasis, with readouts expected in mid-2016 and BLA filing in the second half of 2016.

Coherus said that it is confident that the Patent Trial and Appeal Board decision will lead to a final decision nullifying the '135 Patent.

CHRS closed Tuesday's trading at $18.85, up 15.86%.

Genmab A/S' (GMXAY.OB) supplemental Biologics License Application for Arzerra in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed chronic lymphocytic leukemia has been granted priority review by the FDA, with a decision scheduled for September 10, 2016.

Arzerra received its first FDA approval in October 2009 as monotherapy for the treatment of patients with chronic lymphocytic leukemia who are refractory after prior treatment with fludarabine and alemtuzumab. In January of this year, the FDA approved Arzerra for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia.

GMXAY.OB closed Tuesday's trading at $77.39, up 0.60%.