AMGN Gets FDA Date, PETX On The Move, CTIX Awaits Data In Q2, SHPG Makes 2nd Try

(RTTNews) - Amgen's (AMGN) Biologics License Application for ABP 501, a biosimilar candidate to Humira, has been accepted for review by the FDA.

The Biologics License Application was submitted based on phase III results of ABP 501 in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.

The FDA's decision on ABP 501 is set for September 25, 2016.

AbbVie Inc's (ABBV) Humira, which is indicated in the treatment of rheumatoid arthritis, plaque psoriasis, Crohn's disease, ulcerative colitis, psoriatic arthritis and ankylosing spondylitis, was the world's top-selling drug in 2014 - with global sales of $12.5 billion. The company is expected to report 2015 Humira sales of roughly $14 billion when it releases Q4 results this week.

AMGN closed Monday's trading at $153.43, down 1.70%.

Shares of Aratana Therapeutics Inc. (PETX) were up over 25% in extended trading on Monday after the company announced the filing for Galliprant for the control of pain and inflammation in dogs with osteoarthritis with the FDA's Center for Veterinary Medicine.

The regulatory agency's decision on Galliprant is set for March 25, 2016. The company anticipates commercial availability of Galliprant to veterinarians in fall 2016.

PETX closed Monday's trading at $3.19, up 1.59%. In after hours, the stock was up 25.08% to $3.99.

Cellceutix Corp.'s (CTIX.OB) phase II clinical trial of Prurisol for the treatment of chronic plaque psoriasis is nearing completion - with data expected in the second quarter of this year.

The trial, originally designed to enroll 100 subjects has actually enrolled 115 subjects. The primary efficacy endpoint will be the percentage of subjects with greater than or equal to a 2-point improvement in Investigator's Global Assessment (IGA) rating as defined by visual inspections of patient lesions. The final study visit for the last subject is expected early in April 2016, with top-line data anticipated approximately four weeks later, noted the company.

CTIX.OB closed Monday's trading at $1.26, down 0.79%.

Shares of OncoMed Pharmaceuticals Inc. (OMED) fell to a 52-week low of $9.15 on Monday after an independent data safety monitoring board suggested that a phase II trial of the company's drug candidate Tarextumab in combination with Abraxane plus Gemcitabine in pancreatic cancer patients shows a "low likelihood of a statistically significant benefit in overall survival".

The study, dubbed ALPINE, completed enrollment of 177 patients in August 2015.

Paul Hastings, Chairman and CEO of the company said, "Our aim is to quickly unblind the trial and work with our clinical sites and investigators to verify, analyze, interpret, and fully understand the data, including Notch biomarker subgroup trends, and determine next steps".

OMED closed Monday's trading at $10.04, down 42.86%.

Shire plc (SHPG) has resubmitted the New Drug Application to the FDA for its investigational candidate, Lifitegrast, for the treatment of signs and symptoms of dry eye disease in adults.

Lifitegrast was issued a complete response letter last October - with the FDA requesting requested more information related to product quality.

The resubmitted NDA includes data from a phase III study of Lifitegrast, known as OPUS-3, and the information requested by the FDA regarding product quality.

The FDA has 30 days after resubmission of an NDA to acknowledge receipt and determine if the submission is a complete response. If accepted for review, the FDA will announce its decision within six months of the date of submission - i.e. in July of this year.

SHPG closed Monday's trading at $180.81, down 0.80%.

TRACON Pharmaceuticals' (TCON) investigational drug TRC105 has been granted orphan drug status by the FDA for the treatment of patients with soft tissue sarcoma.

TRC105 is under multiple phase II clinical trials sponsored by both TRACON and the National Cancer Institute for the treatment of multiple solid tumor types in combination with VEGF inhibitors.

TCON closed Monday's trading at $8.68, down 3.45%.