FDA Panel Gives Thumbs Up To MRK's Allergy Pill, TXMD On A High, NYMX On Watch

(RTTNews) - Aratana Therapeutics Inc. (PETX), a pet therapeutics company, has been granted conditional approval by the United States Department of Agriculture for the company's AT-005, a canine-specific monoclonal antibody against antigen CD52, intended as an aid in the treatment of T-cell lymphoma in dogs.

This is the second Canine Lymphoma Monoclonal Antibody to receive conditional approval.

The company's canine B-cell lymphoma therapy, AT-004, received conditional approval from the USDA in 2012 and was licensed to Novartis Animal Health Inc. for commercialization in United States and Canada.

PETX closed Tuesday's trading 5.93% higher at $19.29.

The FDA panel has recommended approval of Merck & Co. Inc.'s (MRK) RAGWITEK, a ragweed sublingual allergy immunotherapy tablet.

RAGWITEK is developed for the treatment of ragweed pollen induced allergic rhinitis, with or without conjunctivitis, in adults 18 to 65 years of age.

The FDA's final decision on RAGWITEK is expected during the first half of 2014.

MRK closed Tuesday's trading at $52.87, up 0.65%.

Nymox Pharmaceutical Corp. (NYMX) said it expects results from the U.S. phase II study of NX-1207 for localized prostate cancer by the end of Q1 or early Q2 2014.

The company also noted that patient participation in the U.S. pivotal phase III study of NX-1207 for benign prostatic hyperplasia has been completed while patient participation in the second U.S. pivotal trial will be completed in Q2 2014.

NYMX closed Tuesday's trading down 4.88% at $5.85.

Teva Pharmaceutical Industries Ltd. (TEVA) has received FDA approval for a new formulation of its blockbuster multiple sclerosis treatment Copaxone. The newly approved three-times-a-week COPAXONE 40mg/mL subcutaneous injection offers patients and their physicians ability to dose less frequently.

The company said that the newly approved formulation of COPAXONE is available for shipping to distribution outlets immediately, and will be available to patients within days.

The daily COPAXONE 20 mg/mL subcutaneous injection was approved in 1996 and will continue to be available.

Teva derives a major part of its revenue from COPAXONE sales. Global revenues for COPAXONE were $1.05 billion in the third quarter ended Sep.30, 2013. The drug has patent exclusivity until May 24, 2014.

TEVA closed Tuesday's trading at $44.10, up 0.80%.

TherapeuticsMD Inc. (TXMD) touched a new 52-week high of $6.18 on Tuesday before closing at $5.88, following positive pharmacokinetic study results for its drug candidate TX 12-004-HR estradiol VagiCap for the treatment of vulvar vaginal atrophy.

According to the company, one of the studies compared relative bioavailability of 10µg of TX 12-004-HR with 10µg of Novo Nordisk's Vagifem. Another study compared 25µg of TX 12-004-HR to 25µg of Vagifem. The study results demonstrated that TX 12-004-HR estradiol VagiCap has lower systemic estradiol exposure while achieving statistically significant clinical efficacy.