SGYP On Watchlist, BXLT Seeks New Use For Hemophilia Drug, ZTS Gets FDA Nod

(RTTNews) - Allergan plc (AGN) has received FDA approval for ACZONE Gel, 7.5%, a new prescription topical treatment for acne in patients 12 years of age and older. The product will be available in May 2016 nationwide, according to the company.

In 2008, Allergan acquired ACZONE Gel 5% product, a topical treatment for acne vulgaris, from QLT Inc. (QLTI).

AGN closed Thursday's trading 4.09% higher at $296.34.

Baxalta Inc. (BXLT) has submitted its supplemental Biologics License Applications to the FDA seeking approval for the use of ADYNOVATE to treat children under the age of 12 with hemophilia A and for use in surgical settings.

ADYNOVATE was approved by the FDA in November 2015 for use in adolescent and adult hemophilia A patients (12 years and older) for prophylaxis to reduce the frequency of bleeding episodes and on-demand treatment and control of bleeding.

The company plans to seek approval of ADYNOVATE in Europe this quarter. The product is also under regulatory review in Canada and Switzerland.

BXLT closed Thursday's trading at $39.50, up 1.33%.

UCB has terminated the Epratuzumab licensing agreement with Immunomedics Inc. (IMMU) that was inked in May 2006.

Consequently, Immunomedics regains the worldwide rights of Epratuzumab for all non-cancer indications.

Epratuzumab is being studied in a phase III clinical trial in pediatric patients with acute lymphoblastic leukemia sponsored by a European consortium, and Bayer has begun studying Epratuzumab as a thorium-227-labeled antibody in patients with advanced non-Hodgkin lymphoma, said Immunomedics.

IMMU closed Thursday's trading at $2.07, down 1.90%.

Synergy Pharmaceuticals Inc. (SGYP) expects to report top-line results from the first phase III trial of its drug candidate Plecanatide in irritable bowel syndrome with constipation in the first half of this year and top-line results from the second phase III IBS-C trial in the second half of this year.

The company submitted its NDA for Plecanatide in chronic idiopathic constipation last month.

SGYP closed Thursday's trading at $3.70, up 4.52%.

Ultragenyx Pharmaceutical Inc. (RARE) has a couple of catalysts to watch out for this year.

The company expects interim phase II study data of KRN23 anti-FGF23 monoclonal antibody in Tumor-Induced Osteomalacia in the first half of 2016.

A phase III study of rhGUS in Mucopolysaccharidosis 7 is fully enrolled, and data are expected in mid-2016.

A phase II study of UX007 in Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD) and Glut1 Deficiency Syndrome is underway - with data expected in the second half of 2016.

Enrollment in a pivotal phase III study of Aceneuramic Acid Extended Release (Ace-ER) in GNE Myopathy is ongoing. Data from the study are expected in 2017.

RARE closed Thursday's trading at $60.85, down 3.01%.

Zoetis Inc.'s (ZTS) Simparica chewables, a once-monthly flea and tick medication for dogs has received FDA approval. This easy-to-administer chewable tablet delivers fast and persistent protection over 35 days from fleas and ticks, without losing efficacy at the end of the month, according to the company.

ZTS closed Thursday's trading at $42.90, up 1.25%.