AZN Gets FDA Nod, It's 22 More For ANIP, OHRP Catches Eyes, ANAC Soars

(RTTNews) - Anacor Pharmaceuticals Inc. (ANAC) soared over 55% on Monday following positive top-line results from its two phase III pivotal studies of Crisaborole Topical Ointment, 2% (formerly AN2728) in patients with mild-to-moderate atopic dermatitis.

According to the trial results, Crisaborole achieved statistically significant results on all primary and secondary endpoints in both studies and demonstrated a safety profile consistent with previous studies.

Anacor expects to submit a New Drug Application for Crisaborole to the FDA in the first half of 2016.

ANAC closed Monday's trading at $131.93, up 55.93%.

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ANI Pharmaceuticals Inc. (ANIP) has acquired 22 previously marketed generic drug products from Teva Pharmaceuticals (TEVA) for $25 million in cash and a percentage of future gross profits from product sales.

The acquisition includes 19 solid-oral dosage products, and 3 oral suspension products, and the total market value for the 22 products is $650 million on a trailing twelve month basis, per IMS Health.

ANIP closed Monday's trading at $67.19, up 7.99%.

AstraZeneca's (AZN) Iressa has been approved by the FDA for the first line treatment of advanced EGFR mutation-positive non-small cell lung cancer.

Iressa is a novel anti-cancer agent that works by blocking the signals for cancer cell growth and survival.

First launched in Japan in 2002, Iressa is approved in 91 countries.

AZN closed Monday's trading at $67.18, up 1.10%.

Cardiovascular Systems Inc. (CSII) has completed enrollment for its Coronary Orbital Atherectomy System Trial, which is assessing the safety, efficacy and economic outcomes of the company's new micro crown Orbital Atherectomy System.

The micro crown Orbital Atherectomy System is designed for treating severely calcified coronary lesions in patients suffering from Coronary Artery Disease.

Taking place in both Japan and the United States, the trial, dubbed COAST, has enrolled a total of 100 patients, and the 30-day data will be presented in calendar 2016.

CSII closed Monday's trading 3.70% higher at $30.81.

Corbus Pharmaceuticals Holdings Inc. (CRBP) has commenced dosing in a phase II clinical study of its investigational drug Resunab for the treatment of skin-predominant dermatomyositis.

The phase II trial will test safety, tolerability, clinical efficacy, biomarkers, and mechanism of action of Resunab in 22 adult subjects whose skin-predominant dermatomyositis is refractory to standard-of-care. Patients will receive oral Resunab or placebo once a day for 28 days, then twice a day for the next 56 days, for a total treatment duration of 84 days, with 28 days follow-up.

The study is expected to be completed in early 2017.

CRBP closed Monday's trading at $2.94, down 1.67%.

Depomed Inc. (DEPO) has adopted a "poison pill" strategy to ward off the hostile takeover bid by Horizon Pharma plc (HZNP).

Last week, Horizon Pharma proposed to acquire Depomed in an all-stock transaction valued at $29.25 per share. Depomed shares have gained 48% since the buyout offer.

DEPO touched a lifetime high of $30.64 on Monday before closing the day's trading at $30.51, up 1.23%.

Five Prime Therapeutics Inc. (FPRX) has initiated patient dosing in its phase 1/2 clinical trial of FPA008, a CSF1 receptor antibody, in pigmented villonodular synovitis.

Pigmented villonodular synovitis, or PVNS, is characterized by inflammatory tumor growth in and around a joint cavity.

In the phase I dose escalation part of the trial, Five Prime will assess the safety and pharmacodynamics of multiple ascending doses of FPA008 to determine the dose for expansion. During the phase II expansion phase, the company will evaluate response rate and duration, as well as measures of pain and joint function, in approximately 30 patients.

The company expects initial data from the phase 1 dose escalation portion by late 2015 or early 2016.

FPRX closed Monday's trading at $26.13, up 0.46%.

Shares of Ohr Pharmaceutical Inc. (OHRP) soared more than 62% on Monday following positive results of a phase II study of its drug candidate OHR-102 in retinal vein occlusion.

According to the study results, patients who continued to receive a combination of topical OHR-102 BID plus Lucentis, following an initial 10 week combination therapy treatment period, achieved greater visual acuity gains than the control group who received Lucentis alone.

OHRP closed Monday's trading at $3.69, up 62.56%.

pSivida Corp.'s (PSDV) phase II investigator-sponsored study of Medidur for uveitis affecting the posterior of the eye has demonstrated a statistically significant reduction in recurrence of the disease and statistically significant improvement in visual acuity.

Medidur is an injectable micro-insert designed to treat posterior uveitis that provides sustained release of flucinolone acetonide (a corticosteroid) for three years.

Two phase III trials with Medidur for posterior uveitis are underway. The company expects top line results from the first phase III trial of Medidur to be available in Q2 2016.

PSDV closed Monday's trading at $4.30, up 5.39%.

Thoratec Corp.'s (THOR) HeartMate PHP has received CE Mark approval, permitting sale in the European Union and other international countries.

HeartMate PHP (Percutaneous Heart Pump) is an acute cardiac assist device designed to uncouple the traditional relationship between size and flow in catheter-based support devices.

The HeartMate PHP European launch will include a measured rollout to targeted countries, staged through the balance of 2015 and 2016, noted the company.

THOR closed Monday's trading at $46.04, up 1.86%.