OPXA Hands Out Pink Slips, KOOL Not So Hot, Time To Follow RVNC

(RTTNews) - The FDA has granted approval for broader use of AstraZeneca's (AZN) breast cancer drug FASLODEX to include use in combination with Pfizer Inc.'s (PFE) breast cancer medication, Ibrance (palbociclib).

The combination use is for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer whose cancer has progressed after endocrine therapy.

FASLODEX has been approved since 2002 as a monotherapy for the treatment of postmenopausal women with HR+ metastatic breast cancer whose cancer has progressed following antiestrogen therapy.

Sales of FASLODEX in 2015 were $704 million, down 2% compared to 2014.

AZN closed Wednesday's trading at $29.01, down 0.03%.

BioMarin Pharmaceutical Inc.'s (BMRN) phase 1/2 pivotal study of its investigational product Cerliponase alfa to treat children with CLN2 disease, a form of Batten disease, has yielded positive results.

According to the study results, in patients receiving Cerliponase alfa treatment there was about 80% reduction in clinical disease progression in one year than in the untreated population over a 48-week period.

Cerliponase alfa was also well-tolerated and resulted in disease stabilization in 65% of patients treated over a 48-week period, said the company.

BioMarin plans to submit marketing applications for Cerliponase alfa with the FDA and European Medicines Agency by mid-year 2016 with anticipated actions by the FDA and EMA in the first half of 2017.

BMRN closed Wednesday's trading at $87.44, down 0.15%.

Catabasis Pharmaceuticals Inc. (CATB), which reported positive top-line results from Part A portion of its phase I/II trial of CAT-1004 for boys aged 4-7 with Duchenne muscular dystrophy, regardless of the underlying mutation, expects to initiate the 12-week Part B efficacy portion of the trial in the first half of 2016. Topline results from Part B portion are expected in late 2016, contingent on patient enrollment.

A phase IIa trial of CAT-2054 in hypercholesterolemia is underway, and top-line results are expected in Q3 2016.

CATB closed Wednesday's trading at $4.40, up 4.76%.

Cesca Therapeutics Inc. (KOOL) has announced a 1-for-20 reverse stock split of its common stock, which will become effective as of 5:00 p.m. Pacific time on March 4, 2016.

The reverse stock split has been implemented with the objective of regaining compliance with the minimum bid price listing maintenance requirements of The Nasdaq Capital Market, and increase the number of shares of Common Stock available for issuance.

KOOL closed Wednesday's trading at $0.24, up 6.02%.

GlycoMimetics Inc. (GLYC) has observed encouraging anti-leukemic activity in patients with advanced acute myeloid leukemia in phase 1 portion of its phase 1/2 trial of GMI-1271.

Of the first 13 evaluable patients, GMI-1271 in combination with chemotherapy produced an overall response rate of 62%. GMI-1271 was also well tolerated in this group of 13 patients, according to the company.

GLYC closed Wednesday's trading at $4.39, down 2.44%.

Opexa Therapeutics Inc. (OPXA) is reducing its work force by approximately 30%, a move which will extend its current cash runaway into the first quarter of 2017.

The company is preparing to complete its phase IIb Abili-T study in secondary progressive multiple sclerosis patients, and top-line data are expected in early Q4 2016.

OPXA closed Wednesday's trading at $2.29, down 2.56%.

Revance Therapeutics Inc. (RVNC) is a stock to put on your radar as the company has a couple of catalysts up its sleeve, which are worth following.

The company's product candidate DaxibotulinumtoxinA Topical Gel (RT001) is under a phase III trial for patients with moderate to severe lateral canthal lines (crow's feet). The top-line results from this trial, dubbed REALISE 1, are expected by the end of the second quarter of 2016.

Last December, the company announced positive interim results from a phase II trial of DaxibotulinumtoxinA Topical Gel for axillary hyperhidrosis. An additional, larger phase II trial is expected to be initiated in the second half of 2016.

An end-of-Phase 2 meeting with the FDA related to DaxibotulinumtoxinA for Injection for the treatment of glabellar (frown) lines is planned for the first half of 2016. Revance expects to initiate a phase III clinical program for DaxibotulinumtoxinA for Injection in the second half of 2016.

Additionally, interim results from the first cohort of a phase II dose-escalating clinical trial of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia are expected in the first half of 2016.

RVNC closed Wednesday's trading at $17.81, up 1.66%. In after hours, the stock was up 9.49% to $19.50.