DERM Awaits Data In Q2, Epic Insights Of MSTX, FOMX Climbs After-Hours

(RTTNews) - AbbVie's (ABBV) supplemental New Drug Application for VIEKIRA PAK without ribavirin in patients with genotype 1b chronic hepatitis C virus and compensated cirrhosis has been accepted by the FDA under priority review status.

The priority review shortens the review period from the standard 10 months to 6 months. This means that the FDA is likely to announce its decision in June of this year.

Approved in December 2014, Viekira Pak is a prescription medicine used with or without ribavrin to treat adults with genotype 1 chronic HCV infection, including people who have a certain type of cirrhosis (compensated).

ABBV closed Thursday's trading at $57.21, down 0.30%.

Dermira Inc. (DERM) has completed patient enrolment in its phase 2b trial of DRM01 in patients with facial acne vulgaris, and topline efficacy and safety results are anticipated in the second quarter of 2016.

Additionally, with enrolment in its phase III clinical trials of DRM04, a potential treatment for axillary hyperhidrosis (excessive underarm sweating), progressing faster than expected, the topline results are now slated for release mid-2016 compared to previous guidance of the second half of 2016.

DERM closed Thursday's trading at $31.29, down 5.18%.

Shares of Foamix Pharmaceuticals Ltd. (FOMX) were up more than 6% in extended trading on Thursday, following positive results from a phase I maximum use pharmacokinetics study of FMX-101 for the treatment of moderate-to-severe acne.

The phase I study was intended to characterize the systemic absorption of minocycline after repeated maximum dose applications of FMX-101 in subjects with moderate-to-severe acne and assess the relative bioavailability of FMX-101 compared to FDA-approved Solodyn.

According to the trial results, relative bioavailability (systemic exposure) of FMX-101 was more than 100 times lower than that for Solodyn. FMX-101 was well tolerated, and no serious adverse events were reported in the study.

FOMX closed Thursday's trading at $8.04, down 1.11%. In after hours, the stock was up 6.34% at $8.55.

Harvard Apparatus Regenerative Technology Inc. (HART), in collaboration with Mayo Clinic, is all set to advance the development of its esophagus, trachea and bronchus organ implants.

Accordingly, large-animal bioengineered organ implant surgeries have been scheduled for January 22 and February 2, 2016, with additional procedures to occur through mid-February, said the company.

Harvard Apparatus noted that it remains committed to advancing its platform development toward its 2016 goals of filing with the FDA to initiate human clinical trials as well as pursuing compassionate use surgeries in humans.

HART closed Thursday's trading at $2.00, down 0.50%.

Integra LifeSciences Holdings Corp. (IART) has received FDA approval for a new indication for its Integra Dermal Regeneration Template - this time for the treatment of diabetic foot ulcers.

The Integra Template was first approved in 1996 for the treatment of life-threatening thermal injuries when the use of a patient's own skin for a graft was not possible. In 2002, it was approved to treat patients undergoing reconstructive surgery for burn scars when they cannot have skin grafts.

Integra Dermal Regeneration Template, with its newly approved diabetic foot ulcer indication, will be marketed under the name Integra Omnigraft Dermal Regeneration Template, and will be commercially launched in mid-2016, according to the company.

IART closed Thursday's trading at $66.54, down 0.43%.

Mast Therapeutics Inc.'s (MSTX) pivotal phase III study of its lead product candidate, Vepoloxamer, in sickle cell disease, which recently surpassed the 90% mark, is expected to complete patient enrolment next month.

The company expects to report top-line results from the study, dubbed EPIC, in the second quarter of 2016.

Patient enrolment in a placebo-controlled phase 2a study of AIR001, designed to measure its effect on cardiovascular hemodynamics in patients suffering from heart failure with preserved ejection fraction, has been completed. Top-line results from this 30-patient, investigator-sponsored study are expected to be available this month.

MSTX closed Thursday's trading at $0.43, down 0.42%.