TTHI, HBIO Put On Notice, Elite Gets FDA Date, VYGR Gets Ready To Sail

(RTTNews) - ARCA biopharma Inc.'s (ABIO) phase IIb/phase III clinical trial comparing the safety and efficacy of Gencaro to Toprol-XL for the treatment of atrial fibrillation is underway. The company expects outcome of interim analysis of phase IIb efficacy data in the first half of 2017.

ABIO closed Thursday's trading at $3.73, up 3.32%.

Harvard Bioscience Inc. (HBIO) has received a notice from NASDAQ for not filing its Annual Report on Form 10-K for the year ended December 31, 2015 by the due date of March 15, 2016.

The company has been given time until May 16, 2016 to submit a plan of compliance to the NASDAQ.

HBIO closed Thursday's trading at $2.77, up 0.73%.

Kura Oncology Inc.'s (KURA) lead product candidate Tipifarnib is under three phase II clinical trials.

A phase II trial of Tipifarnib in patients with advanced tumors that carry HRAS mutations, initiated last May, is underway - with top-line data anticipated during the second half of 2016.

Another phase II clinical trial of Tipifarnib was initiated in patients with advanced urothelial carcinoma tumors with HRAS mutations in November of 2015.

A phase II clinical trial of Tipifarnib in patients with relapsed or refractory peripheral T-cell lymphoma, initiated last September, is progressing ahead, and topline data are anticipated in the second half of 2017.

KURA closed Thursday's trading at $4.45, up 3.01%.

CymaBay Therapeutics Inc.'s (CBAY) pilot phase II clinical study of MBX-8025 in patients with homozygous familial hypercholesterolemia has yielded positive results.

According to the study results, MBX-8025 provided a clinically meaningful reduction in low-density lipoprotein cholesterol (LDL-C) for a subset of patients.

CBAY closed Thursday's trading at $1.70, up 10.39%. In after hours, the stock was down 7.06% to $1.58.

Elite Pharmaceuticals Inc.'s (ELTP.OB) New Drug Application for SequestOX has been granted priority review, and the FDA's decision is set for July 14, 2016.

SequestOx is an immediate-release Oxycodone Hydrochloride containing sequestered Naltrexone which incorporates 5 mg, 10 mg, 15 mg, 20 mg and 30 mg doses of oxycodone into capsules.

ELTP.OB closed Thursday's trading at $0.34, up 13.52%.

Transition Therapeutics Inc. (TTHI) (TTH.TO) has been notified by The NASDAQ Stock Market that the bid price of the company's shares are not in compliance with the Minimum Price Requirement.

The company has been given time until September 12, 2016, to regain compliance. All available options are being considered by it to regain compliance with the Minimum Price Requirement.

TTHI closed Thursday's trading at $0.9734, down 1.68%.

Voyager Therapeutics Inc.'s (VYGR) phase 1b clinical trial of VY-AADC01 in patients with advanced Parkinson's disease is enrolling participants. The top-line human proof-of-concept data from this data are expected in the fourth quarter of 2016.

The company ended the year 2015, with cash of approximately $224 million, which is expected to be enough to support operations into 2019.

VYGR closed Thursday's trading at $10.56, up 2.23%.