CRDC Gets FDA Nod, SYN Surges On Trial Data, Lightlake Sees Opportunity Ahead

(RTTNews) - Aeterna Zentaris Inc. (AEZS) (AEZ.TO) has so far enrolled five patients in its confirmatory phase III clinical study of Macrilen for use in evaluating adult growth hormone deficiency.

The study is designed to enroll approximately 110 subjects, and based on the current rate of enrollment, the trial is expected to conclude by the end of 2016.

The company plans to submit a New Drug Application for Macrilen to the FDA by mid-year 2017 and, if all goes well as planned, the drug may be approved by year-end 2017.

AEZS closed Tuesday's trading at $3.12, up 16.85%.

Cardica Inc. (CRDC) has received FDA clearance to use its MicroCutter XCHANGE 30 surgical stapling device with a white cartridge for the transection and resection in open or minimally invasive urologic, thoracic, and pediatric surgical procedures.

MicroCutter XCHANGE 30 has already received regulatory clearance for use in surgical procedures in the small and large intestine and in the appendix.

The company is planning to introduce the surgical stapler in a limited launch to key opinion leaders throughout the United States, including those surgeons performing video assisted thoracic surgery (VATS) at the annual meeting of the Society of Thoracic Surgeons (STS) in Phoenix, Arizona later this month and leading pediatric surgeons at the American Pediatric Surgical Association annual meeting in San Diego in May 2016.

CRDC closed Tuesday's trading at $0.25, up 24.26%. In after hours, the stock was up 16.60% to $0.29.

Dynavax Technologies Corp. (DVAX) and AstraZeneca plc (AZN) have amended their existing Research Collaboration and License Agreement related to AZD1419, a novel candidate drug for asthma.

Under the amended deal, AstraZeneca will now conduct a phase IIa safety and efficacy trial of AZD1419 in asthma patients that was originally to be conducted by Dynavax. The phase IIa study is planned to be initiated this year.

DVAX closed Tuesday's trading at $21.18, up 0.62%.

Lightlake Therapeutics Inc.'s (LLTP.OB) commercial partner Adapt Pharma Ltd. Is all set to offer NARCAN Nasal Spray at discounted public interest price to 62,000 agencies in state and local government and the non-profit sector.

NARCAN Nasal Spray is the only FDA approved, ready-to-use, nasal spray version of naloxone hydrochloride, indicated for the emergency treatment of opioid overdose.

NARCAN Nasal Spray will be offered at a discounted price of $37.50 per dose ($75 for a 2 pack carton) through the U.S. Communities Purchasing Alliance and Premier Inc.

Under a licensing deal signed in December of 2014 with a subsidiary of Adapt, Lightlake could receive total potential milestone payments of more than $55 million, plus up to double-digit percentage royalties on net sales in exchange for licensing its opioid overdose reversal treatment.

The FDA approval of NARCAN Nasal Spray on November 18, 2015 triggered a milestone payment of $2 million to Lightlake from Adapt Pharma. Lightlake also expects to receive a $2.5 million milestone payment from Adapt after the prospective first commercial sale of NARCAN Nasal Spray in the U.S.

LLTP.OB closed Tuesday's trading at $8.50, down 1.16%.

NewLink Genetics Corp. (NLNK) is scheduled to present phase Ib data from a phase I/II trial examining the combination therapy of Indoximod plus gemcitabine/nab-paclitaxel in patients with metastatic pancreatic cancer on January 22, 2016 at the Gastrointestinal Cancers Symposium.

The phase I/II trial was initiated in August 2014.

NLNK closed Tuesday's trading at $25.71, up 0.39%.

Shares of Synthetic Biologics Inc. (SYN) were up over 34% in extended trading on Tuesday, following positive data from a second phase II trial of SYN-010 for the treatment of irritable bowel syndrome with constipation (IBS-C).

According to the trial results, SYN-010 demonstrated positive effect on decreasing gut methane production, abdominal pain and bloating, and improving stool frequency and quality of life scores in IBS-C patients who are breath-methane positive.

The company may request an end of phase II meeting with the FDA during the first half of 2016. A phase III program for SYN-010 is also being actively planned.

SYN closed Tuesday's trading at $1.52, down 5.59%. In after hours, the stock was up 34.87% to $2.05.