Cool Results From ZLTQ, TNDM On Watch, NEOS Resubmits NDA, Ascent Of ASND

(RTTNews) - Shares of Ascendis Pharma A/S (ASND) touched a new high on Thursday, following the company's positive top-line results from a six-month phase II study of once-weekly TransCon Growth Hormone in 53 treatment-naïve, pre-pubertal children with growth hormone deficiency, or GHD.

According to the trial results, the mean annualized height velocities ranged from 11.9 cm to 13.9 cm among three dosing levels of TransCon Growth Hormone, administered once-weekly compared to 11.6 cm for active comparator, daily injections of Genotropin. There were no reports of drug-related serious or unexpected adverse events, according to the company.

The company plans to initiate a phase III pediatric study of TransCon Growth Hormone in mid-2016.

ASND touched a new high of $23.81 on Thursday before closing the day's trading at $20.87, up 4.72%.

Cipher Pharmaceuticals Inc. (CPHR) (CPH.TO) expects to submit Ozenoxacin, a topical treatment for adult and paediatric patients with impetigo, a highly contagious bacterial skin infection, for regulatory approval in Canada in the first quarter of 2016.

Cipher acquired the Canadian commercialization rights to Ozenoxacin from Ferrer, a privately-held Spanish pharmaceutical company, in January 2015.

Ferrer expects a first regulatory filing of Ozenxacin in Europe in the first quarter of 2016 and expects their U.S. license partner to file for U.S. regulatory approval also in the first quarter of 2016.

CPHR closed Thursday's trading at $8.50, down 1.28%.

Juno Therapeutics Inc. (JUNO) has received FDA clearance to initiate a phase II trial of JCAR015 in adult patients with relapsed/refractory acute lymphoblastic leukemia.

The trial, which is scheduled to begin in the near term, with the potential to file for registration by late 2016 or early 2017, will open at 14 clinical sites in the U.S. and enroll approximately 90 subjects.

JUNO went public last December, priced at $24 a share. The stock closed Thursday's trading at $47.77, down 0.35%.

Neos Therapeutics Inc. (NEOS) has resubmitted a New Drug Application to the FDA for its amphetamine XR orally disintegrating tablet product candidate, NT-0202, for the treatment of attention deficit hyperactivity disorder, or ADHD.

The NDA for NT-0202 was issued a Complete Response Letter by the FDA in September 2013, and the company was requested to submit additional data. The resubmitted NDA addresses the regulatory agency's concerns, according to the company. This submission is a Class 2 resubmission, with a target six-month PDUFA review period.

Cotempla XR-ODT, the company's another drug candidate for ADHD, is under FDA review, with a decision date set for November 9, 2015.

The company went public as recently as July 23, 2015, priced at $15.00 per share. NEOS closed Thursday's trading at $19.56, down 2.78%.

Novavax Inc.'s (NVAX) phase II clinical trial of its recombinant quadrivalent seasonal influenza virus-like particle vaccine candidate (Seasonal Influenza VLP) has demonstrated that the Seasonal Influenza VLP vaccine candidate was well-tolerated with no vaccine-related serious adverse events. The trial met its immunogenicity targets and demonstrated potential to meet the Center for Biological Evaluation and Research criteria for accelerated approval, noted the company.

NVAX closed Thursday's trading 1.42% higher at $12.11.

Synergy Pharmaceuticals Inc.'s (SGYP) second of two pivotal phase III clinical trials of Plecanatide in adult patients with chronic idiopathic constipation has met the primary endpoint.

The company said it has now successfully completed the two largest phase III trials ever conducted in chronic idiopathic constipation and Plecanatide's treatment effect and tolerability profile have been remarkably consistent.

SGYP closed Thursday's trading 4.63% higher at $8.59.

Tandem Diabetes Care Inc. (TNDM), the manufacturer of t:slim and t:flex Insulin Pumps, has reported better-than-expected sales for the second quarter ended June 30, 2015.

Sales for Q2, 2015 were $15.7 million, topping analysts' consensus estimate of $14.92 million. The company's sales in the comparable year-ago quarter was $10.3 million.

Looking ahead to the year ending December 31, 2015, the company expects sales to be in the range of $70.0 million to $75.0 million. This compares with sales of $49.72 million in 2014.

TNDM closed Thursday's trading at $11.54, up 0.17%.

Shares of ZELTIQ (ZLTQ), the maker of Coolsculpting device, were up more than 10% in extended trading on Thursday, following exceptionally strong quarterly results and upwardly revised 2015 revenue outlook.

Total revenue for the second quarter ended June 30, 2015 was $64.4 million compared to $47.1 million in the year-ago quarter.

For full year 2015, the company has revised its revenue outlook again. The company now expects revenue in the range of $245 million to $247 million, up from its previous expectations of $235 million to $238 million.

ZLTQ closed Thursday's trading at $32.11, up 1.10%. In after hours, the stock was up 10.87% to $35.60.