ASND Descends, IG Results Disappoint, NVGN Back On Track, All Eyes On ONCE

(RTTNews) - Shares of Ascendis Pharma A/S (ASND) were down more than 12% in extended trading on Tuesday, following disappointing results from the company's phase 1 single ascending dose study of TransCon Treprostinil in healthy volunteers, which assessed the pharmacokinetics of the drug, as well as injection tolerability and safety parameters.

TransCon Treprostinil is the company's investigational drug for the treatment of pulmonary arterial hypertension, or PAH.

While pharmacokinetic results observed in the phase I study were encouraging - with TransCon Treprostinil producing dose-dependent increases in plasma treprostinil levels in-line with expectations, Treprostinil-related injection-site tolerability issues did not meet the criteria defined in the target product profile.

Ascendis now intends to conduct additional research on new product formulations of TransCon Treprostinil and plans to resume clinical development when product improvements to mitigate current limitations have been addressed.

A phase II study of TransCon Growth Hormone in children with GHD is underway. The company expects to report topline data from this study by mid-year and prepare for the initiation of its phase 3 pediatric study in mid-2016.

ASND closed Tuesday's trading at $18.23, down 7.46%. In after-hours, the stock was down another 12.23% to $16.

Bio-Path Holdings Inc.'s (BPTH) lead compound Liposomal Grb-2 has received orphan drug designation from the FDA for the treatment of acute myeloid leukemia.

Liposomal Grb-2 is currently in a safety segment of a phase 2 trial in combination with chemotherapy drug Ara-C, for acute myeloid leukemia; and is being evaluated for chronic myelogenous leukemia. Pre-clinical development is underway for triple negative and inflammatory breast cancer.

BPTH closed Tuesday's trading at $1.36, unchanged from the previous day's close.

Shares of IGI Laboratories Inc. (IG) plunged more than 32% in extended trading on Tuesday as the company's earnings and revenue for the first quarter ended March 31, 2015 fell short of analysts' consensus estimates.

The adjusted net income was $6.56 million or $0.00 per share on total revenue of $10.67 million in Q1, 2015. This compared with adjusted net income of $167 thousand or $0.01 per share and total revenue of $6.85 million in Q1, 2014. Wall Street analysts were looking for earnings of $0.01 per share and revenue of $12.32 million.

The company has submitted its second abbreviated new drug application of this year to the FDA, which brings its total number of ANDA submissions now pending at the FDA to twenty-four.

According to the company, its current pipeline of twenty-four submissions, exclusive of partnered submissions, pending approval by the FDA now has a combined addressable market of over $702 million based on February 2015 data from IMS Health.

The company said it is on target to file at least another four ANDAs this quarter.

IG closed Tuesday's trading at $7.95, down 3.75%. In after-hours, the stock was down 32.94% to $5.33.

Novogen Ltd. (NVGN) has regained full compliance with NASDAQ Listing Rule 5550(b), thanks to the recent growth in the company's market value, as well as the substantial increase of its assets with the current capital-raising program.

In November 2014, Novogen received a deficiency notice from NASDAQ, requesting the company to submit a plan to regain compliance with the Listing Rule, which requires either (i) a minimum of $2,500,000 in stockholders' equity as of June 30, 2014; (ii) at least $35,000,000 market value of listed securities, or (iii) at least $500,000 of net income from continuing operations for the most recently completed fiscal year or two of the three most recently completed fiscal years.

NVGN closed Tuesday's trading at $6.21, down 1.90%.

Spark Therapeutics Inc. (ONCE) has acquired exclusive rights to license privately held Clearside Biomedical Inc.'s microinjector technology to deliver gene therapies to the back of the eye.

Under an option agreement signed Tuesday, the companies will explore the feasibility of using Clearside's microinjector technology to deliver viral vectors to the choroid and the retina through the suprachoroidal space (SCS).

Clearside is currently conducting a phase 2 clinical trial in macular edema associated with uveitis and a phase 2 clinical trial in macular edema associated with retinal vein occlusion (RVO).

ONCE closed Tuesday's trading at $55.64, up 3.17%.