ONTX Inspired, Avalanche Triggers Panic Again, NBIX Awaits Data In Q4

(RTTNews) - Shares of Avalanche Biotechnologies Inc. (AAVL) slumped more than 14% in after-hours trading on Thursday as the company announced that it will not initiate a phase 2b clinical trial of AVA-101 for the potential treatment of wet age-related macular degeneration, which was supposed to be initiated in the second half of 2015.

On June 15, 2015, the company announced that its phase 2a clinical study for AVA-101 in wet age-related macular degeneration met its 12-month primary endpoint, demonstrating that AVA-101 was well tolerated with a favorable safety profile in the patients. However, investors were not satisfied with the results, and the company's stock cratered 56% to close at $17.05, the following day. The company was planning to conduct a phase 2b clinical study for AVA-101 based on the positive phase 2a data then.

But now, upon further analyses of the previously reported phase 2a trial data of AVA-101, the company has decided not to initiate a phase 2b trial, but conduct additional preclinical studies to investigate optimal dose and delivery of AVA-101 and AVA-201 versus standard of care anti-VEGF protein therapy to select the best gene therapy product candidate for wet AMD to advance back into the clinic.

AVA-201 is also a product candidate that is being developed for the prevention of wet AMD.

AAVL closed Thursday's trading at $13.83, down 3.49%. In after-hours, the stock was down 14.75% to $11.79.

Catabasis Pharmaceuticals Inc. (CATB) has announced positive top-line results from a phase I clinical trial of its hypercholesterolemia product candidate CAT-2054.

According to the trial results, CAT-2054 was well-tolerated with no serious adverse events observed in either the single or multiple ascending dose arms of the double-blind, randomized clinical trial.

In the multiple ascending dose study, decreases in median LDL-C levels of up to 20% were observed at day 21 in healthy volunteers. Importantly, CAT-2054 was also found to be well-tolerated in combination with Atorvastatin, the statin drug most commonly used in the treatment of hypercholesterolemia, and there was no evidence for impact of CAT-2054 on the pharmacokinetics of Atorvastatin, noted the company.

Based on the encouraging data, the company intends to initiate a phase 2a trial in patients with hypercholesterolemia in the fourth quarter of 2015.

Catabasis Pharma went public as recently as June 25, 2015, priced at $12.00 per share.

The stock closed Thursday's trading 4.99% higher at $11.99.

Dermira Inc. (DERM), which initiated a phase III program for DRM04 in hyperhidrosis last month, expects topline results to be available in the second half of 2016.

The DRM04 phase III program consists of two identical, randomized, double-blind, vehicle-controlled studies, ATMOS-1 and ATMOS-2, each enrolling approximately 330 patients. The phase III program also will include an open-label study, ARIDO, assessing the long-term safety of DRM04, in which patients from either of the phase III studies will be permitted to continue to receive treatment for up to an additional 44 weeks.

A phase 2b dose-ranging trial for DRM01 in patients with acne vulgaris is underway, and topline results from this study are expected in the first half of 2016.

A phase III program for CIMZIA in psoriasis continues to enroll patients, and topline results are expected in 2017.

DERM closed Thursday's trading at $25.27, up 0.88%.

Eleven Biotherapeutics Inc. (EBIO), which recently initiated a phase III study of EBI-005 for the treatment of moderate to severe allergic conjunctivitis patients suffering from the late-phase inflammatory response, expects top-line data from the study to be available in the first quarter of 2016.

The company is also planning to advance development of EBI-031 for the treatment of diabetic macular edema and uveitis with an IND filing expected in the first half of 2016.

EBIO closed Thursday's trading at $5, up 22.25%. In after-hours, the stock was up another 6% to $5.30.

Shares of Onconova Therapeutics Inc. (ONTX) were up more than 29% in extended trading on Thursday as investors welcomed the news of the company's submission of its Investigational New Drug Application for a pivotal phase III trial of IV Rigosertib in higher-risk myelodysplastic syndromes.

Upon clearance, the IND enables Onconova to initiate a randomized, controlled pivotal phase III trial in patients with higher-risk myelodysplastic syndromes after failure of hypomethylating agent therapy.

The pivotal trial, dubbed "INSPIRE", is expected to begin enrollment later this year, and will enroll approximately 225 patients at about 100 sites globally.

ONTX closed Thursday's trading at $1.98, up 7.61%. In after-hours, the stock was up 29.80% at $2.57.

Neurocrine Biosciences Inc. (NBIX) expects top line efficacy data from the initial six week assessment of its phase III clinical trial of NBI-98854 in tardive dyskinesia patients in the fourth quarter of 2015.

The trial, dubbed Kinect 3, has completed enrollment of approximately 240 subjects with moderate to severe tardive dyskinesia and an underlying diagnosis of mood disorder, schizophrenia or schizoaffective disorder.

NBIX closed Thursday's trading at $46.90, up 1.91%.

Proteon Therapeutics Inc. (PRTO) expects enrollment in the first phase III clinical study of investigational Vonapanitase, in patients with chronic kidney disease undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis, to be completed by this year-end. The data from this trial is expected to be available in the first quarter of 2017.

Separately, the company announced that data from a study evaluating the safety and technical feasibility of a single treatment of Vonapanitase via a drug-delivery catheter on atherosclerotic human arteries are encouraging.

PRTO closed Thursday's trading at $13.48, down 6.97%.