AXGN Making News, Milestone Events Lined Up For NBIX, Cesca Plays It Cool

(RTTNews) - Aerie Pharmaceuticals Inc. (AERI) is gearing up to file its NDA for Rhopressa for treatment of glaucoma this quarter.

The company expects to report 90-day interim topline efficacy readout from its phase III registration trial of Roclatan in patients with glaucoma, dubbed Mercury 1, in September 2016.

The phase III clinical trial for Rhopressa, dubbed Rocket 4, designed to provide adequate safety data for submission to European regulatory authorities is also underway - with topline 90-day efficacy readout anticipated in the fourth quarter of 2016.

AERI closed Wednesday's trading at $18.03, up 3.98%.

AmpliPhi Biosciences Corp. (APHB) has completed enrollment of its phase I trial of AB-SA01 its proprietary phage cocktail targeting Staphylococcus aureus infections. Topline results from the study are expected by the end of the third quarter of 2016.

APHB jumped 47.50% on Thursday to close the day's trading at $1.77.

Anthera Pharmaceuticals Inc. (ANTH) has completed dosing in its phase III clinical study of Blisibimod for systemic lupus erythematosus, dubbed CHABLIS-SC1. The primary endpoint evaluation is a six-point reduction in the Systemic Lupus Erythematosus Responder Index.

Results from the CHABLIS-SC1 study are expected to be available prior to the annual American College of Rheumatology Annual Meeting in November.

ANTH closed Wednesday's trading at $3.14, up 3.63%.

Shares of AxoGen Inc. (AXGN) were up over 10% in extended trading on Wednesday, following better-than expected second quarter results and revised revenue outlook for full year 2016.

The company's net loss for the second quarter ended June 30, 2016 was $2.80 million or $0.09 per share on revenue of $10.38 million. Analysts polled by Thomson Reuters were expecting the company to report a loss per share of $0.12 and revenue of $9.02 million.

Looking ahead to full year 2016, the company increased its revenue outlook to $40 million from its earlier forecast of $39 million.

AXGN closed Wednesday's trading 7.32% higher at $7.18. In after-hours, the stock was up 10.03% to $7.90.

Shares of Cesca Therapeutics Inc. (KOOL) climbed over 21% on Wednesday, following promising results from 40-month follow-up of patients in a feasibility study that evaluated autologous bone marrow derived stem cells in patients with critical limb ischemia.

The feasibility study was conducted in 2011 at Fortis Escorts Heart Institute in New Delhi, India, which enrolled 17 patients with late stage critical limb ischemia, all of whom had tried all available surgical options short of a major limb amputation.

In the 40-month follow-up, three of the 12 patients that were amputation-free at 12 months could not be contacted, but the remaining nine were clinically assessed. All nine patients still had their limbs and exhibited no sign of disease progression, though two of the nine had in the interim undergone additional SurgWerks treatments to relieve mild to moderate rest pain, the company noted.

KOOL closed Wednesday's trading at $5.42, up 21.80%.

Neurocrine Biosciences Inc. (NBIX), which will be submitting a New Drug Application for Valbenazine for Tardive Dyskinesia this year, is exploring the potential of the compound in Tourette syndrome too.

Two phase II Tourette syndrome studies evaluating Valbenazine in adults and pediatrics, dubbed the T-Forward study and T-Force GREEN study, respectively are underway. Data from both of these studies is expected around year-end 2016.

After successfully completing an initial phase I single site, single dose sequential dose-escalation study of NBI-640756 in up to 32 healthy volunteers, the company has initiated a phase I, single site, multiple-dose, sequential dose-escalation study of NBI-640756 in up to 30 healthy volunteers. NBI-640756 is being developed for patients with essential tremor. Data from this second phase I study is expected later in 2016.

NBIX closed Wednesday's trading at $50.34, down 0.18%.

Vitae Pharmaceuticals Inc. (VTAE) is all set to report top-line results for the ongoing phase 2a proof-of-concept study for VTP-38543 for atopic dermatitis in the fourth quarter of 2016.

The company is planning to initiate a 16-week phase II trial of VTP-43742 in psoriasis patients in the fourth quarter of 2016, the results of which will be reported in the second half of 2017.

VTAE closed Wednesday's trading at $10.29, down 0.58%.

Xenon Pharmaceuticals Inc. (XENE) now expects results from its phase 2 clinical trial of XEN801 for the treatment of moderate to severe facial acne in the first quarter of 2017 compared to its earlier estimated timeline of fourth quarter of 2016.

TV-45070, a product candidate being developed in collaboration with Xenon's partner, Teva Pharmaceutical Industries Ltd., for the treatment of pain, is currently under a phase 2b clinical trial in patients with post-herpetic neuralgia, with results expected in the first half of 2017.

XENE closed Wednesday's trading at $7.36, up 0.82%.