Premarket Biotech Digest – NOVN Reports Topline Results, INNV Receives New Patent, AIQ Signs Merger Agreement

Top Pick of the Day: NBIX

Neurorine Biosciences Inc. (NBIX) announced receiving FDA approval for its drug Ingrezza, which is designed for treating  tardive dyskinesia, a side effect of antipsychotic medications characterized by uncontrolled movements of the face and body. The drug is also the first treatment to be approved for the irreversible disorder, which occurs in 5 percent to 8 percent of patients taking antipsychotic drugs. It is also the first commercial product for Neurorine.
The company stock jumped over 23 percent in the pre-market trading session. The treatment is expected to be in the market by May this year. Its net price will likely be  between $20,000 to $60,000 per year, depending on the required dosage.

Focus Ticker: NOVN

Novan (NOVN) stock skyrocketed as the company reported  positive topline results from the Company’s Phase 2 clinical trial with SB208. The company reported that 80.6% of patients treated with SB208 4% and 74.2% treated with SB208 16% achieved negative fungal culture at day 14 versus 45.5% of patients treated with vehicle. The results were obtained from  the primary efficacy analysis of patients with evaluable culture results. SB208 is a topical, silicone based antifungal gel under development for the treatment of infections caused by dermatophytes such as Trichophyton rubrum, superficial cutaneous fungal infections of the skin and nails, including tinea pedis and onychomycosis.
The company stock rose over 63 percent in the pre-market session.

Sector News

AVEO Pharmaceuticals (AVEO) is scheduled to be listed on the Nasdaq Capital Market on April 13th. The company is currently  working to regain compliance with the $1 minimum bid price requirement. It has until October 9 to address the issue or face possible delisting.

Protalix BioTherapeutics (PLX) reported positive results from a 16-subject Phase 2 clinical trial evaluating AIR DNase (alidornase alfa) in cystic fibrosis (CF) patients previously treated with Pulmozyme (dornase alfa). Preliminary data showed patients treated with alidornase alfa experienced a clinically meaningful improvement in lung function as measured by the percent increase in percent predicted forced expiratory volume in one second (ppFEV1) of 3.4 points from baseline. 

Approvals

Mazor Robotics (MZOR) announced receiving the FDA approval for its Mazor X Align software that supports its Mazor X Surgical Assurance Platform. The software is designed to assist surgeons in planning spinal deformity correction and spinal alignment procedures. The company plans to initiate selective roll out next month while the full commercial launch is expected in the second half of this year.

Innovus Pharmaceuticals announced receiving a patent from the Moroccan Patent Office entitled “Sensitization Composition and Method of Use.” The patent pertains to the company’s Sensum+ product which is designed for reducing penile sensitivity. This is the second major international patent notification that Innovus Pharma has received on its Sensum+ product in the last thirty days. The patent will expire on March 15, 2033.

Deals and Collaborations

BioCryst Pharmaceuticals (BCRX) announced plans for exploring  a new oral liquid formulation of BCX7353, designed for treating of acute attacks in patients with hereditary angioedema (HAE).The purpose of ZENITH-1 is to explore whether single oral doses of a liquid formulation of BCX7353 could have utility in the treatment of acute angioedema attacks. It already has initial regulatory approvals in Europe to initiate the ZENITH-1 exploratory clinical trial.

Alliance HealthCare Services (AIQ) announced signing a definitive merger agreement with Tahoe Investment Group. Under the terms of the agreement, Tahoe Group will acquire all of the outstanding common stock of Alliance for US $13.25 per share in cash. The price  represents a premium of 67% over the Company’s closing trading price on December 9, 2016, the last trading day prior to Tahoe’s initial proposal was publicly disclosed.

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