Hopeful of reduced regulation, biotech stocks stay the course with advanced drug developments.
While various reports indicate the incoming Trump administration appears serious about reducing the FDA’s regulatory strictness as a way to boost advancements and innovation in the medical drug industry, many of the leading biotech and pharmaceutical companies forge ahead with new clinical trials and development of advanced drug treatments and therapies. Biotechs and Pharma companies forging ahead with recent developments include: Moleculin Biotech, Inc., Apricus Biosciences, Inc., CoLucid Pharmaceuticals, Inc., Neurocrine Biosciences, Inc., and Zynerba Pharmaceuticals, Inc.
Moleculin Biotech, Inc., a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, many of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that Drs. Sandra Silberman and Paul Waymack have joined the Company’s Scientific Advisory Board (SAB).
Moleculin’s Chairman and CEO, Walter Klemp, commented, “We are pleased to have attracted Drs. Sandra Silberman and Paul Waymack to our distinguished team of scientific advisors and look forward to their contributions. We strongly believe that enlisting and consulting with highly competent scientific advisors, especially as we enter into a critical period, is key to our future success. We have already been working closely with both of these advisors in our preparation of our IND submission for Annamycin and it’s an honor to have them now formally join our SAB. Clearly their deep scientific expertise at large pharmaceutical companies, top Universities and hospitals, as well as their contacts and overall knowledge base will be extremely helpful.”
In other sector developments of note in the market:
Apricus Biosciences, Inc., a biopharmaceutical company advancing innovative medicines in urology and rheumatology, yesterday announced that Mexico has granted Apricus` commercialization partner, Ferring Pharmaceuticals, market approval for Vitaros®, an on-demand topical cream indicated for the treatment of patients with erectile dysfunction.
CoLucid Pharmaceuticals, Inc. and Eli Lilly and Company (LLY) yesterday announced an agreement for Lilly to acquire CoLucid for $46.50 per share or approximately $960 million. This all-cash transaction will enhance Lilly’s existing portfolio in pain management for migraine, while adding a potential near-term launch to its late-stage pipeline. CoLucid Pharmaceuticals is a public biopharmaceutical company developing an oral 5-HT1F agonist (lasmiditan) for the acute treatment of migraine. CoLucid has completed the first of two pivotal Phase 3 trials. A data read-out for the second Phase 3 trial, SPARTAN, is expected in the second half of 2017. If this trial is positive, submission of lasmiditan for U.S. regulatory approval could occur in 2018.
Neurocrine Biosciences, Inc. announced this week the top-line results from the Company’s Phase II T-Forward study of INGREZZA™ (valbenazine), a highly-selective small molecule Vesicular Monoamine Transporter 2 (VMAT2) inhibitor, in adults with Tourette syndrome. While the study showed a significant improvement in overall symptoms of Tourette syndrome as evidenced by the Clinical Global Impression of Change (p=0.015), the pre-specified primary endpoint, the change-from-baseline in the Yale Global Tic Severity Scale (YGTSS) at Week 8 was not met (p=0.18). Adverse events were dose dependent and consistent with earlier clinical studies.
Zynerba Pharmaceuticals, Inc., a clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today announced that it intends to offer and sell, subject to market conditions, shares of its common stock in an underwritten public offering. All of the shares to be sold in the offering will be offered by Zynerba. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. In addition, Zynerba intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering.
(Source: PR Newswire)