CAMBRIDGE, Mass., May 19, 2016 – CoLucid Pharmaceuticals, Inc., a Phase 3 clinical-stage biopharmaceutical company that is developing oral lasmiditan for the acute treatment of migraine in adults, announced today that the first patient has been randomized in its SPARTAN study, the Company’s second Phase 3 pivotal trial of lasmiditan.
CoLucid Pharmaceuticals Announces Initiation of Second Phase 3 Pivotal Trial of Lasmiditan in Migraine
Envisia Therapeutics Announces Positive Three-Month Interim Results of Low Dose ENV515 in Patients with Glaucoma
RESEARCH TRIANGLE PARK, N.C., May 3, 2016 – Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today reported positive results from an interim three-month analysis of an ongoing 12-month safety and efficacy evaluation of the low dosage form of ENV515 XR (travoprost). ENV515, the Company's lead product candidate, is an extended-release formulation of travoprost that could offer sustained reduction in intraocular pressure (IOP) for more than six months after a single dose.
Afferent Pharmaceuticals Announces Presentations of Chronic Cough Clinical Data and Hypertension Research for the Upcoming American Thoracic Society (ATS) 2016 International Conference
San Mateo, CA – April 25, 2016 – Afferent Pharmaceuticals, a leader in the development of small molecule compounds for the treatment of poorly managed and common neurogenic disorders, announced today that it will present four papers at the upcoming American Thoracic Society (ATS) 2016 International Conference, to be held May 13-18, 2016 in San Francisco. The abstracts will cover clinical and preclinical data related to AF-219 and AF-130, the company’s orally available, first-in-class compounds that selectively block P2X3 receptors.
Envisia Therapeutics Secures $16.5 Million In Additional Series A Financing
RESEARCH TRIANGLE PARK, NC – March 23, 2016 – Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today announced a $16.5 million investment from existing investors to support the accelerated development of the Company's pipeline of innovative extended-release ocular therapies for the three leading causes of preventable vision loss and blindness.
Syndax Announces Pricing of Initial Public Offering
WALTHAM, Mass., March 2, 2016 – Syndax Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on developing entinostat in multiple cancer indications, announced today that it has priced its initial public offering of 4,400,000 shares of its common stock at a public offering price of $12.00 per share, for an aggregate offering of $52.8 million, before underwriting discounts, commissions and expenses. In addition, Syndax has granted the underwriters a 30-day option to purchase up to 660,000 additional shares of common stock at the initial offering price to cover overallotments, if any. All of the common stock is being offered by Syndax. The common stock will begin trading on The NASDAQ Global Select Market on March 3, 2016 under the trading symbol "SNDX." The offering is expected to close on March 8, 2016, subject to customary closing conditions.
CoLucid Pharmaceuticals Announces Special Protocol Agreement for SPARTAN
CAMBRIDGE, Mass., Mar. 1, 2016 – CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD), a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine, has announced that it has received a Special Protocol Agreement for its second pivotal Phase 3 clinical trial, called SPARTAN, from the U.S. Food and Drug Administration (“FDA”). The objective of SPARTAN is to evaluate the safety and efficacy of lasmiditan (50 mg, 100 mg and 200 mg) in comparison to placebo two hours after dosing on freedom from migraine headache pain, which is the primary endpoint, and on freedom from the most bothersome associated symptom of migraine (nausea, phonophobia or photophobia), which is the key secondary endpoint. SPARTAN is a randomized, double-blind, placebo-controlled parallel group study. The study is expected to treat a single migraine in up to 2,226 migraine patients with lasmiditan at approximately 130 sites in the U.S., United Kingdom and Germany. CoLucid expects migraine patients enrolled in SPARTAN will include those who also have one or more cardiovascular risk factors, stable cardiovascular disease or known coronary artery disease (“CAD”).
Thrasos Announces Promising Results for Phase 2 THR-184 Dose Ranging Clinical Study for the Prevention of Acute Kidney Injury (AKI)
MONTREAL Canada & Boston MA, February 29, 2016 – Thrasos Therapeutics, a biotherapeutics company focused on delivering new solutions for kidney disease, today announced it has successfully completed its Phase 2, first-in-patients, dose ranging, clinical study of THR-184 for the prevention of acute kidney injury (AKI) in at risk patients undergoing cardiac surgery (NCT01830920). In the study, there was a reduction in the incidence of AKI in patients treated with the highest dose and THR-184 was safe and well tolerated. The effect was observed across different definitions of AKI and was most prominent in patients with underlying chronic kidney disease (CKD), which is an important risk factor for AKI.
CoLucid Pharmaceuticals Announces Confirmatory Support for Non-vasoconstrictive Mechanism of Action for Lasmiditan
CAMBRIDGE, Mass., Feb. 23, 2016 – CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD), a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine headaches, announced today the completion of a preclinical in vivo study examining the effect of lasmiditan on coronary and carotid artery diameters. This study confirms the lack of effect of lasmiditan on coronary artery and carotid artery vasoconstriction; the data are expected to be used in support of potential future regulatory filings.
One-Year Results From Phase 2 Stroke Study of MultiStem® Cell Therapy Demonstrate a Significantly Higher Rate of Complete or Nearly Full Recovery
CLEVELAND February 17, 2016 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) today announced positive results from the analysis of one-year follow-up data from its Phase 2 clinical study of the intravenous administration of MultiStem® cell therapy to treat patients who have suffered an ischemic stroke. Dr. David Hess, lead clinical investigator of this study and a stroke specialist and Chairman of the Department of Neurology at the Medical College of Georgia, Augusta University, presented the summary results today at the 2016 International Stroke Conference in Los Angeles. The one-year data demonstrates that MultiStem-treated subjects on average continued to improve through one year and had a significantly higher rate of "Excellent Outcome" (defined clinically as attaining mRS 0-1, NIHSS 0-1 and BI ≥95) compared to placebo subjects at one year when evaluating all subjects enrolled in the study (p=0.02), i.e., the intent-to-treat population. The relative improvement in Excellent Outcomes was even more pronounced in the patients who received MultiStem treatment within 36 hours of the stroke (p < 0.01).
Envisia Therapeutics Announces First Patient Dosed in Second Cohort of Novel Phase 2 Program Evaluating ENV515 in Patients with Glaucoma
RESEARCH TRIANGLE PARK, NC – January 12, 2015 – Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today announced it has dosed its first patient in the second cohort of the phase 2 clinical program evaluating the Company's lead product candidate, ENV515. ENV515 is an extended-release formulation of travoprost that could offer sustained reduction in intraocular pressure (IOP) for more than six months after a single dose.
