EAST PROVIDENCE, RI (July 18, 2016) – IlluminOss Medical, a privately-held, commercial stage medical device company focused on minimally invasive orthopedic fracture repair, today announced it has completed enrollment in its first U.S. clinical trial towards FDA approval of its IlluminOss System, the world's first and only system of its kind which supports the treatment of fractures using patient-specific intramedullary implants. Thirteen surgical sites around the country participated in the trial, which included 80 patients -- all with impending or pathologic fractures in the humerus due to metastatic carcinoma. IlluminOss' minimally invasive procedure incorporates the use of a thin walled PET balloon that is infused with a liquid monomer and inserted into the intramedullary canal of the bone conforming to the shape of the patient's specific bone. The device forms a hardened implant once the surgeon activates the visible light delivered within the PET balloon. Once cured, the implant provides longitudinal strength and rotational stability over the length of the implant.
IlluminOss Medical Completes Enrollment for U.S. Clinical Trial Using Groundbreaking Photodynamic Bone Stabilization System
Syndax Expands Pipeline With Exclusive Worldwide License Agreement for UCB’s Colony Stimulating Factor 1 Receptor (CSF-1R) Antibody Program
WALTHAM, Mass., July 6, 2016 – Syndax Pharmaceuticals, Inc. (Nasdaq:SNDX), a clinical stage biopharmaceutical company focused on developing entinostat in multiple cancer indications, today announced that it has entered into an exclusive worldwide license agreement with UCB for UCB6352, an IND-ready anti-CSF-1R monoclonal antibody, which is expected to begin clinical trials in 2016.
Merck to Acquire Afferent Pharmaceuticals
KENILWORTH, NJ & SAN MATEO, CA June 9, 2016 – Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Afferent Pharmaceuticals announced today that the two companies have signed a definitive agreement under which Merck will acquire this privately held pharmaceutical company. Afferent Pharmaceuticals is a leader in the development of therapeutic candidates targeting the P2X3 receptor for the treatment of common, poorly-managed, neurogenic conditions. Afferent’s lead investigational candidate, AF-219, is a selective, non-narcotic, orally-administered P2X3 antagonist currently being evaluated in a Phase 2b clinical trial for the treatment of refractory, chronic cough as well as in a Phase 2 clinical trial in idiopathic pulmonary fibrosis (IPF) with cough.
CoLucid Pharmaceuticals Announces Last Patient Randomized in SAMURAI Phase 3 Pivotal Trial of Lasmiditan in Migraine
CAMBRIDGE, Mass., June 7, 2016 – CoLucid Pharmaceuticals, Inc. (Nasdaq:CLCD), a Phase 3 clinical-stage biopharmaceutical company that is developing lasmiditan oral tablets for the acute treatment of migraine in adults, announced today that the last patient has been randomized in its SAMURAI study, the Company’s first Phase 3 pivotal trial of lasmiditan. Per the SAMURAI protocol, the last patient randomized will have up to eight weeks to complete the study. SAMURAI top-line data are expected to be released when available in the third quarter of 2016, with more detailed results to be presented at a symposium during the 5th European Headache and Migraine Trust International Congress (EHMTIC 2016) taking place in Glasgow, Scotland on September 17th, 2016.
CoLucid Pharmaceuticals Announces Initiation of Second Phase 3 Pivotal Trial of Lasmiditan in Migraine
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.
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”).
