RESEARCH TRIANGLE PARK, N.C., Oct. 17, 2016 – Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today released an interim analysis of its ENV515 (travoprost XR) phase 2 trial in glaucoma patients showing clinically meaningful reduction in intraocular pressure (IOP) for the entire nine-month evaluation period following a single administration. ENV515 also demonstrated an IOP lowering effect comparable to prestudy topical prostaglandin analogs (XALATAN® and LUMIGAN®) and in-study topical timolol maleate 0.5% ophthalmic solution (daily eye drops). Glaucoma is the leading cause of preventable vision loss and blindness due largely in part to poor patient compliance with once-daily eye drops.
Envisia Therapeutics Releases ENV515 (travoprost XR) Phase 2 Data Showing Nine-Month Duration Of Action After A Single Dose In Patients With Glaucoma
Athersys Receives FDA Agreement Under Special Protocol Assessment for Phase 3 Study of MultiStem® Treatment for Ischemic Stroke
CLEVELAND, Sept. 28, 2016 – Athersys, Inc. (NASDAQ:ATHX) announced today that it has received agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design and planned analysis of a Phase 3 clinical trial of Athersys' novel MultiStem® cell therapy product for the treatment of ischemic stroke. The SPA provides agreement from the FDA that the protocol design, clinical endpoints, planned conduct and statistical analyses encompassed in Athersys' planned Phase 3 study are acceptable to support a regulatory submission for approval of the MultiStem product for treating ischemic stroke patients. The results from the Phase 3 trial entitled, "MultiStem Administration for Stroke Treatment and Enhanced Recovery Study-2" (MASTERS-2), together with other available clinical data, would provide the foundation of the regulatory package to be submitted for marketing approval.
CoLucid Pharmaceuticals Announces Achievement of Both Primary and Key Secondary Endpoints in the SAMURAI Phase 3 Pivotal Trial of Lasmiditan in Migraine
CAMBRIDGE, Mass., September 6, 2016 – Cambridge, MA, September 6, 2016 -- CoLucid Pharmaceuticals, Inc., a biopharmaceutical company that is developing lasmiditan oral tablets for the acute treatment of migraine in adults, with or without aura, announced today that its Phase 3 pivotal study evaluating lasmiditan, the SAMURAI study, achieved both the primary and key secondary efficacy endpoints with statistical significance (p < 0.001). Lasmiditan was also well tolerated. SAMURAI was a randomized, double-blind, placebo-controlled parallel group study designed to evaluate the efficacy and safety of lasmiditan (100 mg and 200 mg) in comparison to placebo. SAMURAI is the first of two Phase 3 pivotal trials of lasmiditan, each being conducted under a Special Protocol Assessment agreement (“SPA”) with the U.S. Food and Drug Administration (“FDA”).
Rotation Medical Secures $12 Million in Series B Extension Financing
PLYMOUTH, MN (August 16, 2016) – Rotation Medical Inc., a medical device company focused on developing new technologies to treat rotator cuff disease, today announced that it completed a $12 million Series B extension financing. The existing investors – New Enterprise Associates (NEA), Life Sciences Partners (LSP) and Pappas Ventures – all participated in the financing, which is fundable in two tranches: $8 million initially and $4 million in 2017. The company intends to use the proceeds to continue the acceleration of U.S. commercialization activities for the Rotation Medical rotator cuff system, which is comprised of a proprietary bioinductive implant and disposable instruments that allow the arthroscopic procedure to be performed easily and quickly.
IlluminOss Medical Completes Enrollment for U.S. Clinical Trial Using Groundbreaking Photodynamic Bone Stabilization System
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.
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.
