MONTREAL, July 7, 2015 – Thrasos Therapeutics, a biotherapeutics company focused on delivering new solutions for kidney disease, announced the completion of enrollment in its Phase 2 clinical study of THR-184 for the prevention of acute kidney injury (AKI) in “at risk” patients undergoing cardiac surgery. Results from the 452-patient study are expected by January 2016.
Thrasos Completes Enrollment of Phase 2 THR-184 Clinical Study for Acute Kidney Injury
Afferent Pharmaceuticals Raises $55 Million in Oversubscribed Crossover Financing
SAN MATEO, Calif.—July 8, 2015 – Afferent Pharmaceuticals, a leader in the development of novel small molecule drugs for the treatment of neurogenic respiratory, urologic and pain disorders, today announced the completion of a $55 million Series C financing. The proceeds will fund the advancement of the company’s first-in-class drug candidate AF-219 for the treatment of pathologic cough, including for cough in IPF patients, as well as advancement of its next candidate compound to the clinic for cardiovascular and other diseases. AF-219 is a selective, non-narcotic and orally administered P2X3 antagonist. The oversubscribed Series C financing was led by Fidelity Management & Research Company, with participation from other crossover funds Jennison Associates LLC (on behalf of certain clients), New Leaf Ventures, Partner Fund Management, Redmile Group, Tekla Healthcare Investors and Tekla Life Science Investors, in addition to an undisclosed blue chip public investment fund.
Milestone Pharmaceuticals Closes US$17 Million Series B Financing to Complete Phase 2 Clinical Studies for MSP-2017
MONTREAL, QC, June 15, 2015 – Milestone Pharmaceuticals Inc., a clinical stage cardiovascular company in Phase 2, today announced the close of a US$17 million Series B financing. The round was led by Domain Associates and included participation from all of Milestone’s existing investors including Fonds de solidarité FTQ (FSTQ), Pappas Ventures, BDC Capital, GO Capital, and iNovia Capital. The funding will be used to complete Phase 2 clinical development of MSP-2017. In connection with this financing, Domain’s Debra Liebert will join Milestone’s board of directors.
CoLucid Pharmaceuticals Announces Pricing of Initial Public Offering
BURLINGTON, Mass., May 6, 2015 – CoLucid Pharmaceuticals, Inc. ("CoLucid") (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 pricing of its initial public offering of 5,500,000 shares of common stock at a public offering price of $10.00 per share.
Envisia Therapeutics to Present at ARVO 2015 Annual Meeting
Research Triangle Park, NC - May 1, 2015 – Envisia Therapeutics today announced that eight posters have been selected for presentation at the Association for Research in Vision and Ophthalmology’s (ARVO) Annual Meeting being held May 3 – 7, 2015 in Denver, Colorado. ARVO is the largest gathering of eye and vision researchers in the world, attracting over 11,000 attendees from more than 75 countries. The theme of the ARVO 2015 Annual Meeting is Powerful Connections: Vision Research and Online Networking.
IlluminOss Medical Appoints Amy Orlick Berman as Vice President of Clinical Affairs
EAST PROVIDENCE, RI, Apr 21, 2015 – IlluminOss Medical, a commercial stage medical device company focused on minimally invasive orthopedic fracture repair, today announced the appointment of Amy Orlick Berman as the company's vice president of clinical affairs. Berman brings almost two decades of clinical affairs experience and has extensive expertise leading global research programs from inception through product approval. In her new position, she will be responsible for the global clinical trial program at IlluminOss, including the U.S. Lightfix trial towards securing approval for the treatment of impeding and actual fractures of the humerus in patients with metastatic bone disease.
Prior to joining IlluminOss, Berman was at Cordis, Johnson & Johnson for nearly 10 years where she held roles of increasing responsibility and oversaw a number of high-profile clinical research programs in the U.S., Europe and Japan.
CoLucid Pharmaceuticals Announces Initiation of First Phase 3 Pivotal Trial of Lasmiditan in Migraine
First Patient Randomized in SAMURAI STUDY Trial Being Conducted Under Special Protocol Assessment Agreement with FDA
BURLINGTON, Mass., April 28, 2015 – CoLucid Pharmaceuticals, Inc., a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine headaches in adults, announced today that the first patient has been randomized in its SAMURAI study, the Company’s first Phase 3 pivotal trial of lasmiditan.
The objective of SAMURAI is to evaluate the safety and efficacy of lasmiditan (100 mg and 200 mg) in comparison to placebo two hours after dosing on freedom from migraine headache pain, which is our primary endpoint, and on freedom from the most bothersome associated symptom of migraine (nausea, phonophobia or photophobia), which is our secondary endpoint. SAMURAI is a randomized, double-blind, placebo-controlled parallel group study. The study is expected to treat up to 1,483 migraine patients with lasmiditan at approximately 70 U.S. sites for approximately 12 months. We expect patients will include those with migraine who also have cardiovascular risk factors or cardiovascular disease. SAMURAI is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration.
Envisia Therapeutics Names Dr. Rhett Schiffman Chief Medical Officer
RESEARCH TRIANGLE PARK, NC – April 14, 2015 – Envisia Therapeutics today announced that it has named Rhett M. Schiffman M.D., M.S., M.H.S.A as Chief Medical Officer and Senior Vice President of Development. Prior to Envisia, Dr. Schiffman was the Chief Medical Officer at Neurotech Pharmaceuticals where he led the company’s NT-503 program, a cell-based therapy for wet age-related macular degeneration (AMD), through its phase 1/2 studies. He brings with him more than 20 years of expertise and achievements in ophthalmology.
Thrasos Secures $21 Million to Complete Phase 2 Study of THR-184 in the Prevention of Acute Kidney Injury and Expand the Company's Renal Portfolio
With these funds Thrasos will accelerate the development of its technology for Chronic Kidney Disease and position THR-184 for the next step in clinical development
MONTREAL, March 31, 2015 –Thrasos Therapeutics, a biotherapeutics company focused on delivering new solutions for kidney disease, today announced that it has completed a $21M Series D financing led by BDC Capital and SR One with participation by all current investors. Thrasos' Board of Directors will be expanded with the addition of Ela Borenstein, Managing Partner at BDC Capital Healthcare Venture Fund.
Syndax and Merck to Collaborate on Immuno-Oncology Study Evaluating Entinostat in Combination with KEYTRUDA® (pembrolizumab) in Lung Cancer and Melanoma
WALTHAM, Mass. and KENILWORTH, N.J., March 31, 2015 – Syndax Pharmaceuticals, Inc., and Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that they have entered into a clinical trial collaboration to evaluate the safety and efficacy of combining Syndax’s entinostat, an investigational epigenetic therapy, with Merck’s KEYTRUDA® (pembrolizumab), the first anti-PD-1 therapy approved in the United States. The Phase 1b/2 study will evaluate this novel combination regimen in patients with either advanced non-small cell lung cancer (NSCLC) or melanoma. The study is expected to begin enrolling patients in the second half of 2015.
