CoLucid Pharmaceuticals Announces Initiation of Phase 3 Long-Term, Open-Label Trial of Lasmiditan in Migraine.

CoLucid Pharmaceuticals Announces Initiation of Phase 3 Long-Term, Open-Label Trial of Lasmiditan in Migraine.

CAMBRIDGE, Mass., Oct. 8, 2015 – 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 in adults, announced today that the first patient has been randomized in the Company’s GLADIATOR study, a Phase 3 long-term, open-label trial of lasmiditan.

The objective of GLADIATOR is to evaluate the safety and efficacy of lasmiditan, as well as resource utilization, functional outcomes and disability. Migraine patients who complete CoLucid’s ongoing first Phase 3 pivotal trial, SAMURAI, as well as the Company’s second Phase 3 pivotal trial, scheduled to commence in the first half of 2016, will be eligible to enroll in GLADIATOR. GLADIATOR is expected to enroll up to a total of 2,580 subjects, who will be randomized to receive 100 mg or 200 mg of lasmiditan, and treated for up to eight migraine attacks per month for one year.

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.

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.

CoLucid Pharmaceuticals, Inc., Raises $37.1 Million in Series C Preferred Stock Offering

Durham, NC, January 13, 2015/PRNewswire/ — CoLucid Pharmaceuticals, Inc., today announced that it has completed a $37.1 million Series C preferred stock offering.  The financing was led by TVM Capital Life Science, based in Montreal and Munich,and included participation from new investors Novo Ventures and Auriga Partners. All of the Company’s existing investors also participated in the Series C, including Pappas Ventures, Domain Associates, Care Capital, Triathlon Medical Ventures and Pearl Street Ventures. Joining the board of directors will be Dr. Luc Marengere from TVM Capital Life Science and Dr. Martin Edwards from Novo Ventures.

CoLucid Pharmaceuticals, Inc., Announces Agreement from the FDA on a Special Protocol Assessment (SPA) for the Phase 3 Trial of Lasmiditan in Migraine Including Patients with Risk Factors for Cardiovascular Disease

Durham, NC, MAY 6, 2014/PRNewswire/ — CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, has reached agreement with the U.S. Food and Drug Administration (FDA) for the planned SAMURAI study. The objective of this trial is to evaluate the safety and efficacy of two doses of Lasmiditan in comparison to placebo for the treatment of acute migraine. Patients with risk factors for cardiovascular disease will be included in the study.

The SPA agreement includes two novel endpoints for the approval of acute migraine therapies—a primary endpoint of the proportion of patients who are free of headache pain at 2 hours and a key secondary endpoint of the proportion of patients who no longer suffer from their most bothersome associated symptom of migraine (nausea, photophobia, phonophobia) at 2 hours.

CoLucid Pharmaceuticals and ILDONG Pharmaceutical Enter into a Distribution and Supply Agreement for Lasmiditan, a Novel Agent for Acute Migraine

CoLucid Pharmaceuticals and ILDONG Pharmaceutical Enter into a Distribution and Supply Agreement for Lasmiditan, a Novel Agent for Acute Migraine

DURHAM, N.C., October 22, 2013 /PRNewswire/ — CoLucid Pharmaceuticals, Inc., and ILDONG Pharmaceutical Co., Ltd., announced today that they have entered into a distribution and supply agreement for Lasmiditan in South Korea and Southeast Asia.

Under the terms of the agreement, CoLucid will receive upfront and milestone payments in addition to consideration for product supply in exchange for exclusive rights to ILDONG for development and commercialization of Lasmiditan in the territory. ILDONG will be responsible for the costs and activities related to development and regulatory approvals in the territory and will also participate in key registration trials as part of the global development plan.

CoLucid Pharmaceuticals Raises $7.5 Million of Planned $9.5 Million

DURHAM, N.C., Aug. 30, 2011 /PRNewswire-iReach/ — CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, announced today that it has raised $7.5 million of a planned $9.5 million convertible note financing from its existing investors to support further late stage development of lasmiditan.  Participating in the financing were Pappas Ventures, Domain Associates, Care Capital, Pearl Street Venture Funds and Triathlon Medical Ventures.

CoLucid Pharmaceuticals Receives Clearance For Investigational New Drug (IND) Application For Lasmiditan For The Treatment Of Acute Migraine

 
August 20, 2011

CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, announced that it has received clearance to proceed with clinical studies of lasmiditan (formerly known as COL-144) under IND 103,420 from the Food and Drug Administration (FDA).

Lasmiditan is a first-in-class oral tablet formulation of a Neurally Acting Anti-Migraine Agent (NAAMA) designed to deliver efficacy in migraine without the vasoconstrictor activity associated with previous generations of migraine therapies. Lasmiditan is a member of a novel chemical class called “ditans”, and, unlike triptans, which target vasoconstrictor 5-HT1B receptors, lasmiditan penetrates the central nervous system (CNS) and selectively targets 5-HT1F receptors expressed in the trigeminal nerve pathway.

CoLucid Pharmaceuticals, Inc. announces study data documenting oral efficacy of lasmiditan in the treatment of acute migraine attacks

 

DURHAM, N.C., June 9, 2010 /PRNewswire/ — CoLucid Pharmaceuticals, Inc., (“CoLucid”), an innovative biotechnology company focusing on therapies for central nervous system disorders, today announced that its investigational first-in- class Neurally Acting Anti-Migraine Agent (NAAMA), lasmiditan (also known as COL-144), a selective 5-HT1F receptor agonist, was effective when given orally to treat acute migraine attacks, as documented in a Phase IIb study. Results of this study will allow the selection of doses for pivotal Phase III studies of lasmiditan in the acute treatment of migraine, scheduled to begin in fourth quarter this year.

Phase 2 Results of COL-144 Presented at European Headache and Migraine Trust International Congress 2008

 
LONDON, SEPT. 6, 2008 – CoLucid Pharmaceuticals, Inc., an innovative biotechnology company focusing on therapies for central nervous system disorders, announced Phase II results of its lead compound COL-144 in the treatment of acute migraine. Results demonstrated that COL-144 was safe and effective in relieving migraine headaches. COL-144 is a first-in-class Neurally Acting Anti-Migraine Agent (NAAMA), which unlike triptans, exhibits anti-migraine activity without causing vasoconstriction. COL-144 is a highly potent and selective 5HT1F receptor agonist. The studies were presented in poster presentations at the European Headache and Migraine Trust International Congress 2008 in London, Sept. 4-7, 2008.