Back to News

May 02, 2017

Braeburn Pharmaceuticals and Camurus Announce Positive Top-line Results from Long-term Phase 3 Safety Study of CAM2038

New data support long-term safety and efficacy of weekly and monthly subcutaneous buprenorphine depots in patients with opioid use disorder

Princeton, New Jersey and Lund, Sweden — 2 May 2017 — Braeburn Pharmaceuticals and Camurus (NASDAQ STO: CAMX) today announced positive top-line results from a long-term Phase 3 trial supporting the safety and efficacy of CAM2038 (weekly and monthly buprenorphine depots) in patients with moderate-to-severe opioid use disorder. 

“The positive results from this study, coupled with the earlier reported positive results from the pivotal Phase 3 efficacy trial, enable our teams to finalize regulatory submissions seeking approval in the U.S., Europe and other key global markets,” said Behshad Sheldon, President and CEO of Braeburn Pharmaceuticals. “Opioid addiction is an overwhelming public health epidemic. In the U.S. alone, there are 2.6 million patients diagnosed with opioid addiction, and approximately 30,000 people die every year from opioid overdoses. We look forward to bringing these innovative options of weekly and monthly buprenorphine medicines to patients as quickly as possible.” 

“The successful completion of this study marks an important step forward in the development of provider administered, depot medications for the treatment of opioid use disorder,” noted Michael Frost, MD, medical director, Eagleville Hospital and President of Frost Medical in Philadelphia, and Primary Investigator for the study.  “Having both weekly and monthly formulations as well as multiple dosage strengths available, allows the treatment to be tailored to the individual needs of patients. Those who participated in the study tolerated the treatment well whether they were transitioned from other forms of buprenorphine or were new entrants to treatment.” 

A total of 228 patients were enrolled in the study conducted at 29 sites across the U.S., Europe and Australia. 162 (71 %) patients completed the 48-week study treatment period. The safety profile of CAM2038 was similar to that observed in previous shorter term trials. A total of 17 (7%) serious adverse events were reported in this 48-week study (52 weeks including follow-up), of which none was considered related to the study medication. Importantly, as in the previous Phase 3 efficacy study, no opioid overdoses were reported for patients treated with CAM2038 depot injections. Overall, headache, nausea, vomiting, nasopharyngitis, and urinary tract infection were the most common adverse events; in each case reported by less than 10% of patients. Injection site reactions occurred in 20% of the participants and were generally mild (16.3%) or moderate (3.5%). Severe injection site pain was reported for one patient (0.4%). Notably, more than 5000 injections of CAM2038 were administered in the study. 

Efficacy was assessed by weekly and monthly urine toxicology tests. On average, 75% of the urine samples were negative for illicit opioids across the 48-week treatment period. 

“These new Phase 3 results add to the growing body of evidence supporting the use of our weekly and monthly buprenorphine depots (CAM2038) as a flexible, individualized therapy for patients with opioid use disorder," said Fredrik Tiberg, President and CEO, Camurus. “The present long-term study confirms the safety profile and efficacy of CAM2038 in both new-to-treatment patients and patients on maintenance treatment with daily buprenorphine. The results further strengthen our upcoming regulatory submissions to EMA and FDA in mid-2017." 

 “People living with opioid use disorder need additional therapies that can provide meaningful improvement of treatment outcomes and quality of life. It is particularly important that we reduce the stigma and burdens associated with existing treatment approaches that require daily use of medications,” said Prof. Nicholas Lintzeris, MBBS, PhD, FAChAM, Conjoint Professor of Addiction Medicine, University of Sydney, Australia.  “We are pleased with the study treatments and results of this Phase 3 long-term safety study, showing that these buprenorphine depots were well-tolerated by patients and provided high levels of efficacy across the 48-week treatment period.”    

About the Phase 3 Long-term Safety Trial 
This trial was an open-label multi-center, 12-month (48-week) safety study of CAM2038 once weekly and once monthly in adult outpatients with opioid use disorder. The study was performed at 29 sites in the United States, United Kingdom, Hungary, Denmark, Sweden, Germany, and Australia. It comprised three phases: Screening Phase, Treatment Phase, and Follow-up Phase with at least 48 weeks of CAM2038 treatment and 4 weeks of follow-up (52 weeks in total). Following screening and confirmation of eligibility, participants initiated on weekly or monthly CAM2038 or transitioned to weekly or monthly CAM2038 based on their current treatment status. New-to-treatment patients initiated treatment with weekly CAM2038 and could then transition to monthly CAM2038. 

The primary objective of the study was to demonstrate the safety and tolerability of CAM2038 products in 12-month (48-week) buprenorphine treatment in adult outpatients with opioid use disorder. The secondary objective of the study was to evaluate efficacy of CAM2038 through several efficacy parameters, including urine toxicology, and signs and symptoms of withdrawal and cravings in adult outpatients with opioid use disorder.

About Opioid Use Disorder (OUD) and Treatment 
Opioid-involved overdose deaths are a public health epidemic, resulting in about 30,000 deaths in the United States in 2015. The deaths were caused by prescription-drug misuse (20,000) and a rise in heroin use (10,000). Opioids kill more people than firearms and car accidents. In Europe, it is estimated that over 70,000 lives were lost due to drug overdoses in Europe in the first decade of the 21st century. Reducing drug-related deaths therefore remains a major challenge for public health policy. 

12.5 million people misused opioid pain relievers and over 800,000 people used heroin in the U.S. in 2015. In 2013, prescription opioid abuse accounted for an estimated $78.5 billion in U.S. health and social costs. Despite the extreme high social costs and large patient population with opioid addiction, only about half of the estimated 2.6 million and 1.3 million people diagnosed with opioid addiction in the U.S. and Europe receive treatment medication. 

Opioid use disorder is diagnosed by signs and symptoms of compulsive and harmful (psychologically, socially, physically) ongoing use of opioids even when there is a strong desire to cease their use.  Cravings or desire for use and painful opioid withdrawal symptoms can be overwhelming.  There are clear changes in the brain involved with cognition, memory, and rewards in both conscious and unconscious circuits that underlie opioid addiction.  

Buprenorphine maintenance treatment is currently considered a gold standard for opioid use disorder treatment with more than one million patients receiving buprenorphine in the U.S. and Europe. The medication reduces craving, reduces the risk of relapse, reduces fatalities from opioid overdose, and decreases injection drug behaviors associated with spread of infectious diseases such as hepatitis C and HIV. Currently, most patients on buprenorphine take daily doses.  These forms of the medication are sometimes misused, abused and diverted or accidentally ingested by children. In addition, patients can inadvertently or intentionally miss doses, which makes them vulnerable to relapse and overdose death.   

About CAM2038 Products 

CAM2038 are buprenorphine subcutaneous investigational new drugs in late stage clinical development for the treatment of opioid addiction. Once-weekly and once-monthly formulations have been developed, each with multiple doses, to allow individualized treatment of patients with opioid use disorder as a part of comprehensive treatment plan to include counseling and psychosocial support.  

The CAM2038 products are designed for administration by healthcare personnel to ensure proper delivery, medication adherence, minimization of the risks of diversion, abuse, misuse, and accidental exposure by children. Previously, the CAM2038 products have been evaluated in four completed Phase 1/2 clinical trials, and a pivotal Phase 3 study reported in November 2016. In addition to the long-term safety study reported on today, a Phase 2 trial is underway to evaluate whether weekly and monthly CAM2038 can be expected to produce similar buprenorphine blood levels following administration at various injection sites. To date, nearly 1000 subjects have been enrolled in clinical studies evaluating CAM2038.  

Design attributes of CAM2038 include small dose volumes (maximum volume approximately 0.6 mL for the highest weekly dose) in prefilled syringes with a thin 23 gauge injection needle and administered subcutaneously, intended to minimize discomfort for patients, leading to enhanced patient and physician acceptance. CAM2038 is stored at room temperature, hence avoiding the need for cold chain distribution and refrigerator storage, which most healthcare provider offices do not have. As CAM2038 is provided ready for use in a prefilled syringe, no mixing steps or room temperature conditioning is required.  

About Braeburn Pharmaceuticals 
Braeburn Pharmaceuticals, an Apple Tree Partners company, is a commercial-stage pharmaceutical company delivering individualized medicine in neuroscience. Long-acting therapeutic treatment options can be essential to improving patient outcomes and facilitating recovery in neurological and psychiatric disorders, which are often complicated by stigma and present significant public health challenges. Braeburn’s commercial product, Probuphine® (buprenorphine) implant was approved by the FDA in May 2016. Braeburn’s investigational product pipeline consists of long-acting implantable and injectable therapies for serious neurological and psychiatric disorders, including opioid addiction, pain, and schizophrenia. Braeburn’s pipeline products are at various stages of clinical development and include weekly and monthly CAM2038, subcutaneous injection depot formulations of buprenorphine, being investigated in opioid addiction and pain, BB0417 buprenorphine/granisetron injectable for acute pain, and BB0817, six-month risperidone implant being investigated in schizophrenia. More information on Braeburn can be found at www.braeburnpharmaceuticals.com. 

About Camurus

Camurus is committed to developing and commercializing innovative and long-acting medicines for the treatment of severe and chronic conditions, including opioid dependence, pain, cancer and endocrine disorders. New drug products are created based on our proprietary FluidCrystal® drug delivery technologies with the purpose to deliver improved quality of life, treatment outcomes and resource utilization. The company’s share is listed on Nasdaq Stockholm under the ticker “CAMX”. For more information, visit www.camurus.com. 

Media contacts: 
Fredrik Tiberg, President & CEO Tel. +46 (0)46 286 46 92 fredrik.tiberg@camurus.com 

Rein Piir, VP Investor Relations Tel. +46 (0)70 853 72 92 
ir@camurus.com  

Sherry Feldberg 
MSLGROUP Boston 
781-684-0770 braeburnpharma@mslgroup.com

All news about Braeburn Pharmaceuticals

More News

May 18, 2017

Aileron Announces Oral Presentation at ASCO on ALRN-6924 Targeting p53

Read more

May 16, 2017

Braeburn Keeps Up with Competitors with LongActing Risperidone for Schizophrenia

Read more

May 10, 2017

Otic Pharma Completes Merger with Tokai Pharmaceuticals

Read more

May 02, 2017

Braeburn and Camurus Announce Positive Top-line Results

Read more

May 01, 2017

National Opioid Addiction Treatment Leader Launches Center in Hartford

Read more

May 01, 2017

National Opioid Addiction Treatment Leader Launches Center in Arlington

Read more

Apr 26, 2017

Braeburn Achieves Primary Endpoint in Pivotal Phase 2/3 Study of BB0817

Read more

Apr 24, 2017

New addiction treatment center adds to fight

Read more

Apr 21, 2017

New Addiction Treatment Facility To Open In Hartford

Read more

Apr 17, 2017

National Opioid Addiction Treatment Leader Launches 1st of Three Phoenix Centers

Read more

Apr 11, 2017

CleanSlate Centers' CMO Begins Term as President of ASAM

Read more

Apr 04, 2017

National Opioid Addiction Treatment Leader Launches Center in Lawrence

Read more

Mar 20, 2017

Syntimmune Announces Breakthrough Results of FcRn Inhibition Published in PNAS

Read more

Feb 20, 2017

CleanSlate Centers' Officials Join District Attorney's Addiction Task Force

Read more

Feb 20, 2017

Indiana Medicaid Members Gain Access to Leading Addiction Treatment

Read more

Feb 13, 2017

Fast Company Honors Braeburn as a Top Ten Most Innovative Company in Biotech

Read more

Jan 13, 2017

Braeburn Pharmaceuticals’ Probuphine® Implant Receives J-Code

Read more

Jan 04, 2017

Opioid Addiction Treatment Leader CleanSlate Launches Center in Fort Wayne

Read more

Dec 22, 2016

Tokai Pharmaceuticals and Otic Pharma Enter into Share Purchase Agreement

Read more

Dec 19, 2016

CleanSlate Centers Adds Executive to East Division Leadership

Read more

Dec 12, 2016

National Opioid Addiction Treatment Leader CleanSlate Launches Center in Elkhart

Read more

Nov 21, 2016

Braeburn and CEO Behshad Sheldon Win Stevie Awards

Read more

Nov 17, 2016

Syntimmune Announces Appointment of David De Graaf, Ph.D., as CEO

Read more

Nov 14, 2016

Braeburn Pharmaceuticals and Camurus Announce Positive Top-line Phase 3 Results

Read more

Oct 31, 2016

Opioid Addiction Treatment Leader CleanSlate Launches Center in East Boston

Read more

Oct 27, 2016

​ Probuphine® Wins Popular Science’s “Best of What’s New” Award

Read more

Oct 24, 2016

Braeburn Pharmaceuticals and Camurus Expand Collaboration and License Agreement

Read more

Oct 21, 2016

Braeburn and Camurus announce the presentation of new data

Read more

Oct 04, 2016

OPTUM, CLEANSLATE TO EXPAND ACCESS TO OPIOID ADDICTION TREATMENT FOR MEMBERS

Read more

Oct 03, 2016

Opioid Addiction Treatment Leader CleanSlate Launches Center in Merrillville

Read more

Sep 30, 2016

Braeburn and Camurus Enroll First Patients in a Phase 3 Efficacy Trial

Read more

Sep 08, 2016

Tokai Pharmaceuticals Announces Review of Strategic Alternatives

Read more

Sep 06, 2016

ROX Medical Raises $40M Financing

Read more

Aug 27, 2016

HeartWare Receives FDA Approval To Enroll Supplemental Patient Cohort In Trial

Read more

Aug 23, 2016

Medtronic Completes Acquisition of HeartWare International

Read more

Aug 15, 2016

National Opioid Addiction Treatment Leader CleanSlate Opens Center in Anderson

Read more

Jul 29, 2016

VytronUS, Inc. Raises $49 Million in Series C Financing

Read more

Jul 29, 2016

Apple Tree Bankrolls Johnson & Johnson Spinout Tusker Medical

Read more

Jul 29, 2016

Tokai Pharmaceuticals Announces Reduction in Force

Read more

Jul 20, 2016

Anthony Belott joins CleanSlate Centers as Chief Development Officer

Read more

Jul 19, 2016

Braeburn Pharmaceuticals Announces Probuphine Data Published

Read more

Jul 06, 2016

High-Tech Healthcare Helps Eliminate Unnecessary Hospital Visits

Read more

Jun 27, 2016

Medtronic to Expand Portfolio with Acquisition of HeartWare International

Read more

Jun 26, 2016

Tokai Pharmaceuticals Announces Clinical Update

Read more

Jun 13, 2016

CleanSlate Centers names Gregory C. Marotta President & CEO

Read more

Jun 08, 2016

CleanSlate, a Massachusetts based addiction treatment center, expands nationally

Read more

Jun 02, 2016

Tokai Pharmaceuticals to Participate in Upcoming Investor Conferences

Read more

May 26, 2016

FDA approves first buprenorphine implant for treatment of opioid dependence

Read more

May 18, 2016

Tokai Announces Publication of 3 Abstracts on Galeterone at 2016 ASCO Annual Mtg

Read more

May 10, 2016

Tokai Pharmaceuticals Reports First Quarter 2016 Financial Results

Read more

May 05, 2016

Tokai to Present at Bank of America Merrill Lynch 2016 Health Care Conference

Read more

Apr 26, 2016

Tokai Announces Oral Presentation on Galeterone at the 2016 AUA Annual Meeting

Read more

Apr 20, 2016

Dermatology Services Company QualDerm Unveils $31.8M Growth Investment

Read more

Apr 13, 2016

Tokai Announces Presentations on Galeterone at the AACR Annual Meeting 2016

Read more

Apr 06, 2016

Tokai Pharmaceuticals to Present at 15th Annual Needham Healthcare Conference

Read more

Mar 30, 2016

Tokai Announces Dosing of First Patient in Phase 2 Expansion Study of Galeterone

Read more

Mar 22, 2016

Syntimmune Secures Second Tranche of $26 Million Series A Financing

Read more

Mar 21, 2016

Tokai Strengthens Development Team Through the Addition of Kelly Lindert, M.D.

Read more

Mar 10, 2016

Tokai Pharmaceuticals Reports Full Year 2015 Financial Results

Read more

Feb 22, 2016

Braeburn and Camurus Announce Initiation of a Phase 2 Study

Read more

Feb 17, 2016

Corvidia Therapeutics Raises $26M in a Series A Financing

Read more

Feb 01, 2016

Braeburn Pharmaceuticals and Knight Therapeutics Announce

Read more

Jan 14, 2016

Titan Pharmaceuticals and Braeburn Pharmaceuticals Announce FDA Advisory

Read more

Jan 08, 2016

Tokai Announces Presentation New Data Highlighting Unique Galeterone Mechanism

Read more

Jan 07, 2016

Tokai Announces Update on ARMOR3-SV and Expanded Galeterone Clinical Dev Program

Read more

Dec 15, 2015

Braeburn Pharmaceuticals and Camurus Announces Start of Phase 3 Trial

Read more

Dec 09, 2015

Titan Pharmaceuticals and Braeburn Pharmaceuticals Announce Date of FDA Review

Read more

Nov 10, 2015

Tokai Pharmaceuticals Reports Third Quarter 2015 Financial Results

Read more

Nov 09, 2015

CleanSlate Launches STAT Campaign for Physician Awareness of PA Opioid Epidemic

Read more

Nov 04, 2015

FDA Grants Fast Track Designation for Development of CAM2038

Read more

Sep 28, 2015

FDA Accepts Braeburn’s Resubmission of Probuphine NDA for Review

Read more

Sep 20, 2015

Paul L. Chabot Joins CleanSlate Centers as the New CIO

Read more

Sep 17, 2015

Braeburn Pharmaceuticals Commends HHS Secretary Burwell

Read more

Sep 14, 2015

Patrick J. Murphy Joins CleanSlate Centers as the New Chief Financial Officer

Read more

Sep 04, 2015

Geisinger Health Plan Establishes Relationship with CleanSlate Centers

Read more

Aug 12, 2015

Tokai Pharmaceuticals Reports Second Quarter 2015 Results

Read more

Jul 30, 2015

Abbott to Broaden Foundation in Structural Heart Therapies

Read more

Jun 24, 2015

Tokai Announces Initiation of Phase 3 ARMOR3-SV Trial of Galeterone

Read more

Jun 23, 2015

Gregory C. Marotta Joins CleanSlate Centers as the New Chief Operating Officer

Read more

Jun 08, 2015

Braeburn Reports Positive Results From Phase 3 Study

Read more

Jun 01, 2015

Patrick J Kennedy Accepts Seat on Board of Directors at CleanSlate Centers

Read more

May 12, 2015

Tokai Pharmaceuticals Reports First Quarter 2015 Financial Results

Read more

Apr 14, 2015

Tendyne Announces First Patient Enrolled in US Trial

Read more

Apr 09, 2015

Tendyne Raises $25 Million in Series C

Read more

Apr 06, 2015

VytronUS, Inc. Attracts Industry Veteran John Pavlidis as New President and CEO

Read more

Mar 12, 2015

Tokai Reports Fourth Quarter and Full Year 2014 Financial Results

Read more

Feb 12, 2015

Aileron Therapeutics Initiates Phase 1 Cancer Study of ALRN-6924

Read more

Dec 15, 2014

The Tendyne TMVI system was successfully implanted in the first patient

Read more

Dec 02, 2014

Tendyne Announces Successful First Human Implants of TMVI

Read more

Nov 19, 2014

Tokai Pharmaceuticals Presents Updated Interim Galeterone ARMOR2 Data

Read more

Nov 10, 2014

Tokai Pharmaceuticals Reports Third Quarter 2014 Financial Results

Read more

Oct 29, 2014

​VytronUS, Inc. Raises $31.6 Million in Series B

Read more

Oct 29, 2014

Aileron Therapeutics Secures $33 Million in Series E

Read more

Sep 24, 2014

Braeburn Pharmaceuticals’ Probuphine® Study Hits Enrollment Milestone

Read more

Sep 23, 2014

Tokai Pharmaceuticals Announces Closing of Initial Public Offering

Read more

Jun 02, 2014

Tokai Pharmaceuticals Presents New Clinical Data for Galeterone

Read more

May 16, 2014

Updated Phase 2 Clinical Data on Tokai Pharmaceuticals’ Galeterone

Read more

Mar 07, 2014

Titan Announces Agreement in Principle for Probuphine Clinical Study

Read more

Feb 03, 2014

Tokai's Reformulated Galeterone Demonstrates Robust PSA Reductions

Read more

Jan 13, 2014

New Phase 2 Clinical Data on Tokai Pharmaceuticals’ Galeterone

Read more

Nov 18, 2013

Aileron Therapeutics has secured $30 million in Series E equity financing

Read more

Nov 15, 2013

Titan Pharmaceuticals Announces $5 Million Equity Investment

Read more

Sep 26, 2013

Frank E. Young, Former FDA Commissioner, Joins Braeburn Pharmaceuticals as EVP

Read more

Aug 15, 2013

Aileron Therapeutics Publishes Data

Read more

Aug 13, 2013

Titan Announces Publication of Phase 3 Probuphine Data in Additiction

Read more

Aug 09, 2013

HeartWare Presentation At The Canaccord Genuity 2013 Annual Growth Conference

Read more

Aug 08, 2013

HeartWare International Reports $50.8 Million In Second Quarter 2013 Revenue

Read more

Jun 17, 2013

HeartWare Receives Conditional Approval From FDA

Read more

May 15, 2013

Tokai Pharmaceuticals Announces $35.5 Million Series E Financing

Read more

May 07, 2013

Aileron Successfully Completes First-Ever Stapled Peptide Clinical Trial

Read more

Apr 29, 2013

HeartWare International Reports $49.2 Million In First Quarter 2013 Revenue

Read more

Apr 10, 2013

Aileron Therapeutics Presents New Preclinical Data on Stapled Peptide

Read more

Apr 04, 2013

Tokai Announces Presentation of Galeterone Mechanism of Action Data

Read more

Mar 28, 2013

Tokai Pharmaceuticals Announces Appointment of Jodie Morrison as CEO

Read more

Mar 22, 2013

Titan Announces FDA Advisory Committee Recommends Approval of Probuphine®

Read more

Mar 14, 2013

Titan announces date of FDA Advisory Committee Review of PROBUPHINE®

Read more

Mar 12, 2013

HeartWare Announces Pricing of Public Offering of Common Stock

Read more

Mar 04, 2013

Tokai to Present Data on Galeterone in Advanced Prostate Cancer

Read more

Jan 14, 2013

Aileron Secures $12 Million for First-Ever Stapled Peptide Clinical Trial

Read more

Jan 07, 2013

HeartWare International Announces Preliminary Fourth Quarter 2012 Revenues

Read more

Jan 02, 2013

Probuphine® Receives FDA Priority Review Designation

Read more

Dec 17, 2012

Titan Licenses Exclusive Probuphine® Commercialization Rights in U.S. & Canada

Read more

Dec 13, 2012

Tokai Pharmaceuticals Doses First Patient in a Phase 2 Study of Galeterone

Read more

Nov 20, 2012

HeartWare Receives FDA Approval for HeartWare Ventricular Assist System

Read more

Nov 09, 2012

HeartWare Reports Third Quarter 2012 Results

Read more

Aug 07, 2012

HeartWare Reports Second Quarter 2012 Results

Read more

Aug 02, 2012

HeartWare Completes Acquisition Of World Heart Corporation

Read more

Jun 12, 2012

Tokai Pharmaceuticals’ Galeterone Receives Fast Track Designation From the FDA

Read more

Apr 25, 2012

FDA Advisory Committee Votes in Favor of HeartWare® Ventricular Assist System

Read more

Apr 02, 2012

Positive Phase 1 data presented

Read more

Mar 29, 2012

HeartWare International Expands Intellectual Property and Technology Portfolio

Read more

Mar 14, 2012

10 Top Next-Gen Biotech Platforms

Read more

Feb 16, 2012

HeartWare International Reports Fourth Quarter 2011 Revenues of $23.1 Million

Read more

Nov 17, 2011

Aileron expands stapled peptide drug collaboration with Roche

Read more

Sep 20, 2011

Tokai Pharmaceuticals Raises $23 Million in Funding

Read more

Sep 20, 2011

Tokai Snaps Up $23M From Novartis and Apple Tree

Read more

Sep 20, 2011

Tokai lands new CEO, $23M venture round for PhIIb cancer study

Read more

Jun 16, 2011

FDA Grants Accelerated Approval of ISTODAX(R)

Read more

May 05, 2011

HeartWare International Reports First Quarter 2011 Revenues of $18.0 Million

Read more

Apr 15, 2011

HeartWare Reports Additional Data from Bridge-to-Transplant Clinical Trial

Read more

Mar 24, 2011

HeartWare International Receives Approval From the TGA in Australia

Read more

Feb 28, 2011

FDA Grants Priority Review For ISTODAX(R) sNDA

Read more

Feb 24, 2011

HeartWare International Reports Fourth Quarter 2010 Revenues of $20.9 Million

Read more

Jan 24, 2011

HeartWare Receives Third Patient Allotment From FDA

Read more

Dec 28, 2010

HeartWare Files PMA Application for FDA Approval

Read more

Dec 15, 2010

HeartWare Announces Completion of Concurrent Public Offerings

Read more

Dec 10, 2010

HeartWare Announces Pricing of Concurrent Public Offerings

Read more

Dec 09, 2010

HeartWare International, Inc. Announces Concurrent Public Offerings

Read more

Dec 05, 2010

New Clinical Data Evaluating ISTODAX(R) in Pivotal Open-Label Phase II Study

Read more

Nov 14, 2010

HeartWare 5-Ounce Pump Extends Lives in Heart Failure Patients

Read more

Nov 14, 2010

HeartWare Achieves Primary Endpoint

Read more

Aug 24, 2010

Roche Backs New Method for Drug Delivery to Cells

Read more

Aug 24, 2010

Roche Enters $1.1B Deal With Aileron To Produce New Drugs

Read more

Aug 01, 2010

Stapled Peptides on the cover of the August issue of Nature Chemical Biology

Read more

Jun 24, 2010

HeartWare Announces Board Succession

Read more

Jun 14, 2010

HeartWare Receives Conditional FDA Approval

Read more

Apr 23, 2010

HeartWare Data From First 100 Patients

Read more

Apr 07, 2010

HeartWare Receives FDA Approval of Continued Access Protocol

Read more

Feb 22, 2010

HeartWare Announces Early Conclusion of Enrollment

Read more

Feb 02, 2010

HeartWare Announces Completion of Public Offering of Common Stock

Read more

Jan 26, 2010

HeartWare Announces Commencement of Public Offering of Common Stock

Read more

Dec 07, 2009

Celgene to Acquire Gloucester Pharmaceuticals

Read more

Nov 27, 2009

Tokai eyes novel weapon to battle prostate cancer

Read more

Nov 11, 2009

Aileron Therapeutics Collaborators Publish In Vivo Research in Nature

Read more

Nov 05, 2009

FDA Approves Gloucester's ISTODAX® for Cutaneous T-cell Lymphoma

Read more

Oct 10, 2009

Tokai Pharmaceuticals Initiates ARMOR Program for TOK-001

Read more

Sep 02, 2009

FDA Advisory Committee Recommends Gloucester's Romidepsin for Approval

Read more

Aug 25, 2009

Gloucester raises $29 million

Read more

Aug 21, 2009

HeartWare International Surpasses 50 Implants In The US

Read more

Aug 17, 2009

HeartWare International, Inc. Closes US$60 Million Financing

Read more

Jun 08, 2009

Aileron Therapeutics Closes $40M Financing To Advance Stapled Peptide Platform

Read more

Jun 01, 2009

“Emerging Drug Developer” Tokai Pharmaceuticals

Read more

Oct 22, 2008

Aileron Advances First Stapled Peptide Drug Candidate

Read more