Enalare Therapeutics Inc. is a privately owned clinical-stage biopharmaceutical company dedicated to developing novel therapies for patients suffering from acute respiratory conditions.
October 3rd, 2022
Enalare Therapeutics Receives Orphan Drug Designation From the U.S. FDA on ENA-001 for Apnea of Prematurity (AOP)
Incentives that come with the designation include eligibility for federal grants, orphan drug tax credits, waiver of filing fees, and the potential for a seven-year marketing exclusivity period. The designation does not alter the standard regulatory requirements and process for obtaining marketing approval.
September 27th, 2022
Enalare Therapeutics Receives an Additional Award Worth Up to $50 Million From BARDA, Expanding Its Partnership in Development of ENA-001
The award, stage-gated based on achievement of pre-determined milestones and deliverables, provides funding for Enalare to perform pre-clinical toxicology, human clinical studies, drug and device manufacturing, and regulatory file submission for a formulation of ENA-001 suitable for community use.
August 9th, 2022
Eagle Pharmaceuticals Takes Equity Stake in, with Option to Acquire, Enalare Therapeutics to Advance Global Development of ENA-001, a Novel Agnostic Respiratory Stimulant
As part of the transaction, Eagle will invest up to approximately $55 million, which is expected to occur over the next two years subject to the achievement by Enalare of certain milestones on an agreed upon timeline.
July 1st, 2022
Funding from the NIH’s National Institute on Drug Abuse (NIDA) will Support Further Development of ENA001, an Agnostic Respiratory Stimulant
June 8th, 2022
Enalare Therapeutics Announces Positive Topline Results with Ena001 in a Propofol Induced Respiratory Depression Study
ENA001, an Agnostic Respiratory Stimulant, Successfully Achieved the Study Primary Endpoint and Was Shown to Be Safe and Well Tolerated
January 7th, 2022
Enalare Files Additional Patent Application for Lead Compound ENA-001 – Enhancing Patent Global Exclusivity Through 2042
This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority.
December 14th, 2021
Enalare Therapeutics Receives Rare Pediatric Disease Designation for the Lead Compound ENA-001 for the Treatment of Apnea of Prematurity
Subject to FDA approval of ENA-001 for the treatment of Apnea of Prematurity, Enalare would be eligible to receive a priority review voucher that may be applied either to a subsequent product’s marketing application or sold/transferred to another company.
November 30th, 2021
Enalare Therapeutics Files New Patent Application for Lead Product ENA-001 -Potentially Extending Global Exclusivity Through 2042
This Provisional Patent Application was filed with the United States Patent and Trademark Office for its lead product ENA-001 and related compounds for the reversal of respiratory depression from non-opioid central nervous system depressants, including common surgical anesthetics. Any resultant patent claiming priority to this filing will have an estimated term to 2042.
November 4th, 2021
Enalare Therapeutics Announces First Subject Dosed with Lead Product ENA-001 in a Propofol-Induced Respiratory Depression Study
This study aims to demonstrate the ability of ENA-001 to reverse respiratory depression induced through administration of propofol, a central nervous system depressant commonly utilized globally as a surgical anesthetic.
November 2nd, 2021
Daniel Motto, Enalare’s Chief Operating Officer, will highlight how the successful partnership with BARDA is accelerating the development of Enalare’s lead drug candidate ENA-001 as a potential treatment for respiratory depression in both mass casualty situations and the drug overdose epidemic.
August 4th, 2021
Enalare Therapeutics Expands Its Scientific Team With Appointment of Thomas Miller, PhD, as Vice President of Clinical Development
Enalare Therapeutics Inc., a biopharmaceutical company dedicated to developing novel therapies for patients suffering from life-threatening critical care conditions, announced today that it has expanded its scientific team with the appointment of Thomas Miller, Ph.D., as Vice President of Clinical Development.
April 27th, 2021
Enalare Therapeutics Announces Partnership With BARDA to Advance Development of Its Lead Product ENA-001
Enalare Therapeutics Inc. has received an initial contract from the Biomedical Advanced Research and Development Authority (BARDA) to support development of ENA-001.
February 2nd, 2021
The Company Raises $10 Million to Expand Its Operations and Prepare to Conduct Pivotal Studies of Lead Drug Candidate ENA-001.
January 19th, 2021
The Addition of Dr. Coleman Further Enhances the Company’s Deep Medical, Enterprise Leadership, and Capital Markets Experience.
January 12th, 2021
The Appointments of Professors Albert Dahan MD, PhD and Tong Joo (TJ) Gan MD, MHS, MBA Highlight a World Class Collection of Medical and Pharmaceutical Industry Experts.
November 17th, 2020
The addition of Gino Santini, Bob Yedid, and Joe Petko Significantly Expands Company’s Pharmaceutical and Financial Markets Experience and Capabilities.
November 9th, 2020
Enalare Therapeutics Inc. announced today that it has appointed pharmaceutical industry veteran Daniel Motto as its Chief Business Officer.
October 30th, 2020
Enalare Therapeutics Inc. announced today that it has appointed biopharma industry veteran Herm Cukier as its Executive Chairman of the Board, President, and Chief Executive Officer.
Thomas L. Miller, Ph.D., Lynn M. Raab, MD, Thomas H. Shaffer, MS.E., Ph.D, Alfred Schweikert, Ph.D., RAC, Frank Diana, Ph.D., Prem Fort, MD, Alana S. Frum, LVTg, RVTg, BASVT, Joseph Pergolizzi, Jr., MD, Robert B. Raffa, Ph.D.
Two Studies on Reversal of Opioid-induced Respiratory Depression by BK-channel Blocker GAL021 in Human Volunteers
Margot Roozekrans, M.D., Rutger van der Schrier, M.D., Pieter Okkerse, M.D., Justin Hay, Ph.D., James F. McLeod, M.D., Albert Dahan, M.D., Ph.D
Joseph F. Cotten, M.D., Ph.D.
Francis J. Golder, Matthew M. Hewitt, James F. McLeod
Rutger van der Schier, Margot Roozekrans, Monique van Velzen, Albert Dahan and Marieke Niesters
GAL-021, a new intravenous BKCa-channel blocker, is well tolerated and stimulates ventilation in healthy volunteers
J. F. McLeod, J. M. Leempoels, S. X. Peng, S. L. Dax, L. J. Myers and F. J. Golder
Enalare Corporate Presentation
BARDA Division of Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasures Division
Hear from our KOL, Dr. Eugene Vortsman
Northwell Health System Practicing Emergency Medicine Specialist
Hear from our KOL, Dr. TJ Gan
Stony Brook University Professor of and Chair, Department of Anesthesiology
December 6th, 2022
Eagle Pharmaceuticals’s Investor Day to Feature World-Renowned KOLs on Tuesday, December 6, 2022 at the Lotte New York Palace Hotel
Featured speakers and KOLs include: Scott Tarriff, Herm Cukier, Dr. Richard Dutton, Dr. Prem Fort, Dr. TJ Gan, Dr. Andre Kalil, Dr. Joseph Pergolizzi and Dr. Eugene Vortsman — — Topics include the clinical and scientific rationale for the Company’s hospital-based products and pipeline
May 2nd, 2022
Herm Cukier, President and Chief Executive Officer, will be presenting at the BioNJ’s Twelfth Annual BioPartnering Conference and Chief Operating Officer, Daniel Motto, will be taking questions after the presentation and meeting with potential investors and strategic partners.
May 24th, 2021
December 28th, 2021
Herm Cukier, President and CEO of Enalare Therapeutics, will provide an update on the Company’s ongoing clinical development program as well as progress on other scientific endeavors. The presentations will be available for viewing on-demand beginning on Jan. 10, 2022 via the H.C. Wainright Bioconnect Conference and the Biotech Showcase 2022 Conference platforms.
May 24th, 2021
February 3rd, 2021
- Are opioid receptor antagonists adequate for “Opioid” overdose in a changing reality?
- History of Respiratory Stimulants
- Commentary: New Complications Make Treatment of “Opioid” Overdose Challenging
- Commentary: “Ockham’s Razor” Doesn’t Apply to “Opioid” Overdose Death
- Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial
- The Polysubstance Overdose-Death Crisis
- Increase in Fatal Drug Overdoses Across the United States Driven by Synthetic Opioids Before and During the COVID-19 Pandemic
- The problem of postoperative respiratory depression