EAST PROVIDENCE, R.I., Feb. 26, 2019 (GLOBE NEWSWIRE) -- IlluminOss Medical, Inc., a privately held, commercial-stage medical device company focused on minimally invasive orthopedic fracture repair, today announced the U.S. launch and commercial availability of the IlluminOss® Bone Stabilization System for use in skeletally mature patients in the treatment of traumatic and fragility fractures of the humerus, radius and ulna. IlluminOss recently obtained FDA clearance for these exciting new indications*, having been previously available solely for the treatment of pathological and impending pathological fractures associated with metastatic disease in the U.S. IlluminOss Medical, Inc. will be in Booth #6243 at the AAOS 2019 Annual Meeting in Las Vegas, NV from March 12-16th and will be presenting data regarding the IlluminOss System on March 13th at 1:45 pm in Exhibit Hall B at Booth #3032.
IlluminOss Medical Launches the IlluminOss® Bone Stabilization System for Use in the Treatment of Traumatic and Fragility Fractures in the U.S.
Liquidia Technologies Reports Positive Interim LIQ861 Safety Data on 109 Patients from Pivotal INSPIRE Trial
RESEARCH TRIANGLE PARK, NC, Jan. 07, 2019 -- Liquidia Technologies, Inc. (Nasdaq:LQDA) (“Liquidia”), a late-stage clinical biopharmaceutical company focused on the development and commercialization of human therapeutics using its proprietary PRINT® technology to transform the lives of patients, today reported positive interim safety data from its open-label, multicenter Phase 3 clinical trial (INSPIRE) evaluating LIQ861, an inhaled dry powder formulation of treprostinil, for the treatment of pulmonary arterial hypertension (“PAH”). The safety data at the two-week timepoint addresses the U.S. Food and Drug Administration’s (“FDA”) data request for inclusion in a New Drug Application (“NDA”) submission. Liquidia anticipates submitting the full NDA for LIQ861 to the FDA in late 2019.
Ribometrix Announces $30 Million Series A Funding to Advance Pipeline of RNA-Targeting Small Molecule Therapies
DURHAM, NC -- November 13, 2018 -- Ribometrix, a biotechnology company developing small molecule therapeutics that directly target RNA to treat human diseases, announced today that it has completed a $30 million Series A financing to advance its discovery platform and internal pipeline of novel small molecule drugs that directly modulate RNA activity, as well as expand its team and business development activity. The round was led by M Ventures, with participation of new investors Amgen Ventures, Pappas Capital and Illumina Ventures. Founding investors SV Health Investors, AbbVie Ventures, Hatteras Venture Partners, MP Healthcare Venture Management, the Dementia Discovery Fund and Alexandria Venture Investments also joined the round. Hakan Goker, Ph.D., Senior Investment Director of M Ventures, will join the board as a non-executive director with immediate effect.
Mirum Pharmaceuticals Secures $120 Million in Series A Financing
SAN DIEGO, Nov. 7, 2018 -- Mirum Pharmaceuticals today announced that it has secured $120 million in Series A financing to support development of its lead drug candidate maralixibat for rare cholestatic liver diseases. The financing was led by New Enterprise Associates (NEA) with participation from Deerfield Management, Frazier Healthcare Partners, Novo Holdings A/S, Pappas Capital, RiverVest Venture Partners and Rock Springs Capital. The following have been appointed to Mirum's board of directors in conjunction with the financing: Ed Mathers, partner NEA; Patrick Heron, managing general partner, Frazier Healthcare Partners; Jonathan Leff, partner, Deerfield; Tiba Aynechi, Ph.D., partner, Novo Ventures; and Niall O'Donnell, Ph.D., managing director, RiverVest.
Milestone Pharmaceuticals Announces $80 Million Private Financing
MONTREAL and CHARLOTTE, N.C., Oct. 25, 2018 -- Milestone Pharmaceuticals, a late-stage biopharmaceutical company developing interventions for tachycardias, today announced the completion of an $80 million private financing. The equity financing included the support of new and existing institutional investors. Among new investors were RTW Investments, LP, who led the round, Venrock Healthcare Capital Partners, and Boxer Capital of Tavistock Group. Existing investors included Novo Holdings A/S, Forbion, funds managed by Tekla Capital Management LLC, Domain Associates, BDC Capital, Pappas Capital, GO Capital, and Fonds de solidarité FTQ. This builds on the company's prior series C financing, led by Novo Holdings, which occurred in July 2017.
CuraSen Therapeutics Announces $54.5 Million Series A Financing
SAN MATEO, Calif., Oct. 17, 2018 -- CuraSen Therapeutics, Inc., a privately held biotechnology company focused on developing therapies to treat neurodegenerative diseases, today announced the closing of a $54.5 million Series A financing. Led by New Leaf Venture Partners, the investor syndicate includes Longitude Capital, funds managed by Tekla Capital Management LLC, Alta Partners, Johnson & Johnson Innovation – JJDC, Inc. (JJDC), and Pappas Capital. CuraSen is developing small molecule drugs targeting a novel mechanism in the brain to alleviate disabling symptoms and modify disease pathology in patients who suffer from less common (orphan) neurodegenerative disorders as well as Parkinson's Disease and Alzheimer's Disease.
VelosBio Emerges with $58M in Funding to Steer Cancer Drugs to Clinic
VelosBio, a biotech startup researching new cancer drugs, has raised $58 million in financing. The new VelosBio cash, a Series A round of financing, was led by Arix Bioscience (LSE: ARIX) and Sofinnova Ventures. VelosBio joined Johnson & Johnson’s JLABS @ San Diego incubator in January. The company is developing antibody drug conjugates, a class of cancer drugs that link antibodies to potent cancer-fighting toxins. These drugs are meant to provide a targeted strike to tumors, sparing healthy tissue. The new VelosBio cash is earmarked for completing the work needed to proceed into human studies.
4D Molecular Therapeutics Raises $90 Million Series B Financing
Emeryville, CA, Sept 5, 2018 – 4D Molecular Therapeutics (4DMT), a world-leader in Therapeutic Vector Evolution for adeno-associated virus (AAV) gene therapy vector discovery and product development announced the closing of its $90 million Series B Financing. The round was led by Viking Global Investors, with participation from ArrowMark Partners, Janus Henderson Investors, The Biotechnology Value Fund, MiraeAsset Financial Group, Pappas Capital & Chiesi Ventures, Pfizer Ventures, Perceptive Advisors, Ridgeback Capital Investments, CureDuchenne Ventures and Berkeley Catalyst Fund. The proceeds from this financing will be used to advance its proprietary Therapeutic Vector Evolution platform and pipeline of next-generation AAV gene therapeutics. The company’s lead intravitreally-delivered AAV gene therapy asset for choroideremia is expected to enter clinical trials in 2019.
Milestone Pharmaceuticals Announces First Patient Randomized in the Phase 3 NODE-301 Clinical Trial Evaluating Etripamil for Termination of Paroxysmal Supraventricular Tachycardia (PSVT) Episodes
Montreal, Aug. 8, 2018 /PRNewswire/ -- Milestone Pharmaceuticals, a clinical-stage cardiovascular company, today announced that the first patient has been randomized in its Phase 3 clinical study of etripamil. Etripamil is a new investigational, rapid-onset, short-acting calcium channel blocker administered intranasally by the patient designed to terminate paroxysmal supraventricular tachycardia (PSVT) episodes wherever they occur. PSVT is a recurring and sporadic heart arrhythmia caused by abnormalities in the cardiac conduction system. The current standard of care to terminate these episodes is intravenous medication delivered in the emergency department.
The Phase 3, multicenter, randomized, double-blind, placebo-controlled, event-driven study is planned to be conducted in more than 50 cardiology centers in the United States and Canada and will enroll up to 500 patients. Following an in-office test dose of etripamil, patients will take home either 70 mg of etripamil or placebo for when a PSVT episode occurs. Upon onset of an episode, patients will apply a wireless cardiac monitor to their chest to record their heart rhythm, perform a vagal maneuver, and if symptoms persist, administer study drug.
“The design of the NODE-301 study of etripamil will allow us to obtain more clinical evidence of the benefits of this potential treatment for PSVT in an outpatient, real-world setting,” said Bruce Stambler, MD, FHRS, Piedmont Heart Institute, Atlanta, GA. “PSVT is an unpredictable disorder and the potential for a fast-acting therapy to resolve the symptoms of PSVT wherever the episodes occur could significantly reduce the burden this condition puts on patients and the healthcare system.”
The primary endpoint of the NODE-301 study is time to conversion of PSVT to sinus rhythm after the administration of study drug as confirmed by a central independent adjudication committee. Secondary study endpoints include relief of symptoms commonly associated with an episode of PSVT such as heart palpitations, chest pain, anxiety, shortness of breath, dizziness, and fainting.
“The initiation of the NODE-301 study is an example of our ongoing commitment to improve the lives of patients with PSVT,” said Francis Plat, MD, Milestone’s Chief Medical Officer. “Etripamil, if approved by regulatory authorities, could empower patients to take control of this anxiety-producing arrhythmia without being reliant on chronic medications or trips to an acute-care facility for treatment.”
The study will enroll patients at least 18 years of age with a documented history of PSVT. Patients receiving study treatment in NODE-301 will be eligible to participate in an open-label extension study (NODE-302) where etripamil will be provided for subsequent PSVT episodes. Information regarding the NODE-301 clinical trial can be found here (clinicaltrials.gov study identifier NCT03464019).
“There are well over a million people in the US living with PSVT, resulting in hundreds of thousands of emergency department and doctor’s office visits each year,” said Eileen Handberg, PhD, ANP-BC, FAHA, FACC, FPCNA, Research Professor of Medicine at the University of Florida. “In addition, countless other patients exist who don’t seek care and suffer through their episodes in silence as the current approved treatment options are unpleasant, inconvenient, and/or costly. Providing a way to self-manage PSVT episodes could offer immediate relief for those living with this arrhythmia.”
About Etripamil
Etripamil is a new, potent, short-acting, investigational calcium channel blocker being developed as a rapid-onset nasal spray that can be administered by the patient to terminate paroxysmal supraventricular tachycardia (PSVT) episodes wherever and whenever they occur. A Phase 2 clinical trial (NODE-1) was completed in the United States and Canada and published in the Journal of the American College of Cardiology[1]. Milestone is actively recruiting patients and clinical sites globally for the Phase 3 program of etripamil in the at-home setting enrolling patients with confirmed diagnosis of atrioventricular nodal reentrant tachycardia (AVNRT) and atrioventricular re-entry tachycardia (AVRT). Etripamil is not currently approved for the treatment of PSVT or for any other indication anywhere in the world.
About Paroxysmal Supraventricular Tachycardia
Paroxysmal supraventricular tachycardia is a condition that afflicts more than 1.7 million people and results in at least 600,000 healthcare claims per year in the U.S. alone[2]. During a PSVT episode, patients may feel palpitations while heart rate increases dramatically, sometimes exceeding 250 beats per minute[3]. Although the condition is not life threatening, it causes great distress to the patient and can result in an emergency department visit where a patient is usually administered intravenous medication.
About Milestone Pharmaceuticals
Milestone, headquartered in Montreal, Canada with a US subsidiary in Charlotte, NC, is a clinical-stage drug development company focused on developing an investigational new drug intended to provide rapid-onset and short-acting treatment of PSVT episodes and other episodic conditions. For more information, please visit www.milestonepharma.com.
Contact:
David Pitts
Argot Partners
212-600-1902
david@argotpartners.com
[1] Stambler, B.S. et al.; Etripamil Nasal Spray for Rapid Conversion of Supraventricular Tachycardia to Sinus Rhythm; J Am Coll Cardiol. 2018;72(5):489–97
[2] Sacks, N.C. et al; Prevalence of Paroxysmal Supraventricular Tachycardia (PSVT) in the US in Patients Under 65 Years of Age; Abstract and Oral Presentation at the International Academy of Cardiology Annual Scientific Sessions 2018, 23rd World Congress on Heart Disease; Precision Xtract, Boston, MA, USA
[3] Colucci, R.A.; Common types of supraventricular tachycardia: diagnosis and management.; Am Fam Physician. 2010;82(8), 942-952.
SOURCE Milestone Pharmaceuticals USA, Inc.
Related Links
https://www.milestonepharma.com
Liquidia Technologies Announces Pricing of Initial Public Offering
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Liquidia Technologies, Inc. (the “Company”), a late-stage clinical biopharmaceutical company focused on the development and commercialization of human therapeutics using its proprietary PRINT® technology to transform the lives of patients, today announced the pricing of its initial public offering of 4,545,455 shares of common stock at a public offering price of $11.00 per share, before underwriting discounts and commissions, for gross proceeds of $50.0 million. In addition, the Company has granted the underwriters a 30-day option to purchase up to 681,818 additional shares of common stock at the initial public offering price, less the underwriting discount. The Company’s common stock is expected to begin trading on the Nasdaq Capital Market under the ticker symbol “LQDA” on July 26, 2018. The offering is expected to close on July 30, 2018 subject to customary closing conditions.
Jefferies and Cowen are acting as joint book-running managers for the offering. Needham & Company and Wedbush PacGrow are acting as co-managers.
A registration statement relating to these securities was declared effective by the U.S. Securities and Exchange Commission (the “SEC”) on July 25, 2018. The offering will be made only by means of a prospectus. When available, copies of the final prospectus may be obtained from Jefferies LLC, Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 877-547-6340 or by email at Prospectus_Department@Jefferies.com; or from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at (631) 274-2806 or by fax at (631) 254-7140.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
ABOUT LIQUIDIA TECHNOLOGIES
Liquidia Technologies, Inc. (“Liquidia”) is a late-stage clinical biopharmaceutical company focused on the development and commercialization of human therapeutics using its proprietary PRINT® technology to transform the lives of patients. PRINT® is a particle engineering platform that enables precise production of uniform drug particles designed to improve the safety, efficacy and performance of a wide range of therapies. Currently, Liquidia is focused on the development of two product candidates for which it holds worldwide commercial rights: LIQ861 for the treatment of pulmonary arterial hypertension and LIQ865 for the treatment of local post-operative pain. Liquidia’s lead product candidate, LIQ861, currently being evaluated in a Phase 3 clinical trial (INSPIRE), is designed to improve the therapeutic profile of treprostinil by enhancing deep-lung delivery and achieving higher dose levels than current inhaled therapies by using a convenient, disposable dry powder inhaler. LIQ865, for which Liquidia has recently completed a U.S. Phase 1b clinical trial, is designed to deliver sustained-release particles of bupivacaine, a non-opioid anesthetic, to treat local post-operative pain for three to five days through a single administration. In addition to developing its own product candidates, Liquidia collaborates with leading pharmaceutical companies to develop their own product candidates across a wide range of therapeutic areas, molecule types and routes of administration, leveraging Liquidia’s PRINT®technology.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180725005966/en/
Source: Liquidia Technologies, Inc.
Liquidia Technologies, Inc.
Jennifer Almond, 919-328-4389
media@liquidia.com
