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.
VelosBio Emerges with $58M in Funding to Steer Cancer Drugs to Clinic
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
Kezar Life Sciences Announces Pricing of Initial Public Offering
South San Francisco, CA, June 20, 2018 – Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing novel small molecule therapeutics to treat unmet needs in autoimmunity and cancer, announced today that it has priced its initial public offering of 5,000,000 shares of its common stock at a public offering price of $15.00 per share. The gross proceeds to Kezar, before deducting underwriting discounts, commissions and offering expenses, is expected to be approximately $75 million. All of the common stock is being offered by Kezar. In addition, Kezar has granted the underwriters a 30-day option to purchase up to 750,000 additional shares of common stock to cover over-allotments, if any, at the initial public offering price, less the underwriting discounts and commissions. The common stock are expected to begin trading on The Nasdaq Global Select Market on June 21, 2018 under the trading symbol "KZR." The offering is expected to close on June 25, 2018, subject to customary closing conditions.
FDA Grants Fast Track Designation for OrphoMed's ORP-101 for Treatment of IBS-D
San Francisco, CA, April 25, 2018 – OrphoMed, Inc., a clinical-stage biopharmaceutical company developing first-in-class dimer therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company's lead candidate ORP-101 for the treatment of irritable bowel syndrome with diarrhea (IBS-D). Fast Track designation is a process designed to facilitate the development and expedite the review of new therapies aimed at treating serious conditions and addressing unmet medical needs. This designation allows early and frequent communications between the FDA and the company sponsor throughout the drug development and review process. Additionally, Fast Track designated drugs are eligible for priority review, which can expedite the FDA's review of a New Drug Application (NDA).
Former CoLucid CEO Thomas P. Mathers joins Pappas Capital as Partner
RESEARCH TRIANGLE PARK, N.C., April 10, 2018 — Pappas Capital announced today that Thomas P. “Tom” Mathers has joined the firm as a partner. Mathers previously served as CEO of CoLucid Pharmaceuticals (NASDAQ: CLCD), a Pappas Capital portfolio company that was acquired in early 2017 by Eli Lilly & Company for nearly $1 billion. Mathers’ initial mandate will be to spearhead the formation of a new biopharmaceutical company that is expected to be backed by Pappas and other venture capital investors. In addition to launching the new company, he will source new deals, assist in evaluating prospective investment opportunities and provide expertise and oversight to Pappas portfolio companies. He will be based in Boston.
Amplyx Pharmaceuticals Receives Fourth "Qualified Infectious Disease Product" (QIDP) Designation from the FDA for APX001
San Diego, CA, Mar. 19, 2018 – Amplyx Pharmaceuticals, a company developing first-in-class products for life-threatening infections, including deadly fungal pathogens, today announced that the US Food and Drug Administration (FDA) has granted a fourth Qualified Infectious Disease Product (QIDP) designation to APX001, the company's lead antifungal product candidate. The QIDP designation, a provision under the U.S. Generating Antibiotic Incentives Now (GAIN) Act, was approved by Congress in 2012 to offer incentives to companies to bring to market new treatments for deadly infections. These incentives provide APX001 with eligibility for priority FDA review and fast-track status, and an additional five years of market exclusivity under the Hatch-Waxman Act. Amplyx had previously received QIDP designation as well as orphan drug designation from the FDA for APX001 for the treatment of invasive candidiasis, invasive aspergillosis, and coccidioidomycosis. This new QIDP status expands the eligible population to include the treatment of cryptococcosis.
IlluminOss Medical Granted FDA Marketing Clearance for the IlluminOss® Bone Stabilization System
East Providence, RI, January 09, 2018 – IlluminOss Medical, a privately held, commercial-stage medical device company focused on minimally invasive orthopedic fracture repair, today announced that it has received U.S. Food and Drug Administration (FDA) de novo clearance for the IlluminOss Bone Stabilization System for treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease.
Liquidia Initiates Phase 3 Clinical Trial of LIQ861 in Patients with Pulmonary Arterial Hypertension
RESEARCH TRIANGLE PARK, NC – January 3, 2018 – Liquidia Technologies, Inc., a late-stage clinical biopharmaceutical company focused on improving the performance of medicine by precisely engineering drug particles, today announced the initiation of a Phase 3 clinical trial evaluating LIQ861 for the treatment of pulmonary arterial hypertension (PAH). LIQ861, developed using Liquidia’s proprietary PRINT® technology, is a powder formulation of treprostinil designed for deep-lung delivery using a disposable, dry powder inhaler (DPI). PAH is a chronic, progressive disease caused by the hardening and narrowing of the pulmonary arteries, which often results in heart failure. Previously approved by the U.S. Food and Drug Administration (FDA) in oral, nebulized and parenteral formulations, treprostinil is a synthetic analog of prostacyclin, a vasoactive mediator deficient in patients with PAH yet essential to normal lung function to regulate vessel tone.
