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.
Liquidia Technologies Reports Positive Interim LIQ861 Safety Data on 109 Patients from Pivotal INSPIRE Trial
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.
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.
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).
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.
