FDA Grants Fast Track Status to Amplyx Pharmaceuticals for Fosmanogepix

FDA Grants Fast Track Status to Amplyx Pharmaceuticals for Fosmanogepix

SAN DIEGOSept. 9, 2019 -- Amplyx Pharmaceuticals, a biotech company dedicated to developing innovative therapies for debilitating and life-threatening diseases in patients with compromised immune systems, announced today that the U.S. Food & Drug Administration (FDA) has granted Fast Track designations for both the intravenous (IV) and oral formulations of the company's lead antifungal candidate, fosmanogepix (APX001), for seven indications. These indications include treatment of invasive candidiasis, treatment of invasive aspergillosis, treatment of scedosporiosis, treatment of fusariosis, treatment of mucormycosis, treatment of cryptococcosis and treatment of coccidioidomycosis. Amplyx is investigating the safety and efficacy of fosmanogepix in its ongoing global Phase 2 clinical program.

Mirum Pharmaceuticals Announces Pricing of Initial Public Offering

FOSTER CITY, CA, July 17, 2019 -- Mirum Pharmaceuticals, Inc., a clinical-stage therapeutics company developing a novel approach for treating cholestatic liver diseases, today announced the pricing of its initial public offering of 5,000,000 shares of its common stock at a price to the public of $15.00 per share. The gross proceeds to Mirum from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be $75,000,000. The shares are expected to begin trading on the Nasdaq Global Market on July 18, 2019 under the symbol "MIRM". The offering is expected to close on July 22, 2019, subject to satisfaction of customary closing conditions.

Pappas Capital Expands Leadership Team With Appointments Of Kyle Rasbach To Managing Partner And Matthew Boyer To Chief Financial Officer

RESEARCH TRIANGLE PARK, NC, July 16, 2019 -- Pappas Capital, a leading investor in early-stage life sciences companies, today announced the promotion of Kyle Rasbach, PhD, PharmD to a Managing Partner of Pappas Ventures, the firm's venture capital business. In his new role, Dr. Rasbach will help to oversee Pappas Ventures and lead fundraising and investment efforts for its future venture funds. Pappas Capital also announced that Matthew Boyer has been named Chief Financial Officer, succeeding Ford Worthy who will continue with the firm as a Partner and Senior Advisor.

Reneo Pharmaceuticals Raises $50 Million to Develop Therapeutics to Treat Genetic Mitochondrial Diseases

San Diego, CA, May 20, 2019 -- Reneo Pharmaceuticals, a clinical stage pharmaceutical company, today announced that it has completed a $50 million Series A financing to develop therapies for diseases associated with deficits in cellular metabolism and energy production. The A round was led by New Enterprise Associates. Other participants in the round include Lundbeckfonden Ventures, Pappas Capital and RiverVest Venture Partners. Reneo is currently developing REN001, a PPAR delta agonist, to treat genetically defined rare mitochondrial diseases such as fatty acid oxidation disorders (FAOD) and primary mitochondrial myopathies (PMM). Proceeds from the Series A will be used to support ongoing Phase 1b clinical trials, as well as other clinical and preclinical studies.

Milestone Pharmaceuticals Announces Pricing of Upsized Initial Public Offering

Montreal and Charlotte, NC, May 8, 2019 -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a Phase 3 clinical-stage biopharmaceutical company dedicated to developing and commercializing etripamil for the treatment of cardiovascular indications, today announced the pricing of its upsized initial public offering of 5,500,000 of its common shares at a public offering price of $15.00 per share. The gross proceeds to Milestone, before deducting underwriting discounts, commissions and offering expenses, are expected to be approximately $82.5 million. All of the common shares are being offered by Milestone. In addition, Milestone has granted certain of the underwriters a 30-day option to purchase up to 825,000 additional common shares at the initial public offering price, less the underwriting discounts and commissions.

Aura Biosciences Completes $40 Million Series D Financing

Cambridge, MA -- April 02, 2019 -- Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced that it closed a $40 million Series D financing. New investor Medicxi led the round, with current investors Advent Life Sciences, Arix Bioscience, Chiesi Ventures, Columbus Venture Partners, Lundbeckfonden Ventures and Ysios Capital also participating. The Company plans to use the proceeds from the Series D financing to support the late stage clinical development of their lead asset, light-activated AU-011, for the treatment of primary choroidal melanoma.

IlluminOss Medical Launches the IlluminOss® Bone Stabilization System for Use in the Treatment of Traumatic and Fragility Fractures in the U.S.

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.

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.