FOSTER CITY, Calif.–(BUSINESS WIRE)–Oct. 28, 2019– Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biopharmaceutical company focused on the development and commercialization of novel therapies for debilitating liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for maralixibat for the treatment of pruritus associated with Alagille syndrome (ALGS) in patients 1 year of age and older.
– Tildacerfont demonstrated maximum mean reductions of 84% adrenocorticotropic hormone (ACTH), 82% 17-hydroxyprogesterone (17-OHP) and 79% androstenedione (A4), key disease biomarkers in CAH patients with elevated androgens
– The majority of tildacerfont-treated patients saw their ACTH levels normalize as a result of treatment
– Non-steroidal tildacerfont holds potential as a first-in-class treatment for patients with congenital adrenal hyperplasia
San Francisco – September 19, 2019 – Spruce Biosciences, a clinical-stage biotechnology company developing novel therapies for rare endocrine disorders, today announced positive results from a Phase 2a, multicenter, 12-week trial of tildacerfont, an investigational, oral, once-a-day corticotropin-releasing factor type-1 receptor antagonist, in development for the treatment of congenital adrenal hyperplasia (CAH).
SAN DIEGO, Sept. 16, 2019 /PRNewswire/ — 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 it has executed an exclusive worldwide license agreement with Novartis under which Amplyx has acquired the rights to the Phase 2 anti-BK virus (BKV) monoclonal antibody, MAU868, for the treatment and prevention of BKV disease. Financial terms have not been disclosed.
SAN DIEGO, Sept. 16, 2019 /PRNewswire/ — 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 two independent review committees completed their planned safety and efficacy assessment of data from 50% of the planned study population enrolled in the Company’s Phase 2 open-label clinical trial of fosmanogepix (APX001) for the treatment of candidemia.
Designation Underscores Urgent Need for New Antifungals Targeting Multidrug-Resistant Pathogens
SAN DIEGO – Sept. 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.
REDWOOD CITY, Calif., Aug. 05, 2019 (GLOBE NEWSWIRE) — Allakos Inc. (the “Company”) (Nasdaq: ALLK) today announced positive results from its Phase 2 randomized, double-blind, placebo-controlled trial of AK002 in patients with eosinophilic gastritis and/or eosinophilic gastroenteritis. All AK002 dose arms showed clinically meaningful and statistically significant benefits compared to placebo on all prespecified primary and secondary endpoints, including gastrointestinal tissue eosinophil counts and patient reported disease symptoms. Statistically significant differences in patient symptoms between the active and placebo groups occurred one day following AK002 administration. In addition, patients with comorbid eosinophilic esophagitis treated with AK002 experienced statistically significant decreases in esophageal eosinophil counts and substantial reductions in patient reported dysphagia symptoms.
REDWOOD CITY, Calif., Aug. 06, 2019 (GLOBE NEWSWIRE) — Allakos Inc. (the “Company”) (Nasdaq: ALLK), a biotechnology company developing AK002 for the treatment of eosinophil and mast cell related diseases, today announced the upsizing and pricing of its previously announced underwritten public offering. The size of the offering has been increased from the previously announced $200 million of shares of the Company’s common stock to $350 million of shares of its common stock. The Company is offering 4,545,454 shares at a public offering price of $77.00 per share. The offering is expected to close on August 9, 2019, subject to the satisfaction of customary closing conditions. In connection with the offering, the Company has granted the underwriters a 30-day option to purchase up to $52.5 million of additional shares of its common stock at the public offering price, less the underwriting discounts and commissions.
REDWOOD CITY, Calif., Aug. 05, 2019 (GLOBE NEWSWIRE) — Allakos Inc. (the “Company”) (Nasdaq: ALLK), a biotechnology company developing AK002 for the treatment of eosinophil and mast cell related diseases, today announced it intends to offer and sell, subject to market and other conditions, $200 million of shares of its common stock in an underwritten public offering. In addition, Allakos expects to grant the underwriters a 30-day option to purchase up to $30 million of additional shares of the Company’s common stock. All of the shares in the proposed offering will be sold by the Company. The proposed offering is subject to market and other conditions, and there can be no assurances as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.
ST. LOUIS, MO (July 23, 2019) – Life sciences venture capital firm RiverVest Venture Partners today announced the continued expansion of its team as Derek Rapp joins as managing director and Isaac Zike, Ph.D., as senior associate.
Most recently president & CEO of JDRF, a global organization funding type 1 diabetes research, Rapp also previously served as CEO for life sciences start-up Divergence, Inc., which he led to a successful exit. He also served as head of mergers and acquisitions at a global agtech company where he led transactions totaling more than $6 billion.
FOSTER CITY, Calif., July 17, 2019 /PRNewswire/ — 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.
South San Francisco, CA, JUNE 25, 2019 — InterVene Inc. today announced it has raised $15 million in a Series B financing round. The company’s BlueLeaf® Endovenous Valve Formation System is the first catheter-based solution for deep vein reflux (DVR) — the failure of venous valves in the legs — that does not require an implant.
We mourn the passing of our co-founder, partner and friend, Andrew B. Craig III. He was essential to RiverVest’s founding in 2000 and inspiration to the firm’s high professional and personal standards. We will miss him as a mentor and friend, but forever be enhanced by the great example he set.