Mirum Pharmaceuticals Completes Successful Pre-NDA Meeting with FDA for Maralixibat

Mirum Pharmaceuticals Completes Successful Pre-NDA Meeting with FDA for Maralixibat

December 16, 2019, Foster City, CA, Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biopharmaceutical company focused on the development and commercialization of novel therapies for debilitating liver diseases, today announced the successful completion of its clinical pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for maralixibat for the treatment of pruritus associated with Alagille syndrome. In addition, the company had a chemistry, manufacturing and controls (CMC) meeting with the FDA. The purpose of the meetings was to discuss and confirm the clinical, non-clinical and CMC requirements for the company’s proposed NDA submission. The company also today announced that Rare Pediatric Disease Designation has been granted for maralixibat for Alagille syndrome, and thus may qualify for the receipt of a priority review voucher if the NDA is approved by the FDA. Maralixibat was recently granted Breakthrough Therapy Designation by the FDA for Alagille syndrome.

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.

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.