FDA Grants Fast Track Designation for OrphoMed's ORP-101 for Treatment of IBS-D

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).

OrphoMed Secures $39 Million Series A Financing Round

San Francisco, CA, May 24, 2017 – OrphoMed, Inc., a clinical stage biopharmaceutical company developing first-in-class dimer therapies, today announced the completion of a $39 million Series A financing. The round was led by New Enterprise Associates (NEA), and co-led by existing seed investor Takeda Ventures, Inc., with participation from other prior investors: Pappas Capital, through its newest fund, Pappas Ventures V; Relativity Healthcare Partners and the Mario Family Fund. In conjunction with the financing, Frank Torti, MD, Partner at NEA, and Arthur Pappas, Managing Partner of Pappas Capital, will join the company’s board alongside existing directors Michael Martin, PhD, Global Head Takeda Ventures, Inc.; Kenneth Widder, MD, Executive Chairman; and Nikhilesh Singh, PhD, Chief Executive Officer. The capital will be used to advance the clinical development of OrphoMed’s lead candidate, ORP-101, for the treatment of irritable bowel syndrome with diarrhea (IBS-D).