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Planning for Seladelpar Launch as it Completes Development and Regulatory Submissions
NEWARK, Calif., May 10, 2021 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced that seasoned biopharma executive Lewis Stuart has joined the company as Chief Commercial Officer. Mr. Stuart brings more than 25 years of experience leading the marketing, sales, market access, and other commercial functions at successful biotech companies and launching new therapies in women’s health, oncology, metabolic, and rare diseases.
Mr. Stuart most recently served as Vice President and Prostate Cancer Franchise Leader for Myovant Sciences. In this role he led the company’s Prostate Cancer Launch Readiness cross functional team of commercial, medical, legal, and manufacturing functions. Mr. Stuart also managed the strategic collaboration with Pfizer, focused on the co-promotion and life-cycle plans for ORGOVYXTM, a new therapy for advanced prostate cancer.
“We are delighted to welcome Lewis to the CymaBay team. His addition marks the start of a critical next step in our advancement of seladelpar for patients with PBC,” said Sujal Shah, CymaBay President and Chief Executive Officer. “It is our good fortune to recruit an accomplished biotechnology executive such as Lewis with his record of successfully launching multiple products, including in rare diseases and women’s health. His skills will be a major asset for CymaBay and the timing of his team’s pre-commercial efforts will layer seamlessly on the anticipated completion of our recently launched Phase 3 trial and subsequent regulatory submissions.”
“It’s an honor to join the CymaBay team at this pivotal time, as the company completes its Phase 3 trial of seladelpar and looks ahead to the therapy’s potential market launch,” said Mr. Stuart. “I was drawn to the company because of its patient-care focus, cutting-edge research, and scientific integrity, and I am thrilled to join such a talented team.”
Prior to Myovant, Lewis Stuart held senior leadership roles at several leading biopharmaceutical companies, including Vice President of U.S. Oncology for Genomic Health, a leading provider of genomic-based molecular tests; and Chief Commercial Officer for cardiovascular-focused CV Therapeutics, where he led marketing, commercial operations, medical affairs, as well as a high-performing, 250-person sales team. Other roles include leading the launch of Viracept (nelfinavir), at that time becoming the most-prescribed protease inhibitor for HIV and Vice President, Global Marketing at Insmed, where he led the ultra-rare disease launch of mecasermin in Europe and the Middle East for treatment of Laron’s Syndrome, a type of growth deficiency. Over his career, he has served on the Board of Directors and acted as commercial advisor to multiple biotech companies and investment firms, including Linkage Biosciences, Amygdala Neurosciences and Green House Capital Partners.
About CymaBay
CymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on improving the lives of people with liver and other chronic diseases that have high unmet medical need through a pipeline of innovative therapies. Our deep understanding of the underlying mechanisms of liver inflammation and fibrosis, and the unique targets that play a role in their progression, have helped us receive breakthrough therapy designation (U.S. Food and Drug Administration), PRIority MEdicines status (European Medicines Agency) and orphan drug status (U.S. and Europe) for seladelpar, a first-in-class treatment for people with primary biliary cholangitis (PBC). Our evidence-based decision-making and commitment to the highest quality standards reflect our relentless dedication to the people, families and communities we serve. To learn more, visit www.cymabay.com and follow us on Twitter and Linkedin.
Cautionary Statements
Any statements made in this press release regarding the potential approval, launch and commercialization of seladelpar or timing or plans in regard thereto, as well as statements regarding the completion of ongoing clinical trials and subsequent regulatory submissions are forward looking statements that are subject to risks and uncertainties. Actual results and the timing of events regarding the further development of seladelpar could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of any of CymaBay's product development activities, including clinical trials; effects observed in trials to date that may not be repeated in the future; any delays or inability to obtain or maintain regulatory approval of CymaBay's product candidates in the United States or worldwide; and the ability of CymaBay to obtain sufficient financing to complete development, regulatory approval and commercialization of its product candidates in the United States and worldwide. Additional risks relating to CymaBay are contained in CymaBay's filings with the Securities and Exchange Commission, including without limitation its most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. CymaBay disclaims any obligation to update these forward-looking statements except as required by law.
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LifeSci Advisors, LLC
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Hans@LifeSciAdvisors.com