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Rhythm Pharmaceuticals Announces Appointment of David Meeker, M.D., as Chief Executive Officer

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Rhythm Pharmaceuticals (Nasdaq: RYTM) has appointed David Meeker, M.D. as the new President and CEO, taking over from Hunter Smith, who remains CFO. Dr. Meeker, a seasoned leader in biopharmaceuticals with extensive experience in rare genetic diseases, aims to enhance the company’s strategy as it approaches potential FDA approval for setmelanotide, targeting POMC and LEPR deficiency obesity. The FDA has set a PDUFA goal date of November 27, 2020, for the drug's NDA. Meeker has been with Rhythm since 2015 and has a strong background in launching therapies for rare diseases.

Positive
  • David Meeker's extensive experience in rare genetic diseases may strengthen Rhythm's leadership.
  • Setmelanotide is approaching potential FDA approval, with a PDUFA goal date of November 27, 2020.
Negative
  • The management transition could create concerns about continuity in leadership.

BOSTON, July 20, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, today announced that David Meeker, M.D., the Chairman of Rhythm’s Board of Directors, has been appointed as the President and Chief Executive Officer (CEO) of the company, effective immediately. Dr. Meeker succeeds Hunter Smith, the Company’s Interim President and CEO and Chief Financial Officer (CFO), who will continue in his role as CFO.  

“I am delighted to announce David’s appointment as Rhythm’s new CEO,” said Hunter Smith, CFO of Rhythm. “Since he joined our Board in 2015, David has played a key role in shaping the clinical and commercial strategy for setmelanotide and in fostering our collaborative and patient-focused culture. As we continue to work toward the first potential approval of setmelanotide in pro-opiomelanocortin (POMC) and leptin receptor (LEPR) deficiency obesities later this year, David’s extensive experience leading commercial organizations and managing the launches of new medicines for rare genetic diseases, coupled with his proven ability to build strong relationships with patient and clinician communities, will be invaluable. The Rhythm team is energized by the opportunity to work more closely with David in an effort to deliver setmelanotide and potentially transform the care of people living with rare genetic disorders of obesity.”

“Rhythm is an exciting company that I have long admired, both for its scientifically-rigorous approach to drug development and its commitment to patients with rare genetic disorders of obesity,” said David Meeker, M.D. “With setmelanotide, we have the opportunity to bring one of the first meaningful therapeutic candidates to a segment of that community in dire need. Moreover, we hope our efforts will create visibility for rare genetic disorders of obesity, enabling better care for the people affected and catalyzing ongoing research efforts globally. The current management team has done a great job leading the organization through the transition and I am honored to take the CEO role.”  

Dr. Meeker has served as Chairman of Rhythm Pharmaceuticals since April 2017 and as a  member of the Board since November 2015. Most recently, he served as President and CEO of KSQ Therapeutics. Previously, Dr. Meeker was the Executive Vice President and Head of Sanofi Genzyme, the specialty-care global business unit of Sanofi that focuses on rare diseases, multiple sclerosis, oncology and immunology. Dr. Meeker joined Genzyme in 1994 as Medical Director and, over the course of his tenure, served the company as Vice President of Medical Affairs, Chief Operating Officer, and Chief Executive Officer. He led Genzyme's commercial organization and global market access functions and managed the launch of several treatments for rare genetic diseases, including Aldurazyme®, Fabrazyme® and Myozyme®. Prior to his tenure with Genzyme, Dr. Meeker was Director of the Pulmonary Critical Care Fellowship at the Cleveland Clinic and an Assistant Professor of Medicine at Ohio State University. Dr. Meeker earned his M.D. from the University of Vermont Medical School and completed the advanced management program at Harvard Business School.

About Rhythm Pharmaceuticals
Rhythm is a late-stage biopharmaceutical company focused on the development and commercialization of therapies for the treatment of rare genetic disorders of obesity. The U.S. Food and Drug Administration (FDA) has accepted for filing Rhythm’s New Drug Application (NDA) for setmelanotide for the treatment of POMC deficiency obesity and LEPR deficiency obesity with Priority Review of the NDA and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 27, 2020. Rhythm also submitted a Marketing Authorization Application (MAA) for setmelanotide to treat individuals living with POMC deficiency obesity or LEPR deficiency obesity to the European Medicines Agency (EMA) in June 2020.  Rhythm is also evaluating setmelanotide for reduction in hunger and body weight in a pivotal Phase 3 trial in people living with Bardet-Biedl and Alström syndromes, with topline data from this trial expected in the fourth quarter of 2020 or early in the first quarter of 2021. Rhythm is leveraging the Rhythm Engine -- comprised of its Phase 2 basket study, TEMPO Registry, GO-ID genotyping study and Uncovering Rare Obesity program -- to improve the understanding, diagnosis and potentially the treatment of rare genetic disorders of obesity. For healthcare professionals, visit www.UNcommonObesity.com for more information. For patients and caregivers, visit www.LEADforRareObesity.com for more information. The company is based in Boston, MA.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential, safety, efficacy, and regulatory and clinical progress of setmelanotide, including anticipated timing of data readouts and our expectations surrounding potential regulatory approvals and timing thereof. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the impact of our management transition, our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, risks associated with data analysis and reporting, our liquidity and expenses, the impact of the COVID-19 pandemic on our business and operations, including our preclinical studies, clinical trials and commercialization prospects, and general economic conditions, and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020 and our other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.

Corporate Contact:
David Connolly
Head of Investor Relations and Corporate Communications
Rhythm Pharmaceuticals, Inc.
857-264-4280
dconnolly@rhythmtx.com

Investor Contact:
Hannah Deresiewicz
Stern Investor Relations, Inc.
212-362-1200
hannah.deresiewicz@sternir.com

Media Contact:
Adam Daley
Berry & Company Public Relations
212-253-8881
adaley@berrypr.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/66fae683-bf9b-4498-9dff-20f74fa14502


FAQ

Who has been appointed as the new CEO of Rhythm Pharmaceuticals (RYTM)?

David Meeker, M.D. has been appointed as the new President and CEO of Rhythm Pharmaceuticals.

What is the significance of David Meeker's appointment for Rhythm Pharmaceuticals (RYTM)?

David Meeker's leadership is expected to enhance the company's strategy and operations as it approaches the potential FDA approval for setmelanotide.

What is the PDUFA goal date for Rhythm Pharmaceuticals' (RYTM) setmelanotide?

The PDUFA goal date for setmelanotide is November 27, 2020.

What challenges might Rhythm Pharmaceuticals (RYTM) face following the management transition?

The transition in management may raise concerns regarding continuity and operational stability.

Rhythm Pharmaceuticals, Inc.

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