BOSTON, May 05, 2022 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company committed to transforming care for people with rare genetic obesity-related diseases, announced today Today May 3, 2022, Rhythm’s Board of Directors Compensation Committee granted incentive stock awards covering a total of 50,730 common shares to 10 new employees, consisting of stock options incentives to purchase a total of 16,915 common shares and incentive restricted share units, or RSUs, covering a total of 33,815 common shares. These incentive stock options and incentive RSUs are subject to the terms of the Rhythm Pharmaceuticals, Inc. 2022 Employment Incentive Plan (the “Incentive Plan”).
The stock options have an exercise price of $6.13 per share. Each option will vest 25% of the shares underlying that option on the first anniversary of each individual’s applicable hire date, with the remaining 75% vesting in 12 equal quarterly installments over the following three years, subject to subject to continued use at each vesting date. The PSUs vest over four years, with 25% of the shares vesting on each anniversary of the applicable hire date, subject to the continued employment of each such employee on each vesting date.
About Rhythm Pharmaceuticals
Rhythm is a commercial-stage biopharmaceutical company committed to transforming the treatment paradigm for people with rare obesity-related genetic diseases. Rhythm’s precision medicine, IMCIVREE (setmelanotide), was approved in November 2020 by the U.S. Food and Drug Administration (FDA) for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to confirmed POMC, PCSK1 or LEPR deficiency by genetic testing and in July and September 2021, respectively, by the European Commission (EC) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of obesity and the control of hunger associated with genetically confirmed biallelic POMC loss of function, including PCSK1, LEPR deficiency or biallelic deficiency in adults and children 6 years of age and older. IMCIVREE is the first-ever FDA-approved and EC- and MHRA-cleared therapy for patients with these rare genetic diseases of obesity. The company submitted a Supplemental New Drug Application (sNDA) to the FDA, which was accepted for filing in November 2021 and assigned a Prescription Drug User Fee Act (PDUFA) target date of June 16, 2022, and submitted a Type II variation application to the European Medicines Agency in October 2021 seeking regulatory approval and authorization of setmelanotide to treat obesity and hunger control in adult and pediatric patients 6 years of age and more with BBS or Alström syndrome in the United States and the European Union. In addition, Rhythm is advancing an extensive clinical development program for setmelanotide in other rare obesity genetic diseases and is building on the Rhythm Engine and the largest known obesity DNA database – now with approximately 45,000 sequencing samples – to improve the understanding, diagnosis and care of people living with severe obesity due to certain genetic deficiencies. Rhythm’s headquarters are in Boston, MA.
IMCIVREE® (setmelanotide) Indication
In the United States, IMCIVREE is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1 ) or leptin receptor (LEPR), confirmed by an FDA-cleared genetic test demonstrating variants in POMC, PCSK1or LEPR genes interpreted as pathogenic, probably pathogenic or of uncertain significance (VUS).
In the EU and Great Britain, IMCIVREE is indicated for the treatment of obesity and control of hunger associated with genetically confirmed POMC biallelic loss of function, including PCSK1, LEPR biallelic deficiency or deficiency in adults and children 6 years and older. . IMCIVREE should be prescribed and supervised by a physician experienced in obesity of underlying genetic etiology.
IMCIVREE is not indicated for the treatment of patients with the following conditions because IMCIVREE is not expected to be effective:
Obesity due to suspected POMC, PCSK1 or LEPR deficiency with POMC, PCSK1or LEPR variants classified as benign or probably benign;
Other types of obesity unrelated to POMC, PCSK1 or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity.
Important Safety Information
WARNINGS AND PRECAUTIONS
Disturbance of sexual arousal:
Depression and suicidal thoughts: Some medicines that target the central nervous system, such as IMCIVREE, can cause depression or suicidal thoughts. Monitor patients for new onset or worsening of depression. Consider discontinuing IMCIVREE if patients have suicidal thoughts or behaviors.
Skin pigmentation and darkening of pre-existing moles: IMCIVREE may cause generalized increase in skin pigmentation and darkening of pre-existing moles due to its pharmacological effect. This effect is reversible on discontinuation of the drug. Perform a full body skin examination before initiation and periodically during treatment with IMCIVREE to monitor for pre-existing and new pigmented skin lesions.
Risk of serious adverse effects from preservative benzyl alcohol in newborns and low birth weight infants: IMCIVREE is not approved for use in newborns or infants.
The most common adverse reactions (incidence ≥ 23%) were injection site reactions, skin hyperpigmentation, nausea, headache, diarrhea, abdominal pain, back pain, fatigue, vomiting , depression, upper respiratory tract infections and spontaneous penile erection.
USE IN SPECIFIC POPULATIONS
Discontinue IMCIVREE when pregnancy is recognized unless the benefits of treatment outweigh the potential risks to the fetus.
Treatment with IMCIVREE is not recommended during breastfeeding.
To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1 (833) 789-6337 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release that do not relate to historical facts should be considered forward-looking statements, including, without limited to, statements regarding the potential, safety, efficacy, and regulatory and clinical advancements of setmelanotide. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. These statements are subject to numerous risks and uncertainties, including, but not limited to, our ability to enroll patients in clinical trials, the design and results of clinical trials, the impact of competition, the ability obtain or obtain necessary regulatory approvals, risks associated with data analysis and reporting, our ability to successfully commercialize setmelanotide, 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 “Risk Factors” in our Annual Report on Form 10-Q for the three months ended March 31, 2022 and our other filings with the Securities and Exchange Commission. Except as required by law, we assume no obligation to modify any 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.
Head of Investor Relations and Corporate Communication
Rhythm Pharmaceuticals, Inc.
Stern Investor Relations, Inc.
Berry & Company Public Relations