Rhythm Pharmaceuticals Announces New Hiring Grants

BOSTON, June 11, 2024 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases, announced today that on June 6, 2024, the Board of Directors Compensation and Management Development of Ritmeve granted incentive equity grants covering a total of 56,080 shares of its common stock to ten new employees, consisting of incentive stock options to purchase a total of 9,230 shares of common stock and restricted stock units with incentives, or RSUs, covering a total of 46,850 shares of his common stock.

These incentive stock options and incentive RSUs are subject to the terms of Rhythm Pharmaceuticals, Inc. 2022 Employment Incentive Plan (the “Incentive Plan”).

The incentive plan is used exclusively for the grant of equity awards to individuals as an incentive material to employees entering into employment with Rhythm pursuant to Nasdaq Listing Rule 5635(c)(4). The incentive plan was approved by the Rhythms Board of Directors on February 9, 2022.

The stock options have an exercise price of $39.68 per share. Each option will vest 25% of the shares under that option on the first anniversary of each individual’s applicable date of employment, with the remaining 75% vesting in 12 equal quarterly installments over the following three years, subject to of the conditions of each such employee. continued employment at each vesting date. The RSUs vest over four years, with 25% of the shares vesting on each anniversary of the applicable date of employment, 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 lives of patients and their families living with rare neuroendocrine diseases. Beats main asset, IMCIVREE (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, has been approved by the US Food and Drug Administration (FDA) for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity because of the pros. Deficiency of opiomelanocortin (POMC), protein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) confirmed by genetic testing, or patients with a clinical diagnosis of Bardet-Biedl syndrome (BBS). Both the European Commission (EC) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) have authorized setmelanotide for the treatment of obesity and control of hunger associated with genetically confirmed BBS or genetically confirmed biallelic POMC with loss of function, including PCSK1, Biallelic LEPR deficiency or absence in adults and children 6 years of age and older. In addition, Rhythm is advancing an extensive clinical development program for setmelanotide in other rare diseases, as well as the investigational MC4R agonists LB54640 and RM-718, and a preclinical group of small molecules for the treatment of congenital hyperinsulinism. Rhythms is headquartered in Boston, MA.

Indication of Setmelanotide
In the United States, setmelanotide is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to POMC, PCSK1, or LEPR deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1 GOLD RABBIT genes interpreted as pathogenic, likely pathogenic or of uncertain significance (VUS) or BBS.

In the European Union, setmelanotide is indicated for the treatment of obesity and control of hunger associated with genetically confirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR in adults and children 6 years of age and older. . In Europe, setmelanotide should be prescribed and supervised by a physician with expertise in obesity with an underlying genetic etiology.

Restrictions on Use
Setmelanotide is not indicated for the treatment of patients with the following conditions as setmelanotide is not expected to be effective:

  • Obesity due to suspected deficiency of POMC, PCSK1 or LEPR with POMC, PCSK1 GOLD RABBIT variants classified as benign or potentially benign
  • Other types of obesity not associated with POMC, PCSK1 or LEPR deficiency, or BBS, including obesity associated with other genetic syndromes and general (polygenic) obesity.

Contraindication
Previous serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (eg anaphylaxis) have been reported.

WARNINGS AND WARNINGS

Skin pigmentation and darkening of existing nevi: Generalized increase in skin pigmentation and darkening of existing nevi have occurred due to its pharmacological effect. Full-body skin examinations before initiation and periodically during treatment should be performed to monitor existing and new pigmentary lesions.

Heart rate and blood pressure monitoring: In Europe, heart rate and blood pressure should be monitored as part of standard clinical practice at every medical visit (at least every 6 months) for patients treated with setmelanotide.

Disorders in sexual arousal: Spontaneous penile erections have occurred in men and negative sexual reactions in women. Patients who have an erection lasting more than 4 hours should seek emergency medical attention.

Depression and Suicidal Ideation: Depression and suicidal ideation have occurred. Patients should be monitored for new onset or worsening of depression or suicidal thoughts or behavior. Discontinuation of semelanotide should be considered if patients experience suicidal thoughts or behavior or develop clinically significant or persistent depressive symptoms.

Hypersensitivity reactions: Serious hypersensitivity reactions (eg anaphylaxis) have been reported. If in doubt, advise patients to seek immediate medical attention and discontinue semelanotide.

Pediatric population: The prescribing physician should periodically assess the response to setmelanotide therapy. In growing children, the impact of weight loss on growth and maturation should be evaluated. In Europe, the prescriber should monitor growth (height and weight) using age- and sex-appropriate growth curves.

Risk of serious adverse reactions due to the preservative benzyl alcohol in newborns and low birth weight infants: Setmelanotide is not approved for use in neonates or infants. Serious and fatal adverse reactions, including shortness of breath syndrome, may occur in neonates and low birth weight infants treated with benzyl alcohol-preserved drugs.

NEGATIVE REACTIONS

The most common adverse reactions (incidence 20%) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection.

USE IN SPECIFIC POPULATIONS

Lactation: 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. See section 4.8 of the Summary of Product Characteristics for information on reporting suspected adverse reactions in Europe.

Please see the full prescribing information for additional important safety information.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities 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, potential regulatory filings, approvals and timing of setmelanotide and our other product candidates, and our business strategy and plans, including commercialization of IMCIVREE. Statements that use words such as expect, anticipate, believe, may, will and similar terms are also forward-looking statements. Such statements are subject to numerous risks and uncertainties, including, but not limited to, 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 related to data analysis and reporting, our ability to successfully commercialize setmelanotide, our liquidity and expenses, our ability to retain our key employees and consultants, and to attract, retain and motivate personnel qualified and general economic conditions, and other important factors discussed under the heading Risk Factors in our quarterly report on Form 10-Q for the three months ended March 31, 2024 and our other filings with the Securities and Exchange Commission. Except as required by law, we do not undertake to revise any forward-looking statements contained in this release or to update them to reflect events or circumstances that occur 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

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

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