BOSTON, Aug. 13, 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, today announced that on August 8, 2024, the Compensation and Management Development Committee of Rhythm’s Board of Directors granted incentive restricted stock units, or RSUs, covering an aggregate of 16,200 shares of its common stock to five new employees.
These incentive RSUs are subject to the terms of the Rhythm Pharmaceuticals, Inc. 2022 Employment Incentive Plan (the “Incentive Plan”).
The Incentive Plan is used exclusively to grant equity awards to individuals as an incentive for employees who begin employment with Rhythm in accordance with Nasdaq Listing Rule 5635(c)(4). The Incentive Plan was adopted by Rhythm’s Board of Directors on February 9, 2022.
RSUs vest over a four-year period, with 25% of the shares vesting on each anniversary of the applicable hire date, subject to each such employee’s continued employment on each such 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. Rhythm’s lead asset, IMCIVREE® (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, is approved 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 monogenic or syndromic obesity due to pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing, or patients with a clinical diagnosis of Bardet-Biedl syndrome (BBS). Both the European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have approved setmelanotide for the treatment of obesity and hunger control associated with genetically confirmed BBS or genetically confirmed biallelic loss-of-function POMC, including PCSK1 deficiency or biallelic LEPR deficiency in adults and children aged 6 years and older. The EC has also approved setmelanotide for the control of hunger and the treatment of obesity in children as young as 2 years of age with Barney-Smith syndrome (BBS) or POMC, PCSK1 or LEPR deficiency. In addition, Rhythm is driving a broad clinical development program for the use of setmelanotide in other rare diseases, as well as for the investigational MC4R agonists LB54640 and RM-718, and a preclinical pipeline of small molecules for the treatment of congenital hyperinsulinism. Rhythm is headquartered in Boston, MA.
Indication for 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 either LEPR genes that are interpreted as pathogenic, probably pathogenic, or of uncertain significance (VUS) or BBS.
In the European Union, setmelanotide is indicated for the treatment of obesity and hunger control associated with genetically confirmed Behrens-Schweinberg disease (BBS) or biallelic POMC deficiency with loss of function, including PCSK1 deficiency, or biallelic LEPR deficiency 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 underlying genetic etiology.
Limitations of use
Setmelanotide is not indicated for the treatment of patients with the following conditions because setmelanotide is not expected to be effective:
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Obesity due to suspected POMC, PCSK1 or LEPR deficiency with POMC, PCSK1 either LEPR variants classified as benign or probably benign.
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Other types of obesity not related to POMC, PCSK1 or LEPR deficiency, or BBS, including obesity associated with other genetic syndromes and general (polygenic) obesity.
Contraindication
Previous severe hypersensitivity to setmelanotide or any of the excipients of IMCIVREE. Serious hypersensitivity reactions (e.g. anaphylaxis) have been reported.
WARNINGS AND PRECAUTIONS
Skin pigmentation and darkening of pre-existing nevi:There has been a general increase in skin pigmentation and darkening of pre-existing nevi due to the pharmacological effect of this drug. Skin examinations of the whole body should be carried out before the start of treatment and periodically during treatment to monitor pre-existing and new pigmented lesions.
Heart rate and blood pressure monitoring: In Europe, heart rate and blood pressure should be monitored as part of standard clinical practice at each medical visit (at least every 6 months) in patients treated with setmelanotide.
Alteration of sexual arousal: Spontaneous penile erections have occurred in men and adverse sexual reactions in women. Patients who have an erection lasting more than 4 hours should seek emergency medical attention.
Depression and suicidal ideation: Cases of depression and suicidal ideation have occurred. Patients should be monitored for the emergence or worsening of depression or suicidal thoughts or behaviours. Discontinuation of setmelanotide treatment should be considered if patients experience suicidal thoughts or behaviours or if clinically significant or persistent symptoms of depression occur.
Hypersensitivity reactions:Serious hypersensitivity reactions (e.g. anaphylaxis) have been reported. If suspected, patients should be advised to seek medical attention immediately and discontinue setmelanotide treatment.
Pediatric population: The response to treatment with setmelanotide should be assessed periodically by the prescribing physician. In growing children, the impact of weight loss on growth and maturation should be assessed. In Europe, growth (height and weight) should be monitored by the prescribing physician using age- and sex-appropriate growth charts.
Risk of serious adverse reactions due to benzyl alcohol preservative in neonates and low birth weight infants: Setmelanotide is not approved for use in neonates or infants. Serious and fatal adverse reactions, including “gasping syndrome,” can occur in neonates and low birth weight infants treated with drugs preserved with benzyl alcohol.
ADVERSE 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 Product Features Summary for information on reporting suspected adverse reactions in Europe.
Please see the US Full Prescribing Information and EU Summary of Product Characteristics for additional important safety information.
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 historical facts should be considered forward-looking statements, including, but not limited to, statements regarding the potential, safety, efficacy and clinical and regulatory progress, potential regulatory filings, approvals and the timing thereof of setmelanotide and our other product candidates, and our strategy and business plans, and statements relating to our incentive equity grants. Statements using 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 associated with analyzing and reporting data, 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 qualified personnel, and general economic conditions, and the other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the three months ended June 30, 2024 and our other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligation 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
Press contact:
Adam Daley
Berry & Company Public Relations
212-253-8881
adaley@berrypr.com
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