BOSTON, May 27, 2021 (GLOBE NEWSWIRE) – Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, today announced that David Meeker, MD, President, President and CEO, will participate in a fireside discussion at the Jefferies Virtual Healthcare conference on Friday, June 4, 2021 at 12 p.m. ET.
A live audio webcast of the presentation will be available under “Events and Presentations” in the Investor Relations section of the Company’s website at www.rhythmtx.com. A replay of the webcast will be available on the Rhythm website for 30 days after the presentation.
About Rhythm Pharmaceuticals
Rhythm is a commercial-stage biopharmaceutical company committed to transforming the paradigm for treating people with the rare genetic diseases of obesity. The Company’s precision drug, IMCIVREE ™ (setmelanotide), has been approved by the FDA for chronic weight management in adult and pediatric patients aged 6 years and older with obesity due to POMC deficiency, PCSK1 or LEPR confirmed by genetic testing. IMCIVREE is the first ever FDA approved treatment for these rare genetic diseases of obesity. Rhythm is advancing a large clinical development program for setmelanotide in other rare genetic diseases of obesity. The company leverages the Rhythm Engine and the largest known obesity DNA database – now with approximately 37,500 sequencing samples – to improve the understanding, diagnosis and care of people with severe obesity due to certain impairments genetic. The company is based in Boston, MA.
Indication IMCIVREE ™ (setmelanotide)
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 receptor deficiency leptin (LEPR). The condition should be confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogens, possibly pathogens or of uncertain significance (SUV).
Limitations of use
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, PCSK1, or 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
Disruption of sexual arousal: Sexual side effects may occur in patients treated with IMCIVREE. Spontaneous penile erections in men and sexual adverse reactions in women have occurred in clinical studies with IMCIVREE. Ask patients who have an erection that lasts more than 4 hours to see an emergency doctor.
Depression and suicidal ideation: Certain drugs targeting the central nervous system, such as IMCIVREE, can cause depression or suicidal thoughts. Monitor patients for new or worsening depression. Consider stopping IMCIVREE if patients are having suicidal thoughts or behavior.
Skin pigmentation and darkening of pre-existing Nevi: IMCIVREE may cause a generalized increase in skin pigmentation and darkening of pre-existing nevi due to its pharmacological effect. This effect is reversible when the drug is stopped. Perform a whole body skin examination before initiation and periodically during treatment with IMCIVREE to monitor for pre-existing and new skin pigment lesions.
Risk of serious side effects due to benzyl alcohol preservative 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 erection of the penis.
USE IN SPECIFIC POPULATIONS
Stop IMCIVREE when pregnancy is recognized, unless the benefits of treatment outweigh the potential risks to the fetus.
Treatment with IMCIVREE is not recommended during breast-feeding.
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 the full prescribing information for IMCIVREE.
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 as forward-looking statements, including, without s ” Limit these statements regarding our business strategy and plans and our participation in upcoming events and presentations. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. Such statements are subject to many risks and uncertainties, including, but not limited to, the impact of our management transition, our ability to enroll patients in clinical trials, the design and results of clinical trials. , the impact of competition, the ability to meet or obtain the necessary regulatory approvals, the risks associated with data analysis and reporting, our cash flow and expenses, the impact of the COVID-19 pandemic on our business and our operations, including our preclinical studies, clinical trials and marketing outlook, and general economic conditions, and other significant factors discussed under “Risk Factors” in our Quarterly Report on Form 10-Q for the period quarterly ended March 31, 2021 and our other filings with the Securities and Exchange Commission. Except as required by law, we assume no obligation to revise any forward-looking statements contained in this press release or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, in the future. developments or otherwise.
Head of Investor Relations and Corporate Communications
Rhythm Pharmaceuticals, Inc.
Stern Investor Relations, Inc.
Public Relations Berry & Company