Rhythm Pharmaceuticals to Present at Morgan Stanley 19th Annual Global Healthcare Conference
September 02 2021 - 8:00AM
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, M.D., Chair, President and Chief Executive Officer,
will participate in a fireside chat at the Morgan Stanley 19th
Annual Global Healthcare Conference on Thursday, September 9, 2021
at 8:45 a.m. ET.
A live webcast of the presentation will be available under
“Events & 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
following the presentation.
About Rhythm PharmaceuticalsRhythm is a
commercial-stage biopharmaceutical company committed to
transforming the treatment paradigm for people living with rare
genetic diseases of obesity. The Company’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
POMC, PCSK1 or LEPR deficiency confirmed by genetic testing and by
the European Commission (EC) in July 2021 for
the treatment of obesity and the control of hunger associated with
genetically confirmed loss-of-function biallelic POMC, including
PCSK1, deficiency or biallelic LEPR deficiency in adults and
children 6 years of age and above. IMCIVREE is the first-ever FDA
and EC-approved therapy for patients with these rare genetic
diseases of obesity. Rhythm is advancing a broad clinical
development program for setmelanotide in other rare genetic
diseases of obesity. The Company is leveraging 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 living with severe obesity due to certain
genetic deficiencies. The company is based in Boston, MA.
IMCIVREE® (setmelanotide)
IndicationIn 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) deficiency. The condition must be confirmed
by genetic testing demonstrating variants in POMC, PCSK1,
or LEPR genes that are interpreted as pathogenic, likely
pathogenic, or of uncertain significance (VUS).
In the EU, IMCIVREE is indicated for the treatment of obesity
and the control of hunger associated with genetically confirmed
loss-of-function biallelic POMC, including PCSK1, deficiency or
biallelic LEPR deficiency in adults and children 6 years of age and
above. IMCIVREE should be prescribed and supervised by a physician
with expertise in obesity with underlying genetic etiology.
Limitations of UseIMCIVREE is not indicated for
the treatment of patients with the following conditions as IMCIVREE
would not be expected to be effective:
- Obesity due to
suspected POMC, PCSK1, or LEPR deficiency
with POMC, PCSK1, or LEPR variants classified
as benign or likely benign;
- Other types of
obesity not related to POMC, PCSK1 or LEPR deficiency, including
obesity associated with other genetic syndromes and general
(polygenic) obesity.
Important Safety Information
WARNINGS AND PRECAUTIONS
Disturbance in Sexual Arousal: Sexual
adverse reactions may occur in patients treated with IMCIVREE.
Spontaneous penile erections in males and sexual adverse reactions
in females occurred in clinical studies with IMCIVREE. Instruct
patients who have an erection lasting longer than 4 hours to seek
emergency medical attention.
Depression and Suicidal Ideation: Some
drugs that target the central nervous system, such as IMCIVREE, may
cause depression or suicidal ideation. Monitor patients for new
onset or worsening of depression. Consider discontinuing IMCIVREE
if patients experience suicidal thoughts or behaviors.
Skin Pigmentation and Darkening of Pre-Existing
Nevi: IMCIVREE may cause generalized increased skin
pigmentation and darkening of pre-existing nevi due to its
pharmacologic effect. This effect is reversible upon
discontinuation of the drug. Perform a full body skin examination
prior to initiation and periodically during treatment with IMCIVREE
to monitor pre-existing and new skin pigmentary
lesions.
Risk of Serious Adverse Reactions Due to Benzyl Alcohol
Preservative in Neonates and Low Birth Weight
Infants: IMCIVREE is not approved for use in neonates
or infants.
ADVERSE REACTIONS
- 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
infection, and spontaneous penile erection.
USE IN SPECIFIC POPULATIONSDiscontinue IMCIVREE
when pregnancy is recognized unless the benefits of therapy
outweigh the potential risks to the fetus.
Treatment with IMCIVREE is not recommended for use while
breastfeeding.To report SUSPECTED ADVERSE REACTIONS,
contact Rhythm Pharmaceuticals at +1 (833) 789-6337 or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See Full Prescribing Information for IMCIVREE.
Forward-Looking StatementsThis 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 and our participation in upcoming events and
presentations. 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 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 the other important
factors discussed under the caption “Risk Factors” in our Quarterly
Report on Form 10-Q for the quarter ended June 30,
2021 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 ConnollyHead of
Investor Relations and Corporate CommunicationsRhythm
Pharmaceuticals, Inc.857-264-4280dconnolly@rhythmtx.com
Investor Contact:Hannah DeresiewiczStern
Investor Relations,
Inc.212-362-1200hannah.deresiewicz@sternir.com
Media Contact:Adam DaleyBerry & Company
Public Relations212-253-8881adaley@berrypr.com
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