Rhythm Pharmaceuticals to Present at Jefferies Virtual Healthcare Conference
May 27 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 Jefferies Virtual
Healthcare Conference on Friday, June 4, 2021 at 12 noon ET.
A live audio 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), has
been approved by the 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.
IMCIVREE is the first-ever FDA approved therapy for 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)
IndicationIMCIVREE 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).
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
POPULATIONS
Discontinue 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
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 matters of historical
fact should be considered forward-looking statements, including
without limitation statements regarding our business strategy and
plans and our participation in upcoming events and presentations.
Statements using word 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, the impact of our
management transition, 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 quarterly period ended March 31, 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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