Rhythm Pharmaceuticals to Present at 2021 Canaccord Genuity 41st Annual Growth Conference
August 05 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 Canaccord Genuity 41st
Annual Growth Conference on Thursday, August 12, 2021 at 8 a.m. 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), 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 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 EU,
IMCIVREE is indicated for the treatment of obesity and the control
of hunger associated with genetically confirmed loss-of-function
biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency
or biallelic leptin receptor (LEPR) deficiency in adults and
children 6 years of age and above.In 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
pro-opiomelanocortin (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 (VOUS).
Limitations of UseIMCIVREE should be prescribed
and supervised by physicians with expertise in obesity with
underlying genetic etiology. IMCIVREE 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, 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 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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