Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage
biopharmaceutical company focused on transforming the lives of
patients and their families living with hyperphagia and severe
obesity caused by rare melanocortin-4 receptor (MC4R) pathway
diseases, today announced that David Meeker, M.D., Chair, Chief
Executive Officer and President, will participate in a fireside
chat at the Goldman Sachs 44th Annual Global Healthcare Conference
on Wednesday, June 14, 2023 at 10:40 a.m. PT (1:40 p.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 lives of
patients and their families living with hyperphagia and severe
obesity caused by rare melanocortin-4 receptor (MC4R) diseases.
Rhythm’s lead asset, IMCIVREE® (setmelanotide) is approved by
the U.S. Food and Drug Administration (FDA) and authorized by the
European Commission (EC) and the UK’s Medicines & Healthcare
Products Regulatory Agency (MHRA) for use in accordance with
product labeling. Additionally, Rhythm is advancing a broad
clinical development program for setmelanotide in other rare MC4R
pathway diseases, as well as a preclinical suite of investigational
candidates for the treatment of congenital hyperinsulinism.
Rhythm’s headquarters is in Boston, MA.
Setmelanotide
IndicationIn 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 or LEPR
genes that are interpreted as pathogenic, likely pathogenic, or of
uncertain significance (VUS) or BBS.
In the European Union, setmelanotide is
indicated for the treatment of obesity and the control of hunger
associated with genetically confirmed Bardet-Biedl syndrome (BBS)
or genetically confirmed loss-of-function biallelic
proopiomelanocortin (POMC), including PCSK1, deficiency or
biallelic leptin receptor (LEPR) deficiency in adults and children
6 years of age and above.
Limitations of UseIn the
United States and Europe, Setmelanotide should be
prescribed and supervised by a physician with expertise in obesity
with underlying genetic etiology.
Setmelanotide is not indicated for the treatment
of patients with the following conditions as setmelanotide 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, or BBS, including obesity associated with other genetic
syndromes and general (polygenic) obesity.
WARNINGS AND PRECAUTIONS
Skin
Monitoring: Setmelanotide may lead to generalized
increased skin pigmentation and darkening of pre-existing naevi
because of its pharmacologic effect. Full body skin examinations
should be conducted annually to monitor pre-existing and new skin
pigmentary lesions before and during treatment with
setmelanotide.
Heart rate and blood pressure
monitoring: Heart rate and blood pressure should be
monitored as part of standard clinical practice at each medical
visit (at least every 6 months) for patients treated with
setmelanotide.
Prolonged penile
erection: Spontaneous penile erections have been
reported in clinical trials with setmelanotide. Patients who have a
penile erection lasting longer than 4 hours should be instructed to
seek emergency medical attention for potential treatment of
priapism.
Depression: In clinical
trials, depression has been reported in patients treated with
setmelanotide. Patients with depression should be monitored at each
medical visit during treatment with setmelanotide. Consideration
should be given to discontinuing setmelanotide if patients
experience suicidal thoughts or behaviors.
Pediatric Population: The
prescribing physician should periodically assess response to
setmelanotide therapy. In growing children, the impact of weight
loss on growth and maturation should be evaluated. The prescribing
physician should monitor growth (height and weight) using age- and
sex-appropriate growth curves.
Excipients: This medicinal
product contains 10 mg benzyl alcohol in each ml. Benzyl alcohol
may cause allergic reactions. Patients who are pregnant or
breastfeeding should be advised of the potential risk from the
excipient benzyl alcohol, which might accumulate over time and
cause metabolic acidosis. This medicinal product should be used
with caution in patients with hepatic or renal impairment, because
of the potential risk from the excipient benzyl alcohol which might
accumulate over time and cause metabolic acidosis.
Sodium: This medicinal
product contains less than 1 mmol sodium (23 mg) per dose, that is
to say essentially “sodium-free.”
ADVERSE REACTIONSThe most
frequent adverse reactions are hyperpigmentation (51%), injection
site reaction (39%), nausea (33%), and headache (26%).
USE IN SPECIFIC POPULATIONS
PregnancyThere are no data from
the use of setmelanotide in pregnant women. Animal studies do not
indicate direct harmful effects with respect to reproductive
toxicity. However, administration of setmelanotide to pregnant
rabbits resulted in decreased maternal food consumption leading to
embryo-fetal effects. As a precautionary measure, setmelanotide
should not be started during pregnancy or while attempting to get
pregnant as weight loss during pregnancy may result in fetal harm.
If a patient who is taking setmelanotide has reached a stable
weight and becomes pregnant, consideration should be given to
maintaining setmelanotide treatment as there was no proof of
teratogenicity in the nonclinical data. If a patient who is taking
setmelanotide and still losing weight gets pregnant, setmelanotide
should either be discontinued, or the dose reduced while monitoring
for the recommended weight gain during pregnancy. The treating
physician should carefully monitor weight during pregnancy in a
patient taking setmelanotide.
Breast-feedingIt is unknown
whether setmelanotide is excreted in human milk. A nonclinical
study showed that setmelanotide is excreted in the milk of nursing
rats. No quantifiable setmelanotide concentrations were detected in
plasma from nursing pups. A risk to the newborn/infant cannot be
excluded. A decision must be made whether to discontinue
breastfeeding or to discontinue/abstain from setmelanotide therapy
taking into account the benefit of breastfeeding for the child and
the benefit of therapy for the mother.
FertilityNo human data on the
effect of setmelanotide on fertility are available. Animal studies
did not indicate harmful effects with respect to fertility.
To report SUSPECTED ADVERSE REACTIONS,
contact Rhythm Pharmaceuticals at +1 (833) 789-6337.
See Summary of Product Characteristics’ APPENDIX
V for a list of European national reporting systems to
communicate adverse reactions.
Please see the full Prescribing
Information for additional Important Safety
Information.
Forward-looking StatementsThis press release
contains forward-looking statements within the meaning of
the U.S. 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 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, 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 and general economic conditions 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 three months
ended March 31, 2023 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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