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 on October 10, 2023, the
Compensation Committee of Rhythm’s board of directors granted
inducement equity grants covering an aggregate of 18,295 shares of
its common stock to four new employees, consisting of inducement
stock options to purchase an aggregate of 12,530 shares of common
stock and inducement restricted stock units, or RSUs, covering an
aggregate of 5,765 shares of its common stock.
These inducement stock options and inducement RSUs
are subject to the terms of the Rhythm Pharmaceuticals, Inc. 2022
Employment Inducement Plan (the “Inducement Plan”).
The Inducement Plan is used exclusively for the
grant of equity awards to individuals as an inducement material to
the employees entering into employment with Rhythm pursuant to
Nasdaq Listing Rule 5635(c)(4). The Inducement Plan was adopted by
Rhythm’s board of directors on February 9, 2022.
The stock options have an exercise price of $23.72
per share. Each option will vest as to 25% of the shares underlying
such option on the first anniversary of the applicable date of hire
of each individual, with the remaining 75% vesting in 12 equal
quarterly installments over the three years thereafter, subject to
each such employee's continued employment on each vesting date. The
RSUs vest over four years, with 25% of the shares vesting on each
anniversary of the applicable date of hire, subject to each such
employee’s continued employment on each vesting date.
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), an MC4R agonist
designed to treat hyperphagia and severe obesity caused by rare
MC4R pathway diseases, is approved 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 monogenic or
syndromic obesity due to pro-opiomelanocortin (POMC), proprotein
convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor
(LEPR) deficiency confirmed by genetic testing, or patients with a
clinical diagnosis of Bardet-Biedl syndrome (BBS). Both the
European Commission (EC) and the UK’s Medicines &
Healthcare Products Regulatory Agency (MHRA) have authorized
setmelanotide for the treatment of obesity and the control of
hunger associated with genetically confirmed BBS or genetically
confirmed loss-of-function biallelic POMC, including PCSK1,
deficiency or biallelic LEPR deficiency in adults and children 6
years of age and above. Additionally, Rhythm is advancing a broad
clinical development program for setmelanotide in other rare MC4R
pathway diseases, as well as a preclinical suite of small molecules
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.
In Canada, setmelanotide is indicated for the
treatment of obesity due to Bardet-Biedl syndrome (BBS) or
genetically-confirmed biallelic pro-opiomelanocortin (POMC),
proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin
receptor (LEPR) deficiency due to variants interpreted as
pathogenic, likely pathogenic, or of uncertain significance 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 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, potential regulatory submissions,
approvals and timing thereof of setmelanotide, and our business
strategy and plans, including regarding commercialization of
IMCIVREE. 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 ability to successfully commercialize
setmelanotide, our liquidity and expenses, our ability to retain
our key employees and consultants, and to attract, retain and
motivate qualified personnel, 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 three months ended June 30, 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
Media
Contact:Adam DaleyBerry & Company Public
Relations212-253-8881adaley@berrypr.com
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