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 August 2, 2022, the Compensation
Committee of Rhythm’s board of directors granted inducement equity
grants covering an aggregate of 63,035 shares of its common stock
to three new employees, consisting of inducement stock options to
purchase an aggregate of 38,690 shares of common stock and
inducement restricted stock units, or RSUs, covering an aggregate
of 24,345 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 $14.17 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 transforming
the lives of patients and their families living with hyperphagia
and severe obesity caused by rare melanocortin-4 receptor (MC4R)
pathway diseases. Rhythm’s precision medicine, IMCIVREE
(setmelanotide), 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 POMC, PCSK1 or LEPR deficiency confirmed
by genetic testing, or patients with a clinical diagnosis of
Bardet-Biedl syndrome (BBS). The European Commission (EC) and Great
Britain’s Medicines & Healthcare Products Regulatory Agency
(MHRA) have authorized IMCIVREE 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-approved and EC- and
MHRA-authorized therapy for patients with these rare genetic
diseases of obesity. Rhythm received a positive Committee for
Medicinal Products for Human Use (CHMP) opinion on its Type II
variation application to the European Medicines Agency seeking
regulatory approval and authorization for setmelanotide to treat
obesity and control of hunger in adult and pediatric patients 6
years of age and older with BBS in the European Union and a
decision from the EC is expected in the fourth quarter of 2022.
Additionally, Rhythm is advancing a broad clinical development
program for setmelanotide in other rare genetic diseases of obesity
and is leveraging the Rhythm Engine and the largest known obesity
DNA database -- now with approximately 45,000 sequencing samples --
to improve the understanding, diagnosis and care of people living
with severe obesity due to certain genetic deficiencies. Rhythm’s
headquarters is in Boston, MA.
About SetmelanotideSetmelanotide is a
melanocortin-4 receptor (MC4R) agonist. The MC4R is part of the key
biological pathway that regulates hunger, caloric intake and energy
expenditure. Variants in genes may impair the function of the MC4R
pathway, potentially leading to hyperphagia and early-onset, severe
obesity. Rhythm is developing setmelanotide as a targeted therapy
to potentially restore the function of an impaired MC4R pathway
and, in so doing, potentially reduce hunger and weight in patients
with rare genetic diseases of obesity.
In the EU and Great Britain, 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.
Rhythm’s Type II variation application to the European Medicines
Agency (EMA) for the treatment of obesity and control of
hyperphagia in adult and pediatric patients 6 years of age and
older with BBS is under review. The Company is also continuing to
advance the most comprehensive clinical research program ever
initiated in MC4R pathway diseases, including the pivotal Phase 3
EMANATE clinical trial evaluating setmelanotide in four independent
sub-studies in patients with obesity due to POMC insufficiency
caused by heterozygous variants in the POMC or PCSK1 genes, LEPR
insufficiency caused by heterozygous variants in the LEPR gene,
SRC1 deficiency caused by a variant in the NCOA1 gene, and SH2B1
deficiency caused by a variant in the SH2B1 gene or 16p11.2
deletion encompassing the SH2B1 gene. The Phase 2 DAYBREAK trial is
evaluating setmelanotide in patients with severe obesity and
hyperphagia caused by rare variants associated with 10 prioritized
MC4R-relevant genes. Rhythm has also initiated a Phase 3 pediatric
trial and a Phase 3 trial evaluating a weekly formulation of
setmelanotide.
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
monogenic or syndromic obesity due to:
- Pro-opiomelanocortin (POMC), proprotein convertase
subtilisin/kexin type 1 (PCSK1) or leptin receptor (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)
- Bardet-Biedl syndrome (BBS)
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, or BBS, including obesity associated with other genetic
syndromes and general (polygenic) obesity
WARNINGS AND PRECAUTIONS
Disturbance in Sexual Arousal: Spontaneous
penile erections in males and sexual adverse reactions in females
have occurred. Inform patients that these events may occur and
instruct patients who have an erection lasting longer than 4 hours
to seek emergency medical attention.
Depression and Suicidal Ideation: Depression
and suicidal ideation have occurred. Monitor patients for new onset
or worsening depression or suicidal thoughts or behaviors. Consider
discontinuing IMCIVREE if patients experience suicidal thoughts or
behaviors, or clinically significant or persistent depression
symptoms occur.
Skin Pigmentation and Darkening of Pre-existing
Nevi: Generalized increased skin pigmentation and
darkening of pre-existing nevi have occurred. Perform a full body
skin examination prior to initiation and periodically during
treatment to monitor pre-existing and new 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. Serious
and fatal adverse reactions including “gasping syndrome” can occur
in neonates and low birth weight infants treated with benzyl
alcohol-preserved drugs.
ADVERSE REACTIONS
- The most common adverse reactions (incidence ≥20%) included
skin hyperpigmentation, injection site reactions, nausea, headache,
diarrhea, abdominal pain, vomiting, depression, and spontaneous
penile erection.
USE IN SPECIFIC POPULATIONSTreatment with
IMCIVREE is not recommended when breastfeeding. Discontinue
IMCIVREE when pregnancy is recognized unless the benefits of
therapy outweigh the potential risks to the fetus.
To report SUSPECTED ADVERSE REACTIONS, contact Rhythm
Pharmaceuticals at 833-789-6337 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
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, 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,
2022 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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