- Dan Monahan will lead the commercialization
strategy across Amylyx’ product portfolio, beginning with
avexitide, an investigational, first-in-class glucagon-like
peptide-1 (GLP-1) receptor antagonist for the treatment of
post-bariatric hypoglycemia (PBH)
- Mr. Monahan has more than 20 years of
commercial leadership experience, including launching
industry-leading franchises at Otsuka, Novartis, and Sanofi
- Strong commercial and medical team in place
for potential first-to-market launch in PBH and advancement of
late-stage pipeline with the goal to bring new potential treatment
options to communities with high unmet need
Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the
“Company”) today announced the appointment of Dan Monahan as Chief
Commercial Officer. Mr. Monahan will also join the Company’s
Leadership Team. Mr. Monahan joined Amylyx in January 2024,
bringing more than 20 years of commercial leadership experience in
the biopharmaceutical industry overseeing sales, marketing, and
market access for multiple product lines.
“We are excited to announce the appointment of Dan Monahan to
Chief Commercial Officer as Amylyx prepares for the first
participant dosed in the Phase 3 LUCIDITY clinical trial of
avexitide for the treatment of post-bariatric hypoglycemia planned
in the first quarter of 2025. Dan has a strong track record of
launching medicines and excels in building and leading
high-performing teams that have brought new medicines to
communities with high unmet needs,” said Joshua Cohen and Justin
Klee, Co-CEOs of Amylyx. “Since joining Amylyx earlier this year,
Mr. Monahan has demonstrated invaluable leadership as we work
towards ensuring launch readiness for the avexitide program ahead
of Phase 3 data expected in 2026 and potential future launches. We
are confident that the addition of Mr. Monahan to our leadership
team will play a crucial role in delivering a meaningful impact to
the PBH community as we continue to move forward in our goal for
avexitide to be the first therapy approved for people living with
PBH.”
Throughout his career, Mr. Monahan has remained deeply committed
to launching therapies that address high unmet medical needs,
bringing critical treatments to those who need them most. Prior to
joining Amylyx, Mr. Monahan served as Vice President, Head of CNS
Marketing and Portfolio Strategy at Otsuka Pharmaceuticals, where
he led the U.S. commercialization efforts for the company’s CNS
franchise, including REXULTI® and ABILIFY MAINTENA®, which played a
critical role in treating serious mental health conditions. Before
joining Otsuka, Mr. Monahan held senior leadership roles at
Novartis. He led the commercial execution of the company’s flagship
blockbuster dermatology brand, COSENTYX®, for patients with
autoimmune conditions. Prior to Novartis, Mr. Monahan spent 14
years at Sanofi in positions of increasing leadership
responsibility across sales, marketing and market access. He
received an MBA from Seton Hall University, and is a graduate of
the United States Military Academy at West Point. Dan served as a
Field Artillery Officer in the U.S. Army.
“I look forward to continuing to collaborate with the team on
advancing novel therapies from development through
commercialization, with our first focus on avexitide for the
potential treatment of post-bariatric hypoglycemia,” said Dan
Monahan, Chief Commercial Officer of Amylyx. “Since joining Amylyx,
I have seen first-hand both the resilience of those with
post-bariatric hypoglycemia and the significant quality of life
impacts that this debilitating condition can have. I am deeply
motivated by the opportunity to support people living with PBH and
potentially addressing the critical unmet need for a treatment
option.”
In this role, Mr. Monahan will lead the Company’s
commercialization efforts, particularly as Amylyx prepares for the
potential approval of avexitide, an investigational, first-in-class
glucagon-like peptide-1 (GLP-1) receptor antagonist for the
treatment of post-bariatric hypoglycemia (PBH). Amylyx plans to
initiate LUCIDITY, a multicenter, randomized, double-blind,
placebo-controlled Phase 3 clinical trial designed to evaluate the
efficacy and safety of avexitide in participants with PBH in the
first quarter of 2025.
About Avexitide
Avexitide is an investigational, first-in-class glucagon-like
peptide-1 (GLP-1) receptor antagonist that has been evaluated in
five clinical trials for post-bariatric hypoglycemia (PBH) and has
also been studied in congenital hyperinsulinism (HI). The U.S. Food
and Drug Administration (FDA) has granted avexitide Breakthrough
Therapy Designation for both indications, Rare Pediatric Disease
Designation in congenital HI, and Orphan Drug Designation for the
treatment of hyperinsulinemic hypoglycemia (which includes PBH and
congenital HI). Avexitide is designed to bind to the GLP-1 receptor
on pancreatic islet beta cells and inhibit the effect of GLP-1 to
mitigate hypoglycemia by decreasing insulin secretion and
stabilizing blood glucose levels. In PBH, excessive GLP-1 can lead
to the hypersecretion of insulin and subsequent debilitating
hypoglycemic events. In two Phase 2 PBH trials, avexitide
demonstrated highly statistically significant reductions in
hypoglycemic events. These events can lead to autonomic and
neuroglycopenic symptoms that can have a devastating impact on
daily living.
About the LUCIDITY Trial
LUCIDITY (NCT06747468) is a 75-participant, multicenter,
randomized, double-blind, placebo-controlled Phase 3 clinical trial
evaluating the efficacy and safety of avexitide in participants
with PBH. The Phase 3 trial will be conducted at approximately 20
sites in the U.S. Participants will be randomized 3:2 to receive
either 90 mg of avexitide subcutaneously once daily or placebo. The
trial will include a three-week run-in period and a 16-week
double-blind treatment period. Participants who complete the
double-blind period of the planned study will be eligible to enter
an open-label extension (OLE) period with a duration of 32 weeks.
The primary efficacy objective of LUCIDITY will evaluate the
FDA-agreed upon primary outcome of reduction in the composite of
Level 2 and Level 3 hypoglycemic events through Week 16. Safety and
tolerability will also be evaluated.
About Post-Bariatric Hypoglycemia (PBH)
Symptomatic post-bariatric hypoglycemia (PBH) is a condition
that affects approximately 8% of people who have undergone
bariatric surgery, or approximately 160,000 people, in the U.S. PBH
is thought to be caused by an excessive glucagon-like peptide-1
(GLP-1) response leading to hypoglycemia and impaired quality of
life. PBH can cause debilitating hypoglycemic events associated
with inadequate supply of glucose to the brain, known as
neuroglycopenia. Clinical manifestations can include impaired
cognition, loss of consciousness, and seizures. PBH is also
associated with a high degree of disability that can result in
major disruptions to independent living. There are no approved
therapies for PBH.
About Amylyx Pharmaceuticals
Amylyx is committed to the discovery and development of new
treatment options for communities with high unmet needs, including
people living with serious and fatal neurodegenerative diseases and
endocrine conditions. Since its founding, Amylyx has been guided by
science to address unanswered questions, keeping communities at the
heart and center of all decisions. Amylyx is headquartered in
Cambridge, Massachusetts. For more information, visit amylyx.com
and follow us on LinkedIn and X. For investors, please visit
investors.amylyx.com.
Forward-Looking Statements
Statements contained in this press release and related comments
in our earnings conference call regarding matters that are not
historical facts are “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such
statements include, but are not limited to, the potential of
avexitide as a treatment for PBH; and expectations regarding the
timing of initiation of a Phase 3 trial of avexitide in PBH. Any
forward-looking statements in this press release and related
comments in the Company's earnings conference call are based on
management’s current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in
or implied by such forward-looking statements. Risks that
contribute to the uncertain nature of the forward-looking
statements include: the success, cost, and timing of Amylyx’
program development activities; Amylyx’ ability to execute on its
regulatory development plans and expectations regarding the timing
of results from its planned data announcements and initiation of
clinical studies; the risk that early-stage results may not reflect
later-stage results; Amylyx’ ability to fund operations, and the
impact that global macroeconomic uncertainty, geopolitical
instability, and public health events will have on Amylyx’
operations, as well as the risks and uncertainties set forth in
Amylyx’ United States Securities and Exchange Commission (SEC)
filings, including Amylyx’ Annual Report on Form 10-K for the year
ended December 31, 2023, and subsequent filings with the SEC. All
forward-looking statements contained in this press release and
related comments in our earnings conference call speak only as of
the date on which they were made. Amylyx undertakes no obligation
to update such statements to reflect events that occur or
circumstances that exist after the date on which they were
made.
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version on businesswire.com: https://www.businesswire.com/news/home/20250106578341/en/
Media Amylyx Media Team +1 (857) 799-7274
amylyxmediateam@amylyx.com
Investors Lindsey Allen Amylyx Pharmaceuticals, Inc. +1
(857) 320-6244 Investors@amylyx.com
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