Board of Directors appoints Kyle Gano, Ph.D., Chief Business Development and
Strategy Officer, as CEO-elect, effective October 11, 2024
Kevin Gorman,
Ph.D., to continue to serve on the Neurocrine Board of
Directors
SAN
DIEGO, May 28, 2024 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX), today announced that Kevin Gorman, Ph.D., will retire as Chief
Executive Officer of Neurocrine on October
11, 2024. Kyle Gano, Ph.D.,
currently Neurocrine's Chief Business Development and Strategy
Officer, will succeed him in the CEO role. Dr. Gano will also join
the Company's Board of Directors at that time, and Dr. Gorman will
continue to serve on the Neurocrine Board.
Dr. Gorman founded Neurocrine in 1992 and held numerous
positions across the Company, including Chief Operating Officer,
Chief Business Officer, and Senior Vice President of Business
Development, before being appointed CEO in 2008. Under Dr. Gorman's
three decades of leadership, Neurocrine has emerged as a fully
integrated biopharmaceutical enterprise with a broad, mature
pipeline, strong financial position, and highly successful
commercial product, INGREZZA® (valbenazine). Dr. Gorman's vision to
focus on areas that lack recent innovation or have limited
treatment options has provided the Company with meaningful momentum
in its mission to discover and develop new medicines that relieve
patient suffering. Notably, in late April, Neurocrine submitted to
the FDA two New Drug Applications for crinecerfont as a treatment
for adult and pediatric patients with classic congenital adrenal
hyperplasia (CAH). In addition, the Company now has 17 clinical
development programs in its pipeline focusing on helping patients
across neurology, neuroendocrinology, and neuropsychology. With a
growing multi-billion-dollar medicine in INGREZZA, a rich and
diverse pipeline, and a strong financial profile, Neurocrine is
well positioned to execute on a bold vision for future growth and
impact.
"It has been a privilege to lead the Neurocrine team in
developing life-changing treatments for patients in need," Dr.
Gorman said. "When I took on the role of CEO in 2008, Neurocrine
was a clinical stage company with a limited pipeline and no
approved products. Together, we have built a diverse pipeline and a
leading R&D innovation engine designed to rapidly deliver up to
four INDs per year. We successfully launched INGREZZA, which
has driven strong financial results while improving the treatment
of tardive dyskinesia and chorea associated with Huntington's disease. Importantly, we are
working diligently to be prepared to bring crinecerfont to patients
with CAH next year, if approved. I couldn't be prouder of all that
this team has accomplished, and I have never been more confident in
Neurocrine's future."
Dr. Gorman continued, "With the foundation of a world-class
team, compelling science, and clear vision, it is the right time to
initiate this well-planned leadership transition. The Board of
Directors is confident Kyle is the ideal CEO to lead Neurocrine's
next chapter of growth, as am I. We have worked closely together
for more than 20 years. He has been instrumental in Neurocrine's
success and is an exceptional leader of the organization. I look
forward to supporting him in my continuing role as a member of the
Neurocrine Board."
"I believe deeply in Neurocrine's values and mission, and I am
honored to take the reins from an amazing leader and mentor," Dr.
Gano said. "This is an important year for our organization, as we
look to help even more patients with tardive dyskinesia and
Huntington's disease through
INGREZZA, while potentially bringing crinecerfont to CAH patients
in 2025 – all while advancing our pipeline. I look forward to
continuing to work closely with our leadership team and the Board
to capitalize on our momentum and advance our vision to be a true
global leader in neuroscience."
"On behalf of the Board, I thank Kevin for his unwavering
dedication to Neurocrine Biosciences over the past three decades
and wish him the very best in his well-deserved retirement," said
William H. Rastetter, Ph.D.,
Chairman of the Board of Neurocrine Biosciences. "Having worked
closely with Kevin on succession planning, and knowing Kyle well,
we're thrilled to appoint Kyle as Neurocrine's CEO-elect and look
forward to welcoming him to the Board. We are confident that, with
Kyle's deep substantive expertise, broad experience working with
functions throughout the Company, and clear vision for the future,
Neurocrine will continue to grow and succeed as a leading
neuroscience-focused company for the benefit of patients,
employees, and shareholders."
About Kyle
Gano
Kyle W. Gano,
Ph.D., is a proven executive who joined Neurocrine Biosciences more
than 23 years ago. After beginning his career at Neurocrine in a
market research and analytics role, Dr. Gano has spent the better
part of the last two decades focused on business and corporate
development, assuming the position of Chief Business Development
Officer in 2011 and Chief Business Development and Strategy Officer
in 2020. In his current role, Dr. Gano oversees the Company's
strategic collaborations across multiple therapeutic areas that
bring critical treatments to patients suffering from neurological,
neuroendocrine, and neuropsychiatric disorders. During his tenure,
he has executed and managed many robust partnerships, including
those that are currently active with AbbVie, Idorsia Ltd,
Mitsubishi Tanabe Pharma, Nxera Pharma (formerly Sosei Heptares),
Sanofi S.A., Takeda Pharmaceutical Company Limited, Voyager
Therapeutics, and Xenon Pharmaceuticals. He also led the
acquisition of Diurnal Group Plc in 2021, expanding Neurocrine's
presence to the United Kingdom and
European Union. Beyond his business development and strategy
portfolio, Dr. Gano has led numerous high-impact operational and
business priorities. These include having been the lead inventor on
the patent to the valbenazine molecule, having served as Team Lead
for both the elagolix development program and VMAT2 Franchise Team,
and currently holding oversight responsibility for all muscarinic
development teams and activities. He also played key leadership
roles in the development of three FDA-approved medicines –
INGREZZA® (valbenazine), ORILISSA®
(elagolix), and ORIAHNN® (elagolix, estradiol, and
norethindrone).
Dr. Gano serves on the Board of Directors of California Life
Sciences (CLS). He received his B.S. in Chemistry from the
University of Oregon, B.S. in
Biochemistry from the University of
Washington, and his Ph.D. in Organic Chemistry and M.B.A
from the University of California, Los
Angeles.
About Neurocrine Biosciences, Inc.
Neurocrine
Biosciences is a neuroscience-focused, biopharmaceutical company
with a simple purpose: to relieve suffering for people with great
needs, but few options. We are dedicated to discovering and
developing life-changing treatments for patients with
under-addressed neurological, neuroendocrine, and neuropsychiatric
disorders. The Company's diverse portfolio includes FDA-approved
treatments for tardive dyskinesia, chorea associated with
Huntington's disease,
endometriosis*, and uterine fibroids*, as well as a robust pipeline
including multiple compounds in mid- to late-phase clinical
development across our core therapeutic areas. For three decades,
we have applied our unique insight into neuroscience and the
interconnections between brain and body systems to treat complex
conditions. We relentlessly pursue medicines to ease the burden of
debilitating diseases and disorders, because you deserve brave
science. For more information, visit neurocrine.com, and follow the
company on LinkedIn, X (Formerly Twitter) and Facebook.
(*in collaboration with AbbVie)
NEUROCRINE BIOSCIENCES Logo Lockup, NEUROCRINE, YOU DESERVE
BRAVE SCIENCE, and INGREZZA are registered trademarks of Neurocrine
Biosciences, Inc.
About INGREZZA® (valbenazine)
Capsules
INGREZZA is the only one-capsule, once-daily selective vesicular
monoamine transporter 2 (VMAT2) inhibitor approved by the U.S.
Food and Drug Administration for the treatment of adults with
tardive dyskinesia and the treatment of chorea associated
with Huntington's disease (HD).
INGREZZA, developed by Neurocrine Biosciences, selectively
inhibits VMAT2 with no appreciable binding affinity for VMAT1,
dopaminergic (including D2), serotonergic, adrenergic,
histaminergic or muscarinic receptors. While the specific way
INGREZZA works to treat TD and HD chorea is not fully understood,
INGREZZA selectively targets VMAT2 to inhibit the release of
dopamine, a chemical in the brain that helps control movement.
INGREZZA is believed to reduce extra dopamine signaling, which may
lead to fewer uncontrollable movements. Additionally, INGREZZA can
be taken as one capsule, once daily together with most psychiatric
medications such as antipsychotics or antidepressants.
INGREZZA dosages approved for use are 40 mg, 60 mg and 80 mg
capsules. INGREZZA is not approved in any other dosage form.
Important Information
Approved Uses
INGREZZA® (valbenazine)
capsules or INGREZZA® SPRINKLE (valbenazine)
capsules are prescription medicines used to treat adults with:
- movements in the face, tongue, or other body parts that cannot
be controlled (tardive dyskinesia).
- involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA
SPRINKLE do not cure the cause of involuntary movements, and do not
treat other symptoms of Huntington's disease, such as problems with
thinking or emotions.
It is not known if INGREZZA or INGREZZA SPRINKLE is safe and
effective in children.
IMPORTANT SAFETY INFORMATION
VMAT2 inhibitors, including INGREZZA and INGREZZA
SPRINKLE, can cause serious side effects in people with
Huntington's disease, including:
depression, suicidal thoughts, or suicidal actions. Tell
your healthcare provider before you start taking INGREZZA or
INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have
untreated depression or depression that is not well controlled by
medicine) or have suicidal thoughts. Pay close attention to any
changes, especially sudden changes, in mood, behaviors, thoughts,
or feelings. This is especially important when INGREZZA or INGREZZA
SPRINKLE is started and when the dose is changed. Call your
healthcare provider right away if you become depressed, have
unusual changes in mood or behavior, or have thoughts of hurting
yourself.
Do not take INGREZZA or INGREZZA SPRINKLE if you:
- are allergic to valbenazine, or any of the ingredients in
INGREZZA or INGREZZA SPRINKLE.
INGREZZA or INGREZZA SPRINKLE can cause serious side effects,
including:
- Allergic reactions. Allergic reactions, including
an allergic reaction that causes sudden swelling called angioedema,
can happen after taking the first dose or after many doses of
INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic
reactions and angioedema include: trouble breathing or shortness of
breath, swelling of your face, lips, eyelids, tongue, or throat, or
other areas of your skin, trouble with swallowing, or rash,
including raised, itchy red areas on your skin (hives). Swelling in
the throat can be life-threatening and can lead to death. Stop
taking INGREZZA or INGREZZA SPRINKLE and go to the nearest
emergency room right away if you develop these signs and symptoms
of allergic reactions and angioedema.
- Sleepiness and tiredness that could cause slow reaction
times (somnolence and sedation). Do not drive a car or
operate dangerous machinery until you know how INGREZZA or INGREZZA
SPRINKLE affects you. Drinking alcohol and taking other medicines
may also cause sleepiness during treatment with INGREZZA or
INGREZZA SPRINKLE.
- Heart rhythm problems (QT prolongation). INGREZZA
or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT
prolongation. You have a higher chance of getting QT prolongation
if you also take certain other medicines during treatment with
INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right
away if you develop any signs or symptoms of QT prolongation,
including: fast, slow, or irregular heartbeat (heart palpitations),
shortness of breath, dizziness or lightheadedness, or fainting or
feeling like you are going to faint.
- Neuroleptic Malignant Syndrome (NMS). NMS is a
serious condition that can lead to death. Call a healthcare
provider right away or go to the nearest emergency room if you
develop these symptoms and they do not have another obvious cause:
high fever, stiff muscles, problems thinking, irregular pulse or
blood pressure, increased sweating, or very fast or uneven
heartbeat.
- Parkinson-like symptoms. Symptoms include: body
stiffness, drooling, trouble moving or walking, trouble keeping
your balance, shaking (tremors), or falls.
Before taking INGREZZA or INGREZZA SPRINKLE, tell your
healthcare provider about all of your medical conditions including
if you: have liver or heart problems, are pregnant or plan
to become pregnant, or are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Make sure you tell all
of your healthcare providers that you are taking INGREZZA or
INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with
certain other medicines may cause serious side effects. Especially
tell your healthcare provider if you: take digoxin or take or have
taken a monoamine oxidase inhibitor (MAOI) medicine. You should not
take INGREZZA or INGREZZA SPRINKLE if you are taking, or have
stopped taking, a MAOI within the last 14 days.
The most common side effects of INGREZZA or INGREZZA SPRINKLE
in people with tardive
dyskinesia are sleepiness and tiredness.
The most common side effects of INGREZZA or INGREZZA SPRINKLE
in people with chorea associated with Huntington's disease
include sleepiness and tiredness, raised itchy red areas
on your skin (hives), rash, and trouble getting to sleep or staying
asleep.
These are not all of the possible side effects of INGREZZA or
INGREZZA SPRINKLE. Call your doctor for medical advice about side
effects. You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit MedWatch
at www.fda.gov/medwatch or
call 1-800-FDA-1088.
Dosage Forms and Strengths: INGREZZA and INGREZZA
SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules.
Please see full Prescribing Information, including
Boxed Warning, and Medication Guide.
Forward-Looking Statements
In addition to historical
facts, this press release contains forward-looking statements that
involve a number of risks and uncertainties. These statements
include, but are not limited to, statements related to: our
pipeline, financial position, commercial product strength,
momentum, vision and future growth; the ability of our R&D
innovation engine to deliver INDs; the continued success of
INGREZZA; the regulatory approval and commercialization of
crinecerfont; and the impact of our CEO succession on our future
growth and success. Among the factors that could cause actual
results to differ materially from those indicated in the
forward-looking statements are: our future financial and operating
performance; risks and uncertainties associated with the
commercialization of INGREZZA; risks related to the development of
our product candidates; risks associated with our dependence on
third parties for development, manufacturing, and commercialization
activities for our products and product candidates, and our ability
to manage these third parties; risks that the FDA or other
regulatory authorities may make adverse decisions regarding our
products or product candidates; risks that clinical development
activities may not be initiated or completed on time or at all, or
may be delayed for regulatory, manufacturing, or other reasons, may
not be successful or replicate previous clinical trial results, may
fail to demonstrate that our product candidates are safe and
effective, or may not be predictive of real-world results or of
results in subsequent clinical trials; risks that the potential
benefits of the agreements with our collaboration partners may
never be realized; risks that our products, and/or our product
candidates may be precluded from commercialization by the
proprietary or regulatory rights of third parties, or have
unintended side effects, adverse reactions or incidents of misuse;
risks associated with government and third-party regulatory and/or
policy efforts which may, among other things, impose sales and
pharmaceutical pricing controls on our products or limit coverage
and/or reimbursement for our products; risks associated with
competition from other therapies or products, including potential
generic entrants for our products; risks associated with management
transitions; and other risks described in our periodic reports
filed with the SEC, including our Quarterly Report on Form 10-Q for
the quarter ended March 31, 2024.
Neurocrine Biosciences disclaims any obligation to update the
statements contained in this press release after the date hereof
other than as required by law.
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SOURCE Neurocrine Biosciences, Inc.