Pliant Therapeutics Appoints S. Mishima Gerhart as Chief Regulatory Officer
16 Oktober 2023 - 10:05PM
Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage
biotechnology company and leader in the discovery and development
of novel therapeutics for the treatment of fibrotic diseases, today
announced the appointment of Ms. S. Mishima Gerhart as Chief
Regulatory Officer. Ms. Gerhart will lead the Company’s regulatory
and quality strategies and activities.
“Mishima brings a dynamic set of drug development experiences
including the design and execution of global regulatory strategies
in support of preclinical to commercial-stage programs,” said
Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer
at Pliant. “Mishima’s successful track record, having achieved
results in a variety of diverse, global regulatory and quality
settings, will be an invaluable asset to Pliant as we enter
late-stage development with our expanding portfolio of novel drug
candidates.”
Ms. Gerhart is a recognized leader in the biotechnology and
pharmaceutical industries who brings over 20 years of global
regulatory expertise and experience leading cross-functional teams
across multiple therapeutic areas. Ms. Gerhart previously held the
role of Chief Regulatory Officer and Head of Quality at Taysha Gene
Therapies where she established and grew the regulatory and quality
organizations and was responsible for all US and Ex-US regulatory
interactions. Prior to Taysha, Ms. Gerhart held senior regulatory
roles at Sanofi, serving as Vice President and Head of North
America and Global Labeling where she led teams across multiple
therapeutic areas including rare diseases, oncology, diabetes,
cardiovascular and vaccines. Ms. Gerhart also held the position of
Vice President and Head of Regulatory Affairs, China, and Emerging
Markets where she managed a 500+ person organization and was
responsible for all pre-commercial and commercial-stage products
across numerous therapeutic areas and geographies. Prior to this,
Ms. Gerhart was Head of Regulatory at Genzyme and held regulatory
positions of increasing seniority at AbbVie, Reata Pharmaceuticals,
Pfizer/ Wyeth, AstraZeneca, and Wyeth. Ms. Gerhart received a M.S.
in Quality Assurance and Regulatory Affairs from Temple University
and a B.S. from Kutztown University majoring in biology and
minoring in chemistry.
Ms. Gerhart added, “I am excited to join Pliant at this
important time and draw on my years of regulatory experience in
support of a portfolio focused on addressing areas unmet needs. I
look forward to working with the outstanding leadership team to
further execute on the company’s mission of improving the lives of
patients with fibrotic diseases.”
About Pliant Therapeutics, Inc.Pliant
Therapeutics is a clinical-stage biopharmaceutical company focused
on discovering and developing novel therapies for the treatment of
fibrosis. Pliant's lead product candidate, bexotegrast (PLN-74809),
is an oral, small molecule, dual selective inhibitor of αvß6 and
αvß1 integrins that is in development in the lead indications for
the treatment of idiopathic pulmonary fibrosis, or IPF, and primary
sclerosing cholangitis, or PSC. Bexotegrast has received Fast Track
Designation and Orphan Drug Designation from the U.S. Food and Drug
Administration (FDA) in IPF and PSC and Orphan Drug Designation
from the European Medicines Agency in IPF and PSC. Pliant has
initiated BEACON-IPF, a Phase 2b trial of bexotegrast in IPF.
Pliant has also developed PLN-1474, a small molecule, selective
inhibitor of αvß1 integrin for the treatment of nonalcoholic
steatohepatitis, or NASH with liver fibrosis. Pliant has initiated
a Phase 1 study for its third clinical program, PLN-101095, a small
molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that
is being developed for the treatment of solid tumors. In addition
to clinical-stage programs, Pliant currently has a preclinical
program targeting muscular dystrophies. For additional information,
please visit: www.PliantRx.com. Follow us on social media
Twitter, LinkedIn, Facebook and YouTube.
Inducement Grant Under Nasdaq Listing Rule
5635(c)(4)
In connection with the commencement of Ms. Gerhart’s employment
with the Company on October 16, 2023 (the “Grant Date”), the
Company plans to grant her non-statutory stock options to purchase
an aggregate of 150,000 shares of Company common stock (the
“Inducement Grant”). The Inducement Grant has been granted outside
of the Company’s 2020 Equity Incentive Plan (the “Plan”) but
remains subject to the terms and conditions of the Plan. The
Inducement Grant was granted as an inducement material to Ms.
Gerhart entering into employment with the Company in accordance
with Nasdaq Listing Rule 5635(c)(4). The Inducement Grant has an
exercise price per share that is equal to the closing price of the
Company’s common stock on the Grant Date. The Inducement Grant will
vest over a four-year period, with 25% of the shares vesting on the
one-year anniversary of Ms. Gerhart’s start date, and thereafter
the remainder of the shares vest in 36 equal monthly installments,
subject to Ms. Gerhart’s continued employment with the Company
through the applicable vesting dates.
Investor and Media Contact:
Christopher KeenanVice President, Investor Relations and
Corporate CommunicationsPliant Therapeutics,
Inc.ir@pliantrx.com
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