Edge Therapeutics Appoints Alyssa Wyant as Senior Vice President, Regulatory Affairs and Makes Inducement Grant under NASDAQ ...
February 21 2017 - 7:00AM
Edge Therapeutics, Inc. (Nasdaq:EDGE), a clinical-stage
biotechnology company developing novel hospital-based therapies in
the management of acute, life-threatening conditions, today
announced the appointment of Alyssa Wyant as Senior Vice President,
Regulatory Affairs. Ms. Wyant will oversee all facets of Edge's
regulatory activities, providing oversight for all U.S. and
international regulatory matters, including filings and
interactions with regulatory authorities. Ms. Wyant will report to
Edge’s President and Chief Executive Officer, Brian Leuthner, and
become part of Edge’s executive team.
"We are pleased to have Alyssa join the Edge team.
She has extensive regulatory experience and an outstanding track
record, having supported the advancement of multiple orphan
products through the regulatory approval process, including direct
interaction with the U.S. Food and Drug Administration (FDA) and
international regulatory agencies for both regulatory approvals and
post-approval activities,” said Mr. Leuthner. “Alyssa's experience
will be invaluable to Edge as we continue to advance the clinical
development of EG-1962 through our Phase 3 NEWTON 2 study for
aneurysmal subarachnoid hemorrhage (aSAH), and focus on driving
forward pipeline products from our Precisa Platform™ in the years
ahead."
Ms. Wyant has nearly 20 years of global regulatory
experience with a focus on the development, registration and
successful launches of innovative, biologic and small molecule
orphan disease products. Most recently, Ms. Wyant served as Vice
President, Global Regulatory Affairs at PTC Therapeutics. While at
PTC, she was responsible for the strategic planning and execution
of global regulatory activities for Translarna™ (ataluren) across
five orphan disease indications, acting as regulatory agency
liaison for approval filings in Duchenne muscular dystrophy (DMD)
and cystic fibrosis with the European Medicines Agency (EMA), FDA
and Health Canada, and for maintenance of conditional approval for
DMD with the EMA. As Senior Director, International Regulatory
Affairs at NPS Pharmaceuticals, Ms. Wyant created and implemented
global strategies for the registration and post-approval activities
for orphan disease products in Europe, North America and Latin
America, supporting FDA approval for Natpara® for
hypoparathyroidism and the U.S. and EU launches for Gattex® /
Revestive® for short bowel syndrome. Earlier in her career, she
held multiple leadership positions in global regulatory affairs at
Shire Human Genetic Therapies in the U.S. and Switzerland, where
she was a key contributor in obtaining, maintaining, and extending
registration of the enzyme replacement therapy products Elaprase®,
VPRIV® and Replagal®. She also held regulatory affairs positions at
Vertex Pharmaceuticals and Genetics Institute / Wyeth-Ayerst
Pharmaceuticals. Ms. Wyant has a B.S. in cell and molecular biology
from the University of Washington.
Inducement Grant under NASDAQ Listing Rule
5635(c)(4)
In connection with Ms. Wyant’s new employment, the Compensation
Committee of Edge’s Board of Directors has approved the grant to
Ms. Wyant of non-qualified stock options to purchase 80,000 shares
of Edge’s common stock. The effective date of the grant is March 1,
2017 and the exercise price for such stock options will be equal to
the closing price of Edge’s common stock on such date, as reported
by NASDAQ. The grant was made as an inducement material to Ms.
Wyant’s acceptance of employment with Edge, in accordance with
NASDAQ Listing Rule 5635(c)(4).
The options have a 10-year term and vest over a period of four
years, with 25 percent vesting on February 21, 2018, which is one
year following Ms. Wyant’s date of hire, and the remaining 75
percent vesting in approximately equal monthly increments over the
succeeding thirty-six months, subject to Ms. Wyant’s continuous
employment through each applicable vesting date. In addition, the
options are subject to acceleration or forfeiture upon the
occurrence of certain events as set forth in Ms. Wyant’s stock
option and / or employment agreements.
About Edge Therapeutics, Inc.
Edge Therapeutics, Inc. is a clinical-stage biotechnology
company that discovers, develops and seeks to commercialize novel,
hospital-based therapies capable of transforming treatment
paradigms for the management of acute, life-threatening
neurological and other conditions. EG-1962, Edge’s lead product
candidate, has the potential to fundamentally improve patient
outcomes and transform the management of aSAH, which is bleeding
around the brain due to a ruptured brain aneurysm. Edge is
evaluating EG-1962 in two clinical studies: the pivotal Phase 3
NEWTON 2 study of EG-1962 delivered via external ventricular drain,
and a study of direct intracisternal administration of EG-1962. For
additional information about Edge, please visit
www.edgetherapeutics.com.
Forward-Looking Statements
This press release and any statements of representatives of Edge
Therapeutics, Inc. related thereto that are not historical in
nature contain, or may contain, among other things, certain
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements may include, without limitation, statements with respect
to Edge’s plans, objectives, projections, expectations and
intentions and other statements identified by words such as
"projects," "may," "will," "could," "would," "should," "believes,"
"expects," "anticipates," "estimates," “seeks,” "intends," "plans,"
"potential" or similar expressions, including statements with
respect to Edge’s future clinical and regulatory plans, Edge’s
ability to advance its portfolio of therapies towards
commercialization and the potential effects of its products. These
statements are based upon the current beliefs and expectations of
Edge’s management and are subject to significant risks and
uncertainties. Actual results may differ significantly from those
set forth in the forward-looking statements. These forward-looking
statements involve certain risks and uncertainties that are subject
to change based on various risk factors (many of which are beyond
Edge's control) as described under the heading "Risk Factors" in
Edge’s filings with the United States Securities and Exchange
Commission.
Investor Contact:
Gregory Gin
Edge Therapeutics, Inc.
Tel: 1-800-208 EDGE (3343)
Email: ir@edgetherapeutics.com
Media Contact:
Laura Bagby
6 Degrees
Tel: 312-448-8098
Email: lbagby@6degreespr.com
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