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BERKELEY HEIGHTS, N.J., Feb. 21, 2017 (GLOBE NEWSWIRE) -- 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.
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.
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