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VYNE THERAPEUTICS INC.

(VYNE)
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VYNE THERAPEUTICS INC. : Other Events (form 8-K)

07/02/2021 | 05:04pm EDT

Item 8.01 Other Events.

On June 30, 2021, VYNE Therapeutics Inc. (the "Company") received a paragraph IV certification notice (the "Notice") from Perrigo Israel Pharmaceuticals Ltd. ("Perrigo") advising that Perrigo has submitted to the U.S. Food and Drug Administration (the "FDA") an Abbreviated New Drug Application ("ANDA") seeking approval to manufacture and sell a generic version of the Company's product AMZEEQ® (minocycline) topical foam, 4% in the United States prior to the expiration of the Company's U.S. patents Nos. 8,865,139, 8,945,516, 8,992,896, 9675,700, 10,086,080, 10,137,200, 10,213,512, 10,265,404, 10,398,641, 10,517,882, 10,821,187, and 10,849,847 (the "Challenged Patents"), which are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book." The Notice alleges that the Challenged Patents are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Perrigo's ANDA. The Company is currently reviewing the Notice and intends to vigorously defend and enforce its intellectual property rights protecting AMZEEQ, as needed.

© Edgar Online, source Glimpses

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Financials (USD)
Sales 2021 18,2 M - -
Net income 2021 -70,2 M - -
Net Debt 2021 - - -
P/E ratio 2021 -1,11x
Yield 2021 -
Capitalization 76,8 M 76,8 M -
Capi. / Sales 2021 4,21x
Capi. / Sales 2022 10,7x
Nbr of Employees 106
Free-Float 87,1%
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Number of Analysts 6
Last Close Price 1,49 $
Average target price 6,67 $
Spread / Average Target 347%
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Managers and Directors
David Domzalski President, Chief Executive Officer & Director
Tyler Zeronda Chief Financial Officer & Treasurer
Iain A. Stuart Chief Scientific Officer
Sharon Barbari Independent Director
Steven L. Basta Independent Director
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