Vyne Therapeutics Inc Stock Price, News & Analysis

VYNE Therapeutics has announced a 1-for-4 reverse stock split effective February 16, 2021, to consolidate its shares from approximately 205 million to about 51 million. This move aims to align its share count with companies of similar market capitalizations. Stockholders will receive cash for any fractional shares following the split. The reverse stock split was earlier approved by stockholders at the Annual Meeting on August 3, 2020. The company's trading symbol will remain VYNE, and the new CUSIP number will be 92941V 209.

VYNE Therapeutics announced FDA approval for a label update of AMZEEQ® (minocycline) topical foam, which confirms a low propensity for P. acnes to develop resistance to minocycline. This update is significant for treating inflammatory lesions of moderate to severe acne in patients aged 9 and older. The label states spontaneous mutation frequencies for resistance are less than 1 in 100 million. CEO David Domzalski emphasized this information aids dermatologists in antibiotic choices, while the update is backed by a comprehensive antimicrobial characterization program.

VYNE Therapeutics has completed a registered direct offering of 21,097,046 shares of common stock at $2.37 per share, raising approximately $46.7 million in net proceeds. These funds will be used for working capital and general corporate purposes. Previously, VYNE raised an additional $34.3 million via an at-the-market program, bringing total net proceeds to $81.0 million. The company anticipates this cash influx will cover its operational and capital needs through the end of 2022, allowing for the termination of its at-the-market program.

VYNE Therapeutics Inc. (Nasdaq: VYNE) has announced a registered direct offering of 21,097,046 shares at $2.37 per share, expected to yield approximately $50 million in gross proceeds. This offering is set to close around January 28, 2021, subject to customary conditions. H.C. Wainwright & Co. is the exclusive placement agent. Proceeds will be used for working capital and general corporate purposes. The shares are offered under an effective registration statement.

VYNE Therapeutics (Nasdaq: VYNE) has secured a contract with a major U.S. pharmacy benefit manager (PBM) for its topical foams AMZEEQ (minocycline) 4% and ZILXI (minocycline) 1.5%. AMZEEQ is FDA-approved for treating severe acne, while ZILXI targets inflammatory lesions of rosacea. This contract signifies a major milestone, granting access to millions of covered lives and aligning with VYNE's objective to enhance commercial coverage. Both products utilize VYNE's Molecule Stabilizing Technology, offering new avenues for treating these skin conditions.

VYNE Therapeutics Inc. (Nasdaq: VYNE) has announced that CEO David Domzalski will participate in two panel discussions at the LifeSci Partners 10th Annual Healthcare Corporate Access Event. The first panel, titled Dermatology Innovation: Addressing Physician and Patient Underserved Needs, is scheduled for January 7 at 2:00 PM ET, followed by Executing a Successful Product Launch During a Pandemic on January 8 at the same time. Virtual Q&A will follow both sessions. For more details, visit the event's registration links.

VYNE Therapeutics has successfully concluded its End-of-Phase 2 Meeting with the FDA, setting the stage to initiate the TRILOGY Phase 3 program in 2021 for its innovative acne treatment FCD105. This minocycline-based combination product aims to address moderate-to-severe acne vulgaris, with results from a positive Phase 2 study showing strong efficacy. VYNE received FDA agreement on trial design, which includes two 12-week studies and one 40-week study, potentially expediting the New Drug Application submission.

VYNE Therapeutics Inc. (Nasdaq: VYNE) has been selected for inclusion in the NASDAQ Biotechnology Index, effective December 21, 2020. This index tracks biotechnology and pharmaceutical companies, with eligibility based on market capitalization and trading volume. VYNE, formed through the merger of Menlo Therapeutics and Foamix Pharmaceuticals, focuses on innovative dermatological therapies. The company's FDA-approved products include AMZEEQ and ZILXI, addressing significant dermatological needs.

VYNE Therapeutics announced the listing of a new U.S. patent for AMZEEQ in the FDA’s Orange Book, enhancing its protection in the dermatology market. The newly issued patent (U.S.10,849,847) extends coverage for AMZEEQ, a topical foam containing minocycline, which treats moderate to severe acne in patients aged 9 and older. This adds to 12 patents for AMZEEQ, with patent protection extending until September 2037. VYNE aims to strengthen its innovative portfolio in dermatology, addressing the needs of the 10 million Americans suffering from moderate to severe acne.