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Sol-Gel Technologies Reports Third Quarter 2020 Financial Results and Corporate Update
Epsolay® PDUFA goal date set for April 26, 2021Twyneo® New Drug Application submitted to the U.S. FDATop-line generic product revenue of $2.1 million in 3Q
About this update from Sol-gel Technologies Ltd.
[{"type":"text","content":"Epsolay® PDUFA goal date set for April 26, 2021Twyneo® New Drug Application submitted to the U.S. FDATop-line generic product revenue of $2.1 million in 3Q 2020In October 2020, signed an 11th generic product collaboration agreement with Perrigo NESS ZIONA, Israel, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced financial results for the third quarter ended September 30, 2020 and provided clinical and regulatory updates on its programs.\n “The third quarter was highlighted by a major achievement for Sol-Gel, as our first New Drug Application (NDA) for Epsolay for the treatment of inflammatory lesions of rosacea was accepted by the Federal Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) goal date set for April 26, 2021. We now look forward to the NDA acceptance of our second proprietary product, Twyneo, for the treatment of acne vulgaris,” commented Dr. Alon Seri-Levy, Chief Executive Officer of Sol-Gel. “Also, after the close of the third quarter, we expanded our collaboration with Perrigo to develop an eleventh generic product candidate. While we are successfully expanding our partnership with Perrigo, we continue to focus on our own branded product candidates, Epsolay and Twyneo. We are working towards commercializing both treatments, if approved, in 2021, either on our own or with a partner that has a significant U.S. dermatology presence.” Corporate Highlights and Recent Developments Sol-Gel announced FDA acceptance of NDA for Epsolay (benzoyl peroxide, 5%, cream) with a PDUFA goal date set for April 26, 2021. If approved, Epsolay has the potential to be the first FDA-approved, single-agent benzoyl peroxide prescription drug product for the treatment of inflammatory lesions of rosacea.Sol-Gel submitted an NDA for Twyneo (benzoyl peroxide, 3%, and tretinoin, 0.1%, cream) to the FDA in the beginning of October. If approved, Twyneo has the potential to be the first FDA-approved acne treatment that contains fixed-dose combination of benzoyl peroxide and tretinoin.Sol-Gel was informed by its collaboration partner that the launch of an FDA-approved generic drug is expected in the second quarter of...