Sol-Gel's Collaboration Partner First-to-File ANDA Drug Product Generic to Zoryve® Cream [Yahoo! Finance]
Sol-Gel Technologies Ltd. (SLGL)
Last sol-gel technologies ltd. earnings: 11/13 07:05 am
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Source: Yahoo! Finance
dermatology company pioneering treatments for patients with severe skin conditions, conducting a Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, and with two approved large-category dermatology products, TWYNEO ® and EPSOLAY ® , today announced that Padagis Israel Pharmaceuticals Ltd (“Padagis”), Sol-Gel's collaboration partner, submitted a first-to-file Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration (“FDA”) for Roflumilast Cream, 0.3%, a drug product generic to Zoryve ® Cream (roflumilast cream, 0.3%), indicated for the treatment of plaque psoriasis in patients six years of age and older. On March 26, 2024, Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) (“Arcutis”) initiated a patent infringement action in the U.S. District Court for the District of New Jersey regarding the Padagis Roflumilast Cream, 0.3% ANDA. Annual market sales for Zoryve Cream, 0.3% were approximately $95 million in the 12 months ended in January 2024
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SLGL
News
- Sol-Gel’s Collaboration Partner First-to-File ANDA Drug Product Generic to Zoryve® CreamGlobeNewswire
- Sol-Gel Technologies Full Year 2023 Earnings: Revenues Beat Expectations, EPS In Line [Yahoo! Finance]Yahoo! Finance
- Sol-Gel Technologies GAAP EPS of -$1.01 misses by $0.31, revenue of $1.55M misses by $0.85M [Seeking Alpha]Seeking Alpha
- Sol-Gel Reports Full-Year 2023 Financial Results and Corporate DevelopmentsGlobeNewswire
SLGL
Earnings
- 11/9/23 - Beat
SLGL
Sec Filings
- 4/8/24 - Form SC
- 4/4/24 - Form 424B3
- 4/2/24 - Form EFFECT
- SLGL's page on the SEC website