Sol Gel Technolg Stock Price, News & Analysis

Sol-Gel Technologies (NASDAQ: SLGL) announced FDA approval of TWYNEO® for acne treatment, triggering an $8 million milestone payment from Galderma. The company signed exclusive licensing agreements for TWYNEO® and EPSOLAY®, which is pending FDA action. Second quarter 2021 revenue was $0.9 million, down from $1.1 million in 2020. Research and development costs increased to $6.9 million, while general and administrative costs decreased to $2.0 million. The company reported a net loss of $8.0 million for the quarter and has $38.9 million in cash and securities to fund operations through early 2023.

Sol-Gel Technologies, Ltd. (NASDAQ: SLGL) announced FDA approval for TWYNEO, a once-daily cream for acne vulgaris, combining tretinoin and benzoyl peroxide. This marks the first FDA-approved fixed-dose combination for this treatment, utilizing proprietary microencapsulation technology. TWYNEO is patent protected until 2038. Sol-Gel is set to receive a regulatory milestone payment from Galderma, its U.S. commercialization partner, and retains an option for commercialization rights after five years. The drug is expected to significantly impact the treatment landscape for acne patients.

Sol-Gel Technologies (Nasdaq: SLGL) will report its second quarter 2021 financial results on August 4, 2021, at 7:05 AM ET. The company focuses on developing topical drug products for skin diseases, utilizing its microencapsulation technology platform. TWYNEO and EPSOLAY are under investigation for acne and rosacea, respectively, with NDAs filed with the FDA. However, the approval for EPSOLAY is delayed due to COVID-19 travel restrictions affecting the FDA's inspection of the production site.

Sol-Gel Technologies (NASDAQ: SLGL) announced positive pre-clinical data for its investigational drug, SGT-510, showing superiority over roflumilast cream in a psoriasis model. The human xenograft study, conducted at the Technion Institute, revealed a 60% recovery rate with SGT-510 compared to 30% with roflumilast. Sol-Gel also plans to develop tapinarof cream, aiming for affordability and innovation. Their study for SGT-210 indicated modest improvements in palmoplantar keratoderma. The company will discuss these results in a conference call today at 8 AM EDT.

Sol-Gel Technologies (NASDAQ: SLGL) has announced two exclusive 5-year license agreements with Galderma for the commercialization of its investigational products, EPSOLAY and TWYNEO, in the U.S. EPSOLAY targets inflammatory lesions of rosacea, while TWYNEO is aimed at treating acne vulgaris. The agreements could yield Sol-Gel up to $15 million in upfront and milestone payments, plus royalties ranging from mid-teen to high-teen percentages of net sales. These collaborations are expected to enhance Sol-Gel's financial position without dilution, while the products await FDA approval.

Sol-Gel Technologies, a clinical-stage dermatology firm, will present a company overview at two upcoming virtual investor conferences. The first is the Jefferies Healthcare Conference, scheduled for June 1, 2021, where CEO Dr. Alon Seri-Levy will speak at 8:30 am EDT. The second is the Raymond James Human Health Innovation Conference on June 22, 2021, at 10:00 am EDT. The company focuses on developing topical treatments for skin diseases, with NDA submissions for two products pending FDA review. Recordings of the presentations will be available on their website.

Sol-Gel Technologies (NASDAQ: SLGL) announced its Q1 2021 financial results, reporting revenue of $0.7 million and a loss of $4.1 million, down from a $7.1 million loss in Q1 2020. The company is in advanced negotiations for the commercialization of EPSOLAY® and TWYNEO® with PDUFA goal dates of April 26, 2021, and August 1, 2021, respectively. R&D expenses decreased to $2.5 million, primarily due to reduced clinical trial costs. Sol-Gel has $34.2 million in cash and equivalents expected to sustain operations into Q3 2022.

Sol-Gel Technologies (NASDAQ: SLGL) has provided an update on its EPSOLAY® (benzoyl peroxide) 5% topical cream, aimed at treating inflammatory lesions of rosacea. Initially scheduled for FDA action by April 26, 2021, the process has been delayed due to the COVID-19 pandemic impacting pre-approval inspections. The FDA confirmed that it could not proceed with the NDA until an inspection is conducted. Sol-Gel is actively following up with the FDA to schedule this inspection, as it remains crucial for the product's approval.

Sol-Gel Technologies (NASDAQ: SLGL) reported FY 2020 revenue of $8.8 million, driven largely by collaborations with Perrigo. The company achieved significant milestones, with FDA accepting NDAs for Epsolay and Twyneo, scheduled for PDUFA dates of April 26 and August 1, 2021, respectively. However, Sol-Gel incurred a net loss of $29.3 million, worsening from $24.6 million in 2019. Cash and securities totaled $50.2 million, expected to fund operations through Q3 2022. Operational plans include partnering for commercialization to enhance market capture.