Shares of Sol-Gel Technologies Ltd. nearly doubled Monday, after the Israeli drugmaker said its acne drug Twyneo met the primary endpoints in two late-stage trials.
The topical treatment is a combination of benzoyl peroxide and tretinoin. Sol-Gel SLGL, +95.02% said it plans to submit a new drug application (NDA) for Twyneo to the Food and Drug Administration in the second half of 2020. The company is aiming to have Twyneo available for patients in the second half of 2021.
“We are excited to share these robust results which further demonstrate the potential of our microencapsulation technology to deliver first-of-its kind efficacy in a topical acne treatment,” said Chief Executive Alon Seri-Levy.
The stock shot up 87% toward a record high in morning trading. Volume swelled to 1.2 million shares, well above the full-day average of about 10,200 shares.
Sol-Gel is also developing a treatment for rosacea. Raymond James analyst Elliot Wilbur wrote in a research note earlier this month that “we continue to have confidence in the potential for both branded products, Twyneo (acne vulgaris) and Epsolay (papulopustular rosacea), to emerge as best-in-class therapies.”
According to BMO Research’s Gary Nachman in September, Sol-Gel’s management expects more than $100 million peak sales for Epsolay if the drug is approved.
Sol-Gel’s stock has nearly tripled (up 191%) year-to-date, while the S&P 500 SPX, -0.61% has gained 29%.