Sol‑Gel Technologies Ltd. announced that it will discontinue development of its SGT‑210 candidate for Darier disease after the unblinded Phase 1b data showed no efficacy advantage over vehicle. The decision follows a randomized, double‑blind, vehicle‑controlled study that enrolled patients with the rare genodermatosis and found no statistically or clinically meaningful difference in the primary endpoint.
The Phase 1b trial, which enrolled 30 patients, reported a 0.0% improvement in the Investigator Global Assessment score for SGT‑210 versus 0.0% for vehicle, and no difference in secondary safety endpoints. Because the study failed to demonstrate superiority, Sol‑Gel’s executive chairman Mori Arkin said the company will focus on “very small, low‑cost feasibility studies in other areas of unmet medical need where the mechanistic rationale for SGT‑210 is strong.”
Financially, Sol‑Gel’s Q3 2025 results underscored the impact of the program’s pause. Net loss widened to $5.9 million, or $2.13 per share, compared with a $0.4 million loss ($0.13 per share) in Q3 2024. Revenue fell sharply to $0.4 million from $5.4 million a year earlier, reflecting the loss of sales from the company’s two approved products, TWYNEO and EPSOLAY, and the absence of new pipeline revenue. The company’s cash and marketable securities stood at $20.9 million, sufficient to fund operations through Q1 2027, but the loss trajectory signals a need for stronger revenue streams.
Strategically, Sol‑Gel is redirecting resources toward its flagship SGT‑610 program, which targets Gorlin syndrome and high‑frequency basal cell carcinoma. SGT‑610 has received U.S. and EU Orphan Drug and Breakthrough Therapy designations and is expected to generate an annual U.S. market potential of $400–$500 million. The company’s focus on SGT‑610, coupled with a planned Phase 3 for high‑frequency basal cell carcinoma, represents a shift toward high‑potential assets that can deliver commercial returns and justify the company’s valuation. The halt of SGT‑210 frees capital and clinical bandwidth for these programs.
Management emphasized that the decision was driven by the lack of demonstrated efficacy and that the company will pursue small feasibility studies where the mechanistic rationale remains compelling. Analysts noted that the market reaction was largely driven by the negative Phase 1b outcome, which eliminated a potential development path and increased uncertainty about the company’s near‑term pipeline. The company’s strong balance sheet and ongoing focus on SGT‑610 suggest that the decision is a calculated move to preserve resources for assets with higher probability of success.
Overall, the discontinuation of SGT‑210 signals a strategic pivot that may reduce short‑term pipeline breadth but concentrates Sol‑Gel’s efforts on assets with the greatest commercial upside. Investors will likely view the move as a risk‑mitigating step that aligns the company’s resources with its most promising therapeutic areas, while the financial losses highlight the need for accelerated progress in the SGT‑610 program to restore profitability.
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