Daré Bioscience announced the launch of its first evidence‑based topical sildenafil cream, DARE to PLAY, on December 10 2025. The cream is available for pre‑order by prescription in select U.S. states—Connecticut, Florida, Indiana, Missouri, New Hampshire, New Jersey, Oregon, Pennsylvania, Rhode Island, and Utah—through a 503B compounding facility that operates under cGMP conditions.
The launch marks a significant operational milestone. DARE to PLAY is the first sildenafil cream formulation to complete randomized, placebo‑controlled studies in women, providing a scientific foundation that distinguishes it from other over‑the‑counter or off‑label products. By leveraging a 503B outsourcing facility, Daré can offer the cream to patients immediately, generating revenue while it continues to pursue full FDA approval for a proprietary formulation.
Daré’s Q3 2025 earnings, released on November 13 2025, showed an EPS of –$0.28, beating analyst expectations of –$0.32. The beat was driven by disciplined cost management that offset a $2.5 million decline in revenue, which fell to $0 million from $0 million in the prior quarter due to the company’s focus on product development and the launch of DARE to PLAY. The company’s cash position stood at approximately $23.1 million, providing a runway for continued investment in the product pipeline.
CEO Sabrina Martucci Johnson described the launch as an “inflection point” for the company, emphasizing the dual‑path strategy that combines immediate revenue generation through compounding with a long‑term goal of FDA approval. She noted that the evidence‑based approach and the rigorous clinical data underpinning the cream give the company a competitive advantage in a market that currently lacks approved treatments for female sexual arousal disorder.
Daré plans to expand national distribution of DARE to PLAY in December 2025 and early 2026, targeting an estimated 20 million U.S. women who have no FDA‑approved treatment for genital arousal disorder. The company’s strategy positions it to capture a sizable unmet market while building brand recognition and clinical credibility ahead of a future FDA submission.
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