In a Dec. 12 research note, ROTH Capital Partners analyst Yasmeen Rahimi reported that Daré Bioscience Inc. (DARE:NASDAQ) received U.S. Food and Drug Administration (FDA) approval to clinically advance its Sildenafil cream into a Phase 2b at-home study, "getting one step closer to the first potential approved treatment for female sexual arousal disorder."
Rahimi highlighted that Daré may move forward with the 12-week, placebo-controlled study without having to submit further data, and is preparing to do so. The company will develop screening guidelines and a primary study endpoint from the patient-reported outcomes it collected previously. As for exploratory endpoints, Daré and the FDA agreed on those, which "could potentially be included as endpoints in a future Phase 3 trial," the analyst added.
She also pointed out that "Daré's continued strong execution and on-track program updates will attract significant interest from potential strategic partners and strengthen our confidence in Daré's commitment to delivering on key inflection points for topical Sildenafil, BV1, Ovaprene and its other women's health assets." The company could strike up licensing deals at the upcoming J.P. Morgan Healthcare Conference.
A single, pivotal Phase 3 trial is expected to start this quarter for BV1, a vaginal infection treatment and the "crown jewel of Daré's pipeline," Rahimi noted.
ROTH's target price on Daré is $6 per share, and the biopharma is Buy rated. The stock's currently at $0.82 per share.[NLINSERT]
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Disclosures from ROTH Capital Partners, Daré Bioscience Inc., Flash Note, December 12, 2019
Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.
Within the last twelve months, ROTH has received compensation for investment banking services from Daré Bioscience, Inc.
ROTH makes a market in shares of Daré Bioscience, Inc. and as such, buys and sells from customers on a principal basis.
Shares of Daré Bioscience, Inc. may be subject to the Securities and Exchange Commission's Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.
Within the last twelve months, ROTH has managed or co-managed a public offering for Daré Bioscience, Inc.
ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.