- The stock price of Daré Bioscience Inc (NASDAQ: DARE) is up more than 50% pre-market today. This is why it happened.
The stock price of Daré Bioscience Inc (NASDAQ: DARE) — a clinical-stage biopharmaceutical company that focuses on developing and marketing products for women’s health — is up more than 50% pre-market today. There does not seem to be any direct news from the company. So the stock price gain appears to be speculation from investors about what could be happening with the company behind-the-scenes.
Last month, Daré Bioscience had announced positive topline results from DARE-BVFREE, a Phase 3 trial of DARE-BV1 in patients diagnosed with bacterial vaginosis. DARE-BV1 met the primary endpoint of the study and all pre-specified secondary efficacy endpoints and demonstrated significantly greater clinical cure rates compared to placebo.
DARE-BV1 is an investigational thermosetting bioadhesive hydrogel that contains clindamycin phosphate 2% designed as a convenient one-time vaginally-administered treatment for bacterial vaginosis. And the trial met its primary endpoint demonstrating that a single administration of DARE-BV1 was superior to placebo as a primary therapeutic intervention for women diagnosed with bacterial vaginosis.
“Based on these topline results, DARE-BV1 delivered clinical cure rate values greater than those of currently marketed FDA-approved products for the treatment of bacterial vaginosis. This successful Phase 3 clinical trial marks another important achievement for Daré. We began 2020 with the announcement of a commercial partnership for Ovaprene with Bayer, marketer of one of the most successful contraceptive products in women’s health, and we’re concluding the year with another exciting milestone, the successful completion of our Phase 3 clinical trial of DARE-BV1 to support an NDA for the treatment of bacterial vaginosis,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience in a statement last month. “We believe there is a large unmet need for a more efficacious and convenient, single-dose vaginally-administered product to treat bacterial vaginosis, and we believe DARE-BV1 could become a new front-line treatment option. DARE-BV1 received Fast Track designation from the FDA earlier this year and, based on the topline results of this trial, we plan to file our NDA in the first half of 2021.”
That last part of the statement from Johnson appears to be surfacing in the stock trading forums for Daré Bioscience. There is speculation around the NDA.
And there is also speculation around the deal it made with Bayer last year (rumors about acquisition potential).
Note: If more information surfaces, then I will update this article.
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