Daré Bioscience, Inc.

Daré Bioscience Fast-Tracks Sildenafil Cream Launch with Dual-Market Strategy for Women's Health

a month ago

• Daré Bioscience has unveiled a dual-path approach to make its proprietary Sildenafil Cream formulation available via prescription by Q4 2025, responding to healthcare community urging and women's demand. • The company is exploring a 503B compounding pathway to accelerate market access for its female sexual arousal disorder (FSAD) treatment, potentially creating the first FDA-approved therapy for this condition. • CEO Sabrina Martucci Johnson will present the expanded business strategy at the Jones Healthcare and Technology Innovation Conference, with plans to evaluate similar approaches for other proprietary formulations in their portfolio.

XOMA Royalty Expands Portfolio to Over 120 Assets, Reports Financial Results for 2024

2 months ago

• XOMA Royalty doubled its portfolio to over 120 royalty assets through five strategic transactions in 2024, strengthening its position as a biotech royalty aggregator. • The company completed two whole company acquisitions and celebrated FDA approvals for Day One's OJEMDA™ (tovorafenib) and Zevra's MIPLYFFA™ (arimoclomol), generating significant milestone payments. • Despite reporting a net loss of $13.8 million for 2024, XOMA Royalty received $46.3 million in cash receipts and maintains over $100 million in cash, positioning it for sustainable cashflow from royalties.

Daré Bioscience and Theramex Partner to Develop Novel Biodegradable Contraceptive Implant

3 months ago

• Daré Bioscience and Theramex have entered into a co-development agreement for Casea S, a first-in-category biodegradable contraceptive implant designed to last 18-24 months. • The innovative implant eliminates the need for surgical removal, addressing a key barrier in current contraceptive implants while offering women a convenient, long-acting contraceptive option. • A foundation-funded Phase 1 trial is currently underway to evaluate the pharmacokinetics, removability, safety, and tolerability of Casea S.

Coherus BioSciences' Liver Cancer Triplet Therapy Shows Promise in Phase 2 Study

4 months ago

• Coherus BioSciences' novel triplet therapy combining casdozo, atezolizumab, and bevacizumab demonstrates significant efficacy in treating metastatic hepatocellular carcinoma during Phase 2 trials. • The company's unique anti-IL-27 therapy, casdozo, shows potential for enhancing anti-tumor effects when used in combination treatments, leading to a positive market outlook. • H.C. Wainwright analyst maintains a Buy rating with a $7.00 price target, citing promising clinical data and strategic valuation projections through 2035.

Neuralink Implants Third Human with Brain-Computer Interface, Plans Expansion

4 months ago

• Neuralink has successfully implanted its brain-computer interface device in a third human patient, with all three implants reported to be functioning well. • The company plans to expand its human trials significantly, aiming to implant the device in 20 to 30 more individuals in 2025. • Upgrades to the Neuralink device include more electrodes, higher bandwidth, and longer battery life, enhancing its potential for restoring digital independence. • A new clinical trial site will open at the University of Miami, focusing on patients with paralysis or ALS, to further research and development of the technology.

Sildenafil Cream Shows Consistent Efficacy for FSAD Across Patient Subgroups

5 months ago

• Post-hoc analysis of the phase 2b RESPOND trial reveals that topical sildenafil cream, 3.6%, maintains efficacy for FSAD across various patient subgroups. • Age, race, and hormonal contraceptive use did not significantly impact the efficacy of sildenafil cream in premenopausal women with FSAD. • Daré Bioscience plans to initiate a phase 3 trial of sildenafil cream, 3.6%, for FSAD in 2025, following positive phase 2b results. • The FDA is collaborating with Daré Bioscience on the phase 3 design for this novel therapeutic indication for women.

Daré Bioscience Advances Sildenafil Cream for Female Sexual Arousal Disorder

5 months ago

• Daré Bioscience is moving forward with Phase 3 trials for Sildenafil Cream 3.6% to treat Female Sexual Arousal Disorder (FSAD). • The planned Phase 3 study will assess the cream's efficacy over 12 weeks, focusing on arousal sensations and associated distress. • Sildenafil Cream aims to increase genital blood flow, potentially becoming the first FDA-approved treatment for FSAD, affecting millions of women. • The company plans to submit the protocol and statistical analysis to the FDA in early 2025 and commence the Phase 3 study by mid-2025.

Daré Bioscience Advances Women's Health Portfolio with Funding and Clinical Progress

6 months ago

• Daré Bioscience is progressing its hormone-free contraceptive, Ovaprene, in a Phase 3 efficacy study, boosted by a foundation grant to expand clinical sites. • Sildenafil Cream 3.6% for female sexual arousal disorder is advancing towards Phase 3 after constructive FDA discussions on trial design and endpoints. • DARE-HPV, a novel treatment for HPV-related cervical diseases, is set for a Phase 2 trial, supported by a $10 million ARPA-H award. • Activities are underway for Phase 2 and Phase 1 studies of DARE-VVA1 and DARE-PTB1, respectively, targeting dyspareunia and preterm birth prevention.