Tag: FDA

INFORMATIONS PRIVILÉGIÉES
INFORMATIONS RÉGLEMENTÉES

INSIDE INFORMATION
REGULATED INFORMATION

– Filing based on pivotal Phase 3 VERITAC-2 clinical trial demonstrating statistically significant and clinically meaningful improvement in median progression-free survival versus fulvestrant –

-- Continued Progress on Regulatory Approvals and Global Commercialization of Fertility Portfolio --

ATLANTA, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced its financial results for the second quarter of 2025.

JERUSALEM, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptide and protein replacement therapies, today reported financial results and key business updates for the quarter ended June 30, 2025.

How Ingredient Transparency, Screen-Time Trends, and Clean-Label Formulas Are Shaping the Vision Wellness Movement in 2025

Experience Groundbreaking Sleep and Cellular Support Backed by Terahertz Innovation, Trusted by Wellness Experts in 2025

– Second Quarter 2025 Financial Results and Corporate Update Rescheduled to Monday, August 11, 2025, at 4:30 p.m. ET –

CARSON CITY, Nev., Aug. 07, 2025 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI, BIVIW), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including liver disease and neurological and neuro-degenerative disorders, today announced the pricing of its underwritten public offering of 6,000,000 units, with each unit consisting of one share of common stock and one warrant (the “Warrants”) (or pre-funded units in lieu thereof, with each pre-funded unit consisting of one pre-funded warrant (the “Pre-Funded Warrants”) and one Warrant). Each unit is being sold to the public at a price of $2.00 per unit (and each pre-funded unit is being sold to the public at the public offering price of each unit less the $0.0001 per share nominal exercise price for each Pre-Funded Warrant). The gross proceeds to the Company from this offering are expected to be approximately $12 million, before deducting underwriting discounts and commissions and other estimated offering expenses. The Warrants included in the units and pre-funded units have been approved for listing on the Nasdaq Capital Market and are expected to commence trading under the symbol “BIVIW” on August 8, 2025. Each Warrant will be immediately exercisable, will entitle the holder to purchase one share of common stock at an exercise price of $2.50 per share and will expire five years from the date of issuance. Each Pre-Funded Warrant will be immediately exercisable, will entitle the holder to purchase one share of common stock and may be exercised at any time until exercised in full. The common stock (or Pre-Funded Warrants in lieu thereof) and Warrants can only be purchased together in the offering but will be issued separately. The Company has granted the underwriter a 45-day option to purchase up to an additional 900,000 shares of common stock and/or Pre-Funded Warrants and/or Warrants, or any combination thereof, solely to cover over-allotments, if any, at the public offering price, less underwriting discounts and commissions.

NEW YORK, Aug. 07, 2025 (GLOBE NEWSWIRE) --

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Capricor Therapeutics, Inc. (NASDAQ: CAPR) between October 9, 2024 and July 10, 2025, both dates inclusive (the “Class Period”), of the important September 15, 2025 lead plaintiff deadline.