Tag: drug application

Daix (France), New York City (New York, United States), July 9, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced a leadership transition with the appointment of Jason Campagna, MD, PhD, as President of Research and Development (“R&D”) and Chief Medical Officer (“CMO”) and Martine Zimmermann, PharmD, as Executive Vice President (“EVP”) of Regulatory Affairs and Quality Assurance.

WESTON, Fla., July 08, 2025 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, today announced its entry into a warrant inducement agreement with a single institutional investor of the Company. Terms of the warrant inducement agreement include the immediate exercise of Series A-2 Warrants to purchase up to 957,200 shares of common stock (the “Series A-2 Warrants”) and Series A-3 Warrants to purchase up to 2,105,265 shares of common stock (the “Series A-3 Warrants,” and together with the Series A-2 Warrants, the “Existing Warrants”) at a reduced exercise price of $0.67. Gross cash proceeds were approximately $2.0 million before deducting financial advisor fees and other transaction expenses. The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes.

-- Patients treated with bezuclastinib showed a superior mean change in total symptom score at 24 weeks (-24.3 points vs. -15.4 points, -8.91 point placebo-adjusted difference; p=0.0002), compared to patients treated with placebo, establishing new benchmarks for placebo-adjusted and absolute symptomatic improvement for this patient population --

-- Bezuclastinib demonstrated a powerful effect on mast cell burden, with 87.4% of patients treated with bezuclastinib achieving at least 50% reduction in serum tryptase compared to 0% of patients treated with placebo --

Data show confirmed ORR of 83% (10/12) at doses selected for ongoing expansion study

SAN DIEGO, July 01, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company applying its proprietary Cloudbreak^® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced that the Compensation and Human Capital Committee of its Board of Directors (Compensation Committee) granted non-qualified stock option awards and restricted stock units (RSUs) for an aggregate of 12,100 shares of its common stock to two new employees, pursuant to the Cidara Therapeutics, Inc. 2020 Inducement Incentive Plan, as amended (the Inducement Plan), with a grant date of June 30, 2025. The stock option has an exercise price of $48.71 per share, which is equal to the closing price of Cidara’s common stock on the grant date. The shares subject to the option will vest over four years, with 25% of the shares vesting on the one-year anniversary of the vesting commencement date and the balance of the shares vesting in a series of 36 successive equal monthly installments thereafter. All RSUs vest in four equal annual installments, with 1/4 vesting on each of the first, second, third and fourth anniversaries of the Quarterly Vesting Date (as defined below) that occurs during the calendar quarter that includes the date of grant. “Quarterly Vesting Date” means March 10, June 10, September 10 or December 10. The awards are subject to the award holder’s continuous service through each vesting date and to the terms and conditions of the Inducement Plan and the standard forms of grant agreements thereunder.

SEATTLE and VANCOUVER, British Columbia, June 30, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced the closing of its underwritten public offering of 15,000,000 shares of its common stock and accompanying common warrants to purchase up to 16,766,666 shares of common stock at a public offering price of $3.00 per share and accompanying warrant, which includes common warrants to purchase up to 1,766,666 shares issued upon the partial exercise by the underwriters of their option to purchase additional shares of common stock and/or accompanying warrants. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, were $45.0 million.

— Approval based on Phase III SACHI Trial results which showed a 66% reduced risk of progression or death as compared to platinum-based chemotherapy —

SAN DIEGO, June 26, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (“Cidara”) (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced the closing of its underwritten public offering of 9,147,727 shares of its common stock, including the exercise in full by the underwriters of their option to purchase an additional 1,193,181 shares, at a price to the public of $44.00 per share. The gross proceeds to Cidara from the offering, before deducting underwriting discounts and commissions and offering expenses, were $402.5 million. All of the shares in the offering were sold by Cidara.