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Tag: drug application

SCG Cell Therapy Announces Clearance of Investigational New Drug Application by the China NMPA for SCG101V

SINGAPORE, July 7, 2025 /PRNewswire/ -- SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company pioneering TCR T cell therapy for infectious diseases...

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Red Cat, Reckitt, UroGen and Fortrea and Encourages Investors...

NEW YORK, July 07, 2025 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Reckitt Benckiser Group plc (OTC:RBGLY), UroGen Pharma Ltd. (NASDAQ:URGN), Red Cat Holdings, Inc. (NASDAQ: RCAT) and Fortrea Holdings Inc. (NASDAQ:FTRE). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.

National Heart, Lung, and Blood Institute / National Institutes of Health Signs Clinical Trial Agreement with Vascarta Inc. to Perform Phase 1 Clinical Study...

SUMMIT, N.J., July 7, 2025 /PRNewswire/ -- Under the agreement, the National Heart, Lung, and Blood Institute / National Institutes of Health will perform...

Cogent Biosciences Announces Positive Top-line Results Achieving Statistical Significance Across All Primary and Key Secondary Endpoints from the SUMMIT Trial of Bezuclastinib in Patients...

-- 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 --

Cidara Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)

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.

Achieve Life Sciences Announces Closing of Public Offering of Common Stock and Partial Exercise of Underwriters’ Option to Purchase Additional Securities

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.

HUTCHMED Announces China Approval for ORPATHYS® in Combination with TAGRISSO® for the Treatment of Lung Cancer Patients with MET Amplification After Progression on First-Line...

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

Cidara Announces Closing of Upsized Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

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.

Hummingbird Bioscience Licenses HMBD-002, Phase II-Ready Anti-VISTA Monoclonal Antibody to Percheron Therapeutics

Percheron Therapeutics obtains exclusive worldwide rights to Hummingbird Bioscience’s HMBD-002 for further clinical development

CARsgen Therapeutics Announces NDA Acceptance of Satri-cel by China’s NMPA

SHANGHAI, June 25, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that...

Cidara Announces Pricing of Upsized Public Offering of Common Stock

SAN DIEGO, June 24, 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 pricing of an underwritten public offering of 7,954,546 shares of its common stock at a price to the public of $44.00 per share. All of the shares are to be sold by Cidara.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Red Cat, Reckitt, UroGen and Fortrea and Encourages Investors...

NEW YORK, June 23, 2025 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Reckitt Benckiser Group plc (OTC:RBGLY), UroGen Pharma Ltd. (NASDAQ:URGN), Red Cat Holdings, Inc. (NASDAQ: RCAT) and Fortrea Holdings Inc. (NASDAQ:FTRE). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.

FDA’s Accelerated Drug Review Plan Praised by Former Senior Trump Health Official

Brett P. Giroir M.D., Former Acting FDA Commissioner and Assistant Secretary for Health, Says New Commissioner's National Priority Voucher Program (CNPV) Can Help Speed...

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