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Tag: mutations

Senhwa Biosciences announces first patient dosed in NCI-sponsored pilot study of Pidnarulex (CX-5461) pharmacodynamics in patients with advanced solid tumors

TAIPEI and SAN DIEGO, July 15, 2025 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for...

Menin Inhibitors Market Forecasts Signal Strong Uptake of Menin Inhibitors in Hematologic Oncology Across the 7MM During the Forecast Period (2020-2034) | DelveInsight

The menin inhibitor market is poised for rapid growth, with REVUFORJ setting the foundation and a strong pipeline of innovative, genetically targeted therapies on...

Menin Inhibitors Market Forecasts Signal Strong Uptake of Menin Inhibitors in Hematologic Oncology Across the 7MM During the Forecast Period (2020-2034) | DelveInsight

The menin inhibitor market is poised for rapid growth, with REVUFORJ setting the foundation and a strong pipeline of innovative, genetically targeted therapies on...

Aptose Receives Second Advance under the Loan Agreement with Hanmi Pharmaceutical to Continue Development of Tuspetinib in Triplet Therapy for AML

Aptose has received an additional advance of US$2.0M from Hanmi Pharmaceutical Co. as part of a US$8.5M loan facility agreement.

Ascentage Pharma Announces Pricing of Top-Up Placement

ROCKVILLE, Md. and SUZHOU, China, July 14, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International Inc. (NASDAQ: AAPG; HKEX: 6855) (“Ascentage” or the “Company”), a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers, today announced the pricing of 22 million ordinary shares, par value $0.0001 per share, of the Company (the “Placement Shares”), at a price of HKD68.60 per share, in the offering by Dajun Yang Dynasty Trust, an affiliate of the Company’s Chief Executive Officer, Dajun Yang, M.D., Ph.D. (the “Vendor”) in an offshore transaction outside the United States to non-U.S. persons in reliance on Regulation S under the Securities Act of 1933, as amended (the “Securities Act”)(the “Offshore Placement”), for aggregate gross proceeds of approximately HKD1,509.2 million (or approximately US$192.3 million based on exchange rate of 1 USD to 7.85 HKD), before deducting placing fees and other offering expenses. The Offshore Placement, which was oversubscribed by eight times, is expected to close on July 17, 2025.

Nanoscope Therapeutics Initiates Rolling Submission of Biologics License Application to FDA for MCO-010, the First Gene-Agnostic Therapy to Treat Retinitis Pigmentosa

First modules of BLA submitted to FDA under rolling review, with full submission anticipated in early 2026MCO-010 BLA for retinitis pigmentosa is eligible for priority review...

Ascentage Pharma Announces Proposed Top-Up Placement

ROCKVILLE, Md. and SUZHOU, China, July 14, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International Inc. (NASDAQ: AAPG; HKEX: 6855) (“Ascentage” or the “Company”), a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers, announced that Dajun Yang Dynasty Trust, an affiliate of the Company’s Chief Executive Officer, Dajun Yang, M.D., Ph.D. (the “Vendor”), proposes to offer ordinary shares, par value US$0.0001 per share, of the Company (the “Placement Shares”) in an offshore transaction outside the United States to non-U.S. persons in reliance on Regulation S under the Securities Act of 1933, as amended (the “Securities Act”), subject to market conditions and other factors (the “Offshore Placement”). At the time of the closing of the Offshore Placement, the Vendor would subscribe for, and the Company would issue to the Vendor new ordinary shares of the Company (the “Replacement Shares”) at the same number as the number of the Placement Shares offered in the Offshore Placement and at the same price per share as the price per share for the Placement Shares. The closing of the transaction involving the issuance of the Replacement Shares will be subject to customary closing conditions and take place after the closing of the Offshore Placement. In connection with the Offshore Placement, the representatives in the Company’s U.S. initial public offering in January 2025 waived a lock-up restriction with respect to the Placement Shares held by the Vendor.

Cogent Biosciences Announces Closing of Upsized Public Offering of Shares of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares

WALTHAM, Mass. and BOULDER, Colo., July 10, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the closing of its previously announced upsized underwritten public offering of 25,555,556 shares of its common stock, which includes 3,333,333 shares issued pursuant to the exercise in full by the underwriters of their option to purchase additional shares of common stock in the offering. The public offering price was $9.00 per share. The aggregate gross proceeds to Cogent from this offering were approximately $230 million, including proceeds from the exercise in full by the underwriters of the option to purchase additional shares, before deducting underwriting discounts and commissions and other offering expenses. All of the shares in the offering were sold by Cogent.

REGENXBIO Announces Publication of Preclinical Results Demonstrating Functional Benefits of Novel Microdystrophin Construct in RGX-202 Investigational Gene Therapy for Duchenne Muscular Dystrophy

Construct including CT domain demonstrated higher levels of microdystrophin protein, increased muscle force, and improved resistance to damage in mice lacking dystrophin REGENXBIO's next-generation...

Cancer Innovation Accelerates as Funding Cuts Loom and Biotechs Step Up

USA News Group News CommentaryIssued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, July 10, 2025 /PRNewswire/ -- USA News Group News Commentary – Cancer rates are...

Cancer Innovation Accelerates as Funding Cuts Loom and Biotechs Step Up

USA News Group News CommentaryIssued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, July 10, 2025 /PRNewswire/ -- USA News Group News Commentary – Cancer rates are...

Ultragenyx and Mereo BioPharma Announce UX143 Phase 3 Orbit Study for Osteogenesis Imperfecta Progressing to Final Analysis

Data from Orbit and Cosmic studies expected around the end of the year
Data from Orbit and Cosmic studies expected around the end of the year

Atsena Therapeutics Announces Alignment with FDA on Regulatory Pathway to Approval for ATSN-201 in X-Linked Retinoschisis (XLRS)

Outcome of Regenerative Medicine Advanced Therapy (RMAT) meeting provides clear regulatory pathway to approval in a continuous Phase 1 / 2 / 3 study, avoiding the requirement for an additional registrational study and accelerating time to potential approval

Purespring Therapeutics announce FDA IND clearance for Phase I/II clinical trial for primary IgA nephropathy (IgAN)

London – 9 July 2025 - Purespring Therapeutics, a precision nephrology company focused on transforming the treatment of kidney diseases, today announces that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PS-002, enabling the initiation of a Phase I/II clinical trial in patients with primary IgA nephropathy (IgAN).

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