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Quince Therapeutics calls halt to lead program after Phase III failure

San Francisco-based Quince Therapeutics Inc., revealed that its pivotal Phase III NEAT clinical trial evaluating dexamethasone sodium phosphate encapsulated in autologous erythrocytes…

Feb 2
Regulatory & Policy

Calico Life Sciences' ABBV-CLS-628 secures US FDA Fast Track designation for ADPKD treatment

Calico Life Sciences LLC, a biotechnology company founded by Alphabet Inc., [announced](https://www.prnewswire.com/news-releases/calico-life-sciences-announces-us-fda-fast-track-designation-for-investigational-treatment-of-autosomal-dominant-polycystic-kidney-disease-302573172.html) on October 2, 2025 that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ABBV-CLS-6

Mar 30
Regulatory & Policy

Ichnos Glenmark Innovation's ISB 2001 secures US FDA Fast Track designation for multiple myeloma

Ichnos Glenmark Innovation (IGI) [announced](https://www.prnewswire.com/news-releases/ichnos-glenmark-innovation-igi-receives-us-fda-fast-track-designation-for-isb-2001-for-relapsedrefractory-multiple-myeloma-302445918.html) today that the US FDA has granted Fast Track designation for ISB 2001, an investigational trispecific antibody targeting relapsed or refractory multiple myeloma (RRMM) in adul

Mar 30
Regulatory & Policy

NS Pharma's NS-229 secures US FDA Fast Track designation for eosinophilic granulomatosis with polyangiitis

NS Pharma, Inc., a subsidiary of Nippon Shinyaku Co., Ltd., [announced](https://www.prnewswire.com/news-releases/fda-grants-fast-track-designation-to-ns-229-for-the-treatment-of-eosinophilic-granulomatosis-with-polyangiitis-302550236.html) on Sept. 9, 2025 that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to NS-229, an investigational selective Janus kinase 1 (JAK

Mar 30
Development

Evorpacept Plus Zanidatamab Shows Promise in Phase 2 HER2+ Metastatic Breast Cancer Trial

ALX Oncology has unveiled promising positive clinical trials data for its investigational CD47 inhibitor evorpacept, demonstrating potential breakthrough therapeutic approaches in advanced HER2-positive metastatic breast cancer. The Phase 1b/2 clinical trial exploring evorpacept's combination with zanidatamab revealed intriguing insights into targeted cancer treatment strategies, highlighting the

Mar 31
Business

PranaX Secures $17 Million Series A Funding to Advance Exosome Regenerative Medicine Technology

Houston-based regenerative biologics startup PranaX Corporation has secured $17 million in an oversubscribed Series A funding round, signaling growing investor interest in cutting-edge exosome wellness technologies. The startup funding round was led by a consortium of family offices, trusts, and individual investors with deep expertise across biotechnology, regenerative medicine, and healthcare in

Mar 31
News

Amgen returns OX40 mAb rocatinlimab to Kyowa Kirin

Kyowa Kirin Co., Ltd announced it will regain global control of the development and commercialization program for rocatinlimab, an investigational anti-OX40 monoclonal…

Jan 30
News

Formation Bio adds Chia Tai’s miR-124 molecule for autoimmune diseases in USD 500m deal

Formation Bio, a US-based AI-native biopharmaceutical company, signed up with China’s Jiangsu Chia Tai Feng Hai Pharmaceutical Co., Ltd (CTFH) for a…

Jan 30
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Development

HDM2006: First-in-Human Phase 1 Trial Explores HPK1 Inhibition in Advanced Solid Tumors

Researchers at Fudan University Shanghai Cancer Center have initiated a first-in-human clinical trial investigating HDM2006, an experimental drug targeting the Hematopoietic Progenitor Kinase 1 (HPK1) pathway in patients with advanced solid tumors. The [Phase 1 study](https://clinicaltrials.gov/study/NCT07377591) represents a critical early step in evaluating the safety, tolerability, and potentia

Mar 30
News

Tenpoint bags USD 235m in financial support for Yuvezzi launch

Tenpoint Therapeutics, Ltd., a London- and Seattle-based biotechnology company focused on developing therapies to rejuvenate vision in the aging eye, said it…

Jan 30
News

AstraZeneca strikes USD 18.5b license deal for CSPC obesity pipeline

China’s CSPC Pharmaceutical Group and UK-based AstraZeneca formed a strategic collaboration and license agreement focused on CSPC’s innovative long-acting peptide medicines, anchored…

Jan 30
Business

Moderna and Recordati Seal $160M mRNA Rare Disease Therapy Development Deal

Moderna and Recordati have announced a strategic collaboration to develop and commercialize mRNA-3927, an investigational therapy for propionic acidemia (PA), marking a significant business partnership news event in the rare disease therapeutics space. Under the agreement, Moderna will lead clinical development while Recordati will manage global commercialization, combining the biotech leader's mR

Mar 30
News

Summit seeking 1st US approval for Akeso’s PD-1/VEGF ivonescimab

Summit Therapeutics Inc., has filed a Biologics License Application (BLA) with the US FDA for ivonescimab, seeking approval for the bispecific antibody…

Jan 30
News

Breakthru Medicine gets USD 60m in Series A for molecular glues

Breakthru Medicine, a biotechnology company based in Phoenix, Arizona, closed a Series A financing round totaling USD 60 million to support its…

Jan 29
Development

OMEICOS' OMT-28 Shows Promise in Phase 2a Trial for Primary Mitochondrial Diseases

OMEICOS Advances Mitochondrial Disease Therapy with Promising Phase 2a Results OMEICOS Therapeutics ...

Mar 31