Biologically Active Substance – Page 2

BridgeBio Shifts Filing Plans After Phase 3 Success in Rare Disease Drug BBP-418

1 week ago talkbio0Tagged Acoramidis, Approved, BBP-418, Biological Markers, BridgeBio, commercial, disease drug, File (record), Infrequent, Limb-girdle muscular dystrophy type 2A, NDA, New Drug Application, Phase 3 success, Ribitol, United States Food and Drug Administration

BridgeBio; BBP-418; Phase 3 success; limb-girdle muscular dystrophy type 2I/R9; FDA filing; rare disease drug; NDA (New Drug Application); ribitol; full approval; biomarker; acoramidis; commercial strategy

FDA Rejects Sydnexis Myopia Drug for Kids; Chugai to Buy Renalys for $98M Upfront

2 weeks ago talkbio0Tagged Chugai, Complete Response Letter, methionine, Myopia, Ophthalmology specialty, Pediatric brand name, Renalys, SYD-101, Sydnexis, United States Food and Drug Administration

FDA; SYD-101; Sydnexis; myopia; pediatric; complete response letter; Chugai; Renalys; acquisition; $98M; ophthalmology

Inhibrx to Seek FDA Approval in 2026 After Strong Phase 2 Data for Bone Cancer Drug Ozekibart

2 weeks ago talkbio0Tagged Anti-DR5 Agonistic Monoclonal Antibody INBRX-109, Biological Factors, Chondrosarcoma, Infrequent, Inhibrx, Liver, Malignant Bone Neoplasm, Malignant Neoplasms, ozekibart, Progression-Free Survival, Receptors, Tumor Necrosis Factor, Member 10b, Submission, Toxicity aspects, United States Food and Drug Administration

Inhibrx; FDA submission; ozekibart; INBRX-109; chondrosarcoma; bone cancer; phase 2 clinical trial; progression-free survival; death receptor 5; biologics license application; rare cancer; liver toxicity

Rani Therapeutics Appoints Abe Bassan and Vasudev Bailey to Board of Directors

2 weeks ago talkbio0Tagged Abe Bassan, Anomaly Ventures, BioCapital, Biological Factors, biotherapeutics, Board change, board of directors, Chugai, Collaboration, Obstetric Delivery, Oral cavity, Rani Therapeutics, Samsara, Vasudev Bailey

Rani Therapeutics; Board of Directors; Abe Bassan; Vasudev Bailey; biotherapeutics; oral biologics delivery; Samsara BioCapital; Anomaly Ventures; Chugai collaboration; Board change

Acrivon Therapeutics Showcases AP3 Platform and Preclinical Data for ACR-2316 with Three Poster Presentations at AACR-NCI-EORTC 2025

2 weeks ago talkbio0Tagged ACR-2316, Acrivon, AP3, Conferences, Generative Phosphoproteomics, Inhibitor, KaiSR, partial response, PKMYT1 protein, human, Platform, PLK1 gene, precision oncology, preclinical data, Study models, WEE1 inhibitor

Acrivon Therapeutics; AP3 platform; Generative Phosphoproteomics; KaiSR model; ACR-2316; AACR-NCI-EORTC conference; preclinical data; partial response; WEE1 inhibitor; PKMYT1 inhibitor; PLK1; precision oncology

RAPT Therapeutics Announces Proposed Public Offering of Common Stock

2 weeks ago talkbio0Tagged Biological Factors, conditions, Dilution technique, Gross (qualifier value), Immunology, Market, Pricing, public entity, RAPT

RAPT Therapeutics; public offering; common stock; underwritten offering; biopharmaceutical; immunology; market conditions; share dilution; offering pricing; gross proceeds

Alkermes Acquires Avadel Pharmaceuticals for $2.1B, Gaining Sleep Drug LUMRYZ and Setting Strategic Evolution

2 weeks ago talkbio0Tagged Acquisition, Alkermes, Avadel Pharmaceuticals, Biological Factors, LUMRYZ, Narcolepsy, portfolio, premium, Rare Diseases, Sleep medicine specialist, strategic

Alkermes; Avadel Pharmaceuticals; acquisition; LUMRYZ; narcolepsy; sleep medicine; strategic portfolio; biopharmaceuticals; rare disease; deal premium

Alector’s GSK-partnered dementia drug latozinemab fails in late-stage trial

2 weeks ago talkbio0Tagged Alector, Clinical trial failure, Drug Development, Latozinemab, Phase 3 trial, Pick Disease of the Brain, Presenile dementia, Progranulins, SmithKline Beecham

Alector; GSK; latozinemab; dementia; frontotemporal dementia; Phase 3 trial; clinical trial failure; progranulin; drug development

CHMP Rejects Sanofi’s Rezurock Over Clinical Data Issues, Recommends Approval of BTK Inhibitor Wayrilz

3 weeks ago talkbio0Tagged Autoimmune thrombocytopenia, belumosudil, cGVHD, CHMP, chronic graft-versus-host disease, Clinical Data, Inosine Triphosphate, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, regulatory approval, Rezurock, Rilzabrutinib, sanofi, Wayrilz

Sanofi; CHMP; EMA; Rezurock; Wayrilz; Belumosudil; Rilzabrutinib; chronic graft-versus-host disease; cGVHD; immune thrombocytopenia; ITP; regulatory approval; clinical data

Roche Inks $80M Upfront Deal for Hansoh’s Cancer ADC HS-20110

3 weeks ago talkbio0Tagged CDH17 protein, human, Colorectal Carcinoma, Hansoh Pharmaceutical, HS-20110, milestone payments, Roche (company), royalties, Solid Neoplasm, therapeutic autologous dendritic cells, upfront payment

Roche; Hansoh Pharmaceutical; ADC; HS-20110; CDH17; colorectal cancer; solid tumors; licensing deal; upfront payment; milestone payments; royalties