Temporal Concept – Talk Bio

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

2 days 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

Eye Disease Biotech Kala Bio Collapses After Failed Clinical Trial, Lender Takes Control

3 days ago talkbio0Tagged Clinical trial failure, Corneal epithelial defect, Experimental drug, foreclosure proceedings, Kala Bio, KPI-012, lender takeover, Oxford Finance, PCED, Persistent, Shock, Workforce reduction

Kala Bio; biotech collapse; failed drug trial; KPI-012; persistent corneal epithelial defect; PCED; lender takeover; Oxford Finance; foreclosure proceedings; workforce reduction; clinical trial failure

Sanofi’s efdoralprin alfa (INBRX-101) achieves all endpoints in Phase 2 alpha-1 antitrypsin deficiency (AATD) trial

4 days ago talkbio0Tagged Acquisition, alpha 1-Antitrypsin Deficiency, efdoralprin alfa, INBRX-101, Inhibrx, Phase 2, plasma-derived therapy, Rare Diseases, sanofi, Zemaira

Sanofi; efdoralprin alfa; INBRX-101; AATD; alpha-1 antitrypsin deficiency; Phase 2; Inhibrx; acquisition; rare disease; plasma-derived therapy; Zemaira

Connecticut Biotech Veradermics Secures $150M for Phase 3 Trials of Oral Rogaine

1 week ago talkbio0Tagged Biotechnology, Clinical Development, Clinical Trials, Connecticut biotech, Fund Raising, hair loss treatment, Oral cavity, Phase 3, Rogaine, Veradermics

Veradermics; Connecticut biotech; oral Rogaine; Phase 3 clinical trials; fundraising; hair loss treatment; biotechnology; clinical development

Novo Nordisk Acquires Rights to Omeros’ MASP-3 Inhibitor Zaltenibart

1 week ago talkbio0Tagged Blood, Infrequent, Kidney Diseases, MASP-3 Inhibitor, Novo Nordisk, Omeros, Zaltenibart

Novo Nordisk; Omeros; Zaltenibart; MASP-3 Inhibitor; Rare Blood and Kidney Disorders

Gene Therapy Delivers Long-Term Immune Protection in Children With Rare Immune Disorders

1 week ago talkbio0Tagged Adenosine deaminase deficiency, Clinical Trials, Combined immunodeficiency disease, Congenital leukocyte adherence deficiency, Curative Therapy, gene therapy, immune protection, Leukocyte adhesion deficiency type 1, Long-term, Pediatric immunology, Rare Diseases, Severe (severity modifier)

gene therapy; long-term immune protection; ADA-SCID; severe combined immunodeficiency; LAD-I; leukocyte adhesion deficiency; rare disease; pediatric immunology; clinical trial; curative treatment

Moderna Unveils Promising mRNA-4359 Cancer Antigen Therapy Data in Melanoma Ahead of ESMO 2025

2 weeks ago talkbio0Tagged cancer antigen therapy, checkpoint inhibitor-resistant, disease control rate, Frequency of Responses, IDO1, Immunotherapy, melanoma, Moderna, mRNA-4359, PD-L1, pembrolizumab, Phase 1/2 trial

Moderna; mRNA-4359; cancer antigen therapy; melanoma; ESMO 2025; checkpoint inhibitor-resistant; PD-L1; IDO1; objective response rate; disease control rate; immunotherapy; Phase 1/2 trial; pembrolizumab

FDA Delays Denali’s Hunter Syndrome Therapy Decision by Three Months

2 weeks ago talkbio0Tagged Accelerated, Alfa, amendment, Approved, Biologics License Application, Clinical pharmacology discipline, Deferred, Denali, Mucopolysaccharidosis II, review extension, tividenofusp, United States Food and Drug Administration

FDA delay; Denali Therapeutics; Hunter syndrome; tividenofusp alfa; MPS II; Biologics License Application (BLA); review extension; clinical pharmacology; major amendment; accelerated approval

FDA Drug Approvals in 2025 Remain Within Recent Averages Amid Agency Upheaval

2 weeks ago talkbio0Tagged 2025, CBER, CDER, Drug Approval, molecular entities, trends qualifier, United States Food and Drug Administration

FDA; drug approvals; 2025; new molecular entities; CDER; CBER; trends; novel drugs

Ono’s BMS-Partnered Oral Gastric Cancer Drug Meets Primary Endpoint in Phase 2 Trial

2 weeks ago talkbio0Tagged Advanced phase, Bristol Myers Squibb, EP4 antagonist, EP4 Antagonist ONO-4578, Episodic, HER2-negative, Malignant neoplasm of stomach, nivolumab, Opdivo, Pharmacotherapy, Phase 2, Progression-Free Survival

ONO-4578; EP4 antagonist; gastric cancer; Opdivo; nivolumab; Bristol-Myers Squibb; phase 2; progression-free survival; chemotherapy; HER2-negative; advanced; recurrent