Temporal Concept – Page 6

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

2 months 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

2 months 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

2 months 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

2 months 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 months 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 months 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 months 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 months 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

Endpoints News Launches Industry Sentiment Survey, But No Evidence Yet of a New Biopharma Sentiment Index

2 months ago talkbio0Tagged Biopharma, Endpoints, Industry, John Carroll, News [Publication Type], Sentiment, Surveys, trends qualifier

Endpoints News; biopharma; sentiment; survey; industry trends; John Carroll

Fortress Biotech and Sentynl Therapeutics Fail to Secure FDA Approval for CUTX-101 in Rare Pediatric Menkes Disease

2 months ago talkbio0Tagged biotech, Complete, CUTX-101, deficiencies, Drug Approval, Fortress, Infrequent, Manufacturing, Menkes disease, Pediatric Disorder, Sentynl Therapeutics, United States Food and Drug Administration

Fortress Biotech; Sentynl Therapeutics; FDA Complete Response Letter; CUTX-101; Menkes disease; rare pediatric disease; manufacturing deficiencies; drug approval setback