Biologically Active Substance

Merck’s Oral PCSK9 Inhibitor Enlicitide Significantly Reduces LDL Cholesterol in Phase 3 Trials

1 day ago talkbio0Tagged Administration of prophylactic statin, cholesterol, CORALreef, CORALreef AddOn, enlicitide, HeFH, Hypercholesterolemia, Familial, Hyperlipidemia, LDL-C, Merck, Oral Therapy, PCSK9 inhibitor

Merck; PCSK9 inhibitor; enlicitide; phase 3 trials; cholesterol; LDL-C; oral therapy; hyperlipidemia; familial hypercholesterolemia; CORALreef HeFH; CORALreef AddOn; statin therapy

EMA Identifies Very Rare Eye Condition as Side Effect of Semaglutide

4 days ago talkbio0Tagged Adverse effects, Blindness, Infrequent, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, NAION, Ozempic, Rybelsus, semaglutide, Wegovy

EMA; semaglutide; rare side effect; NAION; vision loss; Ozempic; Wegovy; Rybelsus

Vigil’s Iluzanebart Fails Phase 2 in Rare Neuro Disease; Sanofi Takeover Remains On Track

6 days ago talkbio0Tagged Agonist, amgen, Hereditary Diffuse Leukoencephalopathy with Spheroids, iluzanebart, Neuro Disease, Sanofi acquisition, TREM2, VG-3927, Vigil

Vigil Neuroscience; iluzanebart; Phase II IGNITE trial; rare neuro disease; ALSP; Sanofi acquisition; Amgen; TREM2 agonist; VG-3927

Ascletis’ Sagimet-Sourced Oral FASN Inhibitor Achieves All Endpoints in Pivotal Acne Study

6 days ago talkbio0Tagged Acne Vulgaris, Ascletis, Biosciences, Chinese study, clinical endpoints, Clinical Trials, Denifanstat, Inhibitor, Lesion, oral FASN, Phase 3, Sagimet

Ascletis; Sagimet Biosciences; denifanstat; oral FASN inhibitor; phase 3 clinical trial; acne vulgaris; clinical endpoints; lesion reduction; Chinese study

J&J’s Akeega Advances PARP Inhibition in Prostate Cancer, but FDA Pathway in Broader Patient Subsets Remains Unclear

7 days ago talkbio0Tagged Akeega, Amplitude, Approved, BRCA, HRR gene, Inhibitor, J&J, Malignant neoplasm of prostate, mCSPC, Metastatic castration-resistant prostate cancer, metastatic castration-sensitive prostate cancer, Mutation, PARP1 gene, United States Food and Drug Administration

Akeega; J&J; prostate cancer; PARP inhibitor; FDA approval; BRCA mutations; HRR gene alterations; AMPLITUDE study; metastatic castration-sensitive prostate cancer (mCSPC); metastatic castration-resistant prostate cancer (mCRPC)

BioAge Signs Option Agreement for Obesity Asset from Chinese Biotech Following APJ Agonist Setback

1 week ago talkbio0Tagged Agonist, APJ, BioAge, Exercise, incretin therapy, Metabolic Diseases, mimetics, nanobody, Obesity, small molecule agonists

BioAge; JiKang Therapeutics; obesity; APJ agonist; option agreement; nanobody; small molecule agonists; exercise mimetic; incretin therapy; metabolic diseases

Bristol Myers Squibb Commits Up to $11B+ in Major BioNTech Solid Tumor Bispecific Antibody Deal

1 week ago talkbio0Tagged Antibodies, Bispecific, BioNTech, BNT327, Immunotherapy for cancer, milestone payments, Myers, Partnership, PD-L1, Solid Neoplasm, squibb, Vascular Endothelial Growth Factor A

Bristol Myers Squibb; BioNTech; BNT327; bispecific antibody; solid tumors; PD-L1; VEGF-A; cancer immunotherapy; partnership; milestone payments

Bristol Myers Squibb Signs $11B Deal With BioNTech for Bispecific Cancer Antibody BNT327, Surpassing Recent Merck and Pfizer Moves

1 week ago talkbio0Tagged Antibodies, Bispecific, BioNTech, biotech partnerships, BNT327, immuno-oncology, Malignant Neoplasms, Myers, PD-L1, Solid Neoplasm, squibb, Vascular Endothelial Growth Factor A

Bristol Myers Squibb; BioNTech; BNT327; bispecific antibody; immuno-oncology; cancer; PD-L1; VEGF-A; solid tumors; biotech partnerships

Sanofi, Regeneron’s IL-33 Drug Fails One of Two COPD Studies, Casting Doubt on FDA Approval Timeline

2 weeks ago talkbio0Tagged AERIFY-1, AERIFY-2, Approved, Clinical Trials, COPD, IL33 protein, human, itepekimab, Regeneron, sanofi, United States Food and Drug Administration

Sanofi; Regeneron; COPD; itepekimab; IL-33; Phase 3 trials; AERIFY-1; AERIFY-2; FDA approval; clinical trial results

FDA Rejects Stealth BioTherapeutics’ Rare Disease Drug but Leaves Door Open for Accelerated Approval

2 weeks ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Accelerated, Approved, Elamipretide, Infrequent, muscle strength endpoint, Phase 2 trial, regulatory delay, Rejection, Stealth BioTherapeutics, United States Food and Drug Administration

FDA rejection; Stealth BioTherapeutics; elamipretide; Barth syndrome; rare disease; accelerated approval; muscle strength endpoint; phase 2 trial; regulatory delay