Temporal Concept – Page 11

Phase III Study: Perioperative Padcev & Keytruda Combo Significantly Improves Survival in Bladder Cancer

4 months ago talkbio0Tagged cisplatin-ineligible, enfortumab, Event-Free Survival, Keytruda, Malignant neoplasm of urinary bladder, muscle-invasive bladder cancer, Overall Survival, Padcev, pembrolizumab, perioperative, Phase III, vedotin

Padcev; Keytruda; enfortumab vedotin; pembrolizumab; phase III; bladder cancer; muscle-invasive bladder cancer; cisplatin-ineligible; perioperative; event-free survival; overall survival

Novartis antibody ianalumab clinches another Phase 3 win in rare blood disease (ITP)

4 months ago talkbio0Tagged Autoimmune, Autoimmune thrombocytopenia, B-cell depletion, ianalumab, Infrequent, Inosine Triphosphate, Novartis, Phase 3, platelet levels, Psychological inhibition, regulatory submissions, Sjögren 's disease, TNFRSF13C protein, human, treatment failure, VAY736

Novartis; ianalumab; VAY736; primary immune thrombocytopenia; ITP; rare disease; Phase 3; time to treatment failure; safe platelet levels; eltrombopag; autoimmune; B-cell depletion; BAFF-R inhibition; Sjögren’s disease; regulatory submissions

IO Biotech’s cancer vaccine Cylembio narrowly misses Phase III primary endpoint in advanced melanoma, but company eyes FDA filing in 2025

4 months ago talkbio0Tagged biotech, Blackfoot language, Clinical Trials, Cylembio, Drops - Drug Form, etimupepimut, Hazard Ratio, Io satellite, Keytruda, melanoma, Overall Survival, P-Value, pembrolizumab, Phase 3, Progression-Free Survival, United States Food and Drug Administration

Cylembio; IO Biotech; melanoma; Phase 3; pivotal trial; progression-free survival (PFS); hazard ratio 0.77; p-value 0.056; Keytruda (pembrolizumab); FDA BLA; overall survival (OS) trend; IOB-013/KN-D18; NCT05155254; imsapepimut; etimupepimut; stock drop

Novartis plans global filings after ianalumab hits primary endpoints in two Phase 3 Sjögren’s disease trials

4 months ago talkbio0Tagged B-cell depletion, BAFF‑R, cellular targeting, ESSDAI, ianalumab, NEPTUNUS-1, NEPTUNUS-2, Novartis, Phase 3, regulatory filings, safety profile, Sjögren 's disease

Novartis; ianalumab; BAFF‑R; B-cell depletion; Sjögren’s disease; NEPTUNUS-1; NEPTUNUS-2; ESSDAI; Phase 3; regulatory filings; first targeted treatment; safety profile

Boehringer Ingelheim breaks into oncology as FDA grants accelerated approval to Hernexeos (zongertinib) for HER2 TKD–mutated NSCLC

4 months ago talkbio0Tagged Accelerated, Approved, Beamion, Boehringer Ingelheim, competition, Confirmatory Trial, Enhertu, erbB-2 Receptor, Frequency of Responses, HER2-mutant, Hernexeos, Identifier, LUNG-1, Mutation, Non-Small Cell Lung Carcinoma, non-squamous NSCLC, Oncomine Dx Target Test, oral targeted therapy, Priority Review, Requirement, TKD, United States Food and Drug Administration, Zongertinib

Boehringer Ingelheim; Hernexeos; zongertinib; FDA approval; accelerated approval; non-squamous NSCLC; HER2 TKD mutations; Oncomine Dx Target Test; Beamion LUNG-1; objective response rate; first oral targeted therapy for HER2-mutant NSCLC; priority review; breakthrough therapy designation; confirmatory trial requirement; competition with Enhertu

CDC Launches ‘Free Mind’ Campaign Targeting Teen Substance Use and Mental Health

4 months ago talkbio0Tagged Adolescence, Alcohol or Other Drugs use, Centers for Disease Control and Prevention (U.S.), Drug Overdose, fentanyl, Free Mind ' Campaign, mental health, Strategy, teen suicide

CDC; Free Mind campaign; youth mental health; substance use; drug overdose; fentanyl; teen suicide; coping strategies

Elevidys Sales Surge in Sarepta Q2 2025 Despite Safety Concerns

4 months ago talkbio0Tagged ELEVIDYS, gene therapy, Pauses, Performance, Safety Issues, Sales - occupational activity, United States Food and Drug Administration

Sarepta Therapeutics; Elevidys; Q2 2025; gene therapy; sales performance; FDA; safety issues; shipment pause

Y-mAbs Therapeutics Acquired by SERB Pharmaceuticals in $412 Million Buyout Following Strategic Review

4 months ago talkbio0Tagged all-cash tender, Danyelza, Infrequent, Merger, Neoplasms, pharmaceutical acquisition, Serbs, strategic review, Y-mAbs

Y-mAbs Therapeutics; SERB Pharmaceuticals; buyout; Danyelza; rare oncology; merger; pharmaceutical acquisition; strategic review; all-cash tender offer

Regeneron Faces Another FDA CRL for Eylea HD, Predicts August PDUFA Delay

5 months ago talkbio0Tagged Application procedure, dosing, Eylea HD, IL31RA gene, Interval, PDUFA, Regeneron, Retinal Diseases, Supplement, United States Food and Drug Administration

Regeneron; Eylea HD; CRL; FDA; PDUFA; supplemental Biologics License Application; dosing intervals; retinal diseases

ImmuneOnco and Instil Bio’s PD-L1xVEGF Bispecific Antibody Shows Promising Results in Phase 2 Lung Cancer Trial

5 months ago talkbio0Tagged Bio, Combined, Frequency of Responses, IMM2510/AXN-2510, ImmuneOnco, Instill - dosing instruction imperative, Malignant neoplasm of lung, Non-Small Cell Lung Carcinoma, PD-L1xVEGF, Pharmacotherapy, safety profile

ImmuneOnco; Instil Bio; IMM2510/AXN-2510; PD-L1xVEGF bispecific antibody; NSCLC; Phase 2 clinical trial; response rate; safety profile; chemotherapy combination; lung cancer