Deferred – Talk Bio

Sanofi’s multiple sclerosis drug tolebrutinib flunks Phase 3 in PPMS and faces another FDA PDUFA delay

1 month ago talkbio0Tagged BTK inhibitor, Clinical trial failure, Deferred, Mississippi (geographic location), Multiple Sclerosis, non-relapsing secondary progressive, nrSPMS, Parts per million (qualifier value), PDUFA, Progressive, Regulatory Setback, Review [Publication Type], sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; primary progressive multiple sclerosis; PPMS; non-relapsing secondary progressive MS; nrSPMS; Phase 3 PERSEUS trial; PDUFA delay; FDA review; BTK inhibitor; clinical trial failure; regulatory setback

Bristol Myers Squibb Delays Cobenfy Alzheimer’s Psychosis Trial Readout Due to Site Irregularities

2 months ago talkbio0Tagged ADEPT-2 trial, Alzheimer 's psychosis, Cobenfy, Deferred, Myers Squibb, Phase 3 Clinical Trials, trial site irregularities

Bristol Myers Squibb; Cobenfy; Alzheimer’s psychosis; ADEPT-2 trial; trial site irregularities; Phase III study; delay; 2026

FDA Delays Decision on Ascendis’ Dwarfism Drug by Three Months

2 months ago talkbio0Tagged Achondroplasia, Approved, Ascendis Pharma, CNP gene, Deferred, Dwarfism, navepegritide, PDUFA, post-marketing requirement, TransCon, United States Food and Drug Administration

FDA; Ascendis Pharma; TransCon CNP; navepegritide; achondroplasia; dwarfism; PDUFA; post-marketing requirement; delay; approval

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

3 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

Sanofi’s MS Drug Tolebrutinib Faces FDA Delay Amid Extended Review

4 months ago talkbio0Tagged Breakthrough Therapy, Bruton 's tyrosine kinase inhibitor, Deferred, GEMINI trial, HERCULES trial, Multiple Sclerosis, NDA, nrSPMS, PERSEUS trial, regulatory review, sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; FDA delay; multiple sclerosis; nrSPMS; Bruton’s tyrosine kinase inhibitor; breakthrough therapy; HERCULES trial; GEMINI trial; PERSEUS trial; NDA; regulatory review

FDA Delays Decisions on Regeneron’s Eylea HD Due to Manufacturing Issues

5 months ago talkbio0Tagged Biosimilars, Deferred, Edema, Eylea HD, macular, manufacturing issues, Nordisk facility, Pre-filled Syringe, Regeneron, regulatory approval, Retinal Vein Occlusion, United States Food and Drug Administration

FDA delay; Regeneron; Eylea HD; manufacturing issues; Novo Nordisk facility; biosimilars; pre-filled syringe; macular oedema; retinal vein occlusion; regulatory approval

FDA Extends PDUFA Date for Regenxbio’s Hunter Syndrome Gene Therapy RGX-121

5 months ago talkbio0Tagged clemidsogene lanparvovec, Deferred, gene therapy, IDS gene, Infrequent, Mucopolysaccharidosis II, PDUFA, Regenxbio, RGX-121, United States Food and Drug Administration

FDA delay; PDUFA extension; Regenxbio; Hunter syndrome; clemidsogene lanparvovec; RGX-121; gene therapy; Mucopolysaccharidosis II; IDS gene; rare disease