ENTITY – Talk Bio

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

10 hours 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

Aviceda’s AVD-104 misses Phase 2b primary endpoint vs Izervay but still headed to Phase 3

10 hours ago talkbio0Tagged avacincaptad, AVD-104, Clinical trial failure, Clinical Trials, Dry AMD, Genus Aviceda, Geographic Atrophy, IZERVAY, pegol, Phase 3 prospects, Sialic Acid Binding Immunoglobulin-like Lectins

Aviceda; AVD-104; geographic atrophy; dry AMD; Phase 2b; SIGLEC trial; Izervay; avacincaptad pegol; clinical trial failure; Phase 3 prospects

Immunome’s desmoid tumor drug varegacestat posts landmark Phase 3 results, setting up a potential challenge to Merck KGaA’s Ogsiveo

10 hours ago talkbio0Tagged Fibromatosis, Aggressive, Frequency of Responses, gamma secretase inhibitor, Immunome, Infrequent, Merck KGaA, NDA, Neoplasms, Ogsiveo, Phase 3 RINGSIDE trial, Progression-Free Survival, varegacestat

Immunome; varegacestat; desmoid tumors; Phase 3 RINGSIDE trial; gamma secretase inhibitor; Merck KGaA; Ogsiveo; progression-free survival; objective response rate; rare tumors; oncology; NDA filing

Scaling for a New Era: The Rise of Radiopharma

12 hours ago talkbio0Tagged Clinical Trials, CROs, Diagnostics, Funding, Lutetium-177, M&A, Neoplasms, Pet Animal, precision oncology, radioligand therapy, Radiopharmaceuticals, radiotheranostics, Research Infrastructure, supply chain, targeted alpha therapy

radiopharmaceuticals; radioligand therapy; oncology; precision oncology; targeted alpha therapy; Lutetium-177; Actinium-225; clinical trials; radiotheranostics; M&A; biotech funding; supply chain; infrastructure; CROs; companion diagnostics

Sobi Acquires Arthrosi Therapeutics for $950M Upfront in Gout Drug Deal

15 hours ago talkbio0Tagged Acquisition, Arthrosi, Gout, pozdeutinurad, Sobi

Sobi; Arthrosi Therapeutics; acquisition; gout; pozdeutinurad; AR882

Cynata Completes Patient Enrolment in Phase 2 aGvHD Clinical Trial

1 day ago talkbio0Tagged acute graft, aGvHD, Cynata, enrolment, host disease, Phase 2 trial

Cynata Therapeutics; CYP-001; Phase 2 trial; acute graft versus host disease; aGvHD; patient enrolment

FDA approves new gonorrhea antibiotics from GSK and Innoviva

3 days ago talkbio0Tagged Antibiotic Resistance, Microbial, Approved, Blujepa, first-in-class antibiotic, gepotidacin, Gonorrhea, Gonorrhea genitourinary NOS, Innoviva, Nuzolvence, Oral treatment, SmithKline Beecham, Uncomplicated, United States Food and Drug Administration, zoliflodacin

gonorrhea; antibiotic resistance; GSK; Blujepa; gepotidacin; Innoviva; Nuzolvence; zoliflodacin; FDA approval; uncomplicated urogenital gonorrhea; first-in-class antibiotic; oral treatment

SABCS 2025 Highlights: Celcuity’s Phase 3 VIKTORIA-1 Updates and Relay PI3K Inhibitor News

3 days ago talkbio0Tagged Celcuity, gedatolisib, Malignant neoplasm of breast, Phase 3, PI3 K inhibitors, PIK3CA gene, Relay Device, SABCS25, VIKTORIA-1, wild-type

SABCS25; Celcuity; VIKTORIA-1; gedatolisib; PIK3CA wild-type; Phase 3; breast cancer; Relay; PI3K inhibitors

Innovent’s Mazdutide Shows Promising Obesity Data in Adolescents; No Everest PCSK9 News

4 days ago talkbio0Tagged Adolescent (age group), China, Innovent, mazdutide, Obesity, Phase 1b, Weight Loss

Innovent; mazdutide; obesity; adolescents; Phase 1b; weight loss; China

FDA broadens label for Amgen’s Uplizna as it enters rare disease competition

4 days ago talkbio0Tagged AChR-positive, amgen, Approved, disease market, dosing, expansion, gMG, IgG4-Related Disease, inebilizumab, Infrequent, Labels (device), MINT trial, MuSK-positive, Myasthenia Gravis, Generalized, Neuromyelitis Optica, twice-yearly, United States Food and Drug Administration, Uplizna

Uplizna; inebilizumab; Amgen; FDA approval; label expansion; generalized myasthenia gravis; gMG; AChR-positive; MuSK-positive; neuromyelitis optica spectrum disorder; NMOSD; IgG4-related disease; rare disease market; MINT trial; twice-yearly dosing