Posts

Tyra’s bladder-cancer data offer a bright spot—but miss investor expectations

Tyra Biosciences’ shares fell roughly 20–30% after initial Phase 2 SURF302 results for dabogratinib in FGFR3-altered, low-grade intermediate-risk non-muscle-invasive bladder cancer failed to meet investor expectations. At the 60 mg once-daily dose, 14 efficacy-evaluable patients had a 79% overall response rate and a 64% best overall complete-response rate—below the approximately 70% complete-response benchmark investors had anticipated. The key positive finding was in patients with a single marker lesion: all eight patients responded at 60 mg, while six achieved complete responses at the three-month assessment. This subgroup showed a 75% best overall complete-response rate. Safety was comparatively encouraging. Most side effects were Grade 1–2; there were no Grade 4 or 5 adverse events, no dose reductions or treatment-related discontinuations at 60 mg, and no Grade 3 treatment-related adverse events in that cohort. Tyra said the results provide proof of concept and support ad...

Beeline’s oral lupus drug afimetoran delivers positive Phase 2 results

Drug-pricing policy upheaval forces pharma companies to rethink global launch strategies

Evommune abandons hope for EVO756 as an itch drug after latest Phase 2 failure

FDA Makes CDER and CBER Leadership Permanent While Commissioner Nominee Awaits Senate Confirmation

Solstice Oncology raises $225M to advance next-generation CTLA-4 therapy

Encoded raises $275M to push Dravet gene therapy toward registration

ARPA-H funds companies and research teams to build AI tools for heart disease

Kura spins out Lilly-backed Caspian Therapeutics with $50M for next-gen diabetes therapy

Beyond GLP-1s, obesity-drug competition shifts to preclinical science

Moonwalk raises $70 million to develop fat-targeted siRNA obesity therapy

Pharvaris stock jumps after pivotal Phase 3 success in hereditary angioedema

Amgen’s Imdelltra lands major new lung cancer victory