FDA Clears Path for Depression Treatment GH001 to Enter Final Testing Phase
GH Research's (GHRS) experimental depression treatment GH001 gets FDA approval to proceed with clinical trials after lifting of clinical hold, targeting 2026 Phase 3 launch.
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Barclays Upgrades Oscar Health as Managed Care Outlook Improves
Barclays upgraded Oscar Health to Equal Weight, raising its price target to $18 as analysts see margin expansion and renewed interest in managed care stocks in 2026.
Ironwood Pharmaceuticals Projects Strong Revenue Growth for 2026
Ironwood Pharmaceuticals forecasts revenue of $450-475M for 2026, driven by Linzess sales growth. Stock surges 28% on positive outlook and pipeline progress.
Outlook Therapeutics Stock Plunges After FDA Rejects Eye Drug for Third Time
Outlook Therapeutics (OTLK) shares crashed 63% after FDA rejected its wet AMD treatment ONS-5010/Lytenava again, requesting more efficacy evidence without specifying requirements.
SELLAS GPS Trial Nears Completion as Survival Times Extend Beyond Expectations
SELLAS Life Sciences' Phase 3 REGAL trial for GPS in AML patients approaches 80-event threshold with 72 deaths reported, suggesting potential survival benefits as stock surges 100% in December.
Corcept's Relacorilant Faces FDA Setback for Hypertension Treatment
FDA issues Complete Response Letter for Corcept's relacorilant despite successful trials, requesting more evidence before approval for hypertension treatment in hypercortisolism patients.