EVENTS415
ARTICLES215
CATEGORYMedical
Active
Phase II/III clinical trial readouts from publicly traded biotech companies. Primary endpoints, safety signals, and regulatory pathway updates.
LATEST EVENTS
| Entity | Type | Summary | Impact | Confidence |
|---|---|---|---|---|
| Novo Nordisk, Shionogi, Aquestive Therapeutics | regulatory | Novo Nordisk's CagriSema, Shionogi's ensitrelvir, and Aquestive's Anaphylm are expected to receive first-time FDA approv… | medium | 90% |
| Novo Nordisk, MannKind Corporation, AstraZeneca | regulatory | Novo Nordisk's Wegovy, MannKind's Afrezza, and AstraZeneca's Saphnelo are anticipated for FDA approval for new uses in 2… | medium | 90% |
| Novo Nordisk, MannKind, AstraZeneca, Shionogi, Aquestive Therapeutics | regulatory | Several new drugs and therapies, including Wegovy and Saphnelo, are anticipated for potential FDA approval in 2026. | medium | 90% |
| Multiple Biotech Companies | regulatory | FDA is anticipated to approve several novel drugs and new uses for existing medications, including Wegovy and Anaphylm, … | medium | 90% |
| ARS Pharmaceuticals | regulatory | Anaphylm (epinephrine film) is anticipated to receive first-time FDA approval in 2026. | medium | 85% |
| Shionogi | regulatory | Ensitrelvir is anticipated to receive first-time FDA approval in 2026. | medium | 85% |
| Novo Nordisk | regulatory | CagriSema (cagrilintide / semaglutide) is anticipated to receive first-time FDA approval in 2026. | medium | 85% |
| AstraZeneca | regulatory | Saphnelo (anifrolumab) is anticipated to receive FDA approval for new uses or populations in 2026. | medium | 85% |
| MannKind Corporation | regulatory | Afrezza (inhaled insulin) is anticipated to receive FDA approval for new uses or populations in 2026. | medium | 85% |
| Novo Nordisk | regulatory | Wegovy (semaglutide) is anticipated to receive FDA approval for new uses or populations in 2026. | medium | 85% |
| GoodRx | product | GoodRx reported on several highly anticipated drugs, including Wegovy and CagriSema, that may receive FDA approval in 20… | low | 90% |
| Immunome | regulatory | Immunome announced the U.S. FDA accepted its New Drug Application for varegacestat for treating adults with desmoid tumo… | medium | 90% |
| — | product | CagriSema (cagrilintide / semaglutide), ensitrelvir, and Anaphylm (epinephrine film) are seeking first-time FDA approval… | high | 85% |
| — | product | Wegovy (semaglutide), Afrezza (inhaled insulin), and Saphnelo (anifrolumab) are pending FDA approval for new uses in 202… | medium | 85% |
| FDA | regulatory | The FDA is expected to approve several novel drugs and new uses for existing medications throughout 2026. | medium | 90% |
| Abivax | financial | Abivax's stock rebounded after releasing reassuring safety data for its colitis prospect. | medium | 90% |
| Roche | product | Roche's investigational KRAS G12C inhibitor achieved a phase 3 clinical trial win over Amgen and BMS. | high | 95% |
| Aquestive Therapeutics | regulatory | Aquestive Therapeutics' Anaphylm (epinephrine film) is seeking first-time FDA approval as a novel treatment in 2026. | medium | 75% |
| Shionogi | regulatory | Shionogi's ensitrelvir is seeking first-time FDA approval as a novel treatment in 2026. | medium | 75% |
| Novo Nordisk | regulatory | Novo Nordisk's CagriSema (cagrilintide/semaglutide) is seeking first-time FDA approval as a novel treatment in 2026. | medium | 85% |
WATCHER CONFIG
query: biotech clinical trial results phase III primary endpoint FDA approval PDUFA safety data
event_types: ['product', 'regulatory', 'financial']
impact_floor: medium
time_window: 7
Signal event details
Biotech Clinical Trial Results
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