EVENTS275
ARTICLES160
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 |
|---|---|---|---|---|
| Capricor Therapeutics | regulatory | Capricor Therapeutics' BLA for Deramiocel in DMD is under FDA review with a PDUFA target action date of August 22, 2026. | medium | 90% |
| Capricor Therapeutics | product | Capricor Therapeutics presented positive Phase 3 HOPE-3 data for Deramiocel in DMD at the AAN 2026 Annual Meeting. | medium | 90% |
| Genmab | regulatory | FDA accepted Genmab's sBLA for epcoritamab plus R2 for priority review, with a PDUFA action date of November 30, 2025. | high | 100% |
| Genmab | product | Genmab's Phase 3 EPCORE FL-1 trial for epcoritamab in R/R Follicular Lymphoma met dual primary endpoints with significan… | high | 100% |
| Developer of Veligrotug | regulatory | Developer of veligrotug for thyroid eye disease has a PDUFA target action date in June 2026, based on positive Phase III… | medium | 90% |
| Developer of Ensitrelvir | regulatory | Developer of ensitrelvir for COVID-19 prevention has a PDUFA target action date in June 2026, based on Phase III results… | medium | 90% |
| Developer of Tebipenem HBr | regulatory | Developer of tebipenem HBr for cUTIs has a PDUFA target action date in June 2026, supported by positive Phase III data. | medium | 90% |
| IntraBio | regulatory | FDA accepted IntraBio's sNDA for AQNEURSA (levacetylleucine) for Ataxia-Telangiectasia and granted it Priority Review. | high | 90% |
| AstraZeneca | regulatory | FDA extended PDUFA for AstraZeneca's camizestrant NDA for breast cancer, seeking more data after a negative advisory vot… | medium | 100% |
| Zydus Therapeutics | regulatory | FDA granted Priority Review for Zydus Therapeutics' saroglitazar NDA for PBC, setting a PDUFA date of November 27, 2026. | high | 100% |
| Summit Therapeutics | regulatory | Summit Therapeutics announced FDA acceptance of its BLA for ivonescimab for EGFRm NSCLC, setting a PDUFA goal date of No… | high | 100% |
| Pfizer | product | Pfizer's SSGJ-707 showed a 68% response rate in a key subgroup of non-small cell lung cancer patients in anticipated ASC… | medium | 90% |
| Rocket Pharmaceuticals, Inc. | regulatory | Rocket Pharmaceuticals announced FDA acceptance of its BLA resubmission for KRESLADI™ for severe LAD-I, with a PDUFA dat… | high | 98% |
| ImmunityBio | regulatory | ImmunityBio resubmitted its supplemental BLA for ANKTIVA plus BCG for BCG-unresponsive NMIBC with papillary disease to t… | medium | 95% |
| Orca Bio | regulatory | The FDA set a PDUFA target action date of April 6, 2026, for Orca-T's BLA for hematological malignancies, granted Priori… | high | 98% |
| FDA | regulatory | The FDA released PDUFA reauthorization performance goals and procedures for fiscal years 2023 through 2027, covering rev… | medium | 95% |
| Ascletis Pharma Inc. | product | Ascletis Pharma's Phase 3 trial (NCT05118776) has a primary completion date of June 1, 2025. | medium | 98% |
| Apellis Pharmaceuticals, Inc. | product | Apellis Pharmaceuticals' Phase 3 trial for Pegcetacoplan Long Term Safety and Efficacy Extension Study has a primary com… | medium | 98% |
| FDA | regulatory | The FDA launched a new initiative for real-time clinical trials (RTCTs) to expedite development, including pilot program… | medium | 95% |
| FDA | regulatory | The FDA is increasingly approving drugs based on single pivotal trials, considering disease severity, unmet need, trial … | medium | 95% |
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
FIELD DATA
RAW DATA