Global Registrational Phase III Study of Olverembatinib (HQP1351) Cleared by FDA [Yahoo! Finance]
Unity Biotechnology, Inc. (UBX)
Last unity biotechnology, inc. earnings: 3/11 04:05 pm
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Source: Yahoo! Finance
developing novel therapies for cancer, age-related diseases, and chronic hepatitis B (CHB), announced today that it has received clearance from the US Food and Drug Administration (FDA) to initiate a global registrational Phase III trial of olverembatinib (HQP1351) in previously treated adult patients with chronic-phase chronic myeloid leukemia (CML-CP). Under protocol HQP1351CG301, titled "A Global Multicenter, Open-Label, Randomized, Phase III Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic-Phase Chronic Myeloid Leukemia (POLARIS-2)," the study is designed to assess the efficacy and safety of olverembatinib in the treatment of patients with CML-CP with or without the T315I mutation. The US FDA's clearance of the trial marks the first global registrational Phase III trial for olverembatinib in patients with CP-CML to be conducted. The trial is scheduled to commence during the first half of 2024. Olverembatinib is a global best-in-class novel drug develop
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News
- UNITY Biotechnology Announces Upcoming Presentations at the ARVO 2024 Annual MeetingGlobeNewswire
- ASCO 2024 | Ascentage Pharma to Present Four Studies, Including an Oral Report Featuring the Latest Data of Olverembatinib in SDH-Deficient GIST [Yahoo! Finance]Yahoo! Finance
- UNITY Biotechnology Announces Extension of Phase 2b ASPIRE Clinical Study Evaluating UBX1325 in DMEGlobeNewswire
- Unity Biotechnology, Inc. (NASDAQ: UBX) had its price target lowered by analysts at HC Wainwright from $10.00 to $8.00. They now have a "buy" rating on the stock.MarketBeat
- UNITY Biotechnology, Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates [Yahoo! Finance]Yahoo! Finance
UBX
Earnings
- 11/13/23 - Miss
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Sec Filings
- 4/26/24 - Form ARS
- 4/26/24 - Form DEFA14A
- 4/26/24 - Form DEF
- UBX's page on the SEC website