Puma Biotechnology Announces FDA Allowance to Proceed Under IND for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer
Puma Biotechnology Inc (PBYI)
Last puma biotechnology inc earnings: 2/20 04:07 pm
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Source: Business Wire
LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company (the Company), has been notified by the U.S. Food and Drug Administration (FDA) that its Investigational New Drug Application (IND) submission has been reviewed, and Puma can proceed with the clinical development of alisertib for the treatment of patients with human epidermal growth factor receptor 2-negative (HER2-negative), hormone receptor-positive metastatic breast cancer in Puma’s Phase II ALISCA-Breast1 trial (Study PUMA-ALI-4201). This trial will investigate alisertib in combination with endocrine treatment (consisting of either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen) in chemotherapy-naïve patients with hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer. Patients must have been previously treated with CDK 4/6 inhibitors and received at least two prior lines of endocrine therapy in the recurrent or metastatic setting to be eligi
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PBYI
Earnings
- 2/29/24 - Miss
PBYI
Analyst Actions
- 2/13/24 - HC Wainwright
PBYI
Sec Filings
- 4/26/24 - Form DEFA14A
- 4/26/24 - Form ARS
- 4/26/24 - Form DEF
- PBYI's page on the SEC website