Atossa Therapeutics Receives FDA "Study May Proceed" Letter for (Z)-Endoxifen Investigational New Drug Application for Metastatic Breast Cancer [Yahoo! Finance]
Atossa Therapeutics, Inc. (ATOS)
Last atossa therapeutics, inc. earnings: 11/13 04:10 pm
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Source: Yahoo! Finance
medicines for unmet medical needs, today announced that the U.S. Food and Drug Administration ("FDA") issued a "Study May Proceed" letter for the Company's study in metastatic breast cancer which was the subject of a recent investigational new drug application for (Z)-endoxifen. "This letter marks an important regulatory milestone for Atossa and to potentially expand the use of (Z)-endoxifen for metastatic ER+/HER2- Breast Cancer. We believe its activity, even in tumors that have developed resistance to other endocrine therapies and in the oncogenic signaling pathway, protein kinase C beta 1 (PKCß1), may offer a new tool in treating this disease.," said Dr. Steven Quay, M.D., Ph.D., Atossa Therapeutics President and Chief Executive Officer. "We appreciate the FDA's review and look forward to advancing this clinical investigation." About (Z)-Endoxifen (Z)-Endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated activity across multiple mecha
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News
- Atossa Therapeutics Receives FDA Orphan Drug Designation for (Z)-Endoxifen for the Treatment of Duchenne Muscular DystrophyPR Newswire
- Atossa Therapeutics shares rise after FDA grants orphan drug designation for soft tissue sarcoma [Seeking Alpha]Seeking Alpha
- Atossa Therapeutics Receives FDA "Study May Proceed" Letter for (Z)-Endoxifen Investigational New Drug Application for Metastatic Breast CancerPR Newswire
- Atossa Therapeutics Wins 2025 Clinical Trials Arena Research and Development Excellence Award in Precision Endocrine Therapy Category [Yahoo! Finance]Yahoo! Finance
- Atossa Therapeutics Wins 2025 Clinical Trials Arena Research and Development Excellence Award in Precision Endocrine Therapy CategoryPR Newswire
ATOS
Analyst Actions
- 12/8/25 - Ascendiant Capital
ATOS
Sec Filings
- 1/9/26 - Form 8-K
- 1/6/26 - Form 8-K
- 12/22/25 - Form DEF
- ATOS's page on the SEC website