Atossa Therapeutics received an FDA 'Study May Proceed' letter for their study in metastatic breast cancer for (Z)-Endoxifen.
The Company believes that (Z)-Endoxifen may offer a new tool in treating metastatic ER+/HER2- Breast Cancer.
The FDA's review of Atossa's application marks an important regulatory milestone.
Regulatory Milestone Achieved
FDA issued a 'Study May Proceed' letter for Atossa's (Z)-Endoxifen study in metastatic breast cancer.
Potential Treatment Expansion
Belief in expanding the use of (Z)-Endoxifen for treating resistant tumors in metastatic breast cancer.
Unique Pharmacology
Atossa's oral formulation of (Z)-Endoxifen shows distinct pharmacology from tamoxifen, targeting ER and PKC.
- The issuance of the 'Study May Proceed' letter signifies progress in advancing Atossa's investigational new drug application.
- Atossa's (Z)-Endoxifen program holds promise for offering new therapeutic options in oncology and rare diseases.
Atossa Therapeutics is on track to explore the potential of (Z)-Endoxifen in treating metastatic breast cancer, with a focus on developing innovative medicines for unmet medical needs.