ATOS Atossa Therapeutics

(Z)-endoxifen · NCT06075953 registry update

countries: {'total_sites': 29, 'us_sites': 29} → {'total_sites': 30, 'us_sites': 30}

Atossa Therapeutics Issues Stapled CVRs for Potential PRV Monetization

Atossa executed a CVR agreement granting shareholders 25% of net proceeds (capped at $50M) from monetization of its first qualifying FDA Priority Review Voucher. The CVRs are stapled to shares as of the October 19, 2026 record date and apply to any PRV awarded on or before December 31, 2036. The company has Rare Pediatric Disease Designation for (Z)-endoxifen in DMD and MAS but has not submitted any marketing application.

(Z)-endoxifen · NCT06608641 registry update

status: ACTIVE_NOT_RECRUITING → UNKNOWN

Atossa to Issue CVR to Shareholders Tied to First Rare Pediatric Disease PRV from (Z)-endoxifen

Atossa announced a plan to issue one CVR per ATOS share entitling holders to 25% of net proceeds (capped at $50M aggregate) from monetization of the company's first qualifying Rare Pediatric Disease Priority Review Voucher. The company has already received two RPD designations for (Z)-endoxifen in DMD and MAS; no approval or voucher has been awarded yet. CVRs expire if no qualifying voucher is awarded by December 31, 2036.

(Z)-endoxifen · NCT06075953 registry update

countries: {'total_sites': 28, 'us_sites': 28} → {'total_sites': 29, 'us_sites': 29}

Atossa Therapeutics CEO to Speak at ARDD 2026 on Clinical Trials & Regulatory Pathways

Atossa CEO Dr. Steven Quay will participate in a panel at the ARDD 2026 meeting discussing clinical trial design, endpoints, and regulatory pathways for diseases of aging. The panel occurs on October 1, 2026 at Harvard University. This is a non-regulatory conference appearance with no direct impact on (Z)-endoxifen's development path.

Atossa Receives RPD and ODD for (Z)-endoxifen in MAS and DMD

Atossa Therapeutics has obtained Rare Pediatric Disease (RPD) designation for (Z)-endoxifen in both McCune-Albright Syndrome (MAS) and Duchenne Muscular Dystrophy (DMD), plus Orphan Drug Designation (ODD) for DMD. IND clearance for both indications is anticipated in 2H 2026 with Phase 2 initiation in 2027. This provides eligibility for a Priority Review Voucher upon approval.

Atossa receives FDA Study May Proceed letter for (Z)-endoxifen in metastatic breast cancer

FDA cleared the IND application for (Z)-endoxifen in metastatic ER+/HER2- breast cancer, allowing the company to initiate the planned clinical study. This regulatory green-light advances the program into the next stage of clinical development.

Atossa completes FDA Type C meeting on (Z)-endoxifen regulatory strategy

Atossa held a Type C meeting with the FDA on November 17, 2025, receiving feedback on expedited regulatory pathways for (Z)-endoxifen across metastatic, neoadjuvant, and risk-reduction settings. The Company plans to incorporate this feedback to accelerate development timelines and pursue streamlined registrational approaches. An IND for metastatic breast cancer has been submitted and is awaiting feedback.

Atossa Therapeutics schedules FDA Type C meeting for (Z)-endoxifen

Atossa requested and received preliminary FDA comments for a Type C meeting on November 17, 2025 to discuss regulatory strategy for accelerating (Z)-endoxifen development in breast cancer risk reduction. The meeting aims to align on NDA requirements and potential expedited programs, with meeting minutes expected in December 2025.