Atossa Therapeutics, Inc. ATOS
Atossa Therapeutics, Inc. (Nasdaq: ATOS) is an oncology drug developer. Its lead program, (Z)-endoxifen, is in Phase 2 for ER+/HER2- breast cancer (neoadjuvant), breast density reduction, DCIS; rare disease exploration (DMD, MAS). Its next catalyst on record is (Z)-endoxifen I-SPY 2: Data from expanded combination arms (H2 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: (Z)-endoxifen I-SPY 2 — Data from expanded combination arms (H2 2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| (Z)-endoxifen - Karisma (mammographic breast density) | mammographic breast density reduction | small molecule | Phase 2 |
| (Z)-endoxifen - I-SPY 2 Endocrine Optimization Pilot | ER+/HER2- early breast cancer, neoadjuvant | small molecule | Phase 2 |
| (Z)-endoxifen - RECAST DCIS | low-risk ductal carcinoma in situ | small molecule | Phase 2 |
| (Z)-endoxifen - EVANGELINE | premenopausal ER+/HER2- breast cancer, neoadjuvant with OFS | small molecule | Phase 2 |
| (Z)-endoxifen - Duchenne muscular dystrophy | DMD (orphan and rare pediatric designations) | small molecule | Pre-clinical |
| (Z)-endoxifen - McCune-Albright Syndrome | MAS precocious puberty (rare pediatric designation) | small molecule | Pre-clinical |
Recent results and decisions
- Oct 8, 2026n/a Atossa executes contingent value rights agreement providing shareholders 25% of net proceeds from the first qualifying priority review voucher, subject to a $50 million cap.
The CVRs provide shareholders with a contractual right to participate in the potential future value of the first qualifying FDA priority review voucher awarded to Atossa.
Filing - Oct 8, 2026n/a Atossa executed a Stapled Contingent Value Rights Agreement providing shareholders 25% of net proceeds from monetization of the first qualifying FDA priority review voucher, subject to a $50 million cap.
The Stapled CVRs represent the Company's commitment to distribute to its stockholders a portion of the net proceeds of any sale of the first FDA priority review voucher that may be awarded to the Company in the future.
Filing - Sep 18, 2026completed enrollment EVANGELINE Phase 2 enrollment completed as of June 30, 2026.
EVANGELINE Phase 2 enrollment completed as of June 30, 2026
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 oncology companies
- Tango Therapeutics, Inc. TNGX
- Tyra Biosciences, Inc. TYRA
- Verastem, Inc. VSTM
- Obsidian Therapeutics, Inc. OBX
- Puma Biotechnology, Inc. PBYI
- Fulgent Genetics, Inc. FLGT
- Delcath Systems, Inc. DCTH
- Unknown Unknown
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.