Kyntra Bio, Inc. KYNB
Kyntra Bio, Inc. (Nasdaq: KYNB) is an oncology drug developer. Its lead program, FG-3246 (CD46-targeted ADC) with FG-3180 PET imaging agent, is in Phase 2 for metastatic castration-resistant prostate cancer (mCRPC), post-ARPI pre-chemotherapy. Its next catalyst on record is FG-3246: Interim analysis of Phase 2 dose optimization study (composite PSA50/ORR) (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: FG-3246 — Interim analysis of Phase 2 dose optimization study (composite PSA50/ORR) (Q4 2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| FG-3246 (CD46 ADC, MMAE payload) | mCRPC (randomized Phase 2 dose optimization, ~75 pts) | antibody | Phase 2 |
| FG-3180 (CD46 PET biomarker/imaging agent) | mCRPC patient selection (exploratory sub-study) | radiopharmaceutical | Phase 2 |
| roxadustat (HIF-PHI) | anemia in lower-risk MDS with high transfusion burden (US Phase 3 planned) | small molecule | Phase 2 |
Recent results and decisions
- Sep 30, 2026n/a Kyntra Bio received Nasdaq delisting determination for failure to meet continued listing requirements under Rule 5450(b) and has requested a hearing to seek additional time for compliance.
The Company had not yet demonstrated compliance with Nasdaq Listing Rule 5450(b) as of the September 29, 2026 deadline and that, as a result, the Staff had determined to delist the Company's common stock from the Nasdaq Global Select Market.
Filing - Aug 13, 2026positive Post hoc analysis of Phase 3 MATTERHORN presented at EHA 2026 showed clinically meaningful improvement in transfusion independence versus placebo in HTB LR-MDS, with similar rates in RS+ and RS- disease.
In a post hoc analysis of the Phase 3 MATTERHORN study, patients treated with roxadustat showed a clinically meaningful improvement in transfusion independence (TI) in patients with LR-MDS and HTB compared to placebo.
Filing - Mar 16, 2026positive Investigator-sponsored FG-3246 plus enzalutamide study in mCRPC showed median rPFS of 7.0 months overall and 10.1 months in patients who progressed on only one prior ARPI (presented at ASCO GU 2026).
FG-3246 and enzalutamide combination therapy, in biomarker unselected patients with androgen receptor pathway inhibitor (ARPI)-treated, taxane-naïve mCRPC, led to a median radiographic progression free survival (rPFS) of 7.0 months in the overall study cohort, with median rPFS of 10.1 months observe
Filing
3 more on record.
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
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- 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.