Business
Kyntra Bio Reports First Quarter 2026 Financial Results and Provides Business Update
Phase 2 monotherapy trial of FG-3246, a potential first-in-class antibody drug conjugate (ADC) targeting CD46, in metastatic castration-resistant prostate
About this update from Kyntra Bio, Inc.
[{"type":"text","content":"Phase 2 monotherapy trial of FG-3246, a potential first-in-class antibody drug conjugate (ADC) targeting CD46, in metastatic castration-resistant prostate cancer (mCRPC) is progressing well with the interim analysis anticipated in 4Q 2026 Positive results from the investigator-sponsored study of FG-3246 in combination with enzalutamide in patients with mCRPC were presented at ASCO GU in February 2026, further validating key Phase 2 monotherapy design elements Pivotal Phase 3 trial protocol of roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high transfusion burden is being finalized following feedback from the U.S. Food and Drug Administration (FDA) Cash, cash equivalents, investments, and accounts receivable of $100.3 million, providing cash runway into 2028 Kyntra Bio to host conference call and webcast presentation today at 5:00 PM ET SAN FRANCISCO, May 11, 2026 (GLOBE NEWSWIRE) -- Kyntra Bio (Nasdaq: KYNB) today reported financial results for the first quarter 2026 and provided an update on the company’s recent developments. “In the first quarter, we continued to make steady progress across our pipeline. We are encouraged by the pace of enrollment in our Phase 2 trial of FG-3246 in patients with mCRPC and are on track for the interim analysis in the fourth quarter of 2026. We remain confident in the potential of FG-3246 to deliver competitive progression free survival results in the Phase 2 monotherapy trial,” commented Thane Wettig, Chief Executive Officer of Kyntra Bio. “In addition, following FDA feedback, we are finalizing the protocol for the pivotal Phase 3 trial of roxadustat for the treatment of lower-risk MDS, and anticipate trial initiation in the second half of 2026.” Key Highlights of First Quarter, Recent Developments, and Upcoming Milestones FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent) Phase 2 monotherapy trial of FG-3246, a potential first-in-class ADC targeting CD46, in mCRPC is actively enrolling and remains on track for interim analysis in the fourth quarter of 2026Topline results from the investigator-sponsored Phase 1b/2 study, conducted by UCSF, of FG-3246 in combination with enzalutamide in patients with mCRPC were presented at ASCO GU 2026 In biomarker unselected patients with androgen receptor pathway inhibitor (AR...