Foghorn’s AML/MDS Program Likely Still A Go Despite Partial Hold

The company’s Phase I study of FHD-286 had a patient death due to differentiation syndrome, but that’s a known adverse event in multiple approved AML drugs.

Foghorn announced a partial clinical hold on its Phase I AML/MDS study following a patient death • Source: Shutterstock

Foghorn Therapeutics Inc.’s development program for FHD-286 has run into trouble as the US Food and Drug Administration has placed a partial clinical hold in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) following a patient death. But the drug may still be able to move forward as the death was due to a problem that has occurred with some approved AML drugs.

The company said 19 May that the FDA had placed the partial clinical hold on its dose-escalation study of FHD-286...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

Alkermes Two-For-Two In Narcolepsy As Alixorexton Succeeds In NT2 Trial

 

The drugmaker plans to move into Phase III development of the drug, which has now posted positive Phase II results in narcolepsy types 1 and 2.

MASH Updates: Sagimet, Altimmune, GSK Discuss Development Plans At AASLD

 
• By 

Sagimet may shift focus to later-stage MASH while it lines up Phase III financing. Altimmune expects its dual agonist to show efficacy and tolerability, while GSK is readying efimosfermin as the third FGF21 analog into Phase III for MASH.

enGene’s Detalimogene On Track For H2 2026 FDA Filing In NMIBC

 

The company announced data from patients enrolled after a protocol amendment designed to bring the study in line with non-muscle invasive bladder cancer (NMIBC) standards of care.

A Week Is A Long Time In Biotech, Just Ask Galecto

 
• By 

A long time on the ropes, the US firm is now well-financed to advance potential candidates for essential thrombocythemia and myelofibrosis into the clinic.

More from R&D

AnaptysBio Scraps Rosnilimab Ulcerative Colitis Trial After Phase II Miss

 

The biopharma plans to advance the PD-1 agonist in rheumatoid arthritis despite its failure in ulcerative colitis.

Neurocrine’s Depression Drug Misses In Phase II

 

Small study fails to turn up efficacy signals in the major depressive disorder candidate, leaving Neurocrine with one remaining depression candidate in development.

Beijing Mabworks Scores World-First Phase III Win In Membranous Nephropathy

 

In a world-first, Beijing Mabworks has scored a Phase III clinical win for its novel anti-CD20 antibody in the treatment of primary membranous nephropathy. However, multiple global contenders including Roche are threatening to come from behind in the race.