MarketPulse

FDA Fast Track designation

6 articles
The Motley FoolThe Motley Fool··Robert Izquierdo

MoonLake CEO Sells $2.8M in Stock as Biotech Faces Clinical Setbacks

MoonLake Immunotherapeutics CEO Jorge Santos da Silva sold $2.8M in shares, reducing holdings 4.9%. Stock down 47% year-over-year amid disappointing trial results.
MLTXhigh-risk investmentinsider selling
GlobeNewswire Inc.GlobeNewswire Inc.··Not Specified

Radiopharm Theranostics Partners with Siemens on RAD101 PET Imaging Agent for Brain Metastases

Radiopharm Theranostics and Siemens Healthineers sign manufacturing supply agreement for RAD101 PET imaging agent, advancing toward Phase 3 trial with strong interim data.
SMMNYRADXradiopharmaceuticalsPET imaging
GlobeNewswire Inc.GlobeNewswire Inc.··Okyo Pharma Limited

OKYO Pharma to Showcase Urcosimod Data at ASCRS Meeting Ahead of Late-Stage Trial

OKYO Pharma presents Phase 2 urcosimod data at ASCRS conference; plans Phase 2b/3 trial launch in H1 2026 for neuropathic corneal pain.
OKYOPhase 2 clinical trialbiopharmaceutical
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Zymeworks Wins FDA Fast Track for Cancer Drug ZW191, Accelerating Path to Market

Zymeworks secures FDA Fast Track designation for ZW191, an ovarian cancer antibody-drug conjugate, accelerating development timelines.
ZYMEantibody-drug conjugatePhase 1 clinical trial
GlobeNewswire Inc.GlobeNewswire Inc.··Incannex Healthcare Inc.

Incannex Accelerates Sleep Apnea Drug After FDA Fast Track Win, Phase 2 Success

Incannex Healthcare receives FDA Fast Track Designation for IHL-42X sleep apnea treatment following positive Phase 2 results, plans optimized Phase 3 pathway.
IXHLPhase 2 clinical trialdrug development
GlobeNewswire Inc.GlobeNewswire Inc.··Na

OKYO Pharma's Neuropathic Eye Pain Therapy Earns ARVO 2026 Presentation Slot

OKYO Pharma's urcosimod earns ARVO 2026 presentation slot for neuropathic eye pain therapy. Phase 2a data shows pain reduction and quality-of-life improvements; Phase 2b/3 trial planned for 2026.
OKYOclinical trial resultsneuropathic corneal pain