AnaptysBio Faces Another Setback For Imsidolimab, Stalls Work In Skin Scarring Indication
AnaptysBio Inc (NASDAQ: ANAB) announced topline data from its HARP Phase 2 trial of imsidolimab for moderate-to-severe hidradenitis suppurativa (HS).
Vaxart Shares Positive Top-line Data From Mid-Stage Oral Pill COVID-19 Vaccine Study
Vaxart (NASDAQ: VXRT) announced positive top-line data from the first part of a planned two-part Phase 2 study of its Wuhan S-only oral pill COVID-19 vaccine candidate, VXA-CoV2-1.1-S.
The top-line data readout exhibited that the trial met its primary safety and secondary immunogenicity endpoints.
Axsome Therapeutics Commences Late-Stage Migraine Study
Axsome Therapeutics (NASDAQ: AXSM) has enrolled the first patient in the EMERGE trial of its lead candidate AXS-07 for the acute treatment of migraine.
Sanofi’s Rare Disease Drug Xenpozyme Scores FDA Approval
Soon after the European Commission’s (EC) approval, Sanofi SA (NASDAQ:SNY) scooped up the FDA’s OK for the first approved therapy to treat symptoms…
Ascendis Seeks FDA Nod For TransCon PTH In Adults With Hypoparathyroidism
Ascendis Pharma (NASDAQ: ASND) has submitted a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for TransCon PTH, an investigational pro-drug designed to restore parathyroid hormone (PTH [1-34]) to physiological levels over 24 hours in adult patients with hypoparathyroidism.
BioCryst Secures FDA Orphan Drug Status For Rare Connective Tissue Disease Candidate
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for BioCryst’s (NASDAQ: BCRX) lead asset BCX9250 for the treatment of fibrodysplasia ossificans progressiva (FOP).
Medtronic Announces Partnership With Biointellisense For Exclusive U.S. Distribution Of Multi-parameter Wearable For Continuous Remote Patient Monitoring From In-Hospital To Home
Partnership reflects commitment to patient safety; BioButton® wearable offers up to 1,440 vital signs measurements daily, monitoring patients transitioning from higher to lower acuity settings
Technology
Recap Of Tuesday’s Biotech Catalysts – End Of the Day Summary
Amgen (NASDAQ:AMGN) announced top-line results from the global Phase 3 CodeBreaK 200 trial evaluating once daily oral LUMAKRAS (sotorasib)…