Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
FDA Approval For AstraZeneca-Daiichi's Enhertu Expands To Earlier Use In Metastatic Breast Cancer
The FDA has approved AstraZeneca plc AZN and Daiichi Sankyo's DSKYF Enhertu (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive breast cancer.
The approval covers patients who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of therapy.
AstraZeneca's Dapagliflozin Meets Primary Goal In Heart Failure Patients
AstraZeneca announced high-level results from the DELIVER Phase 3 trial of Farxiga (dapagliflozin) to treat heart failure patients.
Data showed Farxiga reached a statistically significant and clinically meaningful reduction in the primary composite endpoint of cardiovascular death or worsening heart failure.
AstraZeneca's Ultomiris Aces Late-Stage Trial In Rare Autoimmune Disease
AstraZeneca announced topline data from the Phase 3 CHAMPION-NMOSD trial of Ultomiris (ravulizumab-cwvz) in neuromyelitis optica spectrum disorder.
Data exhibited that Ultomiris achieved a statistically significant and clinically meaningful reduction in the risk of relapse in adults with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) NMOSD compared to the external placebo arm.
Notably, no relapse was observed in 58 patients over a median treatment duration of 73 weeks.
Jazz Pharma, Sumitomo Pharma Ink Licensing Pact For Sleeping Disorder Candidate
Jazz Pharmaceuticals plc JAZZ has acquired development and commercialization rights in the U.S., Europe, and other territories for Sumitomo Pharma's investigational DSP-0187.
DSP-0187 is initially planned to be evaluated in patients with narcolepsy.
It will receive an upfront payment of $50 million and is eligible to receive development, regulatory, and commercial milestone payments of up to $1.09 billion.
Axogen Aces Phase 3 Study For Avance Nerve Graft
Axogen Inc AXGN announced topline results from its RECON Clinical Study comparing Avance Nerve Graft to conduits in digital nerve injuries.
The Phase 3 pivotal study met its primary endpoint for the return of sensory function as measured by static two-point discrimination, and the safety profile was consistent with previously published data.
Argenx's Vyvgart Meets Primary Goal In Late-Stage Bleeding Disorder Study
Argenx SE's ARGX Phase 3 ADVANCE trial of Vyvgart (efgartigimod alfa-fcab) in adults with primary immune thrombocytopenia (ITP) met its primary endpoint.
A higher proportion of patients with chronic ITP receiving VYVGART (17/78; 21.8%) than placebo (2/40; 5%) achieved a sustained platelet response.
Numerically fewer WHO-classified bleeding events occurred in treated patients throughout the trial, but the difference from placebo was not statistically significant.
Incyte-Novartis' Ruxolitinib Scores European Approval For Steroid-Refractory GVHD
The European Commission (EC) has approved Incyte Corporation's INCY Jakavi (ruxolitinib) for patients aged 12 years and older with acute or chronic graft-versus-host disease (GVHD) who have an inadequate response to corticosteroids or other systemic therapies.
Ruxolitinib is marketed as Jakavi by Novartis AG NVS in Europe and as Jakafi by Incyte in the United States.
On The Radar
Intellia Therapeutics Inc NTLA: Before Market Open
BioCryst Pharmaceuticals Inc BCRX: Before Market Open
AVEO Pharmaceuticals Inc AVEO: Before Market Open
Karyopharm Therapeutics Inc KPTI: Before Market Open
Agios Pharmaceuticals Inc AGIO: Before Market Open
Aldeyra Therapeutics Inc ALDX: Before Market Open
Arbutus Biopharma Corp ABUS: Before Market Open
Argenx SE ARGX: Before Market Open
Autolus Therapeutics PLC AUTL: Before Market Open
Selecta Biosciences Inc SELB: Before Market Open
Vanda Pharmaceuticals Inc VNDA: After Market Close
Nabriva Therapeutics PLC NBRV: After Market Close
Sangamo Therapeutics Inc SGMO: After Market Close
Prothena Corporation PLC PRTA: After Market Close
Theravance Biopharma Inc TBPH: After Market Close
INmune Bio Inc INMB: After Market Close
Galapagos GLPG: After Market Close
Xencor Inc XNCR: After Market Close
Ultragenyx Pharmaceutical Inc RARE: After Market Close
Coherus Biosciences Inc CHRS: After Market Close
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