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Regulatory

RNAC

Cartesian Therapeutics announced positive results from its Phase 2b trial of Descartes-08 for treating Generalized Myasthenia Gravis, achieving its primary endpoint with significant improvements in patients. The company plans to discuss next steps with the FDA.

Portfolio Pulse from Benzinga Newsdesk

October 15, 2024 | 11:47 am

NSPR

InspireMD has established its global headquarters in Miami, Florida, to support the anticipated U.S. launch of the CGuard Prime carotid stent system in 2025, pending approval.

Portfolio Pulse from Benzinga Newsdesk

October 15, 2024 | 11:42 am

AMD

ARM

ASML

MU

NVDA

Nvidia, AMD, and other chipmakers are experiencing a decline in premarket trading due to potential U.S. export curbs on advanced AI chips, particularly affecting sales to Persian Gulf nations.

Portfolio Pulse from Shanthi Rexaline

October 15, 2024 | 11:42 am

JAZZ

Jazz Pharmaceuticals announced results for its combination therapy of Zepzelca and Atezolizumab in first-line maintenance for small cell lung cancer. The company plans to submit a supplemental New Drug Application in the first half of 2025.

Portfolio Pulse from Benzinga Newsdesk

October 15, 2024 | 11:35 am

LYRA

Lyra Therapeutics has completed enrollment for its Phase 3 ENLIGHTEN 2 trial of LYR-210, targeting chronic rhinosinusitis. The company is also advancing its third gene therapy program with AMT-162 for SOD1-ALS, aiming for rapid proof-of-concept data.

Portfolio Pulse from Benzinga Newsdesk

October 15, 2024 | 11:21 am

MGTX

MeiraGTx has reported positive data from a clinical bridging study of AAV-GAD for treating Parkinson's Disease, meeting the primary objective of safety and tolerability.

Portfolio Pulse from Benzinga Newsdesk

October 15, 2024 | 11:18 am

QURE

uniQure has initiated a Phase I/II clinical trial for AMT-162, a treatment for SOD1-ALS, with the first patient dosed. The trial, named EPISOD1, is being conducted in the US and will assess safety, tolerability, and exploratory efficacy across three dose-escalating cohorts.

Portfolio Pulse from Benzinga Newsdesk

October 15, 2024 | 11:16 am

MGTX

MeiraGTx Holdings plc announced positive top-line data from its clinical study of AAV-GAD gene therapy for Parkinson's disease, showing safety and significant improvements in motor and quality of life scores. The study supports further clinical development and regulatory discussions.

Portfolio Pulse from Benzinga Newsdesk

October 15, 2024 | 11:13 am

SYRE

Paragon Therapeutics has granted Spyre Therapeutics an exclusive license to develop, manufacture, and commercialize antibodies targeting IL-23 for irritable bowel disease. Paragon will receive up to $22 million in milestone payments, including $2.5 million upon the first human dosing in a Phase 1 trial.

Portfolio Pulse from Benzinga Newsdesk

October 15, 2024 | 10:41 am

HOTH

Hoth Therapeutics shares rise following the award of a US patent for its HT-ALZ Alzheimer's treatment. The company plans to prepare for clinical trials to validate its efficacy in humans.

Portfolio Pulse from Benzinga Newsdesk

October 15, 2024 | 10:40 am