Streetbeat News

Regulatory

AMLX

Amylyx Pharmaceuticals has received Orphan Drug Designation from the European Commission for its drug AMX0035, aimed at treating Wolfram Syndrome. The company expects topline data from its Phase 2 HELIOS trial in Fall 2024.

Portfolio Pulse from Benzinga Newsdesk

August 02, 2024 | 1:01 pm

NCPLW

Trading halt status was updated at 9:00:00 AM ET, with a quotation resumption announced. The news and resumption times are provided.

Portfolio Pulse from Benzinga Newsdesk

August 02, 2024 | 1:00 pm

GLASF

Glass House Brands is advocating for the complete de-scheduling of cannabis, following the DEA's comment period on rescheduling cannabis from a Schedule 1 to a Schedule 3 drug. The company highlights the immense public support for this change and sees a political opportunity for leaders to address this demand. The advocacy also focuses on addressing injustices faced by those incarcerated for cannabis-related offenses.

Portfolio Pulse from Abbey Higginbotham

August 02, 2024 | 12:56 pm

NCPL

Trading halt status for NCPL was updated at 8:55:00 AM ET. The quotation resumption times and related news are expected to follow.

Portfolio Pulse from Benzinga Newsdesk

August 02, 2024 | 12:55 pm

SYTA

Trading halt status for SYTA was updated at 8:55:00 AM ET. The halt was due to pending news and the resumption times were provided.

Portfolio Pulse from Benzinga Newsdesk

August 02, 2024 | 12:55 pm

ADAP

GLPG

The FDA has approved Adaptimmune Therapeutics' (NASDAQ:ADAP) Tecelra for treating unresectable or metastatic synovial sarcoma, marking the first engineered cell therapy for solid tumors in the U.S. and the first new therapy for this rare cancer in over a decade. The approval is based on the SPEARHEAD-1 trial results, showing a 43% overall response rate. Adaptimmune plans to establish multiple treatment centers. Additionally, Adaptimmune has entered a collaboration with Galapagos NV (NASDAQ:GLPG) for future TCR T-cell therapies.

Portfolio Pulse from Vandana Singh

August 02, 2024 | 12:46 pm

LH

Labcorp has received FDA De Novo marketing authorization for its PGDx elio plasma focus Dx, a pan-solid tumor liquid biopsy test. This is the first kitted test of its kind, allowing for tumor mutation profiling from a simple blood draw.

Portfolio Pulse from Benzinga Newsdesk

August 02, 2024 | 12:34 pm

INSP

Inspire Medical Systems has received FDA approval for its Inspire V Therapy System, which includes a next-generation neurostimulator and Bluetooth-enabled patient remote and physician programmer. This approval marks a significant advancement in the treatment of obstructive sleep apnea.

Portfolio Pulse from Benzinga Newsdesk

August 02, 2024 | 12:07 pm

CVRX

CVRx announced that the Centers for Medicare & Medicaid Services (CMS) has reassigned the Barostim implant procedure to MS-DRG 276 with a national average payment of $43,000 in the FY 2025 Medicare Hospital Inpatient Prospective Payment System. The new payment will be effective starting October 1, 2024.

Portfolio Pulse from Benzinga Newsdesk

August 02, 2024 | 12:06 pm

ITRM

Iterum Therapeutics has received a Notice of Allowance from the USPTO for two U.S. patents and has been issued a Canadian patent by CIPO for Sulopenem Etzadroxil and Probenecid (Oral Sulopenem).

Portfolio Pulse from Benzinga Newsdesk

August 02, 2024 | 12:04 pm