Streetbeat News

Regulatory

LEGN

Legend Biotech has submitted an application to the European Medicines Agency (EMA) for the expanded use of CARVYKTI, a CAR T-cell therapy for multiple myeloma patients.

Portfolio Pulse from Benzinga Newsdesk

May 25, 2023 | 12:33 pm

ARVL

KCGI

EV startup Arrival expects its merger with Kensington Capital Acquisition Corp V and subsidies from the US Inflation Reduction Act (IRA) to drive business growth. The merger will provide Arrival with up to $283 million to build a factory in North Carolina for its XL van, which qualifies for IRA tax credits up to $40,000.

Portfolio Pulse from Lekha Gupta

May 25, 2023 | 12:30 pm

HRMY

Harmony Biosciences (NASDAQ:HRMY) has completed enrollment for its Phase 3 INTUNE study evaluating the safety and efficacy of pitolisant in adult patients with idiopathic hypersomnia (IH) nine months ahead of schedule. Topline results are expected in Q4 2023.

Portfolio Pulse from Happy Mohamed

May 25, 2023 | 12:23 pm

AMTX

Aemetis, Inc. (NASDAQ: AMTX) has resumed production at its 65 million gallon per year capacity Keyes, California ethanol plant after completing extensive maintenance and system upgrades. The upgrades include a new Allen Bradley Decision Control System (DCS) with over 1,100 sensor connections to enhance automation and enable AI management of energy use. The company received $16.7 million in grants from the California Energy Commission and Pacific Gas & Electric for the upgrades.

Portfolio Pulse from Happy Mohamed

May 25, 2023 | 12:22 pm

CLNN

Clene, Inc. (NASDAQ:CLNN) has been awarded a grant from the National Multiple Sclerosis Society (NMSS) to advance the development of its lead drug candidate, CNM-Au8, in non-active progressive multiple sclerosis. The grant will fund Cohort 2 of the REPAIR-MS Phase 2 clinical study, which aims to determine the effects of CNM-Au8 on brain energy metabolites in patients with non-active progressive MS.

Portfolio Pulse from Happy Mohamed

May 25, 2023 | 12:20 pm

MNMD

MindMed has published a report by Greenleaf Health, led by former senior FDA officials, validating the company's MM-120 drug development strategy. The report supports MindMed's ongoing Phase 2b trial for MM-120 in patients with generalized anxiety disorder and highlights the risks of skipping Phase 2.

Portfolio Pulse from Happy Mohamed

May 25, 2023 | 12:18 pm

OTRK

Ontrak, Inc. (NASDAQ:OTRK) has achieved NCQA certification as a Credentials Verification Organization (CVO), reinforcing its commitment to quality assurance in healthcare. This certification validates Ontrak's high standards of quality and compliance in its healthcare solutions, enabling customers to meet their accreditation goals.

Portfolio Pulse from Happy Mohamed

May 25, 2023 | 12:16 pm

ONTX

Onconova Therapeutics has announced the dosing of the first participant in an investigator-sponsored Phase 2 trial of oral rigosertib plus pembrolizumab for metastatic melanoma patients who have progressed on prior PD-1/L1 inhibitor therapy. The trial aims to explore the potential of rigosertib to enhance the efficacy of immune checkpoint blockade in metastatic melanoma.

Portfolio Pulse from Happy Mohamed

May 25, 2023 | 12:15 pm

FEXD

Fintech Ecosystem Development Corp. received a notice from Nasdaq for non-compliance with continued listing standards due to the late filing of its Q1 2023 Form 10-Q. The company has since filed the Form 10-Q to rectify the issue.

Portfolio Pulse from Happy Mohamed

May 25, 2023 | 12:14 pm

TLRY

Tilray Brands' medical cannabis division, Tilray Medical, and its Italian subsidiary FL Group have received authorization from Italy's Ministry of Health to distribute three new medical cannabis compounds. Tilray also announced a partnership with Pharmaidea to market and educate over 12,000 pharmacies across Italy on medical cannabis patient care.

Portfolio Pulse from Vuk Zdinjak

May 25, 2023 | 12:06 pm