Streetbeat News

Regulatory

AAPL

The UK Government's Online Safety Bill, which demands messaging services like Apple's iMessage and WhatsApp to allow scanning of messages for illicit content, has put the future of Apple's iMessage service in the UK in doubt. The government had previously asked Apple to disable end-to-end encryption on iMessage for security reasons. Despite reports suggesting the government was planning to abandon this requirement, it has now denied such claims. The EU has also identified Apple as a digital gatekeeper under its new Digital Markets Act, potentially restricting iMessage operations in mainland Europe.

Portfolio Pulse from Benzinga Neuro

September 07, 2023 | 12:13 pm

EWY

FXI

SPY

China's leader Li has met with South Korea's President Yoon and stated that China will continue to work for peace talks on Korean Peninsula issues.

Portfolio Pulse from Charles Gross

September 07, 2023 | 12:09 pm

MULN

Mullen Automotive Inc. (NASDAQ:MULN), an emerging electric vehicle manufacturer, has received a delisting determination from Nasdaq for failing to maintain a minimum bid price of $1.00. The company has requested a hearing before the Nasdaq Listing Qualifications Panel to seek an extension of time and present its plan to regain compliance.

Portfolio Pulse from Happy Mohamed

September 07, 2023 | 12:09 pm

HRMY

Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to pitolisant for the treatment of idiopathic hypersomnia (IH).

Portfolio Pulse from Benzinga Newsdesk

September 07, 2023 | 12:07 pm

ZEV

Lightning eMotors (NYSE:ZEV), a provider of zero-emission commercial vehicles and EV technology, has achieved ISO 9001:2015 certification for its quality management system. The certification demonstrates the company's commitment to quality and strengthens its ability to comply with commercial and regulatory requirements. The ISO 9001 audit evaluated Lightning's processes against seven key parameters, and the certification recognizes Lightning's prioritization of quality control.

Portfolio Pulse from Happy Mohamed

September 07, 2023 | 12:07 pm

LGVN

LGVNR

Longeveron Inc. (NASDAQ:LGVN, NASDAQ:LGVNR), a clinical stage biotechnology company, announced that an abstract highlighting long-term survival data from its ELPIS 1 trial of Lomecel-B™ for patients with hypoplastic left heart syndrome (HLHS) has been accepted for presentation at the upcoming meeting of the American Heart Association (AHA).

Portfolio Pulse from Benzinga Newsdesk

September 07, 2023 | 12:04 pm

VBIV

VBI Vaccines has announced that the first patients have been dosed in a Phase 2B study of its cancer vaccine immunotherapeutic candidate, VBI-1901, for first recurrent glioblastoma. Interim data analysis is expected mid-year 2024, subject to the speed of enrollment.

Portfolio Pulse from Benzinga Newsdesk

September 07, 2023 | 12:03 pm

GERN

Geron Corporation (NASDAQ:GERN) has announced data presentations from its Phase 3 clinical trial, IMerge, evaluating its investigational telomerase inhibitor imetelstat in patients with lower risk myelodysplastic syndromes (MDS). The data, presented at the Society of Hematologic Oncology Annual Meeting, showed promising results including transfusion independence, increases in hemoglobin, and improvement in fatigue. Based on these results, Geron has submitted a New Drug Application for imetelstat that has been accepted for review by the FDA.

Portfolio Pulse from Happy Mohamed

September 07, 2023 | 12:03 pm

FDMT

4D Molecular Therapeutics (NASDAQ:FDMT) has enrolled the first patient in the Phase 2 SPECTRA clinical trial for 4D-150, a treatment for diabetic macular edema (DME). The company has also expanded the 4D-150 Phase 2 stage of the PRISM Clinical Trial for wet age-related macular degeneration (wet AMD).

Portfolio Pulse from Benzinga Newsdesk

September 07, 2023 | 12:02 pm

INO

INOVIO Pharmaceuticals has received FDA Breakthrough Therapy Designation for its drug INO-3107, intended for the treatment of Recurrent Respiratory Papillomatosis.

Portfolio Pulse from Benzinga Newsdesk

September 07, 2023 | 12:02 pm