Streetbeat News

Regulatory

BTAI

The Centers for Medicare & Medicaid Services has issued a permanent and product-specific J-code for BioXcel Therapeutics' Igalmi Sublingual Film, which is approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. The IGALMI J-Code J1105 will become effective from January 1, 2024.

Portfolio Pulse from Benzinga Newsdesk

October 30, 2023 | 11:21 am

VYNE

VYNE Therapeutics Inc. has announced positive data from its Phase 1b trial evaluating once-daily dosing of VYN201 in patients with nonsegmental vitiligo. The trial assessed the safety, tolerability and pharmacokinetics of VYN201 in 29 patients across three dose cohorts. The efficacy of VYN201 was also evaluated, including its ability to arrest the progression of skin depigmentation and support skin repigmentation in patients with active disease.

Portfolio Pulse from Benzinga Newsdesk

October 30, 2023 | 11:07 am

BMY

The European Medicines Agency (EMA) has validated Bristol Myers Squibb's application for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

Portfolio Pulse from Benzinga Newsdesk

October 30, 2023 | 11:00 am

MNKD

MannKind Corporation has announced a new US patent for its Clofazimine Inhalation Suspension (MNKD-101), which is under development for Nontuberculous Mycobacterial Lung Disease. The patent will expire on June 8, 2039.

Portfolio Pulse from Benzinga Newsdesk

October 30, 2023 | 10:21 am

BYDDF

FXI

LI

NIO

TSLA

VGK

XPEV

Fitch Ratings reports that rising regulatory risks in the EU may hamper the strategy of some global automakers to sell China-made new energy vehicles in the region. This could affect companies like BYD Co Ltd (BYDDF), iShares China Large-Cap ETF (FXI), Li Auto Inc. (LI), NIO Inc. (NIO), Tesla Inc. (TSLA), Vanguard FTSE Europe ETF (VGK), and XPeng Inc. (XPEV).

Portfolio Pulse from Charles Gross

October 30, 2023 | 10:19 am

TPST

Tempest Therapeutics has regained compliance with Nasdaq's $1.00 minimum price rule, according to a formal notification from Nasdaq on October 26, 2023.

Portfolio Pulse from Charles Gross

October 30, 2023 | 10:10 am

FXI

China's Finance Ministry has issued a notice to guide insurance funds for long-term investment, according to a Reuters report.

Portfolio Pulse from Charles Gross

October 30, 2023 | 9:34 am

EWU

FXI

SPY

VGK

China is sending its Vice Minister of Science and Technology, Wu Zhaohui, to a global summit on artificial intelligence in Britain this week, as reported by Reuters.

Portfolio Pulse from Charles Gross

October 30, 2023 | 9:24 am

GOOG

GOOGL

Lawmakers and antitrust regulators are expressing concerns over Google's development of advanced AI products, according to a report by the NY Post. They fear that these developments could further entrench Google's online search monopoly.

Portfolio Pulse from Charles Gross

October 30, 2023 | 9:20 am

FSM

Fortuna Silver Mines Inc. (NYSE:FSM) (TSX:FVI) has received a positive ruling from the Mexican Federal Administrative Court, reinstating the 12-year environmental impact authorization (EIA) for the San Jose Mine. The decision is subject to appeal by SEMARNAT, but the company's operations will remain protected by a permanent injunction.

Portfolio Pulse from Benzinga Newsdesk

October 30, 2023 | 9:13 am