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MESO

Mesoblast Limited (NASDAQ:MESO) stock surged 17.2% in premarket trading after announcing FDA support for an accelerated approval pathway for rexlemestrocel-L for end-stage ischemic heart failure with reduced ejection fraction (HFrEF) and a left ventricular assist device (LVAD). The LVAD-MPC Study #2 showed significant benefits of rexlemestrocel-L over placebo in reducing mortality and improving weaning off LVAD support. Mesoblast plans to request a pre-BLA meeting with the FDA to discuss accelerated approval filing.

Portfolio Pulse from Vandana Singh

March 11, 2024 | 1:24 pm

MFG

MUFG

NMR

SMFG

Japanese bank stocks are trading lower following the Nikkei's decline after Japan's Q4 GDP revision upwards, indicating avoidance of a technical recession. This has led to increased expectations that the Bank of Japan might shift from negative interest rates.

Portfolio Pulse from Benzinga Newsdesk

March 11, 2024 | 1:21 pm

NVAX

Novavax, Inc. announced that the Canada National Advisory Committee has published a recommendation for the use of Novavax's Nuvaxovid XBB.1.5 COVID-19 vaccine. The recommendation states that Nuvaxovid XBB.1.5 can be used in both unvaccinated or previously vaccinated individuals aged 12 years and older.

Portfolio Pulse from Benzinga Newsdesk

March 11, 2024 | 1:21 pm

LUMN

Lumen Technologies, Inc. (NYSE:LUMN) has initiated a consent solicitation to amend indentures and facilitate the completion of transactions under a previously disclosed transaction support agreement (TSA). The company aims to close the TSA transactions by the end of the month, pending the satisfaction of remaining conditions. Guggenheim Securities, LLC and Wachtell, Lipton, Rosen & Katz are advising Lumen on the TSA.

Portfolio Pulse from Benzinga Newsdesk

March 11, 2024 | 1:16 pm

LOPE

The Arizona State Approving Agency for the Department of Veterans Affairs has concluded a risk-based audit of Grand Canyon University with no findings, indicating no issues were discovered during the audit.

Portfolio Pulse from Benzinga Newsdesk

March 11, 2024 | 1:09 pm

APRE

DUO

MESO

Fangdd Network (DUO) shares surged 151% following the announcement of its 2024 strategic plan to enter the real estate stock asset services sector. Mesoblast Limited (MESO) saw a 52% increase in its shares after the FDA supported an accelerated approval pathway for Rexlemestrocel-L for end-stage heart failure patients with LVAD. Aprea Therapeutics (APRE) shares jumped 91% after announcing FDA clearance for APR-1051 and a private placement financing deal worth up to $34 million.

Portfolio Pulse from ryanfaloona@benzinga.com

March 11, 2024 | 12:40 pm

APRE

Aprea Therapeutics' stock is trading higher following the FDA's clearance of its Investigational New Drug (IND) application for APR-1051. Additionally, the company has secured private placement financing of up to $34 million.

Portfolio Pulse from Benzinga Newsdesk

March 11, 2024 | 12:38 pm

NRXP

NRx Pharmaceuticals, Inc. (NRXP) and its subsidiary HOPE Therapeutics have completed a Memorandum of Understanding with Conversio Health and established a partnership with Nephron Pharmaceuticals for the distribution of IV Ketamine. This collaboration aims to provide a consistent supply of high-quality, FDA- and DEA-compliant IV ketamine to patients and clinics nationwide. The company is preparing for the initial sale of ketamine by the end of March 2024 and plans to file a New Drug Application (NDA) for HTX-100, with a potential launch in early 2025.

Portfolio Pulse from Benzinga Newsdesk

March 11, 2024 | 12:36 pm

BTCUSD

ETHUSD

A trader predicts Bitcoin could reach $89,000 soon if it closes above $73,000 today, citing USDT minting and ETF inflows as positive signs. The UK's Financial Conduct Authority's decision to allow cryptocurrency-linked ETP filings and the upcoming Bitcoin halving event are also seen as bullish indicators. Ethereum also saw gains, crossing the $4,040 mark.

Portfolio Pulse from Murtuza Merchant

March 11, 2024 | 12:32 pm

FXI

SPY

China has requested banks to increase financing support for the state-backed real estate giant, China Vanke, and urged creditors to consider extending the maturity of private debt, according to Reuters.

Portfolio Pulse from Benzinga Newsdesk

March 11, 2024 | 12:20 pm