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Mesoblast Gets FDA Approval for New Ryoncil Potency Assay

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Mesoblast (MESO) said Thursday that the US Food and Drug Administration approved a new potency assay, T-cell Proliferation Inhibition BioAssay, for release and stability monitoring of all new commercial Ryoncil lots.

The assay will be used alongside existing potency tests to detect potential shifts in product potency resulting from manufacturing process changes or production at new facilities, the company said.

Mesoblast said the assays are intended to ensure Ryoncil remains consistent and potent and meets the requirements of its biologics license, it added.

Mesoblast shares were up 5.9% in premarket activity.

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Everpure Reaffirms Fiscal 2027 Guidance, Sets 2028 Forecast

Everpure (P) said late Wednesday it reaffirmed its fiscal 2027 adjusted operating income guidance of $940 million to $960 million on revenue of $5.03 billion to $5.07 billion.Analysts polled by FactSet expect $959.8 million and $5.05 billion, respectively.The company also expects fiscal 2028 adjusted operating income of $1.7 billion to $1.9 billion on revenue of $7 billion to $7.3 billion.Analysts expect $1.32 billion and $6.19 billion, respectively.Shares of Everpure rose about 7% during after-hours trading.

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NeoVolta Fiscal Q4 Loss Widens, Revenue Falls; Shares Drop After Hours

NeoVolta (NEOV) reported a fiscal Q4 loss late Wednesday of $0.24 per diluted share, widening from the loss of $0.05 a year earlier.Analysts polled by FactSet expected a loss of $0.09.Revenue in the three months ended June 30 fell to $13,460 from $4.75 million a year earlier.Analysts projected $1.3 million.NeoVolta shares fell 5.4% in after-hours trading.

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Top Cryptocurrencies Fall; Bitcoin Drops Below $85,000 Level

Top cryptocurrencies fell Wednesday, with Bitcoin (BTC-USD) dropping below the $85,000 Level.The CoinDesk Market Index, which tracks dozens of digital assets including Bitcoin, fell 3.4% in the past 24 hours. The Nasdaq 100 shed 0.9%, the S&P 500 lost 0.8%, and the Dow Jones Industrial Average declined 0.6%.Bitcoin fell 2% to $84,527, according to CoinMarketCap data. The most popular cryptocurrency's 24-hour trading volume rose 9.3% to $46.85 billion.Ethereum (ETH-USD), the second-largest digital asset by market value, declined 2.7% to $2,677.XRP (XRP-USD) lost 5.2%, BNB (BNB-USD) slumped 2.4%, and Solana (SOL-USD) shed 2.9%. Dogecoin (DOGE-USD) dropped 7.3%, and Cardano (ADA-USD) decreased 5.3%.The total market value of the cryptocurrency industry fell 2.3% in the past 24 hours to $2.87 trillion, with trading volume rising 11.2% to $130.57 billion.Price: $84527.49, Change: $-1667.79, Percent Change: -1.93%

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