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Regulatory

THMO

ThermoGenesis Corp. has received approval from the China FDA for its 'Cord Blood Separation Device' JQY2301651, manufactured by Beijing Polyongchang Medical Technology Co., Ltd. The device's registration certificate number is National Weapons Injection 20143105298, and the approval was granted on December 8, 2023.

Portfolio Pulse from Benzinga Newsdesk

December 14, 2023 | 2:52 pm

APLS

Apellis Pharmaceuticals Inc (NASDAQ:APLS) is trading lower after being informed of a negative trend vote by the CHMP of the EMA on its marketing application for pegcetacoplan for geographic atrophy. The CHMP is expected to adopt a negative opinion at its January 2024 meeting. Apellis plans to appeal if a negative opinion is adopted. The application was based on Phase 3 studies published in The Lancet, showing reduced lesion growth and a good safety profile. Apellis disclosed safety events related to Syfovre in July. APLS shares are down 17.3% at $52.

Portfolio Pulse from Vandana Singh

December 14, 2023 | 2:35 pm

MVIS

MicroVision expects its FY23 revenue to be near the higher end of its previously issued guidance of $6.5M-$8M, according to a recent SEC filing.

Portfolio Pulse from Benzinga Newsdesk

December 14, 2023 | 2:34 pm

VGK

European Commission President Christine Lagarde stated on CNBC Europe that a recession in the Eurozone is not the baseline forecast, suggesting a more optimistic outlook for the region's economy.

Portfolio Pulse from Benzinga Newsdesk

December 14, 2023 | 2:29 pm

AAPL

GOOGL

The European Commission has requested information from Apple and Google under the Digital Services Act (DSA) to assess their compliance with online marketplace rules and transparency in their App Store and Google Play services. The companies must respond by January 15, 2024, and failure to provide accurate information could result in fines or periodic penalty payments. This action follows their designation as Very Large Online Platforms, which mandates them to mitigate systemic risks and protect users.

Portfolio Pulse from Benzinga Newsdesk

December 14, 2023 | 2:27 pm

TPIC

TPI Composites, Inc. has improved its liquidity by approximately $190 million and reduced future obligations by up to $90 million through a refinancing transaction with Oaktree Capital Management. The agreement involves converting Oaktree's $436 million Series A Preferred Stock into a $393 million senior secured term loan and $43 million in common equity. The term loan's maturity is extended to March 31, 2027, and the company has the option to pay interest in kind until December 31, 2025. The transaction eliminates certain financial covenants and prepayment penalties, enhancing TPI's financial flexibility.

Portfolio Pulse from Benzinga Newsdesk

December 14, 2023 | 2:24 pm

SNES

SenesTech, Inc. (NASDAQ:SNES) has received substantial orders for its new product, EVOLVE Soft Bait, a non-lethal rodent fertility control solution. Launched in November 2023, EVOLVE has seen strong demand, leading to increased production. The product is seen as an alternative to traditional poisons, with some regions like New England considering bans on second-generation anticoagulants (SGARs) due to environmental concerns.

Portfolio Pulse from Benzinga Newsdesk

December 14, 2023 | 2:14 pm

GE

GE Vernova, a segment of GE, has signed a framework agreement with Forestalia to install up to 693 MW of onshore wind turbines in Aragon, Spain. The agreement includes 110 GE 6.1-158 turbines across 16 sites, with the first phase of 33 turbines already in progress. This deal extends GE's wind energy presence in Spain and contributes to the country's energy transition and decarbonization efforts. Deliveries are scheduled to be completed by the end of 2024, and the partnership also includes GE's first European PPA signed in 2022.

Portfolio Pulse from Benzinga Newsdesk

December 14, 2023 | 2:02 pm

GKOS

The FDA has approved Glaukos Corporation's iDose TR, an eye implant for treating intraocular pressure in glaucoma patients. The approval is based on positive Phase 3 trial results. Glaukos plans to start commercial launch in early 2024 with a set price of $13,950 per dose. The company also reaffirmed its 2023 sales guidance and provided a preliminary 2024 sales guidance, which is above consensus estimates. GKOS shares rose 7.58% in premarket trading.

Portfolio Pulse from Vandana Singh

December 14, 2023 | 1:53 pm

GKOS

Glaukos Corporation's stock is trading higher following the announcement of FDA approval for its iDose TR product. The company also provided preliminary net sales guidance for 2024 that exceeded analyst estimates.

Portfolio Pulse from Benzinga Newsdesk

December 14, 2023 | 1:52 pm