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Regulatory

MIST

Milestone Pharmaceuticals Inc (NASDAQ:MIST) stock is plummeting after the FDA issued a Refusal to File letter for the NDA of etripamil nasal spray for PSVT. The FDA's preliminary review found the NDA, submitted in October 2023, incomplete for substantive review, specifically requesting clarification on adverse event data timing in Phase 3 trials. While no concerns about the severity of adverse events were raised, Milestone is planning to meet with the FDA for clarification. MIST shares dropped 32.30% to $1.95.

Portfolio Pulse from Vandana Singh

December 26, 2023 | 2:53 pm

EPOW

Sunrise New Energy's subsidiary, Sunrise New Energy Materials Co, received preliminary approval for a sodium-ion battery hard carbon composite material patent from the National Intellectual Property Office. The patent, titled 'Fiber-Structured Titanium-Doped Amorphous Carbon Coated Silver Hard Carbon Composite Material and the Preparation Method,' is documented under number 2023121501155630 and relates to sodium-ion battery material preparation.

Portfolio Pulse from Benzinga Newsdesk

December 26, 2023 | 2:30 pm

BCLI

Brainstorm Cell Therapeutics' stock is up following the announcement of granted patents for its Allogeneic Exosome Platform-Product, aimed at treating neurological disorders.

Portfolio Pulse from Benzinga Newsdesk

December 26, 2023 | 2:07 pm

AAPL

MASI

The Biden Administration has upheld a U.S. trade tribunal's decision to ban imports of certain Apple Watch models. Apple has responded by filing an appeal to the U.S. Appeals Court to overturn the import ban.

Portfolio Pulse from Happy Mohamed

December 26, 2023 | 2:06 pm

AMD

INTC

NVDA

QQQ

SPY

SSNLF

TSM

Nvidia Corp (NVDA) is outperforming peers AMD and INTC, with expected FY23 revenue of $58.86 billion, a 118% increase year-on-year. However, production delays at key suppliers TSMC (TSM) and Samsung (SSNLF) in their Arizona and Texas plants may impact Nvidia. These plants may be delayed until after the 2024 U.S. presidential election. Additionally, a U.S. Department of Commerce survey in 2024 on legacy chip sourcing could pose risks for Nvidia's China market. Chinese companies are also developing AI products to circumvent U.S. technology embargoes. NVDA stock has gained over 241% year-to-date, outpacing gains by AMD, INTC, SPY, and QQQ.

Portfolio Pulse from Anusuya Lahiri

December 26, 2023 | 2:04 pm

AMGN

Amgen announced that the FDA has completed its review of the supplemental New Drug Application for full approval of LUMAKRAS (sotorasib), resulting in a Complete Response Letter. The FDA issued a new postmarketing requirement for an additional confirmatory study to be completed by February 2028. The FDA confirmed the dosing of LUMAKRAS at 960 mg once-daily for patients with KRAS G12C-mutated NSCLC under accelerated approval. Over 15,000 patients have received LUMAKRAS worldwide through various programs.

Portfolio Pulse from Happy Mohamed

December 26, 2023 | 2:03 pm

GRCL

HOLI

NVDA

SSYS

TSLA

USDT-USD

Sam Altman's Worldcoin outperformed Bitcoin and Ethereum during Christmas as technical indicators turned bullish. Tether issued $1B USDT on Ethereum's network. Solana surpassed $100 with increased network activity, and Dogecoin's growing addresses could signal a rally. Over 90,000 Bitcoin wallets are now worth $1M+. The SEC is in talks with major players regarding a Bitcoin ETF. US markets saw pre-market movement in stocks like Gracell Biotechnologies, Stratasys, and Hollysys Automation Technologies. The FBI is concerned about China's AI misuse for espionage. In tech, Nvidia is poised to become the biggest chipmaker by revenue, and Tesla's stock rebounded post-Christmas. An AI startup backed by LVMH can verify the authenticity of Louis Vuitton bags.

Portfolio Pulse from Akanksha Bakshi

December 26, 2023 | 1:55 pm

MIST

Milestone Pharmaceuticals' stock is trading lower following the FDA's Refusal to File letter for the New Drug Application of etripamil nasal spray, intended to treat paroxysmal supraventricular tachycardia.

Portfolio Pulse from Benzinga Newsdesk

December 26, 2023 | 1:55 pm

SXTP

60 Degrees Pharmaceuticals shares have risen following the announcement of IRB approval for a Phase IIA clinical study of tafenoquine for babesiosis.

Portfolio Pulse from Benzinga Newsdesk

December 26, 2023 | 1:39 pm

ZKIN

ZK International Group Co., Ltd. (NASDAQ:ZKIN) has resolved its Nasdaq bid price deficiency and is now in compliance with Nasdaq's minimum bid price requirement. The company's stock price remained above $1.00 for 10 consecutive business days, satisfying the Nasdaq Capital Market's Listing Rule 5550(a)(2). The Nasdaq Listing Qualifications Panel will continue listing ZKIN's securities, and the company has acknowledged the assistance of Donohoe Advisory Associates LLC in this matter.

Portfolio Pulse from Happy Mohamed

December 26, 2023 | 1:33 pm