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BIIB

Biogen Inc. has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for SKYCLARYS, a treatment for Friedreich's Ataxia. This is a significant step towards potential approval and commercialization in the European market.

Portfolio Pulse from Benzinga Newsdesk

December 15, 2023 | 2:07 pm

SCLX

Scilex Holding Company (NASDAQ:SCLX) has announced that a major national pharmacy chain will stock ELYXYB, a non-opioid pain management product for acute migraine treatment, in most of their stores across the U.S. This follows a previous initiative with another leading pharmacy chain and ongoing negotiations with additional chains. ELYXYB is FDA-approved and offers fast, long-lasting relief, addressing unmet needs for patients with insufficient response to triptan therapy or contraindications to its use.

Portfolio Pulse from Benzinga Newsdesk

December 15, 2023 | 2:01 pm

AADI

Aadi Bioscience's stock price has declined following the release of interim results from the PRECISION1 trial of their drug nab-sirolimus.

Portfolio Pulse from Benzinga Newsdesk

December 15, 2023 | 2:01 pm

MRK

NVS

The FDA has approved Merck & Co Inc's (NYSE:MRK) drug Welireg (belzutifan) for advanced renal cell carcinoma (RCC) in patients previously treated with PD-1/PD-L1 inhibitors and VEGF-TKI. This marks the first new treatment class approved for advanced RCC since 2015. The approval is based on the LITESPARK-005 trial results, where Welireg showed superior progression-free survival (PFS) and objective response rate (ORR) compared to Novartis AG's (NYSE:NVS) Afinitor (everolimus). MRK shares rose 0.58% in premarket trading.

Portfolio Pulse from Vandana Singh

December 15, 2023 | 1:59 pm

FSR

SGRY

VRCA

Verrica Pharmaceuticals' partner Torii Pharmaceutical announced positive Phase 3 trial results for TO-208 in Japan, boosting VRCA shares by 52%. Fisker released the final 2023 over-the-air software update for the Fisker Ocean, with plans for regular updates in 2024, increasing FSR shares by 11%. Surgery Partners' stock fell by 6% after announcing a proposed secondary offering of common stock.

Portfolio Pulse from ryanfaloona@benzinga.com

December 15, 2023 | 1:47 pm

NIO

TSLA

Nio (9866.HK) plans to launch its more affordable Firefly brand in Europe by 2025, targeting family-oriented consumers with smaller models. The move comes as Chinese EV makers seek to expand in Europe amid slowing domestic demand and a cost advantage over Western competitors. However, the EU is scrutinizing Chinese EV imports for potential competition rule breaches. Nio, facing increased losses due to a price war initiated by Tesla (TSLA.O) and higher production costs, has reduced its workforce by 10% and is exploring spin-offs and partnerships to reduce expenses. Partnerships with Geely (0175.HK) and Changan Automobile (000625.SZ) aim to develop a new battery pack and chassis architecture.

Portfolio Pulse from Benzinga Newsdesk

December 15, 2023 | 1:39 pm

INTC

MSFT

NVDA

Microsoft Corp (NASDAQ:MSFT) is advancing in AI chipmaking with its new Maia 100 chip, which utilizes liquid cooling, a more efficient method than traditional air cooling. This shift is driven by the need to manage the heat from power-intensive AI chips, like Nvidia Corp's (NASDAQ:NVDA) H100 AI accelerator. Microsoft plans to install Maia chips and cooling hardware in data centers from 2024, with Azure expanding liquid cooling operations. Intel Corp (NASDAQ:INTC) is also exploring liquid cooling and has updated policies to support customer-created liquid cooling systems. The move towards liquid cooling is crucial for data center evolution, especially for AI demands. Equinix plans to use warm water outflow for heating at the 2024 Paris Olympics. MSFT shares saw a slight increase in premarket trading.

Portfolio Pulse from Anusuya Lahiri

December 15, 2023 | 1:37 pm

AMZN

Jeff Bezos, founder of Amazon.com, Inc. (NASDAQ:AMZN) and Blue Origin, discussed his feelings and thoughts when he left his job in New York to start Amazon during a podcast interview with Lex Fridman. Bezos acknowledged the low odds of success at the time, estimating them at 30%, and emphasized the need for a balance between realism and optimism in startups. Despite challenges, Bezos expressed gratitude for the journey with Amazon, which now has a market cap of $1.537 trillion. The company's stock has seen tremendous growth since its IPO in 1997.

Portfolio Pulse from Ananya Gairola

December 15, 2023 | 1:30 pm

TAK

Takeda Pharmaceutical Company Limited has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for HYQVIA as a maintenance therapy for patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The European Commission will review this opinion for potential marketing authorization in the EU. HYQVIA is an up to once-monthly subcutaneous treatment that can be administered at home or in-office. The CHMP's positive opinion is based on the Phase 3 ADVANCE-CIDP 1 study, which met its primary endpoint by showing a statistically significant reduction in the relapse rate of CIDP patients.

Portfolio Pulse from Benzinga Newsdesk

December 15, 2023 | 1:23 pm

TSLA

Univision has claimed copyright on a YouTube video featuring Tesla's Gen 2 Optimus robot, which has led to a response from Elon Musk. Farzad Mesbahi, a former Tesla employee and stockholder, posted a video including the Optimus bot, and received a copyright notice from Univision. Mesbahi and others have been prevented from monetizing their content due to this claim. Tesla's Gen 2 Optimus robot has been upgraded with faster walking speed, lighter weight, and improved body control, including hands capable of delicate tasks.

Portfolio Pulse from Anan Ashraf

December 15, 2023 | 1:22 pm