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SRPT

Sarepta Therapeutics has submitted an efficacy supplement to the FDA to expand the label for ELEVIDYS to include Duchenne Muscular Dystrophy patients without restrictions on age or ambulatory status. This could potentially increase the patient population eligible for treatment with ELEVIDYS.

Portfolio Pulse from Benzinga Newsdesk

December 22, 2023 | 1:02 pm

NVO

The FDA and Novo Nordisk have warned of counterfeit Ozempic in the U.S. market. Thousands of units of the diabetes drug have been seized, with confirmed counterfeit components including needles, pen labels, and packaging. The FDA has identified a specific lot and serial number to avoid and is investigating five non-serious adverse events related to the counterfeit product. High demand for Ozempic and Wegovy has led to supply restrictions and the emergence of knockoffs. Novo Nordisk's stock (NVO) fell slightly in premarket trading.

Portfolio Pulse from Vandana Singh

December 22, 2023 | 12:52 pm

AZN

IONS

The FDA has approved AstraZeneca and Ionis Pharmaceuticals' Wainua (eplontersen) for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Wainua is unique as it can be self-administered via an auto-injector. The approval is based on positive results from the NEURO-TTRansform Phase 3 trial. The companies plan to commercialize Wainua in the U.S. and seek approval in other regions. Analysts estimate peak sales could reach $3.5 to $7 billion with expanded approval. IONS shares rose 7% and AZN shares increased 0.47% in premarket trading.

Portfolio Pulse from Vandana Singh

December 22, 2023 | 12:49 pm

TSLA

Tesla Inc (NASDAQ:TSLA) has acquired land in Shanghai for a new Megapack battery factory, with construction expected to start in Q3 and production by mid-2024. The factory will have a capacity of 10,000 megapacks per year, complementing Tesla's energy generation business which grew 40% to $1.6 billion in Q3. Megapacks store energy to stabilize the grid, with each unit capable of powering 3,600 homes for an hour.

Portfolio Pulse from Anan Ashraf

December 22, 2023 | 12:12 pm

ASML

INTC

SSNLF

TSM

ASML Holding NV has started shipping components for its new high-NA EUV lithography machine to Intel Corp's D1X factory in Oregon. This move is part of Intel's strategy to lead in manufacturing technology and ASML's effort to sustain the chip industry's dependence on its equipment. The first model, Twinscan EXE:5200, costs around $275 million, with a more advanced model expected to be more expensive. Intel aims to begin production with this system in 2025. ASML's stock rose 3.52% to $755.27 following the news.

Portfolio Pulse from Anusuya Lahiri

December 22, 2023 | 12:09 pm

TSLA

Tesla Inc (NASDAQ:TSLA) is offering a 50% discount on supercharging at select locations in Australia during off-peak hours this holiday season. The promotion is available to Tesla and other EV drivers between December 22, 2023, and January 7, 2024, before 9 am and after 9 pm. Customers can find details on the Tesla app or vehicle touchscreens. Additionally, Tesla's annual 'holiday update' for its vehicles has begun rolling out, featuring new software enhancements such as a trip planner, Apple podcasts, and automatic 911 calls.

Portfolio Pulse from Anan Ashraf

December 22, 2023 | 12:04 pm

ACM

AECOM announced it has been selected as the delivery partner for the Eglinton Crosstown West Extension project in Toronto, which is a significant infrastructure development. This selection is likely to have a positive impact on AECOM's future revenue and business prospects.

Portfolio Pulse from Benzinga Newsdesk

December 22, 2023 | 11:58 am

KGEI

Kolibri Global (KGEI) forecasts FY23 revenue of $51M-$53M, a 36%-41% increase YoY, and adjusted EBITDA of $39M-$41M, up 55%-63% YoY. The company also expects average production to rise by 71%-83% YoY to 2,800-3,000 boepd.

Portfolio Pulse from Benzinga Newsdesk

December 22, 2023 | 11:56 am

AAPL

Beeper, a chat app developer, is facing constant disruptions from Apple Inc. (NASDAQ:AAPL), leading to a strategic shift. Beeper Mini, which aimed to bridge iMessage between iPhone and Android users, has been affected by Apple's interference, causing reputational damage for Beeper. As a response, Beeper is making its iMessage connection software open-source and focusing on long-term goals. This follows a series of service disruptions and calls for an antitrust investigation into Apple's actions against Beeper Mini.

Portfolio Pulse from Benzinga Neuro

December 22, 2023 | 11:55 am