Streetbeat News

Regulatory

TSLA

Tesla Inc (NASDAQ:TSLA) has informed customers that the lowered range estimates for some of its vehicles are due to 'comfort and functionality improvements' and changes in the EPA's range testing guidance. The updated guidance aims to reflect real-world range more accurately. This has led to a decrease in the range for certain Model S and X variants by up to 37 miles, and a nearly 20-mile reduction for higher-end Model Y versions. Customers with pending orders are urged to update their configurations by January 10th or face order cancellation.

Portfolio Pulse from Anan Ashraf

January 08, 2024 | 2:46 am

ANNX

Annexon, Inc. (NASDAQ: ANNX) has outlined its strategic priorities for 2024, focusing on late-stage clinical milestones for its complement-based medicines targeting autoimmune, ophthalmic, and neurodegenerative diseases. The company is on track to report Phase 3 data for ANX005 in Guillain-Barré syndrome (GBS) in the first half of 2024, which could become the first approved treatment for GBS in the U.S. ANX007's global pivotal program for geographic atrophy (GA) is set to initiate in mid-2024, and ANX1502's clinical proof-of-concept study for autoimmune diseases will begin in the first half of 2024. Annexon's recent $125 million financing extends its operating runway into Q2 2026.

Portfolio Pulse from Benzinga Newsdesk

January 08, 2024 | 1:22 am

ASND

Ascendis Pharma A/S (NASDAQ:ASND) introduced Vision 2030 and selected 2024 corporate milestones. The company expects ~€400M in cash and securities as of December 31, 2023, and forecasts 2024 SKYTROFA revenue of €320M-€340M. SKYTROFA is approved in the U.S. and EU for growth hormone deficiency. Ascendis plans to submit applications for other products in 2024 and aims to achieve blockbuster status for multiple products. The company will present at the J.P. Morgan Healthcare Conference and expects to be operating cash flow breakeven by end of 2024.

Portfolio Pulse from Benzinga Newsdesk

January 08, 2024 | 1:16 am

ALK

BA

SPR

Boeing is set to hold a company-wide webcast on safety on Tuesday in response to a recent safety event involving Alaska Airlines. The webcast aims to address Boeing's response to the incident and reinforce the company's commitment to safety.

Portfolio Pulse from Charles Gross

January 08, 2024 | 12:57 am

EXAS

Exact Sciences Corp. (EXAS) reported preliminary Q4 2023 revenue of $645.5M-$647.5M, surpassing estimates of $631.52M. Full-year 2023 revenue is expected to be $2.4985B-$2.5005B, exceeding the $2.48B estimate. For FY24, revenue is projected to match estimates at $2.83B. The company also announced the submission of the next-generation Cologuard to the FDA and a CFO succession plan, with Jeff Elliott stepping down and a search for a new CFO underway.

Portfolio Pulse from Benzinga Newsdesk

January 07, 2024 | 10:22 pm

LMDX

LumiraDx Limited (NASDAQ:LMDX) announced that its securities will be suspended from Nasdaq trading on January 9, 2024, due to non-compliance with listing standards. The company had previously been warned about delisting for failing to meet the minimum bid price requirement. LumiraDx's appeal was withdrawn following the appointment of administrators for two subsidiaries and the sale of certain assets to Roche. Nasdaq confirmed the withdrawal and the upcoming suspension of trading.

Portfolio Pulse from Benzinga Newsdesk

January 07, 2024 | 8:24 pm

RETO

ReTo Eco-Solutions, Inc. received a notification from Nasdaq for not complying with the minimum stockholders' equity requirement for continued listing. The company reported a negative stockholders' equity of approximately $0.83 million as of June 30, 2023. ReTo has 45 days to submit a compliance plan to Nasdaq to maintain its listing, with a possible extension of up to 180 days.

Portfolio Pulse from Benzinga Newsdesk

January 07, 2024 | 8:22 pm

AAPL

AMZN

GOOGL

MSFT

Apple Inc. (AAPL) faces multiple challenges including a potential fifth consecutive quarter of sales decline, late entry into AI, and regulatory scrutiny of the App Store. Bloomberg's Mark Gurman suggests that while iPhone sales, especially in China, are concerning, they are not Apple's biggest challenge. Apple's AI tools are expected to be unveiled at the WWDC in June but may lag behind competitors like Microsoft, Alphabet, and Amazon. The App Store is also facing regulatory challenges in the EU, which could lead to revenue decline and increased competition.

Portfolio Pulse from Shanthi Rexaline

January 07, 2024 | 8:20 pm

IDYA

IDEAYA Biosciences, Inc. (NASDAQ:IDYA) reported a strong balance sheet with $511.1M in cash and securities as of September 30, 2023. The company expects the funds, including $134.7M from follow-on financing and $10M receivable from GSK, to support operations into 2028. IDEAYA announced updates at the J.P. Morgan Healthcare Conference, including international patient enrollment in a Phase 2/3 trial for darovasertib and crizotinib, and various clinical program updates for 2024. The company is also advancing collaborations with GSK and targeting IND submissions and new development candidate nominations in 2024.

Portfolio Pulse from Benzinga Newsdesk

January 07, 2024 | 8:15 pm

VRTX

Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) provided updates on its pipeline and business operations before the 42nd Annual J.P. Morgan Healthcare Conference. Key highlights include the launch of CASGEVY in the U.S., UK, and Bahrain, completion of pivotal studies for cystic fibrosis treatments, and progress in studies for sickle cell disease, acute pain, peripheral neuropathic pain, kidney disease, type 1 diabetes, and myotonic dystrophy. Vertex also revised patient estimates for cystic fibrosis and sickle cell disease. The company expects to share study results and advance various programs in 2024.

Portfolio Pulse from Benzinga Newsdesk

January 07, 2024 | 8:06 pm