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Regulatory

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 LumiraDx's appeal was withdrawn following the appointment of administrators for two subsidiaries and the sale of certain assets to Roche.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

ASND

Specialised Therapeutics Asia has signed an exclusive agreement with Ascendis Pharma to distribute and commercialize three endocrinology therapies in Australia and select South-East Asia countries. The therapies include SKYTROFA for paediatric growth hormone deficiency, YORVIPA for hypoparathyroidism, and TransCon CNP for achondroplasia. The agreement covers Australia, New Zealand, Singapore, Malaysia, Brunei, Thailand, and Vietnam. Two of the products are already internationally approved.

Portfolio Pulse from Charles Gross

January 07, 2024 | 7:34 pm

ALK

SPR

VGK

The European Union Aviation Safety Agency (EASA) has adopted the FAA's emergency airworthiness directive for the Boeing 737-9, stating that no EU operators are affected by this directive.

Portfolio Pulse from Charles Gross

January 07, 2024 | 3:30 pm

BLK

BTCUSD

SHIBUSD

The first week of 2024 saw mixed expectations for a Bitcoin ETF approval by the SEC, with only 39% of financial advisors confident in an approval this year. BlackRock, VanEck, and Valkyrie Investments are awaiting the SEC's decision on their Bitcoin ETF applications. Economist Peter Schiff warned that the market might be disappointed by the outcome. Shiba Inu's burn rate surged by 373%, indicating a cautiously optimistic outlook for 2024. Crypto analysts highlighted the importance of Bitcoin and other cryptocurrencies like Solana and Ethereum, with the upcoming Bitcoin halving event also being a point of focus.

Portfolio Pulse from Benzinga Neuro

January 07, 2024 | 2:07 pm

ALK

SPR

SPY

The FAA has issued a temporary grounding order for certain Boeing 737 Max 9 aircraft operated by U.S. airlines or within U.S. territory. This action may affect the operations of airlines using this aircraft model and could have implications for Boeing's stock as well as its suppliers and the broader market.

Portfolio Pulse from Charles Gross

January 07, 2024 | 3:01 am