Morning Brew: FDA Warning Shakes IOVA, Crypto Stocks Surge, and Tesla Prepares Model Y Revamp

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Shares of Iovance Biotherapeutics (IOVA, Financial) plummeted nearly 22% in pre-market trading after the FDA placed a clinical hold on its phase 2 trial for a lung cancer therapy, following a fatal adverse event. The company is investigating the incident, which may be related to the trial's pre-conditioning regimen.

Cryptocurrency-related stocks outperformed the actual cryptocurrencies with BIT Mining (BTCM, Financial), Bit Digital (BTBT, Financial), Greenidge Generation (GREE, Financial), Marathon Digital (MARA, Financial), and Hut 8 (HUT, Financial) all posting significant gains in pre-market trading. This surge comes amid investor optimism for a potential SEC approval of a spot bitcoin ETF and expectations of declining U.S. interest rates in 2024.

The New York Times Company (NYT, Financial) has initiated a lawsuit against Microsoft (MSFT, Financial) and OpenAI, alleging copyright infringement through the use of the newspaper's content to train AI models without permission or compensation. Both NYT and MSFT stocks showed little movement in pre-market trading following the news.

Fisker (FSR, Financial) celebrated the delivery of its first Fisker Ocean Sport electric SUV to a UK customer, marking a significant step in its global sales and delivery strategy. The Ocean Sport, a competitor to Tesla's (TSLA, Financial) Model Y, saw Fisker's shares rise by approximately 2% in pre-market trade.

First Wave BioPharma (FWBI, Financial) saw its shares soar over 107% after announcing plans to sell its niclosamide program, which is in development for treating inflammatory bowel diseases. The deal includes an upfront payment and potential future milestones and royalties.

Eli Lilly (LLY, Financial) completed its acquisition of Point Biopharma (PNT, Financial) for $1.4 billion, with the tender offer for Point's shares concluding after several extensions. The purchase strengthens Eli Lilly's portfolio in cancer drug development.

Tesla (TSLA, Financial) is reportedly preparing to launch a revamped version of its Model Y from its Shanghai plant, aiming to compete more effectively with Chinese auto manufacturers. The updated Model Y is expected to begin mass production in mid-2024, featuring significant design changes.

Apple (AAPL, Financial) design chief for the iPhone and Apple Watch, Tang Tan, is set to join Sir Jony Ive's design firm LoveFrom, where he will work on AI hardware projects. Apple's shares remained stable following the announcement.

Coherus BioSciences (CHRS, Financial) experienced a 36.4% surge in its stock after the FDA approved an on-body injector version of its biosimilar Udenyca. Bit Digital (BTBT, Financial) also saw its shares rise by 9.1% after revealing plans to double its Bitcoin mining fleet in 2024.

The FDA issued a warning letter to Amazon (AMZN, Financial) for selling products containing undisclosed and potentially harmful pharmaceutical ingredients. The products, marketed as energy supplements, contained sildenafil and tadalafil, which could dangerously interact with nitrates found in some prescription drugs.

Main Street Capital (MAIN, Financial) announced the completion of a $43.2M investment in Pinnacle Plastics and Integrity Plastics, which includes a combination of debt and equity, as well as a revolving line of credit to support growth. MAIN shares traded slightly higher pre-market.

Cytokinetics (CYTK, Financial) shared positive Phase 3 data for its heart disease therapy, aficamten, leading to a pre-market stock increase of around 43%. The trial showed significant improvements in exercise capacity and other secondary endpoints for patients with obstructive hypertrophic cardiomyopathy.

Anthropic, an AI startup, is projecting over $850M in annualized revenue by the end of 2024. The company, which has ties to former OpenAI executives, is in talks to raise $750M in a funding round that could value it at over $18B.

Disclosures

I/We may personally own shares in some of the companies mentioned above. However, those positions are not material to either the company or to my/our portfolios.