Major Pharma Stock Soaring After FDA Approval of Schizophrenia Drug

Good morning. It's September 27th, and today, we’ll look at Bristol Myers Squibb's stock rally after receiving FDA approval for its new Schizophrenia drug, Costco’s disappointing results, and the latest news on Intel’s $8.5B funding from the U.S. government.

Previous Close 📈

Stocks closed higher on Thursday, with the S&P 500 up 0.8%, the Dow Jones rising 0.3%, and the Nasdaq advancing 1.4% for the week. Investors were reassured by strong economic data, including a drop in Initial Jobless Claims and a solid 3% growth rate for second-quarter GDP, signaling a resilient U.S. economy.

Futures

U.S. stock futures are little changed today as traders brace for the release of the Fed’s preferred inflation metric, the PCE Price Index. Dow futures are down 5 points, S&P 500 futures have dipped 0.1%, and Nasdaq 100 futures are down 0.2%. Investors are hoping the data shows inflation cooling, which could influence future Fed policy decisions.

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What to Watch

Several important economic indicators will be released this morning at 8:30 a.m. Eastern, including Personal Income and Personal Spending data for August, the PCE Index for August, and the Advanced U.S. Trade Balance in Goods for August.

Additionally, Advanced Wholesale Inventories and Advanced Retail Inventories for August will be published at the same time.

At 10:00 a.m. Eastern, the final Consumer Sentiment Index for September will be released, providing insights into consumer confidence levels.

Technology

Intel Set to Secure $8.5B in US Chip Funding as Year-End Talks Progress

Intel is moving closer to finalizing $8.5 billion in direct funding from the U.S. government, with an agreement expected by the end of 2024, according to a report from the Financial Times.

The deal is part of the Biden administration's broader effort to enhance domestic semiconductor production. The talks are in advanced stages, though no guarantee has been made for completion within the year.

This funding would provide $8.5 billion in grants, with an additional $11 billion in loans to support Intel's operations in Arizona, where the company plans to build two new factories and upgrade an existing facility.

Intel, once a leader in the chipmaking industry, has recently faced significant challenges, losing ground to competitors like Taiwan Semiconductor Manufacturing Co. and struggling to keep up with demand for artificial intelligence chips.

Reports also surfaced earlier this month that Qualcomm had approached Intel regarding a potential acquisition, further complicating the ongoing negotiations.

Retail

Costco Beats EPS Estimates But Falls Short on Revenue

Costco released its fiscal Q4 results on Thursday, showing mixed outcomes. The company's earnings per share (EPS) beat expectations, coming in at $5.29, surpassing Bloomberg's estimate of $5.07. However, revenue fell slightly short at $79.7 billion, just below the $79.96 billion anticipated by analysts.

The stock is trading at about 1% below its previous closing price during premarket trading today.

Same-store sales growth for the quarter reached 6.9%, exceeding the expected 6.4%, with e-commerce growth at 19.5%, slightly underperforming estimates of 19.63%. Notably, U.S. same-store sales were up 6.3%, while international sales rose 9.3%.

Costco CFO Gary Millerchip attributed the company's performance to increased non-food spending as inflation eased. The company's private-label Kirkland Signature brand continues to grow, and recent price reductions on various items have led to a boost in sales.

Despite a membership fee increase earlier this month, Costco's membership revenue came in at $1.51 billion, falling short of the projected $1.54 billion. Shares of Costco dropped 1.4% in extended trading following the report.

Pharmaceuticals

New Schizophrenia Drug Cobenfy Receives FDA Approval, Sending Bristol Myers Squibb Rallying

The FDA has approved Bristol Myers Squibb’s new drug, Cobenfy, marking the first novel schizophrenia treatment in over seven decades. The news is causing the company’s stock to soar by more than 5% in premarket trading.

Schizophrenia, a chronic mental disorder that affects millions, has had limited treatment options until now. Cobenfy, a twice-daily pill, is expected to be available by late October. The drug offers a new approach by not directly blocking dopamine, a method used by traditional antipsychotic treatments.

Cobenfy’s approval comes as a significant development for the 3 million U.S. adults affected by schizophrenia, many of whom struggle to find effective and tolerable treatments.

Existing medications often lead to patients discontinuing use due to severe side effects. Bristol Myers Squibb’s Chief Medical Officer, Dr. Samit Hirawat, noted that Cobenfy’s formulation could help reduce these issues.

Priced at $1,850 per month before insurance, Cobenfy is in line with current branded treatments, and the company has pledged to offer financial assistance for patients. The drug maker also aims to study the drug's potential for treating conditions such as bipolar mania and Alzheimer’s-related psychosis.

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Establishment Labs Holdings [ESTA] - Last Close: $41.19

Establishment Labs is up 28% in premarket trading today after receiving U.S. FDA approval for its Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast implants for primary and revision breast augmentation.

This FDA approval is expected to elevate the company's market presence, especially with positive results from clinical trials showing low complication rates.

Establishment Labs' expansion into the U.S. market is anticipated to boost growth, aligning with the company's mission to advance women's health and wellness.

NAAS Technology Inc. [NAAS] - Last Close: $3.49

NAAS Technology is seeing a 12% increase before the opening bell today after announcing a strategic partnership with IM Motors, a joint venture focused on high-end intelligent electric vehicles by Alibaba, SAIC Motor, and Zhangjiang Hi-Tech.

This collaboration will integrate NAAS’s extensive EV charging network with IM Motors, providing their customers seamless access to intelligent and convenient charging solutions.

This agreement strengthens NAAS's position as a leading player in China's EV charging service industry, expanding its partnerships with major EV manufacturers like BYD, Geely, and NIO.

Real Good Food Company [RGF] - Last Close: $0.37

Real Good Food Company stock is up by 30% so far in premarket trade following the announcement of new debt refinancing transactions with PMC Financial Services and Emblem Investments Fund I, LP.

The company secured a $60 million term loan from Emblem, using $8 million to repay its existing PMC financing and allocating $52 million for general corporate purposes and transaction fees.

This refinancing provides Real Good Foods with substantial liquidity to enhance its manufacturing capabilities and drive key corporate initiatives aimed at long-term growth.

As part of the deal, the company issued 19.99% of its outstanding equity to Emblem, signaling strong alignment and confidence in the company's future.

CEO Tim Zimmer emphasized that these transactions will strengthen the company's supply chain and help meet growing demand for its health-focused frozen and refrigerated food products.

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Everything Else

• Shigeru Ishiba is set to become Japan's next Prime Minister after winning the LDP leadership vote.

• Zimbabwe slashed the value of gold-backed currency in response to economic pressures.

• Chinese stimulus measures are fueling Alibaba and Tencent gains as the tech index hit a 13-month peak.

• Berlin stepped up its efforts to block UniCredit's advances on Commerzbank.

• UK Retail Sales rebounded in September with further growth expected for October.

• Tokyo Electron is preparing for expansion in India as Modi’s government courts chipmakers.

• ByteDance inked a $10.8 billion loan amid global challenges.

That’s all for today. Thank you for reading. If you have any feedback, please reply to this email.

Best Regards,

— Adam Garcia
Elite Trade Club

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