Hello Part-time Trader…👋

Premium Stock Alerts is here with your pre-market cheat sheet. In today's issue, we delve into:

• Fed's Latest Announcements: Understand the Federal Reserve's recent decisions and economic outlook, and how they might influence the markets.

• Volume Anomalies: Identify stocks witnessing unusual trading volumes, pointing to potential opportunities or risks.

• Top Pre-Market Movers: Identify early winners poised for a strong market opening.

• Market Indices & Sector Overview: Get a snapshot of key market indices and sector performances to gauge the day's potential trends.

• FDA Approvals & Upcoming Decisions: Keep an eye on the latest FDA approvals and crucial upcoming decisions affecting biotech and pharmaceutical stocks.

Now, let's dive into today's edition for a closer look at the insights and analysis that will shape your trading decisions.

Happening Today

✓ 08:30 AM ET – Continuing Jobless Claims

✓ 08:30 AM ET – Core PCE Prices (Q1)

✓ 08:30 AM ET – GDP (QoQ) (Q1)

✓ 08:30 AM ET – Initial Jobless Claims

✓ 11:00 AM ET – Crude Oil Inventories

PREMARKET SNAPSHOT 📈

Stock futures point lower with S&P 500 down 0.74%, Dow Jones off 1.06%, and Nasdaq slipping 0.70%.

SECTOR SNAPSHOT ✨

Broad market sell-off with Healthcare leading the plunge, while IT and Energy defy the trend with modest gains.

Unusual Volume

📈 Banner Corporation (BNAI): Up 107.87% with heavy volume of 108.22 million shares traded. BNAI announced that Co-CEO Paul Chang will present at the Maxim Group’s 2024 Virtual Tech Conference (Charting the Course: Navigating the Intersection of TMT and Business in the AI Era).

📈 Chris Craft Holdings (CCG): Up 8.27% with significant volume of 31.39 million shares traded. CCG announced its unaudited financial results for the first quarter ended March 31, 2024.

📈 Greatview Housing Group (GVH): Down 10.06% with unusual volume of 20.02 million shares traded. E-commerce logistics provider Globavend (GVH) eyes expansion in Australia with potential investment in Top Logistics.

📈 Rockwell Medical Inc. (RSLS): Up 34.74% with high volume of 212.55 million shares traded. Reshape Lifesciences (RSLS) soars on heavy volume despite no company news, potentially due to its penny stock status.

Premarket Movers

Foot Locker, Inc. (FL) is trading at $25.67 with a gain of +$3.15 (+13.99%) in Pre-Market at 7:51 AM EDT after reporting Q1 results: total sales decreased 2.8%, comparable sales decreased 1.8%, EPS of $0.09, non-GAAP EPS of $0.22, inventory decreased 5.6% YoY, and reaffirming 2024 EPS outlook.

Smart for Life Inc. (SMFL) stock surged by 71.61% to $6.71 in pre-market trading after the company announced significant updates on the successful completion of its comprehensive restructuring program.

Burlington Stores, Inc. (BURL) is trading at $225.30 with a gain of +$24.94 (+12.45%) in Pre-Market at 7:57 AM EDT after Q1 2024 earnings: total sales up 11%, net income $79M, EPS $1.22, comparable sales up 2%, adjusted EPS up 68% to $1.42, and raising FY24 adjusted EPS outlook to $7.35-$7.75.

Important FDA 

Recently Announced

The FDA has been particularly active in recent weeks, delivering a mix of outcomes for biotech companies seeking approval for their innovative treatments.

Abeona Therapeutics Inc. (ABEO) On April 22, 2024, Abeona Therapeutics faced a hurdle as the FDA issued a Complete Response Letter for Pz-cel, their treatment for recessive dystrophic epidermolysis bullosa. This decision signifies that more information or modifications are required before the drug can gain approval.

Novo Nordisk A/S (NVO) On May 24, 2024, an FDA panel reviewed Awiqli (Insulin Icodec), a diabetes treatment for adults proposed by Novo Nordisk. The panel voted 7-to-4 against recommending approval, representing a significant setback for the company’s diabetes treatment lineup.

Bristol-Myers Squibb Co. (BMY) There was positive news on May 16, 2024, for Bristol-Myers Squibb. The FDA approved Breyanzi for the treatment of relapsed or refractory follicular lymphoma. This approval broadens the therapeutic options available to patients fighting this form of cancer.

 Announcing Today

AstraZeneca PLC (AZN.L, AZN) & Daiichi Sankyo Company Limited (DSKYF.PK) Both AstraZeneca and Daiichi Sankyo are awaiting the FDA's decision today, May 30, 2024, regarding the expanded use of Enhertu. This drug is proposed for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumors. The approval could significantly advance treatment options for these patients, as Enhertu is already approved in other countries for similar uses.

Upcoming Announcements

Catalyst Pharmaceutical Partners Inc. (CPRX) Catalyst Pharmaceutical Partners is awaiting an FDA decision on June 4, 2024, regarding their request to increase the indicated maximum daily dosage of Firdapse Tablets from 80mg to 100mg for the treatment of Lambert-Eaton myasthenic syndrome. This decision is crucial for enhancing treatment options for patients with this rare neurological disorder.

GSK plc (GSK.L, GSK) Looking ahead, GSK is anticipating a critical FDA decision on June 7, 2024. The agency will decide on the extension of the indication for AREXVY, an adjuvanted respiratory syncytial virus (RSV) vaccine, to adults aged 50-59. This decision could potentially expand the protective reach of this vaccine to a broader age group, enhancing public health defenses against RSV.

Stay tuned for further updates as we continue to track these important FDA decisions and their implications for the biotech industry.

Happy investing,

Maeve Grace
Editor In Chief
Premium Trade Alerts

Important: This newsletter does not provide investment advice. The stocks mentioned should not be taken as recommendations. Your investments are solely your decisions.

Disclosure: I hold no positions in any companies mentioned, either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I have no business relationship with any company whose stock is mentioned in this article.