Morning Market Brief: Emerging Leaders & Key FDA News

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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.


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Happening Today

✓ 10:00 AM ET – Existing Home Sales (Apr)

✓ 10:00 AM ET – Existing Home Sales (MoM) (Apr)

✓ 10:30 AM ET – Crude Oil Inventories

✓ 10:30 AM ET – Cushing Crude Oil Inventories

✓ 01:00 PM ET – 20-Year Bond Auction

✓ 02:00 PM ET – FOMC Meeting Minutes

PREMARKET SNAPSHOT 📈

Stock futures are flat ahead of the market open, with S&P 500 leading with a minor gain of 0.25%.

S&P500

$5321.41

⬆️ 0.25%

Dow

$39872.99

⬆️ 0.16%

NASDAQ

$18713.797

⬆️ 0.21% 

SECTOR SNAPSHOT 

Sectors are showing mixed performance today, with Financials leading the gainers at 0.57% and Energy lagging behind at -0.51%.

NAME

PRICE

%CHANGE

Consumer Discretionary

1,451.49

+0.49% 🟢

Consumer Staples

833.68

+0.60% 🟢

Energy

713.38

-0.51% 🔴

Financials

700.23

+0.57% 🟢

Health Care

1,701

+0.18% 🟢

Industrials

1,057.28

-0.33% 🔴

Materials

580.57

-0.01% 🔴

Real Estate

240.98

-0.05% 🔴

Information Technology

3,961.00

+0.31% 🟢

Communication Services

298.44

+0.05% 🟢

Utilities

368.62

+0.97% 🟢


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Unusual Volume

📈 MGO Global Inc (MGOL) jumped 443.71% to $1.25 on a whopping 328.03 million shares traded after it announced Q1 2024 results.

📈 Investors went wild, sending Mangoceuticals Inc (MGRX) stock soaring 103.68% to $0.52 on a massive volume of 236.19 million shares after the company annouced the development of proprietary oral formulations of Semaglutide and Tirzepatide to aid in weight management.

📈 Abnormal activity shook AgriFORCE Growing Systems ltd (AGRI), pushing it up 17.15% to $0.15 on a whopping 201.46 million shares traded.

📈 Barnes & Noble Education Inc (BNED) stock recently closed 74.23% upper at $0.54 on substantial volume of 200.51 million shares.

📈 Biodexa Pharmaceuticals Plc ADR (BDRX) increase by 83.46% in a single trading session, with abnormally high trading volume of 124.99 million shares. The company announced that results of a Phase 2 clinical trial of eRapa in Familial Adenomatous Polyposis are scheduled for presentation at the prestigious 2024 Digestive Disease Week annual meeting in Washington D.C.


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Premarket Movers

Akoustis Technologies, Inc. (AKTS) experiences a substantial 157.29% surge in pre-market trading after announcing the final release to manufacturing of design updates across its product portfolio.

Mustang Bio, Inc. (MBIO) sees a significant 55.87% increase, reaching a pre-market price of $0.48. The company filed 8-k form with the SEC.

Rezolute, Inc. (RZLT) demonstrates a noteworthy 25.67% surge, with a pre-market price of $3.77 after reporting positive topline results from the Phase 2 clinical study of RZ402 in patients with DME who are naïve to or have received limited anti-vascular growth factor (anti-VEGF) injections.

Pre Market Gainers

Pre Market Change

Pre Market Volume

AKTS

+157.29%

70.15M

MBIO

+55.87%

11.67M

RZLT

+25.67%

1.66M

BZFD

+24.00%

1.49M

HLTH

+3.14%

1.15M

NKLA

+2.75%

398.39K

ASTI

+2.90%

213.26K

BURU

+2.24%

207.44K

SHOP

+2.60%

154.08K

FCEL

+3.03%

72.70K


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Important FDA 

Recently Announced

The past few weeks have been positive for several biotech companies seeking approval from the U.S. Food and Drug Administration (FDA). Bristol-Myers Squibb (BMY) received a welcome decision on May 16th, 2024 with the expansion of Breyanzi's use. This drug can now be used to treat patients with relapsed or refractory follicular lymphoma, providing a new option in the fight against this cancer.

Dynavax Technologies (DVAX) also received an update on their application for HEPLISAV-B, a vaccine designed for adults undergoing hemodialysis treatment. Unfortunately, the FDA requires further information before granting approval for the vaccine in May 14th update.

There was better news for Day One Therapeutics (DAWN) as they celebrate the FDA's approval of Tovorafenib, which will be marketed under the brand name OJEMDA. This medication offers new hope for children with relapsed or progressive pediatric low-grade glioma, a specific type of brain tumor.

X Pharmaceuticals (XFOR) joins the list of companies celebrating positive FDA decisions. They received approval for XOLREMDI (Mavorixafor), a medication representing a significant advancement in treating WHIM syndrome, a rare and complex condition affecting individuals twelve years of age and older.

Upcoming Announcements

Diabetes patients and investors alike have a key date on their calendars: May 24th. That's when a panel of experts at the FDA will be reviewing Awiqli, a new drug from Novo Nordisk (NVO) specifically designed to treat adult diabetes. While the outcome remains uncertain, a positive decision could be a game-changer for both the company's future and the lives of millions struggling with diabetes.

The spotlight then shifts to Bristol-Myers Squibb (BMY) on May 31st. Just a week after the Awiqli review, the FDA will be making a crucial announcement regarding Breyanzi, a treatment currently used for a specific type of lymphoma. A positive ruling could significantly expand Breyanzi's application, potentially benefiting a much wider range of patients.

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.

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