Rising Stars & FDA Updates: Your Pre-Market Briefing

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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

✓ 08:30 AM ET – Initial Jobless Claims

✓ 09:45 AM ET – S&P Global US Manufacturing PMI (May)

✓ 09:45 AM ET – S&P Global Services PMI (May)

✓ 10:00 AM ET – New Home Sales (Apr)

PREMARKET SNAPSHOT 📈

Stock futures are pointing towards a slightly negative open today with the Dow Jones Industrial Average leading the decline at -0.50%.

S&P500

$5307.01

⬇️ -0.27%

Dow

$39671.04

⬇️ -0.50%

NASDAQ

$18705.203

⬇️ -0.04%

SECTOR SNAPSHOT 

Market mixed today. Energy slumped 1.83%, while Tech held firm. Healthcare bucked the trend, edging up 0.2%.

NAME

PRICE

%CHANGE

Consumer Discretionary

1,439.19

-0.85% 🔴

Consumer Staples

832

-0.26% 🔴

Energy

700.32

-1.83% 🔴

Financials

696.76

-0.50% 🔴

Health Care

1,704.44

+0.20% 🟢

Industrials

1,058.90

+0.15% 🟢

Materials

574.85

-0.99% 🔴

Real Estate

238.91

-0.86% 🔴

Information Technology

3,963.79

+0.07% 🟢

Communication Services

297.67

-0.26% 🔴

Utilities

364.26

-1.18% 🔴


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Unusual Volume

📈 Akoustis Technologies Inc (AKTS) jumped 128.83% to $0.32 on a whopping 537.66 million shares traded after completing rollout of its XBAW® design updates.

📈 Investors went wild, sending Crown ElectroKinetics Corp (CRKN) stock soaring 3.10% to $0.13 on a massive volume of 514.48 million shares after the company announced that it has secured a new long haul dark fiber construction project spanning approximately 250 miles from Las Cruces, New Mexico to El Paso, Texas.

📈 Abnormal activity shook Barnes & Noble Education Inc (BNED), pushing it up 109.22% to $1.13 on a whopping 300.66 million shares traded.

📈 Bruush Oral Care Inc. (BRSH) stock recently closed 25.57% upper at $0.15 on substantial volume of 196.16 million shares.

📈 MGO Global Inc (MGOL) decrease by -7.20% in a single trading session, with abnormally high trading volume of 82.94 million shares. The company recently announced first quarter 2024 results.


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Premarket Movers

OneMedNet Corporation (ONMD) experiences a substantial 109.27% surge in pre-market trading after revealing a greater than five (5)-fold expansion of its proprietary iRWD™ network and platform.

NVIDIA Corporation (NVDA) sees a significant 7.09% increase, reaching a pre-market price of $1016.84 following the release financial results for first quarter fiscal 2025.

Vocodia Holdings Corp. (VHAI) demonstrates a noteworthy 15.54% surge, with a pre-market price of $0.14 following the filing of 10-K form with the SEC.

Pre Market Gainers

Pre Market Change

Pre Market Volume

ASTI

+65.37%

93.50M

ZCAR

+127.33%

26.32M

NCPL

+17.11%

23.46M

ISPC

+38.58%

13.18M

WKHS

+11.07%

8.01M

VHAI

+15.54%

7.77M

AGRI

+3.38%

2.20M

ONMD

+109.27%

1.83M

SVMH

+21.82%

1.51M

NVDA

+7.39%

503.45K


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Important FDA 

Recently Announced

The FDA has been busy in recent weeks, delivering a mixed bag of news for biotech companies seeking its approval. Bristol-Myers Squibb (BMY) scored a win on May 16th with the expansion of Breyanzi's use. This drug can now be wielded against relapsed or refractory follicular lymphoma, offering a fresh weapon in the fight against this cancer.

Dynavax Technologies (DVAX) wasn't as fortunate. Their application for HEPLISAV-B, a vaccine designed to protect adults undergoing hemodialysis, hit a snag on May 14th. The FDA requested further information before granting its approval.

Better news arrived for Day One Therapeutics (DAWN) as they celebrated the FDA green light for Tovorafenib, to be marketed as OJEMDA. This medication brings new hope to children battling relapsed or progressive pediatric low-grade glioma, a specific type of brain tumor.

X Pharmaceuticals (XFOR) can also raise a glass to a positive FDA decision. They secured approval for XOLREMDI (Mavorixafor), a medication representing a major step forward in treating WHIM syndrome, a rare and complex condition affecting those twelve and older.

Upcoming Announcements

The coming week holds its breath for both diabetes patients and investors. May 24th marks a critical date as a panel of experts at the FDA reviews Awiqli, a new drug from Novo Nordisk (NVO) designed specifically to combat adult diabetes. While the verdict is yet to be announced, a positive decision could be transformative, impacting not only the company's future but also the lives of millions grappling with diabetes.

The focus then swivels to Bristol-Myers Squibb (BMY) on May 31st. Just a week after the Awiqli review, the FDA will deliver a crucial verdict regarding Breyanzi, a treatment currently used for a specific type of lymphoma. A favorable ruling could significantly broaden Breyanzi's application, potentially extending its reach to a much wider patient population.

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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