FDA Approvals & Hot Pre-Market Stocks for Your Portfolio!

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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 – Richmond Manufacturing Index (May)

✓ 10:30 AM ET – Dallas Fed Services Revenues (May)

✓ 10:30 AM ET – Texas Services Sector Outlook (May)

✓ 10:30 AM ET – Dallas Fed Mfg Business Index (May)

✓ 16:30 PM ET – API Weekly Crude Oil Stock


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PREMARKET SNAPSHOT 📈

Stock futures nudge lower on Wednesday, with the Dow Jones leading the decline by around 0.55%.

S&P500

$5306.04

⬆️ 0.0249%

Dow

$38852.86

⬆️ -0.055%

NASDAQ

$18869.44

⬆️ 0.32%

SECTOR SNAPSHOT 

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

NAME

PRICE

%CHANGE

Consumer Discretionary

1,426.67

-0.09 🔴

Consumer Staples

816.48

-0.84 🔴

Energy

701.55

1.08 🟢

Financials

683.31

-1.10 🔴

Health Care

1,659.75

-1.25 🔴

Industrials

1,038.50

-1.26 🔴

Materials

572.5

-0.40 🔴

Real Estate

232.32

-0.63 🔴

Information Technology

4,086.66

1.38 🟢

Communication Services

299.42

0.46 🟢

Utilities

361.17

-0.12 🔴


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Unusual Volume

📈 Sharps Technology Inc (STSS) jumped 141.44% to $0.52 on a whopping 303.37 million shares traded after CEO issues letter to shareholders on FDA actions and tariffs affecting Chinese syringes.

📈 Investors went wild, sending Vocodia Holdings Corp (VHAI) stock soaring 23.40% to $0.19 on a massive volume of 193.25 million shares.

📈 Abnormal activity shook Oblong Inc (OBLG), pushing it up 24.89% to $0.22 on a whopping 148.57 million shares traded.

📈 Sobr Safe Inc (SOBR) stock recently closed 88.76% upper at $0.42 on substantial volume of 131.04 million shares.

📈 Gamestop Corporation (GME) increase by 25.16% in a single trading session, with abnormally high trading volume of 105.08 million shares after it made $933 million in sales of 45 million common stock on Friday, May 24.


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Premarket Movers

Scorpius Holdings was up +42.7167% to 0.1597 in the premarket session today as the company announced that it has achieved 359% Year-Over-Year increase in revenue for the first quarter of 2024.

Surmodics, Inc (SRDX) is trading at $42.40 with a gain of +$7.30 (+20.79%) in Pre-Market at 8:14 AM EDT after news of Surmodics entering a definitive agreement to be acquired by GTCR for $43.00 per share in cash, representing an approximate equity value of $627 million.

Tellurian Inc. (TELL) is trading at $0.6219 with a gain of +$0.0611 (+10.90%) in Pre-Market at 8:22 AM EDT after news of Aethon Energy acquiring Tellurian's integrated upstream assets.

D-Wave Quantum Inc. (NYSE: QBTS) was rising +13.57% or +0.19 to 1.5900 in pre-market today as it announced that it has been featured in a Wall Street Journal article on quantum computing, which highlighted its technology’s strengths in tackling real-world optimization problems.

Pre Market Gainers

Pre Market Change

Pre Market Volume

STSS

+51.92%

33.92M

CRKN

+3.88%

30.78M

PEGY

+33.90%

27.83M

OBLG

+79.88%

18.86M

POAI

+100.67%

4.33M

FFIE

+8.70%

4.24M

OPTT

+15.81%

1.70M

GME

+39.10%

1.55M

INSM

+16.92%

1.44M

ONFO

+11.51%

477.07K


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Important FDA 

Recently Announced

The FDA has been particularly active in the past month, bringing a variety of outcomes for pharmaceutical companies seeking approval for their treatments.

Abeona Therapeutics Inc. (ABEO)

On April 22, 2024, Abeona Therapeutics received a Complete Response Letter from the FDA regarding their drug Pz-cel. This treatment was intended for recessive dystrophic epidermolysis bullosa, a rare and severe skin condition. Unfortunately, the FDA's decision indicates that additional information or modifications are needed before the drug can be approved.

Novo Nordisk A/S (NVO)

On May 24, 2024, an FDA panel reviewed Awiqli (Insulin Icodec), Novo Nordisk's new treatment for adult diabetes. The panel voted 7-to-4 against recommending approval. This decision represents a significant setback for Novo Nordisk as they seek to expand their diabetes treatment portfolio.

 Announcing Today

Novo Nordisk A/S (NVO)

Novo Nordisk announced that the FDA panel reviewed its drug Awiqli (Insulin Icodec) for treating adult diabetes. Despite the panel's decision against recommending approval, the official FDA decision is still pending, marking a crucial juncture for Novo Nordisk’s diabetes treatment advancements.

Upcoming Announcements

Bristol-Myers Squibb Co. (BMY)

Attention shifts back to Bristol-Myers Squibb as the FDA is set to make another critical decision regarding Breyanzi on May 31, 2024. This forthcoming decision could potentially expand Breyanzi’s use even further, benefiting a broader patient population battling lymphoma.

Stay tuned for more updates as we continue to monitor these pivotal FDA decisions and their impacts on the biotech landscape.

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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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