Explosive Pre-Market: FDA News & Top Stocks!

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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 – Core PCE Price Index (MoM) (YOY) (Apr)

✓ 08:30 AM ET – PCE Price index (MoM)(YoY) (Apr)

✓ 08:30 AM ET – Personal Spending (MoM) (Apr)

✓ 09:45 AM ET – Chicago PMI (May)

✓ 10:30 AM ET – Atlanta Fed GDPNow (Q2)


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PREMARKET SNAPSHOT 📈

Market futures indicate a bearish sentiment: S&P Futures are down, Dow Futures have slipped, and Nasdaq Futures have fallen.

S&P500

$5235.48

⬇️ -0.59%

Dow

$38111.48

⬇️  -0.85%

NASDAQ

$18538.66

⬇️ -1.05%

SECTOR SNAPSHOT 

Overall market trend is positive with a broad rally, led by Real Estate and Utilities, while Information Technology and Communication Services are underperforming with notable losses.

NAME

PRICE

%CHANGE

Consumer Discretionary

1,421.31

0.18 🟢

Consumer Staples

812.39

0.26 🟢

Energy

690.87

0.24 🟢

Financials

681.64

0.61 🟢

Health Care

1,647.70

0.07 🟢

Industrials

1,030.92

0.70 🟢

Materials

569.05

0.83 🟢

Real Estate

233.65

1.51 🟢

Information Technology

3,972.26

-2.45 🔴 

Communication Services

294.58

-1.06 🔴 

Utilities

361.43

1.41 🟢

🔴 


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Unusual Volume

📈 Cue Health Inc (HLTH): Exhibited an extraordinary trading volume of 581.28 million shares. The stock closed at $0.07, marking a substantial increase of 32.30% even after announcing plans to wind down its business.

📈 Verb Technology Company Inc (VERB): Experienced a notable trading volume of 164.96 million shares compared to its average of 26,705.19 shares. The stock price stood at $0.16, reflecting a slight decline of 1.86%.

📈 Momentus Inc (MNTS): Recorded an unusual trading volume of 135.20 million shares, after the company announced it has secured a contract from DARPA. The stock price surged to $0.87, achieving a significant gain of 66.35%.

📈 Sharps Technology Inc (STSS): Saw an exceptional trading volume of 128.85 million shares, after company signed a 5-year $200 million syringe sales agreement with Nephron Pharmaceuticals. The stock price rose to $0.48, with an increase of 5.38%.

📈 Innovative Eyewear Inc (LUCY): Reported an unusually high trading volume of 122.83 million shares after the launch of new smart eyewear with voice access to ChatGPT. The stock closed at $0.79, experiencing a notable drop of 16.75%.


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Premarket Movers

Novo Integrated Sciences, Inc. (NVOS) is trading at $0.6737 in pre-market, up 49.38% at 7:49 AM EDT after HSBC confirmed a $78 million Standby Letter of Credit. The company received written confirmation for a Ready, Willing, and Able (RWA) issued for the delivery of a Standby Letter of Credit via Swift MT 760.

The Gap, Inc. (GPS) is trading at $27.66 with a gain of +$5.14 (+22.82%) in Pre-Market at 7:52 AM EDT after reporting Q1 fiscal 2024 results: net sales increased 3% to $3.4 billion, online sales up 5%, gross margin increased 410 basis points to 41.2%, and net income of $158 million with diluted EPS of $0.41. The company raised its full-year guidance.

Pre Market Gainers

Pre Market Change

Pre Market Volume

BURU

+54.50%

35.70M

FFIE

+16.50%

14.65M

GWAV

+3.33%

14.14M

SLNA

+9.87%

13.23M

CRKN

+9.25%

8.55M

PRST

+17.75%

4.29M

NVOS

+46.59%

3.90M

BGXX

+16.68%

3.74M

VHAI

+9.15%

1.86M

SCPX

+6.15%

1.03M


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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.

AstraZeneca PLC (AZN.L, AZN) & Daiichi Sankyo Company Limited (DSKYF.PK) On April 6, 2024, both AstraZeneca and Daiichi Sankyo celebrated a significant milestone as the FDA approved Enhertu for the expanded treatment of adult patients with unresectable or metastatic HER2-positive solid tumors. This approval marks a major advancement in the treatment options for these patients, as Enhertu is already approved in other countries for similar uses.

Abeona Therapeutics Inc. (ABEO) On April 22, 2024, Abeona Therapeutics faced a setback when 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.

Announcing Today

Bristol-Myers Squibb Co. (BMY) Bristol-Myers Squibb is awaiting an FDA decision today, May 31, 2024, regarding the expanded use of Breyanzi for the treatment of relapsed or refractory mantle cell lymphoma. A positive outcome could significantly broaden the treatment options for patients battling this aggressive form of cancer.

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.

Eli Lilly and Co. (LLY) Eli Lilly is also in the spotlight with an upcoming FDA panel review on June 10, 2024, for Donanemab, their treatment for early symptomatic Alzheimer’s disease. This review is a critical step towards providing new hope for patients and families affected by this debilitating condition.

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

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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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