Unlock Profits: FDA Approvals & Hot Stocks Inside!

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Hello Part-time Trader…👋

Welcome to your premarket updates. Stocks ended May on a weak note as AI enthusiasm cooled and concerns over Federal Reserve interest rates persisted. Over the past week, the Nasdaq Composite stayed flat, the S&P 500 rose slightly, and the Dow Jones fell nearly 1%.

This week, keep an eye on the labor market with the May jobs report, job openings, and private wage growth updates. We’ll also see readings on services and manufacturing activity. Corporate earnings to watch include CrowdStrike (CRWD), Lululemon (LULU), and Dollar Tree (DLTR).

In major news, GameStop shares rocketed over 90% in premarket trading after Keith Gill, known as DeepF— Value on Reddit, posted a screenshot of a $116 million investment in the company. This included five million shares and 120,000 call options. The stock could add roughly $6 billion to its market value if gains hold.

Additionally, AMD unveiled its latest AI processors, the MI325X accelerator, set to release in Q4 2024, in a bid to challenge Nvidia. AMD shares rose 1.4%, while Nvidia gained about 3% premarket. The AI chip race is heating up, with AMD aiming to compete more aggressively against Nvidia’s market dominance.

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

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

✓ 10:00 AM ET – Construction Spending (MoM) (Apr)

10:00 AM ET – ISM Manufacturing Employment (May)

✓ 10:00 AM ET – Total Vehicle Sales

✓ 01:00 PM ET – Atlanta Fed GDPNow (Q2)

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PREMARKET SNAPSHOT 📈

The S&P 500 saw a modest rise, the Dow Jones Industrial Average experienced a significant gain, while the NASDAQ 100 remained nearly flat with a slight dip.

S&P500

$5277.51

⬆️ 0.80%

Dow

$38686.32

⬆️ 1.50%

NASDAQ

$18536.65

⬇️ -0.011%

SECTOR SNAPSHOT 

Market surges with Energy and Real Estate leading gains, while Information Technology remains stagnant.

Consumer Discretionary

1,423.51

0.15 🟢

Consumer Staples

824.23

1.46 🟢

Energy

708.04

2.49 🟢

Financials

691.28

1.41 🟢

Health Care

1,670.88

1.41 🟢

Industrials

1,042.88

1.16 🟢

Materials

575.27

1.09 🟢

Real Estate

238

1.86 🟢

Information Technology

3,972.21

- 🔴

Communication Services

296.23

0.56 🟢

Utilities

367.47

1.67 🟢

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Unusual Volume

📈 Novo Integrated Sciences Inc (NVOS): Exhibited an extraordinary trading volume of 310.28 million shares, after the company announced its board is conducting a review to increase the company’s stock repurchase program. The stock closed at $1.05, marking a substantial increase of 132.82%.

📈 Nuburu Inc (BURU): Experienced a notable trading volume of 144.46 million shares compared to its average of 12.84 million shares. The stock price stood at $0.17, reflecting an increase of 6.25%.

📈 Sirius XM Holdings Inc (SIRI): Recorded an unusual trading volume of 101.09 million shares. Sirius XM Holdings's (SIRI) short interest has risen to 22.99% of the float, up 10.53% since last report, with short positions taking an average of 9.59 days to cover. The stock price rose to $2.82, achieving a gain of 2.92%.

📈 Brand Engagement Network Inc (BNAI): Saw an exceptional trading volume of 67.99 million shares, compared to its average volume of 2.89 million shares. The stock price surged to $5.44, with a significant increase of 110.85%.

📈 Dell Technologies Inc (DELL): Reported an unusually high trading volume of 67.19 million shares. The stock closed at $139.56, experiencing a notable drop of 17.87% despite reporting upbeat earnings and sales results for the first quarter.

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Premarket Movers

Bio-Path Holdings, Inc. (BPTH) is trading at $3.67 in pre-market, up 78.16% at 7:43 AM EDT after presenting data from its ongoing Phase 2 combination study of Prexigebersen for treating acute myeloid leukemia at the ASCO Annual Meeting.

MingZhu Logistics Holdings Limited (YGMZ) is trading at $0.5145 in pre-market, up 47.04% at 7:47 AM EDT after announcing its agreement to acquire Oxylus Global, targeting continued aggressive diversification and growth acceleration.

Calidi Biotherapeutics, Inc. (CLDI) is trading at $0.2100 in pre-market, up 10.53% at 7:25 AM EDT after presenting the CLD-101 Phase 1 trial update and preclinical data on RTNova and CLD-201 at the 2024 ASCO Annual Meeting.

Pre Market Gainers

Pre Market Change

Pre Market Volume

CRKN

+35.90%

32.47M

FFIE

+26.29%

22.43M

AMC

+27.71%

12.87M

GME

+85.03%

10.20M

YGMZ

+62.96%

4.46M

HOLO

+15.86%

4.02M

VHAI

+7.18%

2.50M

LUCY

+6.80%

1.17M

PLUG

+5.41%

954.28K

PRST

+5.71%

678.55K

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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.

Bristol-Myers Squibb Co. (BMY) On May 30, 2024, Bristol-Myers Squibb received positive news as the FDA approved the expanded use of Breyanzi for the treatment of relapsed or refractory mantle cell lymphoma. This approval broadens the therapeutic options available for patients battling this aggressive form of cancer.

AstraZeneca PLC (AZN.L, AZN) & Daiichi Sankyo Company Limited (DSKYF.PK) Both AstraZeneca and Daiichi Sankyo celebrated a significant milestone on April 6, 2024, when 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.

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
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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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