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Good Morning! 

It's Chris from Elite Trade Club, here to give you this morning's premarket trading news.

Let’s get ready to trade!

Markets 📈

Stocks posted modest gains on Wednesday, led by the Nasdaq’s half-point gain. The Russ2K was the lone loser among notable U.S. indexes.

  • Dow [<0.1%]

  • S&P 500 [+0.1%]

  • Nasdaq [+0.5%]

  • Russell 2K [-0.2%]

Futures are drifting lower in early trading. S&P 500 contracts are down by about 0.2%.

What to Watch Today:
Second revision Q1 GDaaP numbers are set to drop at 8:30 a.m. and the report will give investors a glimpse under the U.S. economy’s hood. The figures could have a significant impact on investor sentiment, and they could also affect the Federal Reserve’s outlook for interest rate cuts. We’ll also get new data on weekly jobless claims this morning, and Nike will report its earnings after the closing bell.

This CEO sold his first company to Microsoft. Now he's quietly building a new AI company that the tech giant is already eyeing.

Microsoft did their due diligence, and they say this AI company's tech is raising the bar.

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Premarket Highlights 🔎

U.S. FDA Declines to Approve Merck-Daiichi’s ‘Guided Missile’ Cancer Drug 🚫

The U.S. Food and Drug Administration (FDA) has declined to approve Merck and Japan-based Daiichi Sankyo’s lung cancer treatment, patritumab deruxtecan, a targeted therapy likened to a “guided missile.” The decision was communicated in a complete response letter from the FDA, which cited issues identified during an inspection of a third-party manufacturing facility.

Manufacturing Concerns 💼
The FDA's complete response letter indicated that while there were no concerns about the efficacy or safety data of the drug, the third-party manufacturing facility did not meet the necessary standards. Merck and Daiichi Sankyo have committed to working with the FDA and the manufacturer to resolve these issues.

ADCs 🎯
Patritumab deruxtecan is part of a class of drugs known as antibody-drug conjugates (ADCs). ADCs combine a monoclonal antibody, which targets specific tumor cells, with a toxin that kills these cells, sparing healthy ones. This method is highly targeted, resembling the precision of a “guided missile.” Merck’s collaboration with Daiichi Sankyo, valued up to $22 billion, focuses on developing these innovative therapies.

Targeted Therapy 🚀
The companies sought FDA approval for patritumab deruxtecan to treat non-small cell lung cancer in patients who have not responded to two previous therapies and whose tumors express a mutation leading to uncontrolled growth of the EGFR protein. Other approved treatments for EGFR-mutated non-small cell lung cancer in the U.S. include Johnson & Johnson’s Rybrevant and AstraZeneca’s Tagrisso and Iressa.

Next Steps 🔄
Merck and Daiichi Sankyo plan to address the FDA’s feedback and rectify the issues at the third-party manufacturing facility. They aim to resubmit the application for patritumab deruxtecan, emphasizing their commitment to bringing this advanced therapy to patients in need.

Featured Earnings 💰️ 

  • McCormick & Company [MKC] ... AM

  • Walgreens Boots Alliance [WBA] ... AM

  • Acuity Brands [AYI] ... AM

  • The Simply Good Foods [SMPL] ... AM

  • Apogee Enterprises [APOG] ... AM

  • Lindsay [LNN] ...AM

  • Nike [NKE] ... PM

  • Accolade [ACCD] ... PM

  • Dynagas LNG Partners LP [DLNG] ... PM

  • Pinstripes Holdings [PNST] ... PM

Economy 🏗

  • Initial jobless claims [Jun] ... 8:30a

  • GDP (2nd revision) [Q1] ... 8:30a

  • Durable-goods orders [May] ... 8:30a

  • Pending home sales [May] ... 10:00a

Running Hot 🔥

Gainers
  • SinglePoint [SING] >> +88.9%

  • Purple Biotech [PPBT] >> +13.4%

  • GeoVax [GOVX] >> +22.5.%

Decliners
  • BranchOut Food [BOF] >> (38.2%)

  • Tonix Pharma [TNXP] >> (31.6%)

  • Immutep [IMMP] >> (29.9%)

Casi Pharma [CASI] - Last Close: $3.59

Late Wednesday, Casi Pharma made several big announcements that are rallying its shares today.

First, Casi said it plans to submit a new drug application for CID-103. In addition, the company has received a non-binding proposal to acquire its entire China business in exchange for $40 million in cash & debt assumption.

Last but not least, the company also announced a $15 million private-placement with a group of institutional investors.

CASI is up 46.7% on just over 3 million shares traded in today’s premarket.

My Take: It was a busy evening for CASI yesterday, but it all looks like good news.

Vigil Nueroscience [VIGL] - Last Close: $3.78

Early their morning, Vigil announced the Big Pharma giant Sanofi [SNY] has purchased $40 million in common stock priced at $7.44 per share.

Sanofi paid a 96% premium compared to VIGL’s Wednesday closing price.

Vigil said the funds will go towards R&D activities and extend its cash runway into 2026.

VIGL is up 29.3% on more than 7 million shares traded.  

My Take: SNY paid a big premium for their position in VIGL, and that’s enough to make a guy wonder if there’s more than meets the eye here. I am keeping my eye on this one.

Assure Holdings [IONM] - Last Close: $0.2320

In a Form RW filing dated June 26th, Assure Holdings withdrew from its registration statement announced back on May 3rd, 2024.

According to the statement from CEO John Farlinger, the company is withdrawing because it “no longer plans to proceed with the business combination contemplated in the registration statement.”

IONM is today’s top mover with a 196% gain on 74 million shares traded.

My Take: IONM is getting a big boost from this news but I don’t think the party will last very long. Be prepared for a pullback.

NLS Pharma [NLSP] - Last Close: $0.1826

NLS Pharma is pushing higher after Nasdaq granted its request for an extension to comply with its continued listing requirements on Tuesday.

The company also filed a Form 6-K after Wednesday’s closing bell announcing a special meeting of shareholders set to take place today.

NLSP is up 85.2% on more than 18 million shares traded.

My Take: NLSP has been trading erratically lately, but it appears to have found some support at the $0.18 mark.

That's it for today! Thanks for reading, and good luck out there!

Best Regards,

— Chris D.
Elite Trade Club

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