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.

Happening Today

✓ 10:00 AM ET – CB Employment Trends Index (May)

✓ 11:30 AM ET – 3-Month Bill Auction

✓ 11:30 AM ET – 6-Month Bill Auction

✓ 01:00 PM ET – 3-Year Note Auction

PREMARKET SNAPSHOT 📈

The S&P 500, Dow, and NASDAQ all experienced declines, with the S&P 500 down 0.11%, the Dow falling 0.22%, and the NASDAQ dipping 0.10%.

SECTOR SNAPSHOT ✨

Market declines led by Consumer Staples and Utilities, with modest gains in Financials and Information Technology.

PreMarket Unusual Volume Stocks

📈 Presto Automation Inc (PRST): Exhibited a trading volume of 51.64 million shares, higher than its average volume of 11.59 million shares. The stock closed at $0.13, marking an increase of 40.52%.

📈 New Horizon Aircraft Ltd (HOVR): Experienced a notable trading volume of 12.06 million shares compared to its average of 0.11 million shares. The stock price stood at $1.54, reflecting a significant increase of 113.89%.

📈 Calidi Biotherapeutics Inc (CLDI): Recorded an unusual trading volume of 6.89 million shares, well above its average volume of 1.25 million shares. The stock price rose to $0.26, achieving a gain of 34.20%.

📈 Big Tree Cloud Holdings Ltd (DSY): Saw an exceptional trading volume of 5.49 million shares, compared to its average volume of 0.11 million shares. The stock price surged to $3.81, with a significant increase of 99.57%.

📈 Spectaire Holdings Inc (SPEC): Reported a trading volume of 3.97 million shares against its average of 1.26 million shares. The stock closed at $0.69, experiencing an increase of 60.09%.

Premarket Picks

Spectaire Holdings Inc. (SPEC) is trading at $0.7132 in pre-market, up 67.97% at 8:00 AM EDT after filing an S-1 general registration statement for all companies, including face-amount certificate companies.

Calidi Biotherapeutics (CLDI) is surging 32% pre-market following their collaboration agreement with SIGA Technologies for a potential universal cancer treatment.

ProKidney Corp. (PROK) is up nearly 7% pre-market on positive interim results from their kidney disease treatment trial.

Below is a list of other hot stocks in pre-market today:

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.

GSK plc (GSK.L, GSK) On June 7, 2024, GSK received positive news as the FDA approved the extension of the indication for AREXVY, an adjuvanted respiratory syncytial virus (RSV) vaccine, to adults aged 50-59. This approval significantly broadens the age range for this vaccine, enhancing public health defenses against RSV.

Catalyst Pharmaceutical Partners Inc. (CPRX) On May 30, 2024, Catalyst Pharmaceutical Partners received FDA approval to increase the indicated maximum daily dosage of Firdapse Tablets from 80mg to 100mg for the treatment of Lambert-Eaton myasthenic syndrome. This approval enhances the treatment options available for patients with this rare neurological disorder.

Bristol-Myers Squibb Co. (BMY) Also on May 30, 2024, Bristol-Myers Squibb received approval from the FDA for 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.

Amgen Inc. (AMGN) On May 16, 2024, Amgen received FDA approval for Tarlatamab, under the brand name IMDELLTRA. This is the first and only T-cell engager therapy approved for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.

Announcing Today

Ipsen SA (IPSEY) & Genfit S.A. (GNFT) Both Ipsen SA and Genfit S.A. are anticipating an FDA decision today, June 10, 2024, regarding Elafibranor, proposed for the second-line treatment of primary biliary cholangitis. This decision is important for advancing treatment options for this chronic liver disease.

Eli Lilly and Co. (LLY) Eli Lilly is also in the spotlight today, June 10, 2024, with an FDA panel review 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.

Upcoming Announcements

Zai Lab Limited (ZLAB) Zai Lab Limited is anticipating an FDA decision on June 15, 2024, regarding the expanded use of Augtyro for the treatment of patients with NTRK-positive locally advanced or metastatic solid tumors. This decision could significantly enhance treatment options for patients with these specific cancer types.

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

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.