Pre-Market Edge: Rising Stars & Market-Moving FDA News

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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

✓ 09:00 AM ET – FOMC Member Mester Speaks

✓ 11:00 AM ET – NY Fed 1-Year Consumer Inflation Expectations

✓ 11:30 AM ET – 3-Month Bill Auction

✓ 11:00 AM ET – 6-Month Bill Auction

PREMARKET SNAPSHOT 📈

Stock futures are pointing towards a positive open today, with the Dow Jones Industrial Average leading the pack with a rise of over 2%.

S&P500

$5222.68

⬆️ 1.85%

Dow

$39512.84

⬆️ 2.16%

NASDAQ

$18161.18 

⬆️ 1.51% 

SECTOR SNAPSHOT 

Today's Sectors performance is mixed, with Consumer Staples leading the gainers at 0.64% and Consumer Discretionary falling the most at -0.61%.

NAME

PRICE

%CHANGE

Consumer Discretionary

1,455.72

-0.61% 🔴

Consumer Staples

828.29

+0.64% 🟢

Energy

716.44

-0.55% 🔴

Financials

695.29

+0.46% 🟢

Health Care

1,672.26

+0.22% 🟢

Industrials

1,062.84

+0.08% 🟢

Materials

578.21

+0.13% 🟢

Real Estate

236.78

-0.40% 🔴

Information Technology

3,787.39

+0.48% 🟢

Communication Services

292.33

-0.15% 🔴

Utilities

361.36

-0.16% 🔴


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Unusual Volume

📈 AEye Inc (LIDR) jumped 115.00% to $2.58 on a whopping 158.99 million shares traded after it announced partnership with LITEON.

📈 Investors went wild, sending Ginkgo Bioworks Holdings Inc (DNA) stock declining -17.29% to $0.76 on a massive volume of 124.48 million shares after the company released first quarter 2024 financial results.

📈 Abnormal activity shook Greenwave Technology Solutions Inc (GWAV), pushing it down -37.20% to $0.04 on a whopping 91.14 million shares traded.

📈 Gamestop Corporation (GME) stock recently closed -3.05% lower at $17.46 on substantial volume of 36.83 million shares.

📈 Macrogenics Inc (MGNX) decrease by -77.44% in a single trading session, with abnormally high trading volume of 35.15 million shares following the release of financial results for the quarter ended March 31, 2024.


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Premarket Movers

Tevogen Bio Holdings Inc. (TVGN) experiences a substantial 56.42% surge in pre-market trading after announcing that it has entered into a binding term sheet [with an existing investor] to secure up to $50 million of financing..

AC Immune SA (ACIU) sees a significant 51.13% increase, reaching a pre-market price of $3.49 after reporting Q1 2024 financial results.

MiNK Therapeutics, Inc. (INKT) demonstrates a noteworthy 19.98% surge, with a pre-market price of $1.07 after announcing that it has entered into a stock purchase agreement to sell securities in a private placement financing (PIPE) for $5.8 million.

Pre Market Gainers

Pre Market Change

Pre Market Volume

KITT

+23.98%

14.21M

TVGN

+56.42%

6.10M

ACIU

+51.13%

5.91M

AMC

+10.31%

4.95M

INKT

+19.98%

2.49M

SMX

+7.38%

1.18M

SQSP

+12.94%

810.81K

LUXH

+21.88%

705.59K

KOSS

+5.07%

422.08K

JAN

+7.23%

332.71K


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Important FDA 

Recently Announced

On April 29th, 2024, the FDA granted full approval to TIVDAK, a groundbreaking treatment for recurrent or metastatic cervical cancer developed by Pfizer (PFE). This decision validates TIVDAK's effectiveness and safety, offering renewed hope for patients who have exhausted initial treatment options. TIVDAK has the potential to significantly improve outcomes for these individuals.

April 30th, 2024, marked a significant milestone for Neurocrine Biosciences (NBIX) with the FDA's approval of a new, orally administered formulation of INGREZZA. This innovative delivery system offers a more convenient way to manage tardive dyskinesia and chorea associated with Huntington's disease.

For X4 Pharmaceuticals (XFOR), April 30th, 2024, was a historic day. The FDA's green light for Mavorixafor brings long-awaited relief to patients aged 12 and above battling WHIM syndrome. This approval not only confirms the drug's effectiveness and safety but also represents a major step forward in treating this rare and complex condition.

Upcoming Announcements

May 13th, 2024, is a critical day for Dynavax Technologies Corp. (DVAX) as the FDA deliberates on the approval of HEPLISAV-B for a broader use case. This innovative vaccine has the potential to significantly improve protection against hepatitis B in adults undergoing hemodialysis, a vulnerable population with a higher risk of infection. A positive decision could represent a major breakthrough in their standard of care.

The spotlight falls on Ascendis Pharma A/S (ASND) on May 14th, 2024, as the FDA considers their resubmitted New Drug Application (NDA) for TransCon PTH. This treatment targets the unmet needs of adult patients battling hypoparathyroidism, a condition that disrupts calcium regulation in the body. A favorable outcome could usher in a new era of treatment, offering long-awaited relief and improved management for those struggling with this challenging condition.

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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