RegMed Investors’ (RMi) pre-open: What and which news is good news?

September 2, 2025 7:45am

A holiday-shortened trading week, as we expect the expected; 2 more catalysts in the pipeline for September: new labor-market data and the Fed’s next policy meeting

News: Ionis Pharmaceuticals (IONS) positive topline results from the pivotal P3 CORE and CORE2 studies of olezarsen in people with severe hypertriglyceridemia (sHTG). Olezarsen is the first therapy for sHTG to significantly reduce acute pancreatitis events. <more see below>

Never leave an investor uninformed … I say what others won’t, so you can do what others can’t!

Indexes showed solid performance for the month of August; pushing the stock market to all-time highs — with the S&P 500 achieving 5 record closes in August, and the Nasdaq achieving 4 and the Dow closed at a record 2x this past month, exceeding the previous highs it set in 2024. Not so… in the cell and gene therapy sector which saw a few too many fits and starts

Don’t get too hot but, be bothered by what could be coming! Rate-cut bets face a key test in Friday's jobs report for August, after disappointing inflation data dented stocks last week. Readings on job openings and private payrolls precede the crucial report, while an update on US manufacturing on Tuesday will shed light on the economy.

Remember that overnight and pre-open actions’ futures and markets doesn’t necessarily translate into actual trading in today’s market session.

Friday’s night’s … RMi) Closing Bell: Today’s retreat from the week’s withdrawal minus one … https://www.regmedinvestors.com/articles/14086

RegMed Investors (RMi) Research Note: Harvard Apparatus GT (OTCQB): Just another wrinkle – Q2/25’s 10-Q – liabilities exceed cash position … https://www.regmedinvestors.com/articles/13812

Tuesday: The pre-open Dow futures are DOWN -0.54% or (-247 points), the S&P futures are DOWN -0.72% or (-47 points) and the Nasdaq futures are DOWN -0.94% or (-219 points)

• U.S. stock futures were diving lower Tuesday, 9/2
• European markets traded lower,
• Asia Pacific markets close mixed.

Henry’omics: We need to more than consider the economic environment to comprehend the micro re “our” universe of cell and gene therapy companies

• U.S. markets were closed Monday for the Labor Day holiday, global markets did remain open
• Friday: The Dow closed DOWN 92.02- points or -0.20%, the S&P closed DOWN -41.60 points or -0.64% while the Nasdaq closed DOWN -249.608 points or -1.15%
• Thursday: The Dow closed UP +71.67 points or +0.16%, the S&P closed UP +20.46 points or +0.32% while the Nasdaq closed UP +115.019 points or +0.53%
• Wednesday: The Dow closed UP +147.16 points or +0.32%, the S&P closed UP +15.46 points or +0.24% while the Nasdaq closed UP +45.87 points or +0.21%
• Tuesday: The Dow closed UP +135.60 points or +0.30%, the S&P closed UP +26.62 points or +0.41% while the Nasdaq closed UP +94.978 points or +0.44%
• Monday: The Dow closed DOWN -349.27 points or -0.77%, the S&P closed DOWN -27.59 points or -0.43% while the Nasdaq closed DOWN -47.243 points or -0.22%
• Last week, the Dow was down 0.2%, the S&P 500 shed 0.1% and Nasdaq lost 0.2%.
• For August, the Dow was up +3%, the S&P +2% and the Nasdaq +1%

Economic Data Docket: S&P final U.S. manufacturing PMI - Aug., ISM manufacturing - Aug. and Construction spending

• Data on job openings for the month of July is coming on Wednesday;
• ADP employment data and initial jobless claims will arrive on Thursday;
• The government’s monthly employment report, with the unemployment rate and wage data, is set for Friday.
• Along with a rash of Fed presidents and governors speaking
• Will the econ “bit stay in the teeth”, holding back the market and its children, the cell and gene therapy sector?

As of 9/2/25 – I am adding to my cell and gene therapy coverage (now 40) and comparable universe:

• Capricor Therapeutics (CAPR)
• Vertex (VRTX)
• Rocket Therapeutics (RCKT)
• Arrow Pharmaceuticals (ARWR)
• Entrada Therapeutics (TRDA)

Ionis Pharmaceuticals (IONS) (continued)

• In the studies, olezarsen demonstrated a highly statistically significant placebo-adjusted mean reduction in fasting triglycerides of up to 72% and a highly statistically significant reduction in acute pancreatitis events of 85% with favorable safety and tolerability with nearly 1,100 patients who were required to be on standard of care lipid-lowering therapy throughout the treatment period.
• The CORE and CORE2 studies met the primary endpoint, with both 80 mg and 50 mg monthly doses of olezarsen demonstrating a highly statistically significant placebo-adjusted mean reduction in fasting triglyceride levels at 6 months:

Q3 – September, 1 holiday

• August - 11 negative and 9 positive closes
• July – 1 market holiday, 13 positive and 9 negative closes

Companies in my headlights – It’s your decision; I provide ideas and context

I post about “indication intelligence” looking toward investment conferences … to assist investors with insight into sector vulnerabilities and strengths.  A dictionary definition of “indicate” refers to something less than a certainty; an indication could be a signal of being oversold or overbought, a recommendation, or grounds for inferring or a basis for believing.

• Let ‘em ride, I see some green within the muddle of red leading up to August’s close, along with the usual ups, downs and just plain uncertainties

The BOTTOM LINE: Just another level of uncertainty entered the fray … as uncertainty remains around tariffs resulting into higher prices; while the labor market has been showing signs of slowing down, and there’s uncertainty around how much that will continue.

• After a federal appeals court on Friday ruled that most of President Donald Trump’s global tariffs are illegal.
• The U.S. Court of Appeals for the Federal Circuit determined in a 7-4 ruling that only Congress has the authority to apply sweeping levies.
• President Trump called the decision “Highly Partisan” and has said that he will appeal the ruling to the U.S. Supreme Court. <CNBC<

Those developments could weigh on sentiment to start a new trading month.

• September is historically the worst month for equities, with the S&P 500 averaging a 4.2% drop over the last five years, and falling more than 2% on average over the last 10.
• Don’t forget about Fed governor Lisa Cook and her issues of being fired or not

September is in the front window: understand the “flow” … the previous week of August:

• 8/29 – Friday closed negative with 7 positive, 27 negative and 1 flat
• 8/28 – Thursday closed negative with 15 positive, 17 negative and 3 flats
• 8/27 – Wednesday closed negative with 16 positive, 17 negative and 2 flats
• 8/26 - Tuesday closed positive with 25 positive, 9 negative and 1 flat
• 8/25 – Monday closed negative with 4 positive, 29 negative and 2 flats

Econs are the focus of the week; earnings had determined  share pricing outcomes, after ...

• Earnings:  4 net incomes and 25 net losses of 29 releases to date

I also hate to be so negative or contrarian but, this is a NO spin zone and truth is its product; I can always be WRONG but, I am mostly EARLY!”

Welcome to my world of defining the “grey’ in our universe!

• I am more frequently right than consequentially wrong; if I wanted to be liked, I wouldn’t have been an analyst/journalist.

Opinions expressed are those of the author and are subject to change, and not intended to be a forecast of future events, a guarantee of future results, nor investment advice. All investments are subject to risks. Investors should consider investment objectives.

Whether information or intelligence is good, bad or somewhere in between; I put into context what is relevant and useful for investors.  All investments are subject to risks. Investors should consider investment objectives.  Regulation Analyst Certification (Reg AC): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and it’s or their securities.

 I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed.