RegMed Investors’ (RMi) pre-open: Flat lining after eking-out gains

August 19, 2025 7:45am

Uncertainty looms over talks to end the war in Ukraine and the Federal Reserve's next call on interest rates

“Uncle algo and his electronic trading dwarfs” are in the house

News: REGENXBIO (RGNX +$0.13 pre-open) FDA extends its review timeline of the Biologics License Application (BLA) for clemidsogene lanparvovec (RGX-121) for the treatment of Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome. The Prescription Drug User Fee Act (PDUFA) goal date has been extended from November 9, 2025 to 2/8/26. Pfizer (PFE) Canada ULC and BioNTech SE (BNTX +$0.97 pre-open) announced today that Health Canada has authorized the LP.8.1 variant adapted COMIRNATY® COVID-19 vaccine for individuals aged 6 months and older. The updated COMIRNATY® vaccine targets the Omicron LP.8.1 variant, one of the most recently circulating SARS-CoV-2 lineages.

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

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

There are buying opportunities and sell signals, but many names are likely to reverse direction after the open …

Pre-open (my) Signals: 4 Negative and 1 Positive Indications

My interpretation of the morning’s numbers is written to be informative; it’s built on what happened to make “it” happen today!

Monday’s night’s … RegMed Investors (RMi) Closing Bell: Some slippage in the sector’s Advance/Decline (A/D) line … https://www.regmedinvestors.com/articles/14068

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 -0.02% or (-9 points), the S&P futures are DOWN -0.10% or (-6 points) and the Nasdaq futures are DOWN -0.14% or (-33 point)

• Stock futures ticked lower Tuesday, 8/19 waiting for Jerome and more retail earnings,
• European markets edged higher reacted positively to the outcome of Ukrainian talks,
• Asia-Pacific markets closed lower.

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

• Monday: The Dow closed DOWN -34.30 points or -0.08%, the S&P closed DOWN -0.65 points or -0.01% while the Nasdaq closed UP +6.797 points or +0.03%
• Friday: The Dow closed UP +34.85 points or +0.08%, the S&P closed DOWN -18.74 points or -0.29% while the Nasdaq closed DOWN -87.693 points or -0.40%
• Last week, the S&P 500 was up +0.9%. the Nasdaq is up +0.8% and the Dow +1.7%
• The previous week, the S&P 500 has gained 2.5%, the Nasdaq has added +3.9% and the Dow has advanced 1.4%.

Economic Data Docket: Housing starts – July, Building permits – July, and Fed Vice Chair for Supervision Michelle Bowman TV appearance                                                              

Q3 – August - 6 negative and 6 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.

• This week’s upcoming Fed messaging,econs and more earnings releases will set the tone pre and post their release with the usual ups, downs and just plain uncertainty

Although …

• Alnylam Pharmaceuticals (ALNY closed up +$7.96 after last Friday’s +$6.18 after Thursday’s +$10.21, Wednesday’s +$2.59, the previous Tuesday’s -$5.07 with a positive +$0.50 pre-open – SELL into Strength

• IQVIA Holdings (IQV closed up +$1.45 after Friday’s +$1.69 after Thursday’s -$0.83, Wednesday’s +$4.27 and last Tuesday’s +$5.90 with a negative -$0.01 pre-open

• Sarepta Therapeutics (SRPT closed down -$0.82 after Friday’s +$1.51 with a positive +$0.03 pre-open – SELL into Strength

• Precigen (PGEN closed up +$0.01 after Friday’s +$1.09 after FDA approval with a negative -$0.07 pre-open

• CRISPR Therapeutics (CRSP closed down -$2.14 after Friday’s +$0.91 and Thursday’s +$1.55 with a positive +$0.23 pre-open

The BOTTOM LINE: Reiterating, Sector closes Monday barely ups, econs … the causes and effect … “

The cell and gene therapy sector continuous rally to record a barely high; suggests to me that some investors take profits to buy back after equities get cheaper.

… As lagging sectors like Health Care (XLV) as well as risky investments like small- and mid-cap stocks — have played a larger role in this summer's sector moves.

When momentum sector equities look like about to stall or sell-off, it can really hit investors as usual hard if other areas of the market are advancing.

August: understand the “flow” …

• 8/18 – Monday closed barely positive with 18 positive, 17 negative and 0 flat
• 8/15 – Friday closed positive with 25 positive, 9 negative and 1 flat
• 8/14 – Thursday closed positive with 18 positive, 17 negative and 0 flat
• 8/13 – Wednesday closed positive with 32 positive, 2 negative and 1 flat
• 8/12 - Tuesday closed positive with 28 positive, 6 negative and 1 flat
• 8/11 – Monday closed negative with 10 positive, 25 negative and 0 flat
• 8/8 – Friday closed negative with 11 positive, 23 negative and 1 flat
• 8/7 – Thursday closed negative with 9 positive, 24 negative and 2 flats
• 8/6 – Wednesday closed negative with 11 positive, 22 negative and 2 flats
• 8/5 – Tuesday closed negative with 15 positive, 19 negative and 1 flat
• 8/4 – Monday closed positive with 27 positive, 8 negative and 0 flats
• 8/1 – Friday closed negative with 9 positive, 20 negative and 6 flats

Earnings are still the highlight of the week: Meeting earnings expectation and/or missing consensus will deem share pricing outcomes.

• 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!”

Reiterating, “There are always some big ifs, especially given some of the headlines that could emanate after a past few months of news flatulence.

• As always, I brace myself for earnings associated with share pricing volatility, some economics and tariff developments and their effects?

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.