RMi pre-open: New month

November 3, 2025 7:51am

A seasonality boost? 

News: uniQure N.V. (QURE -$47.07 or -69.28%) NEGATIVE feedback received from the FDA during a recent pre-Biologics License Application (BLA) meeting regarding AMT-130, an investigational gene therapy for Huntington’s disease (HD). QURE believes that the FDA currently no longer agrees that data from the P1/2 studies of AMT-130 in comparison to an external control, as per the prespecified protocols and statistical analysis plans shared with the FDA in advance of the analyses, may be adequate to provide the primary evidence in support of a BLA submission. The timing of the BLA submission for AMT-130 is now unclear.

Earnings today: BioNTech (BNTK), Vertex (VRTX) and Sarepta Therapeutics (SUPN)

Earnings this week: Ultragenyx Pharmaceuticals (RARE), Supernus Therapeutics (SUPN) on 11/4 and Regenxbio (RGNX), Moderna (MRNA) and Vericel (VCEL) on 11/6 followed by Cellectis SA (CLLS) on 11/7

Pre-open Signals: 6 Positive and 1 Negative Indications

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

Eventful week, the government remains shut down. Also, the Supreme Court is expected to hear oral arguments on legality of the Trump administration’s tariffs.

Friday night’s … RMi Closing Bell: October’s over … https://www.regmedinvestors.com/articles/14177    

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

Monday: The pre-open Dow futures are DOWN -0.05% or (-18 points), the S&P futures are UP +0.29% or (+20 points) and the Nasdaq futures are UP +0.62% or (+161 points)

• Stock futures are slipping mixed, Monday 11/3
• European markets opened positive,
• Asia Pacific markets climbed.

Henry’omics: We need to more than consider the market’s setting to grasp the micro re “our” universe of cell and gene therapy companies

• Friday: The Dow closed UP +40.75 points or +0.09%, the S&P closed UP +17.86 points or +0.26% while the Nasdaq closed UP +143.813 points or +0.61%
• Thursday: The Dow closed DOWN -110.07 points or -0.23%, the S&P closed DOWN -68.23 points or -0.99% while the Nasdaq closed DOWN -377.329 points or -1.58%
• Wednesday: The Dow closed DOWN -74.37 points or -0.16%, the S&P closed DOWN -0.30 points or -0.00% while the Nasdaq closed UP +139.98 points or +0.55%
• Tuesday: The Dow closed UP +161.78 points or +0.34%, the S&P closed UP +15.76 points or +0.23% while the Nasdaq closed UP +190.037 points or +0.80%
• Monday: The Dow closed UP +337.47 points or +0.71%, the S&P closed UP +83.47 points or +1.23% while the Nasdaq closed UP +432.589 points or +1.86%
• Last week: The S&P 500 is up 1.5%, the Dow +0.9% and the Nasdaq is up +3.2%
• The previous week: the S&P 500 was up +2%, the Dow +2% and the Nasdaq added +2%.
• Last month: the S&P 500 was up +2.3%, the Nasdaq’s +4.7% and the Dow’s is up +2.5%.
• 2025 to date: the S&P is up +16%, the Nasdaq +22% and thew Dow +12%

Q4 – Monday, 11/3 – 1^st session

• October, 1 neutral, 10 positive and 12 negative closes

• Q3 – September, 1 holiday, 9 negative and 12 positive closes; 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.

Alnylam Pharmaceuticals (ALNY) closed up +$6.98 after Thursday’s -$32.03, Wednesday’s +$5.68, Tuesday’s -$2.67 and Monday’s +$15.15 with a positive +$0.50 or +0.11% pre-open

Vertex (VRTX) closed up +$5.91 after Thursday’s +$2.68, Wednesday’s -$5.18 after Tuesday’s +$2.22 and Monday’s -$1.2 with a positive +$1.36 or +0.32% pre-open

CRISPR Therapeutics (CRSP) closed up +$2.88 after Thursday’s -$1.46, Wednesday’s -$1.61, Tuesday’s -$1.55 and Monday’s -$1.89 with a positive +$0.96 or +1.50% pre-open

Sarepta Therapeutics (SRPT) closed up +$1.11 after Thursday’s -$0.20, Wednesday’s -$0.77, Tuesday’s +$0.72 after Monday’s +$0.69 with a positive +$0.33 or +1.37% pre-open

BioNTech (BNTX) closed down -$0.95 after Thursday’s +$1.32, Wednesday’s -$1.68, Tuesday’s -$1.02 and Monday’s +$0.39 with a positive +$1.09 or +1.05% pre-open

IQVIA Holdings (IQV) closed down -$0.46 after Thursday’s +$1.41 with a negative -1.62 or -0.75% pre-open

Lenz Therapeutics (LENZ) closed down -$0.30 with a positive +0.51 or +1.72% pre-open

The BOTTOM LINE: I got on my computer/laptop/ my horse with a lantern as I ride yelling … “earnings are here, earnings are here”!

Q3 Earnings coming … in the front-view mirror next week … more coming

• Ultragenyx Pharmaceuticals (RARE), Supernus Therapeutics (SUPN) on 11/4 followed by Regenxbio (RGNX), Moderna (MRNA) and Vericel (VCEL) on 11/6, followed by Cellectis SA CLLS) on 11/7 with Capricor Therapeutics (CAPR) on 11/10

Expect earnings’ results that meet, beat or miss revenue estimates, EPS as to pricing expectations, consensus … sector earnings while LPS (loss-per-share) assumes adjustments

• As sector earnings meet, beat or miss expectations; whipsaw actions could ensue depreciations or the stock market heads south, back pedal -- fast.

Upcoming;

• Sarepta Therapeutics (SRPT) is soon to post loss of $0.03 per share forQ3/25. This estimate indicates a year-over-year change of -104.8%. This Q3's revenue is expected to be $346.23 million, down 25.9% from the year-ago quarter.
• Ultragenyx Pharmaceuticals (RARE) is expected to post a Q3 loss of $0.85 per share which represents a year-over-year change of +6.6%. Revenues are expected to be $6.93 million, up 202.6% from the year-ago quarter
• uniQure NV (QURE) is expected to post quarterly loss of $0.85 per share in its upcoming report, which represents a year-over-year change of +6.6%Revenues are expected to be $6.93 million, up 202.6% from the year-ago quarter.

The shutdown enters its 34^th day and 6^th today, with lawmakers still unable to agree on a funding bill … as Democrats block the 13th voting negotiation

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

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

The top three (3) performing last week:

• Friday: Alnylam Pharmaceuticals (ALNY), Vertex (VRTX) and CRISPR Therapeutics (CRSP)

• Thursday: Moderna (MRNA), Vertex (VRTX) and Ionis Pharmaceuticals (IONS)
• Wednesday: Alnylam Pharmaceuticals (ALNY), AxoGen (AXGN) and Supernus Therapeutics (SUPN)
• Tuesday: Vertex (VRTX), uniQure NV (QURE) and Sarepta Therapeutics (SRPT)
• Monday: Alnylam Pharmaceuticals (ALNY), uniQure NV (QURE) and Ionis Pharmaceuticals (IONS)

The worst three (3) last week:  

• Friday: Supernus Therapeutics (SUPN), Moderna (MRNA) and BioNTech (BNTX
• Thursday: Alnylam Pharmaceuticals (ALNY), uniQure NV (QURE) and CRISPR Therapeutics (CRSP)
• Wednesday: Vertex (VRTX), Vericel (VCERL) and Ionis Pharmaceuticals (IONS)
• Tuesday: Alnylam Pharmaceuticals (ALNY), CRISPR Therapeutics (CRSP) and Moderna (MRNA
• Monday: Intellia Therapeutics (NTLA), IQVIA Holdings (IQV) and CRISPR Therapeutics (CRSP)

November to understand the flow review some of October:

• November, new week begins

Last week:

• 10/31 – Friday closed positive with 28 positive, 11 negative and 1 flat
• 10/30 – Thursday closed negative with 13 positive, 25 negative and 2 flats
• 10/29 - Wednesday closed negative with 9 positive, 30 negative and 1 flat
• 10/28 -Tuesday closed negative with 16 positive, 21 negative and 3 flats
• 10/27- Monday closed negative with 18 positive, 22 negative and 0 flats

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.