November 3, 2025 4:37pm

Off the sector’s value tree as November began with collateral damage yet with a few share pricing comebacks; so much for an initial seasonality boost

34st day’s shutdown, 2nd month with 13th Democratic negative votes and counting

News: A number of P1/2 study results; Cellectis SA (CLLS), Moderna (MRNA), Caribou Biosciences (CRBU), Editas Medicine (EDIT) and Beam Therapeutics (BEAM) as uniQure NV (QURE-48.10%) tumbled after reporting a likely regulatory setback for one of its gene therapies.

RMi collects, interprets and disseminates cell and gene therapy sector (C&GT) fact-based news, trusted and verified intel and share pricing data to bridge the gap to an investment decision

Never leave an investor uninformed!  


Investors still face a murky economic outlook after the Fed pushed back on the prospect of further interest-rate reductions, with the US in a data blackout based on the government shutdown

RMi pre-open: New month … https://www.regmedinvestors.com/articles/14178

The past, present and future values of RMi’s analysis sheds light on the cell and gene therapy’s (C&GT) sector’s “current” acrobatics

 

Monday: The Dow closed DOWN -226.19 points or -0.48%, the S&P closed UP +11.77 points or +0.17% while the Nasdaq closed UP +109,766 points or +0.46%

  • Theme of the session: suppressed by market’s weak breadth

We need to more than consider the macro-economic environment to comprehend the micro re “our” universe of cell and gene therapy

  • Factory activity in the U.S. pulled back further in October; the ISM manufacturing index for the month registered a 48.7% reading, representing the share of companies reporting growth. That was off 0.4% point from September and below the Dow Jones consensus estimate for 49.3%. Within the survey, the prices index fell 3.9 points though still was showing growth at 58%. Production slipped 2.8 points to 48.2% while employment edged higher to 46%, though still in contraction territory after rising 0.7 points.
  • BofA sentiment Sell Side Indicator nudged higher to 55.7% in October, a 6th consecutive month of gains that marks the longest streak since 2021. A reading of around 58 marks extended sentiment that historically has been a good time to sell stocks.

Monday’s (my) 40-company covered sector’s advance/decline line opened negative with 3 incliners, 36 decliners and 1 flat ending with a negative close of 10 incliners, 26 decliners and 4 flats

Metrics:  Monday …

  • The RUT was down -8.14 points or -0.33%,
  • The IWM was down -0.79 or -0.32%;
  • The IBB was down -1.92 points or -1.20%,
  • The NBI was down -66.62 points or -1.24%;
  • The XLV was up +0.20 points or +0.14%,
  • The XBI was down -2.85 points or -2.53% … while
  • The VIX was down -0.29 points or -1.66% at 17.15

 

Q4 – November- 1 negative close

  • October -1 neutral, 11 positive and 12 negative closes

Q3 – September - 1 holiday, 9 negative and 12 positive closes; August - 12 negative and 9 positive closes; July - 1 market holiday, 13 positive and 9 negative closes

 

Monday Closing UP (10 of 10)

  • Vericel (VCEL +$1.65 after Friday’s +$0.65),
  • AxoGen (AXGN +$1.03 after Friday’s -$0.97),
  • Supernus Therapeutics (SUPN +$0.57 after Friday’s -$2.01),
  • Intellia Therapeutics (NTLA +$0.45),
  • Sarepta Therapeutics (SRPT +$0.44 after Friday’s +$1.11),
  • Vertex (VRTX +$0.43 after Friday’s +$5.91)
  • BioNTech (BNTX +$0.04 after Friday’s -$0.95),
  • Brainstorm Cell Therapeutics (BCLI +$0.02)
  • Precigen (PGEN +$0.02),
  • Caribou Biosciences (CRBU +$0.01)

Flat (4)

  • Agenus (AGEN)
  • BioLife Solutions (BLFS),
  • Compass Therapeutics (CMPX),
  • Harvard Apparatus RT (OTCQB: HRGN)

Monday’s Closing DOWN (10 of 26):

  • uniQure NV (QURE -$33.40 after Friday’s -$0.62),
  • Alnylam Pharmaceuticals (ALNY -$22.12 after Friday’s +$6.98),
  • Arrowhead Pharma (ARWR -$2.78),
  • IQVIA Holdings (IQV -$2.46 after Friday’s -$0.46),
  • Moderna (MRNA -$2.25 after Friday’s -$1.06),
  • CRISPR Therapeutics (CRSP -$2.02 after Friday’s +$2.88),
  • Lenz Therapeutics (LENZ -$1.79 after Friday’s -$0.30),
  • Ultragenyx Pharmaceuticals (RARE -$1.13 after Friday’s -$0.15),
  • Regenxbio (RGNX -$0.78),
  • Beam Therapeutics (BEAM -$0.76 after Friday’s +$0.76),

 

The Bottom Line: More of the … WHYs

Sector equities got leveled today as Q3 earnings continued to flow as the market stuttered mixed

Issue … sector BREATH

The electronic trading algos’ “rules” sought safer ground by selling into the sector which has been a usual practice but, not as “loud” as today.

Funny how the uniQure NV (QURE) implosion signified the relationship to “the hope for a cure”!

 

It’s not hard to be on the cusp so often, it’s about refining expectation, defining insight and NOT being indentured to ANY financial institution!

 

I see mid-week an interruption coming … from earnings expectation and consensus always considering earnings season LPS (loss-per-share).

  • Sector Q3 earnings begin … Supernus Therapeutics (SUPN) on 11/4, Moderna (MRNA) and Vericel (VCEL) on 11/6 followed by Capricor Therapeutics (CAPR) on 11/10
  • Think about it; one of the biggest problems with the cell and gene therapy sector’s share pricing is …  99% of them have no earnings! Revenue from collaborations and runways have become indications of sustainability.
  • I believe earnings per share (EPS) estimates need to be revised along with the response to their share pricing declines upon their release to shake-off pipeline uncertainties
  • Meeting earnings expectation and/or missing consensus will deem share pricing outcomes
  • As earnings evolve, I think it's important to focus on fundamentals, advancing clinical catalysts, “runways” and sector company’s capacity/ability to finance

 

As the leading voice of cell and gene therapy investors; I am NOT always a doom and gloom analyst/journalist but a man who has been “there” (BUY, SELL, VC and multiple operating roles) with the gray hair and a readership following with real numbers to prove it!

 

November: understand the “flow” …

New week

  • 11/3 – Monday closed negative with 10 positive, 26 negative and 4 flats

October’s 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

 

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.
  • “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!”

 

Why do I keep repeating, framed in a different para, so investors can make the connection

The top three (3) performing in the session:   

  • Monday: Vericel (VCEL), AxoGen (AXGN)and Supernus Therapeutics (SUPN)  
  • Friday: Alnylam Pharmaceuticals (ALNY), Vertex (VRTX) and CRISPR Therapeutics (CRSP)

The worst three (3) in the session:

  • Monday: uniQure NV (QURE), Alnylam Pharmaceuticals (ALNY) and Arrowhead Pharma (ARWR)
  • Friday: Supernus Therapeutics (SUPN), Moderna (MRNA) and BioNTech (BNTX

 

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. 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.

Henry McCusker, the editor, and publisher of RegMed Investors does not hold or have positions in securities referred to in this publication. 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 in this report.