November 14, 2025 5:12pm

After a week of 2 push and 2 pull closes, a Friday negative close was marginalized by trading sentiment

Pre-open Indication Scoring: 5 Hits and 4 Miss

News: Sarepta Therapeutics (SRPT +$0.99 or +5.56% to $18.81 with an aftermarket of +$0.11) The FDA added a new warning and other limitations to a gene therapy for Duchenne’s muscular dystrophy. The infused therapy from SRPT will carry a boxed warning alerting doctors and patients to the risk of potentially fatal liver failure with the treatment. The 1-time therapy, Elevidys, has been under FDA scrutiny since the company reported the 1st of 2 deaths of teenage boys in March.

Earnings: Brainstorm Cell Therapeutics (BCLI)

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! 

TGIF

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

Friday’s RMi pre-open Bell: Consequences … https://www.regmedinvestors.com/articles/14196   

RMi Research Note: Harvard Apparatus GT (OTCQB): Broke … https://www.regmedinvestors.com/articles/13812

The peril facing the cell and gene therapy (C&GT) sector’s share pricing isn’t just applications of macro or even micro econs, sentiment or algorithms within electronic trading; it’s losing highly reliable, accurate and transparent data.

 

Friday: The Dow closed DOWN -309.74 points or -0.65%, the S&P closed DOWN -3.38 points or -0.05% while the Nasdaq closed UP +30.234 points or +0.13%

  • Theme of the session:  Trading sentiment dived yet, the Nasdaq snapped a 3-session losing streak

Friday’s (my) 40-company covered sector’s advance/decline line opened negative with 24 incliners, 16 decliners and 0 flat ending with a positive close of 19 incliners, 21 decliners and 0 flat

Henry’omics: We need to more than consider the macro-economic environment to comprehend the micro re “our” universe of cell and gene therapy (C&GT) sector

  • Kansas City Fed President Jeffrey Schmid on Friday reiterated that he does not believe additional interest rate cuts are warranted. Schmid joins a growing chorus of hawks at the Fed who have voiced opposition or hesitation recently to more cuts from the current fed funds target rate of 3.75%-4%. Market pricing Friday morning tilted slightly in favor of a hold at the Dec. 8-9 meeting, down from about 95% odds for a cut a month ago. <CNBC>

Metrics:  Friday …

  • The RUT was up +5.24 points or +0.22%,
  • The IWM was up +0.69 or +0.29%;
  • The IBB was up +0.87 points or +0.53%,
  • The NBI was up +34.22 points or +0.62%;
  • The XLV was down -0.91 points or -0.60%,
  • The XBI was up +2.10 points or +1.88% … while
  • The VIX was down -0.17 points or -0.85% at 19.83

 

Q4 – November - 3 positive and 7 negative closes

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

 

Friday Closing UP (10 of 19)

  • Vertex (VRTX +$2.63 after Thursday +$0.33 after Wednesday’s +$4.97, Tuesday’s +$4.86 and Monday’s +$11.73),
  • Ionis Pharmaceuticals (IONS +$1.71 after Thursday -$2.83 after Wednesday’s +$0.22, Tuesday’s +$2.91 and Monday’s -$4.01),
  • CRISPR Therapeutics (CRSP +$1.42 after Thursday -$1.08 and Wednesday’s -$3.02),
  • Precigen (PGEN +$0.99),
  • Sarepta Therapeutics (SRPT +$0.99),
  • Supernus Therapeutics (SUPN +$0.56),
  • Wave Life Sciences (WVE +$0.41),
  • Cellectis SA (CLLS +$0.33),
  • Ultragenyx Pharmaceuticals (RARE +$0.18 after Thursday -$0.63 after Wednesday’s +$0.28, Tuesday’s +$1.31, and Monday’s +$1.31),
  • Arrowhead Pharma (ARWR +$0.12),

Flat (0)

Friday’s Closing DOWN (10 of 21):

  • Alnylam Pharmaceuticals (ALNY -$4.81 after Thursday +$1.23, Wednesday’s +$0.79, Tuesday’s +$10.25 and Monday’s -$1.00),
  • IQVIA Holdings (IQV -$2.95 after Thursday +$2.67, Wednesday’s +$2.34, Tuesday’s +$5.47 and Monday’s +$2.59),
  • BioLife Solutions (BLFS -$1.07 after Thursday -$0.78),
  • Lenz Therapeutics (LENZ -$0.89 after Thursday +$0.99, Wednesday’s -$0.95 and Tuesday’s +$3.26),
  • BioNTech (BNTX -$0.79 after Thursday -$7.82, Wednesday’s +$3.05, Tuesday’s +$3.58 and Monday’s +$1.93),
  • AxoGen (AXGN -$0.49),
  • uniQure NV (QURE -$0.46 after Thursday +$0.22, Wednesday’s -$0.72 and Tuesday’s +$4.57),
  • Generation Bio (GBIO -$0.25 after Thursday +$0.13),
  • Moderna (MRNA -$0.19 after Thursday $1.75, Wednesday’s +$0.30 and Tuesday’s +$1.17),
  • Capricor Therapeutics (CAPR -$0.17),

 

The Bottom Line: More of the … WHYs

Indexes ended Friday's trading session mixed, with the Dow falling 2/3rds of a %.

  • Yet, all 3 of the market averages closed Friday's session to set fresh record highs,
  • After starting Friday with a sharp drop of 1.3%, the S&P 500 erased all of it before ending with a slight dip of 0.1%.
  • The Nasdaq composite flipped to a gain of 0.1%, while the Dow trimmed its loss to 309 points after earlier being down nearly 600. <AP>

For the week:

  • The S&P 500 is up 5.31 points, or 0.1%.
  • The Dow is up 160.38 points, or 0.3%.
  • The Nasdaq is down 103.95 points, or 0.5%.
  • The Russell 2000 is down 44.60 points, or 1.8%.

For the year:

  • The S&P 500 is up 852.48 points, or 14.5%.
  • The Dow is up 4,603.26 points, or 10.8%.
  • The Nasdaq is up 3,589.80 points, or 18.6%.
  • The Russell 2000 is up 158.07 points, or 7.1%.

 

C&GT sector equities continue to level share pricing as Q3 earnings release

I have seen share pricing interruption … from earnings expectation and consensus always considering earnings season LPS (loss-per-share).

  • 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!

A real question, are cell and gene therapy (C&GT) sector companies with high insider ownership present … opportunity?

  • Do they often demonstrate alignment between management and shareholder interests … a critical factor in navigating volatile market conditions?
  • I will be looking into this …! Stay tuned.

 

November: understand the “flow” …

New week:

  • 11/14 - Friday closed negative with 19 positive, 21 negative and 0 flats
  • 11/13 – Thursday closed negative with 8 positive, 32 negative and 0 flat
  • 11/12 – Wednesday closed negative with 18 positive, 22 negative and 0 flat
  • 11/11 – Tuesday closed positive with 34 positive, 4 negative and 2 flats
  • 11/10 - Monday closed positive with 26 positive, 14 negative and 0 flats

Last week:

  • 11/7 – Friday closed negative with 16 positive, 24 negative and 0 flat
  • 11/6 – Thursday closed negative with 15 positive, 24 negative and 1 flat
  • 11/5 - Wednesday closed positive with 20 positive, 18 negative and 2 flats
  • 11/4 – Tuesday closed negative with 10 positive, 30 negative and 0 flat
  • 11/3 – Monday closed negative with 10 positive, 26 negative and 4 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:   

  • Friday: Vertex (VRTX), Ionis Pharmaceuticals (IONS) and CRISPR Therapeutics (CRSP)
  • Thursday: IQVIA Holdings (IQV), Alnylam Pharmaceuticals (ALNY) and Lenz Therapeutics (LENZ)
  • Wednesday: Vertex (VRTX), BioNTech (BNTX) and IQVIA Holdings (IQV)
  • Tuesday: Alnylam Pharmaceuticals (ALNY), Vertex (VRTX) and IQVIA Holdings (IQV)
  • Monday: Vertex (VRTX), IQVIA Holdings (IQV) and BioNTech (BNTX)

The worst three (3) in the session:

  • Friday: Alnylam Pharmaceuticals (ALNY), IQVIA Holdings (IQV) and BioLife Solutions (BLFS)
  • Thursday: BioNTech (BNTX), Ionis Pharmaceuticals (IONS) and Moderna (MRNA)
  • Wednesday: CRISPR Therapeutics (CRSP), Supernus Therapeutics (SUPN) and Lenz therapeutics (LENZ)
  • Tuesday: BioLife Solutions (BLFS), MiMedx (MDXG) and CRISPR Therapeutics (CRSP)
  • Monday: Ionis Pharmaceuticals (IONS), uniQure NV (QURE) and Alnylam Pharmaceuticals (ALNY),

 

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.