October 28, 2025 4:47pm

To BUY, SELL or HOLD as sector earnings season will leave “our” investors guessing into December

The 2-day Fed meeting starts, expecting to cut its benchmark “interest” rate for a 2nd time this year

28th-day’s shutdown, 13th Democratic negative vote begins 5th week and counting

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

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

Never leave an investor uninformed!  

There’s a difference between trust and conviction. Trust is something you can rely on, beyond certainty. Conviction doesn't demand that you, or anyone else, play by the rules. After gains, there is pain.

RMi pre-open: Slow Walk … https://www.regmedinvestors.com/articles/14170

Think of “our” universe as a game of shuts and ladders or sometimes monopoly … and follow RMi’s “interchanges” to gain profit moves or recoup losses – eat the popcorn and ponder ANY moves!

 

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%

  • Theme of the session: a slow yet still upward mobile market

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

  • Private sector employers added an average 14,250 jobs per week over the past four weeks, according to ADP, a turnaround from the negative September numbers. The 14,250 increase suggests monthly job growth totaled around 55,000 for the 4-week period, compared with a loss of -32,000 reported for September in the National Employment Report (NER). However, the total is subject to revision with the release of the NER.
  • The Conference Board showed a small 1-point decline on a monthly basis in October to 94.6 as consumers’ view of current business and labor conditions improved slightly. Short-term expectations for income, business, and labor market conditions, however, weakened by 2.9 points and continued to remain below a threshold “that typically signals a recession ahead”

Monday’s (my) 40-company covered sector’s advance/decline line opened negative with 9 incliners, 30 decliners and 1 flat ending with a negative close of 16 incliners, 21 decliners and 3 flats

Metrics:  Tuesday …

  • The RUT was down -13.78 points or -0.55%,
  • The IBB was up +0.55 points or +0.35%,
  • The XLV was down -0.92 points or -0.63%,
  • The XBI was up +0.41 points or +0.37% … while
  • The VIX was up +0.67 points or +4.25% at 16.44

 

Q4 – 1 neutral, 9 positive and 10 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

 

Tuesday Closing UP (10 of 16) 

  • Vertex (VRTX +$2.22 after Monday’s -$1.22)
  • uniQure NV (QURE +$2.08 after Monday’s +$6.91),
  • Sarepta Therapeutics (SRPT +$0.72 after Monday’s +$0.69),
  • IQV Holdings (IQV +$0.64 after Monday’s -$3.15),
  • Ionis Pharmaceuticals (IONS +$0.58 after Monday’s +$2.13),
  • Supernus Therapeutics (SUPN +$0.45),
  • Vericel (VCEL +$0.36),
  • AxoGen (AXGN +$0.31 after Monday’s -$0.40),
  • MiMedx (MDXG +$0.15),
  • Arrowhead Pharma (ARWR +$0.07 after Monday’s +$1.48),

Flat (3)

  • Brainstorm Cell Therapeutics (BCLI)
  • Capricor Therapeutics (CAPR)
  • Harvard Apparatus RT (OTCQB: HRGN)

Tuesday’s Closing DOWN (10 of 21): 

  • Alnylam Pharmaceuticals (ALNY -$2.67 after Monday’s +$15.15),
  • CRISPR Therapeutics (CRSP -$1.55 after Monday’s -$1.89),
  • Moderna (MRNA -$1.31),
  • BioNTech (BNTX -$1.02 after Monday’s +$0.39)
  • Intellia Therapeutics (NTLA -$0.83 after Monday’s -$10.81),
  • Ultragenyx Pharmaceuticals RARE -$0.54 after Monday’s +$1.78),
  • Lenz Therapeutics (LENZ -$0.48 after Monday’s -$0.68),
  • Regenxbio (RGNX -$0.46 after Monday’s +$0.59),
  • Prime Medicine (PRME -$0.33 after Monday’s -$0.18)
  • Beam Therapeutics (BEAM -$0.30 after Monday’s -$1.23),

 

The Bottom Line: More of the … WHYs

Indexes were on pace for a 3rd consecutive record close …

  • investors rode-through the latest IQVIA Holdings (IQV) earnings while waiting for the Fed’s meeting to confirm an interest rate cut.

The Russell 2000 small-cap index lagged behind the three leading U.S. indexes on Tuesday.

Some bad: Intellia Therapeutics (NTLA -2.62%) just ran into a serious test of investor confidence. NTLA has paused 2 late-stage studies of its flagship therapy, nex-z, after a patient was hospitalized with possible liver injury.

  • The patient, a man in his early 80s treated for ATTR-cardiomyopathy, reported stomach pain that led to blood tests showing elevated liver enzymes and bilirubin levelssigns of liver stress.
  • CEO John Leonard told investors the patient remains under medical care, and the company is assessing the data before making further decisions. <gurufocus>

Some good: Vertex Pharmaceuticals (VRTX) to surpass expectations when it reports its Q3/25 results on Nov. 3, after market close. Zacks Consensus Estimate for the to-be-reported quarter’s revenues is pegged at $3.04 billion, while the same for earnings is $4.55 per share.

  • Vertex’s Earnings ESP is +0.57% as the Most Accurate Estimate currently stands at $4.58, higher than the Zacks Consensus Estimate, which is pegged at $4.55.
  • Their model estimate for Trikafta/Kaftrio sales are currently pegged at $2.57 billion and $2.56 billion, respectively.

More bad: Beam Therapeutics Inc. (BEAM) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended September 2025.

  • BEAM is expected to post quarterly loss of $0.98 per share in its upcoming report, which represents a year-over-year change of +16.2%.
  • Revenues are expected to be $12.99 million, down 9% from the year-ago quarter.
  • The consensus EPS estimate for the quarter has been revised 5.19% higher over the last 30 days to the current level.

 

It’s not hard to be right 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 continue … with
  • ... MiMedx (MDXG), AxoGen AXGN) MiMedx (MDXG) Ionis Pharmaceuticals IONS), AxoGen AXGN) on 10/29
  • ... Sarepta Therapeutics (SRPT) and BioNTech (BNTK) on 11/3
  • ...Supernus Therapeutics (SUPN) on 11/4 followed by
  • ...Moderna (MRNA) and Vericel (VCEL) on 11/6

 

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

 

“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!”

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!

 

October: understand the “flow” …

New week

  • 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

Last week:

  • 10/24 - Friday closed positive with 25 positive, 13 negative and 2 flats
  • 10/23 – Thursday closed negative with 15 negative, 22 negative and 3 flats
  • 10/22 – Wednesday closed negative with 4 positive, 34 negative and 2 flat
  • 10/21 - Tuesday closed negative with 17 positive, 23 negative and 0 flat
  • 10/20 - Monday closed positive with 34 positive, 4 negative and 2 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:   

  • 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) in the session:

  • Tuesday: Alnylam Pharmaceuticals (ALNY), CRISPR Therapeutics (CRSP) and Moderna (MRNA
  • Monday: Intellia Therapeutics (NTLA), IQVIA Holdings (IQV) and CRISPR Therapeutics (CRSP)

 

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.