December 5, 2025 5:23pm

“Uncle algo and his electronic trading dwarfs” fed at the upside trough 

Capricor Therapeutics (CAPR closed +$1.49) Research Note; will the FDA’s Vinay Prasad M.D. regulatory status and past comments re Duchenne muscular dystrophy (DMD) effect the post financing outcome?? Ongoing regulatory hurdles and rising R&D costs could quickly undermine the outlook. The FDA DID issue a complete response letter (CRL) stating it could not approve CAPR’s BLA in its PAST form, citing a lack of sufficient clinical evidence to demonstrate effectiveness and requesting additional data. The agency also pointed to certain unresolved issues within the CMC section of the regulatory application - caution is STILL warranted!

RMi collects, curates, 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

Pre-open Indication Scoring: 6 Hit and 6 Miss

It’s not always time to buy or sell; but it is time to KNOW and why!

Never leave an investor uninformed!

TGIF and the cocktail hour!

Stocks tumbled on Friday in beginning December trading as investors weighed stark signs of a weakening economy … breadth is narrowing, valuations are resting on a fulcrum, rebalancing as defensive positioning is building as cell and gene therapy squeeze through 2025 to into 2026.

Friday’s RMi Pre-opening Bell: Econs … https://www.regmedinvestors.com/articles/14217   

RMi Financing: Capricor Therapeutics (CAPR) prices offering of 6 M shares at $25.00 per share … with skepticism https://www.regmedinvestors.com/articles/14218

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 UP +104.05 points or +0.22%, the S&P closed UP +13.28 points or +0.19% while the Nasdaq closed UP +72.992 points or +0.31%

  • Theme of the session: digesting inflation data

Friday’s (my) 40-company covered sector’s advance/decline line opened negative with 16 incliners, 20 decliners and 4 flats ending with a negative close of 13 incliners, 26 decliners and 1 flat

  • I knew it was coming, "uncle algo and his electronic trading dwarfs" smelled bloody profit

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

  • Personal consumption expenditures (PCE) price index for September – which was delayed due to the record-setting U.S. government shutdown – showed an annual rate of 2.8%, lower than the 2.9% estimate.
  • The core personal consumption expenditures price index, which excludes volatile food and energy prices, indicated a 0.2% monthly rise while the annual rate was 2.8%. The monthly rate was in line with the consensus, but the annual level was 0.1% lower. The core annual rate edged down from 2.9% in August. Headline PCE increased 0.3% for the month, putting the annual inflation rate also at 2.8%. Both of those readings were in line with expectations though the annual rate was up 0.1 % point from August
  • The University of Michigan’s consumer survey, a report that provides a glimpse at sentiment as well as the view on inflation over the near and longer term, came in higher than expected for December.

The C&GT sector closed negative while the CBOE Fear (VIX) index closed at 15.32 after Thursday’s 15.79, Wednesday’s 16.08, Tuesday’s 16.57, Monday’s 17.34 and last Friday’s 16.35

Metrics:  Friday …

  • The RUT was down -9.67 points or -0.38%,
  • The XLV was down -0.64 points or -0.42%,
  • The NBI was down -25.87 points or -0.45%;
  • The XBI was up +0.16 points or +0.13%
  • The IWM was down -1.07 or -0.42%;
  • The IBB was down -0.95 points or -0.55%,
  • The VIX was down -0.46 points or -2.91% at to 15.32

 

Q4 – December – 2 positive and 3 negative closes

  • November – 1 holiday, 8 positive and 11 negative closes
  • October -1 neutral, 11 positive and 12 negative closes

 

Friday Closing UP (13 of 13) 

  • Capricor Therapeutics (CAPR +$1.49 after Thursday’s -$4.46 and Wednesday’s +$23.60),
  • Moderna (MRNA +$2.21 after Thursday’s +$0.34 and Wednesday’s +$1.12),
  • IQVIA Holdings (IQV +$0.93 after Thursday’s -$2.73, Wednesday’s +$1.61, Tuesday’s -$2.81 and Monday’s -$1.52),
  • Mesoblast (MESO +$0.68),
  • Supernus Therapeutics (SUPN +$0.58),
  • AxoGen (AXGN +$0.47),
  • BioNTech (BNTX +$0.25 after Thursday’s -$0.72),
  • Harvard Apparatus RT (OTCQB: HRGN +$0.20 with 16,739 shares traded)
  • Regenxbio (RGNX +$0.18),
  • Entrada Therapeutics (TRDA +$0.16),
  • Adverum Biotechnologies (ADVM +$0.09 after Thursday’s $0.00),
  • MiMedx (MDXG +$0.07),
  • Generation Bio (GBIO +$0.07)

Flat (1)

  • Brainstorm Cell Therapeutics (BCLI $0.00 after Thursday’s $0.00 after Wednesday’s -$0.02 after Tuesday’s +$0.0210),

Friday’s Closing DOWN (10 of 16): 

  • Alnylam Pharmaceuticals (ALNY -$7.22 after Thursday’s -$7.71, Wednesday’s +$8.36, Tuesday’s +$10.37 and Monday’s +$3.33),
  • Arrowhead Pharma (ARWR -$3.22 after Thursday’s -$0.76, Wednesday’s +$7.12, Tuesday’s +$1.70 and Monday’s +$3.55),
  • Vertex (VRTX -$1.88 after Thursday’s -$6.01, Wednesday’s +$29.98, Tuesday’s +$7.55 and Monday’s -$8.01),
  • Beam Therapeutics (BEAM -$1.82 after Thursday’s +$2.17, Wednesday’s +$3.37, Tuesday’s -$0.68 and Monday’s -$1.28),
  • uniQure NV (QURE -$1.41 after Thursday’s -$2.39),
  • CRISPR Therapeutics (CRSP -$1.30 after Thursday’s +$2.19, Wednesday’s+$4.41, Tuesday’s -$0.59 and Monday’s -$1.30),
  • Lenz Therapeutics (LENZ -$1.18 after Thursday’s -$0.18),
  • Vericel (VCEL -$0.56 after Thursday’s -$0.67),
  • Sarepta Therapeutics (SRPT -$0.56 after Thursday’s +$0.98, Wednesday’s +$1.37, Tuesday’s +$0.75 and Monday’s -$1.62),
  • BioLife Solutions (BLFS -$0.37),

 

The Bottom Line: More of the … WHYs

The Dow, S&P and Nasdaq ended Friday's session higher as investors “seemed” satisfied with the September inflation results.

  • The S&P 500 added 0.2% and finished just shy of its record closing level in October. The Dow added 0.2%, and the Nasdaq gained 0.3%.

The latest reading from the Fed's preferred inflation gauge, the personal consumption expenditures index, showed prices on a year-over-year basis up 3%, above the 2.8% consensus. Core prices also rose 3%, above the 2.9% consensus.

  • Following the PCE reading, traders retained their view that the Fed will cut its key interest rate by a quarter percentage point this month. Odds of a rate cut were 87.2%, according to the CME FedWatch tool, compared with 88.2% a day earlier.
  • While the Russell 2000 dropping 0.4%.
  • Volume was higher on the Nasdaq exchange and barely higher on the NYSE versus Thursday. On the Nasdaq exchange losers beat winners by roughly 5-to-4, while on the NYSE falling stocks modestly topped rising issues.
  • The 10-year Treasury yield inched up three basis points to 4.14%.
  • Oil prices rose to around $60.15 a barrel.  <IBD>

For the week:

  • The S&P 500 is up 21.31 points, or 0.3%.
  • The Dow is up 238.57 points, or 0.5%.
  • The Nasdaq is up 212.44 points, or 0.9%.
  • The Russell 2000 is up 21.05 points, or 0.8%.

 

Most C&GT sector equities dived Friday, after popping Thursday after Wednesday ++ following “taking a licking” on Tuesday and Monday’s.

 

The American Association of Individual Investors:

  • Only 30.8% of those surveyed said they were bearish in the latest week, down 11.9 points from 42.7% last week, and also the first time that pessimism fell below its historical average of 31.0% since last January.
  • Optimism about the immediate outlook for stocks jumped 12.3 points to 44.3%, up from just 32.0% last week and the first time the measure was above the historical average of 37.5% for optimists in 4 weeks.
  • The % of investors describing themselves as neutral — believing stocks won’t do much either way over the next 6 months — fell to 24.9% from 25.3%, meaning that such sentiment is below its historical average of 31.5% for the 72nd week out of 74.

A question does NOT answer an inquiry; investors need more than a few catalysts that could revive a rally, I do NOT expect end end-of-year flurry!

  • Depleted market valuations and the uncertain payoff from heavy spending as we get closer to 2025 ends and then coming Q4 and FY25 financial and achievement results

 

This December week:

  • 12/5 – Friday closed negative with 13 positive, 26 negative and 1 flat
  • 12/4 – Thursday closed positive with 26 positive, 12 negative and 2 flats
  • 12/3 – Wednesday closed positive with 35 positive, 4 negative and 1 flat
  • 12/2 - Tuesday closed negative with 10 positive, 29 negative and 1 flat
  • 12/1 – Monday closed negative with 5 positive, 31 negative and 0 flat

Last week, November's end:

  • 11/28 - Friday closed positive with 29 positive, 10 negative and 1 flat
  • 11/27 – Thursday, a market holiday
  • 11/26 – Wednesday closed positive with 28 positive, 12 negative and 0 flat
  • 11/25 – Tuesday closed positive with 24 positive, 15 negative and 1 flat
  • 11/24 - Monday closed positive with 25 positive, 14 negative and 1 flat

 

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.

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 facts and truth are its products; 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!

 

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: Moderna (MRNA), Capricor Therapeutics (CAPR) and IQVIA Holdings (IQV)
  • Thursday: AxoGen (AXGN), CRISPR Therapeutics (CRSP) and Beam Therapeutics (BEAM)
  • Wednesday: Vertex (VRTX), Capricor Therapeutics (CAPR) and Alnylam Pharmaceuticals (ALNY)
  • Tuesday: Alnylam Pharmaceuticals (ALNY), Vertex (VRTX) and Arrowhead Pharma (ARWR)
  • Monday: Capricor Therapeutics (CAPR) and Adverum Biotechnologies (ADVM)

The worst three (3) in the session:

  • Friday: Alnylam Pharmaceuticals (ALNY), Arrowhead Pharma (ARWR) and Vertex (VRTX)
  • Thursday: Alnylam Pharmaceuticals (ALNY), Vertex (VRTX) and Capricor Therapeutics (CAPR)
  • Wednesday: Harvard Apparatus RT (OTCQB: HRGN), Vericel (VCEL) and Cellectis SA (CLLS)
  • Tuesday: Lenz Therapeutics (LENZ), IQVIA Holdings (IQV) and BioNTech (BNTX)
  • Monday: Vertex (VRTX), BioNTech (BNTX) and Moderna (MRNA)

 

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.