December 18, 2025 4:43pm

Dramatic interchange, foretells opposite moves

Capricor Therapeutics (CAPR) yells as the roller-coaster crests-up, now waiting for the downslide groan! Opened -$0.04, flipped +$0.66, mid-day to -$0.02 closing at +$0.04. Doubts still abound re: regulatory fragility and marginal HOPE-3 results! I am NOT the ONLY dissenter – <see The Bottom Line>

News: Below, MRNA & SGMO <below>

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

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

Never leave a retail investor uninformed! 

I write this blog/newsletter to inform investors with facts and supporting numbers focused on what they need to hear that others will not say or write about – facts in evidence!

Updating … RMi Pre-opening: CPI data is a catalyst … https://www.regmedinvestors.com/articles/14235

 

News:

  • Sangamo Therapeutics (SGMO -$0.0082 to $0.43) initiated a rolling submission of a BLA to the FDA seeking accelerated approval of isaralgagene civaparvovec, or ST-920, a wholly owned investigational gene therapy for the treatment of adults with Fabry disease. <Rolling submission allows for completed modules of the BLA to be submitted and reviewed by the FDA on an ongoing basis rather than waiting for the entire BLA to be submitted at once>
  • Moderna (MRNA +$0.44 to $30.95) The Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to $54.3 M to support a pivotal P3 clinical trial that aims to help advance MRNA's investigational mRNA-based H5 pandemic influenza vaccine candidate, mRNA-1018, to licensure. The funding marks a significant step forward in global pandemic preparedness that could enable fast, equitable access to vaccines for one of the world's most pressing health threats.

 

I also, follow the dictum, quoting Churchill that “short words are best, and the old words when short are best of all.”

Thursday: The Dow closed UP +65.88 points or +0.14%, the S&P closed UP +53.34 points or +0.79% while the Nasdaq closed UP +313.038 points or +1.38%

  • Theme of the session: lighter-than-expected inflation data

Thursday’s (my) 40-company covered sector’s advance/decline line opened positive with 30 incliners, 8 decliners and 2 flats ending with a positive close of 22 incliners, 16 decliners and 2 flats

  • Market sentiment turned more constructive at the open as equities rebounded from a sharp midweek selloff, supported by a cooler-than-expected inflation print and renewed hopes for additional Fed rate cuts.
  • Sector equities came-off a 5-session rough patch, pressured by sharp losses in “names” tied to the artificial intelligence trade

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

  • CPI showed headline annual inflation of 2.7%, below the 3.1% that economists had expected. The 12-month rate for core CPI, which excludes food and energy, was 2.6%, also lower than the Dow Jones forecast for 3%.
  • Initial claims for unemployment insurance saw a decline last week from the prior period. 1st-time filings for the week ended Dec. 13 came in at 224,000, down from the previous week’s upwardly revised figure of 237,000. Economists had estimated 225,000 for the weekly period.

The CBOE Fear (VIX) index closed Thursday at 16.74 after Wednesday’s 17.66 after Tuesday’s 16.48, Monday’s 16.46 following Friday’s 15.81 and last Thursday’s 14.85

 

Metrics: Thursday …

  • The RUT was up +15.57 points or +0.62%,
  • The XLV was up +0.12 points or +0.08%,
  • The NBI was down -42.19 points or -0.75%;
  • The XBI was down -0.93 points or -0.77%
  • The IWM was up +1.45 or +0.59%;
  • The IBB was down -1.34 points or -0.80%,
  • The VIX was down -0.88 points or -4.99% at to 16.74

 

Q4 – December – 5 positive and 9 negative closes

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

 

Thursday Closing UP (10 of 22) 

  • Alnylam Pharmaceuticals (ALNY +$3.94 after Wednesday’s +$0.93),
  • Arrowhead Pharma (ARWR +$1.67 after Wednesday’s +$0.14 after Tuesday’s -$3.79 after Monday’s -$1.51),
  • IQVIA Holdings (IQV +$1.09 after Tuesday’s -$1.95 after Monday’s +$0.81),
  • uniQure NV (QURE +$0.90 after Wednesday’s +$1.14 after Tuesday’s +$1.46 after Tuesday’s +$0.60),
  • Lenz Therapeutics (LENZ +$0.70 after Wednesday’s +$0.33),
  • Beam Therapeutics (BEAM +$0.57 after Wednesday’s -$1.16),
  • Ionis Pharmaceuticals (IONS +$0.55 after Wednesday’s -$1.29 after Tuesday’s -$1.39 after Monday’s -$1.21),
  • Supernus Therapeutics (SUPN +$0.53 after Wednesday’s +$0.43 after Tuesday’s +$1.04 after Monday’s +$0.42),
  • Moderna (MRNA +$0.44 after Wednesday’s +$0.62),
  • Regenxbio (RGNX +$0.34 after Wednesday’s -$0.94 after Tuesday’s +$0.28),

Flat (2)

  • Adverum Biotechnologies ADVM) – acquired
  • Fate Therapeutics (FATE),

Thursday’s Closing DOWN (10 of 16): 

  • Vertex (VRTX -$2.14 after Wednesday’s -$5.44 after Tuesday’s +$0.75 after Monday’s +$3.57),
  • Wave Life Sciences (WVE -$0.80),
  • Sarepta Therapeutics (SRPT -$0.80 after Wednesday’s -$1.17 after Tuesday’s +$0.76 after Monday’s +$0.20),
  • Ultragenyx Pharmaceuticals (RARE -$0.37 after Wednesday’s -$1.13 after Tuesday’s -$1.89 after Monday’s +$0.18),
  • Entrada Therapeutics (TRDA -$0.28),
  • Vericel (VCEL -$0.24 after Wednesday’s +$0.90 after Tuesday’s -$0.99),
  • Voyager Therapeutics (VYGR -$0.14)
  • Prime Medicine (PRME -$0.14),
  • BioNTech (BNTX -$0.14 after Wednesday’s -$0.63 after Tuesday’s -$1.52 after Monday’s -$0.77),
  • Mesoblast (MESO -$0.10 after Wednesday’s +$0.41 after Tuesday’s +$0.58 after Monday’s -$0.31),

 

 

The Bottom Line: More of the … WHYs

Gains after pains … after a surprise CPI inflation report of 2.7% compared to estimates of 3.1%.

  • Despite the encouraging inflation data, signs of economic strain remain. The U.S. unemployment rate rose to 4.6% in November 2025, its highest level since 2021.

Most C&GT sector equities popped on Thursday after Wednesday and Tuesday declined followed Monday after Friday and last Thursday’s declines

 

Capricor Therapeutics (CAPR +$0.04) – I am NOT the ONLY dissenter as valuation concerns remain a key hang-up!

  • CAPR remains a structurally challenged, chronically unprofitable company whose valuation is disconnected from fundamentals.
  • Despite years of promoting Deramiocel (CAP-1002) as a potential treatment for Duchenne muscular dystrophy (DMD), the company has yet to generate meaningful revenue, relying instead on repeated capital raises and marketing narratives to sustain operations.
  • Statistical significance was achieved only by the thinnest margins (PUL: p=0.029; LVEF: p=0.041), highlighting the fragility of the data, and efficacy claims are largely optical, derived from percentage slowing of progression in a late-stage, non-ambulatory patient population where functional measurements are inherently noisy.
  •  Safety reporting remains limited, and pivotal cardiac endpoints are based on a thin sample size, providing support but not decisiveness.
  • As a result, the FDA’s approval probability remains uncertain, with HOPE-3 improving sentiment but not fundamentally de-risking the asset.
  • While headlines may drive short-term stock pops, the underlying business model, dependence on speculative clinical outcomes, and marginal trial data suggest prolonged regulatory friction and a likely eventual reset closer to cash value, reinforcing the bearish thesis for investors seeking evidence-based returns.  <Insider Monkey>

 

Take it a session at a time … the REAL question is … how long will this sentiment and conviction “run” last in the “clean-out-the-exposure” December?

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

 

3rd week of December:

  • 12/18 – Thursday closed positive with 22 positive, 16 negative and 2 flats
  • 12/17 – Wednesday closed negative with 12 positive, 26 negative and 2 flats
  • 12/16- Tuesday closed negative with 17 positive, 21 negative and 2 flats
  • 12/15 – Monday closed negative with 15 positive, 23 negative and 2 flats

2nd December week:

  • 12/12 – Friday closed negative with 12 positive, 26 negative and 2 flats
  • 12/11 – Thursday closed negative with 18 positive, 19 negative and 3 flats
  • 12/10 – Wednesday closed positive with 24 positive, 12 negative and 4 flats
  • 12/9 - Tuesday closed negative with 10 positive, 27 negative and 3 flats
  • 12/8 - Monday closed positive with 22 positive, 16 negative and 2 flat

 

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!

 

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 also 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!”

 

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

The top three (3) performing in the session:   

  • Thursday: Alnylam Pharmaceuticals (ALNY), Arrowhead Pharma (ARWR) and IQVIA Holdings (IQV)
  • Wednesday: AxoGen (AXGN), uniQure NV (QURE) and Alnylam Pharmaceuticals (ALNY)
  • Tuesday: uniQure NV (QURE), Supernus Therapeutics (SUPN), and Sarepta Therapeutics (SRPT)
  • Monday: Vertex (VRTX), IQVIA Holdings (IQV) and Moderna (MRNA)

The worst three (3) in the session:

  • Thursday: Vertex (VRTX), Wave Life Sciences (WVE) and Sarepta Therapeutics (SRPT)
  • Wednesday: Vertex (VRTX), Ionis Pharmaceuticals (IONS) and CRISPR Therapeutics (CRSP)
  • Tuesday: Arrowhead Pharma (ARWR), IQVIA Holdings (IQV) and Ultragenyx Pharmaceuticals (RARE)
  • Monday: Alnylam Pharmaceuticals (ALNY), Arrowhead Pharma (ARWR) and Ionis Pharmaceuticals (IONS)

 

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.