September 10, 2025 5:06pm

The Dow and Nasdaq continued to lag Wednesday while the S&P traded higher reacting to surprise inflation data

… With yet another econ, CPI on deck projecting a clearer picture of where the economy is headed after the PPTI rattled the market

News: IQVIA (IQV -$5.77), Arrowhead Pharmaceuticals, Inc. (ARWR +$1.16) and Capricor Therapeutics (CAPR -$0.15) <see below>

Remember, “The sector is what it is, until it isn’t, even if it doesn’t seem to be, it yet will be.” 

Never leave an investor uninformed!  

I answer and qualify the sector’s equity’s movement; with an emphasis on which company is gaining or losing stride in your portfolio for the short-term

 

News: IQVIA (IQV -$5.77) launched its Clinical Trial Financial Suite (CTFS), an AI-enabled platform orchestrating all financial aspects of clinical trials. CTFS is designed to eliminate inefficiencies created by siloed systems and fragmented processes. In contrast to other industry offerings, CTFS unifies budgeting, contracting, forecasting and payment workflows with shared data and end-to-end processes.

Arrowhead Pharmaceuticals, Inc. (ARWR +$1.16) has filed a request for regulatory clearance to initiate a P1/2a clinical trial of ARO-MAPT, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for tauopathies including Alzheimer’s disease, a progressive neurodegenerative disease characterized by cognitive and functional decline. 

Capricor Therapeutics (CAPR -$0.15) has publicized a statement addressing the FDA’s decision to reject its Duchenne muscular dystrophy (DMD) drug deramiocel. The allogenic cardiosphere-based cell therapy was rejected by the FDA because the HOPE-2 (NCT05126758) and its open-label extension portion “failed to demonstrate efficacy for its prespecified primary … and secondary endpoints”. The allogenic cardiosphere-based cell therapy was rejected by the FDA because the HOPE-2 (NCT05126758) and its open-label extension portion “failed to demonstrate efficacy for its prespecified primary … and secondary endpoints”.

  • In the CRL (complete response letter), CAPR noted that the FDA’s call to reject deramiocel was “difficult to understand” and “unprecedented,” as the company was encouraged to file a BLA by the agency before its rejection …
  • Linda Marbán, CAPR’s CEO stated that the company “respects the FDA’s process” in a 9/9 statement, stressing the importance of investor and patient access to both the CRL and CAPR’s response, which was publicized …
  • It might be a bumpy road ahead for CAPR, as Levi & Korinsky are now filing a lawsuit against CAPR for alleged securities fraud related to deramiocel. The plaintiff claims that Capricor intentionally misled investors with “overwhelmingly positive statements relating to the four-year safety and efficacy data from the HOPE-2 trial”, as well as the company’s ability to obtain a BLA for the drug. <GlobalData, AK Allen>

 

Wednesday’s RegMed Investors’ (RMi) pre-open: Waiting for PPI, it’s here … https://www.regmedinvestors.com/articles/14099

RegMed Investors (RMi) Research Note: Harvard Apparatus GT (OTCQB): Just another wrinkle – Q2/25’s 10-Q – liabilities exceed cash position … https://www.regmedinvestors.com/articles/13812

 

Wednesday: The Dow closed DOWN -220.42 points or -0.18%, the S&P closed UP +19.43 points or +0.30% while the Nasdaq closed UP +6.572 points or +0.03%

  • Theme of the session, wholesale prices unexpectedly declined, now with investors insisting for a Fed rate cut next week

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

  • The latest producer price index reading showed that wholesale prices fell 0.1% in August. Economists had estimated a 0.3% gain. Core PPI, which excludes food and energy prices, likewise declined 0.1%, while the consensus called for 0.3%.
  • Economists expect the CPI data to show overall prices up 2.9% from a year ago, an increase from June and July's 2.7% pace.

Wednesday’s my 40-company covered sector’s advance/decline line opened negative with 19 incliners, 20 decliners and 1 flat ending with a negative close of 13 incliners, 26 decliners and 1 flat

Metrics:  Wednesday, the IBB was down -2.29%, the XBI was down -1.08% while the VIX was up +0.31 points or +2.06% at 15.35

 

Q3 – 1 holiday, 3 negative and 4 positive closes

  • August – 12 negative and 9 positive closes
  • July – 1 market holiday, 13 positive and 9 negative closes

 

Wednesday Closing UP (10 of x13) 

  • Lenz Therapeutics (LENZ +$1.82),
  • Arrowhead Pharmaceuticals (ARWR +$1.16 after Tuesday’s +$0.56 after Monday’s -$1.91),
  • Mesoblast (MESO +$0.56 after Tuesday’s +$0.45 after Monday’s +$0.16),
  • Solid Biosciences (SLDB +$0.24 after Tuesday’s -$0.13),
  • Cellectis SA (CLLS +$0.20),
  • Supernus Therapeutics (SUPN +$0.18),
  • Voyager Therapeutics (VYGR +$0.155 after Tuesday’s -$0.36 after Monday’s +$0.02),
  • BioLife Solutions (BLFS +$0.09),
  • Entrada Therapeutics (TRADA +$0.08 after Tuesday’s -$0.14),
  • Compass Therapeutics (CMPX +$0.04),

Flat (1)

  • Harvard Apparatus RT (OTCQB: HRGN $0.00 after Monday’s +$0.17)

Wednesday’s Closing DOWN (10 of 26): 

  • Alnylam Pharmaceuticals (ALNY -$12.82 after Tuesday’s +$27.10 after Monday’s +$3.03),
  • Vertex Pharmaceuticals (VRTX -$7.93 after Tuesday’s +$1.23 after Monday’s -$0.87),
  • IQV Holdings (IQV -$5.77 after Tuesday’s +$1.99),
  • CRISPR Therapeutics (CRSP -$1.88),
  • Vericel (VCEL -$1.23 after Tuesday’s -$0.68 after Monday’s -$0.83),
  • BioNTech SE (BNTX -$1.09 after Tuesday’s -$0.57 after Monday’s -$9.80),
  • Intellia Therapeutics (NTLA -$0.59),
  • Beam Therapeutics (BEAM -$0.49 after Tuesday’s +$0.42 after Monday’s -$0.94),
  • Sarepta Therapeutics (SRPT -$0.42),
  • Ionis Pharmaceuticals (IONS -$0.42 after Tuesday’s +$3.42),

 

The BOTTOM LINE:  More of the … WHYs …

Reiterating from Monday, “The cell and gene therapy seems to be currently residing and possibly staying in a … catalyst vacuum with more downside drift potentially coming into the markets which is … flirting with all-time highs in a … seasonally weak period.”

  • Again, from Monday’s morning post, “Thursday's CPI (inflation data) initial jobless claims, the weekly update on mortgage rates will be closely watched. Friday’s consumer sentiment could offer uncertain mix of upcoming inflation pressures; followed by None on Friday – Thankfully.
  • The PPI report serves as a positive sign regarding the state of inflation in the U.S. economy heading into tomorrow’s consumer price index reading.

… unless there’s some event out of left field with regard to tariffs, the CPI or who knows what …

 

September: understand the “flow” …

  • 9/10 – Wednesday closed negative with 13 positive, 26 negative and 1 flat
  • 9/9 - Tuesday closed positive with 24 positive, 15 negative and 1 flat
  • 9/8 – Monday closed negative with 10 positive, 28 negative and 2 flats
  • 9/5 - Friday closed positive with 35 positive, 5 negative and 0 flat
  • 9/4 – Thursday closed negative with 17 positive, 21 negative and 2 flats
  • 9/3 - Wednesday closed positive with 22 positive, 16 negative and 2 flats
  • 9/2 -Tuesday closed positive with 22 positive, 18 negative and 0 flat
  • 9/1 -Monday was a holiday

 

Welcome to my world of defining the “grey’ in our universe!

  • “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!”
  • If I have learned one thing as a former research analyst in a venture and public fund, operating executive, x-FBI, x-military officer and an adjunct (MBA) business school professor now a journalist; my life and your portfolio are largely tied to knowledge of price movements and questioning pricing targets and more.
  • I was once told by a “very” prominent figure early in my career, “write it right, keep it tight without hype and never lose the stride to guide the reader” – they were pretty simple instructions to follow!

 

Why do I keep repeating, so investors can make the connection …

The top three (3) performing in the session:   

  • Wednesday:
  • Tuesday: Alnylam Pharmaceuticals (ALNY), Ionis Pharmaceuticals (IONS) and IQV Holdings (IQV)
  • Monday: Alnylam Pharmaceuticals (ALNY), Prime Medicine (PRME) and Harvard Apparatus RT (OTCQB: HRGN)

The worst three (3) in the session: 

  • Wednesday: Alnylam Pharmaceuticals (ALNY), Vertex (VRTX) and IQVIA Holdings (IQV)
  • Tuesday: Vericel (VCEL), BioNTech (BNTX) and CRISPR Therapeutics (CRSP)
  • Monday: BioNTech (BNTX), Lenz Therapeutics (LENZ) and Arrowhead Pharmaceuticals (ARWR)

 

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.