September 25, 2025 8:05am

Investors should consider stepping back, a bit; as winners become losers and decliners become appreciated

Also, prepping for the end of September as Q3 is coming to a close – 5 sessions to go

News: Capricor Therapeutics (CAPR +$0.11 pre-open) Provides a regulatory update on Deramiocel program for Duchenne Muscular Dystrophy following FDA meeting <see below>

 

Never leave an investor uninformed … I say what others won’t, so you can do what others can’t!

 

News: The goal of CAPR’s FDA Type A meeting was to establish a path toward potential approval of Deramiocel for the treatment of DMD. Key outcomes included: The HOPE-3 clinical trial should (or is it could?) serve as the “additional study” requested in the CRL (Complete Response Letter).

  • Their HOPE-3 data "can be" submitted within the current BLA, maintaining PUL v2.0 as the primary efficacy endpoint and "suggesting" left ventricular ejection fraction (LVEF) as a key secondary endpoint, which CAPR "intends" to request for labeling consideration.
  • My view, blah, blah; wait for the clinical data’s release! HOPE-3 pivotal trial completed; topline data “expected” mid-Q4 2025 to support BLA resubmission???
  • Word salad ...!

 

Remember that overnight and pre-open actions’ futures and markets doesn’t necessarily translate into actual trading in today’s market session.

BREAKING: Initial claims for unemployment insurance were lower than expected. First-time filings for jobless benefits were at a seasonally adjusted 218,000 for the week ended Sept. 20. That’s less than the 235,000 that economists had estimated. The weekly jobless claims figure is also 14,000 less than the prior period’s initial unemployment claims, which had eased after seeing a brief spike the week before that. The solid jobs data as well as a strong upward revision to Q2 gross domestic product, (GDP) which was raised to 3.8% from 3.3.

I answer or 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 striving toward the near and longterm

 

Wednesday night’s … RMi Closing Bell: Indexes cooled … https://www.regmedinvestors.com/articles/14121

Updated … RMi Research Note: Harvard Apparatus GT (OTCQB): Who is wasting lipstick on this pig? … https://www.regmedinvestors.com/articles/13812

 

Thursday: The pre-open Dow futures are DOWN -0.12% or (-58 points), the S&P futures are DOWN -0.37% or (-24 points) and the Nasdaq futures are DOWN -0.50% or (-124 points)

  • Futures are falling on Thursday, 9/25
  • Europe markets moved lower,
  • Asia pacific markets were mixed

 

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

  • Wednesday: The Dow closed DOWN -171.50 points or -0.37%, the S&P closed DOWN -18.95 points or -0.28% while the Nasdaq closed DOWN -75.618 points or -0.34%
  • Tuesday: The Dow closed DOWN -88.76 points or -0.19%, the S&P closed DOWN -36.83 points or -0.65% while the Nasdaq closed DOWN -215.503 points or -0.95%
  • Monday: The Dow closed UP +66.27 points or +0.14%, the S&P closed UP +29.39 points or +0.44% while the Nasdaq closed UP +157.50 points or +0.70%
  • Last week: The Dow was up +1%, the S&P 500 +1.2% and the Nasdaq +2.2%.

Economic Data Docket: Initial jobless claims, GDP (3rd estimate), Advanced U.S. trade balance in goods - Aug., Advanced retail inventories - Aug., Advanced wholesale inventories - Aug., Durable-goods orders - Aug., Durable-goods minus transportation and Existing home sales

 

Q3 – September, 1 holiday, 8 negative and 9 positive closes

  • August - 11 negative and 9 positive closes
  • July – 1 market holiday, 13 positive and 9 negative closes

 

Companies in my headlights – It’s your decision; I provide ideas and context

I post about “indication intelligence” looking toward investment conferences … to assist investors with insight into sector vulnerabilities and strengths.  A dictionary definition of “indicate” refers to something less than a certainty; an indication could be a signal of being oversold or overbought, a recommendation, or grounds for inferring or a basis for believing.

  • I see red after as September continues to close with more econs coming and proximity to the Q’s end, along with the usual ups, downs and just plain uncertainties
  • Passing … as econs seem to dissolve share pricing or so it has!

 

The BOTTOM LINE: This week's theme ... “It’s always darkest before the pitch dark” …

The cell and gene therapy sector has responded in its usual alternating trend as I have written “econs have been poison” to our universe

  • Indexes fell for the 2nd day in a row on yesterday, ending a record-breaking rally fueled by a rate cut and AI fervor.
  • Fed Chair Powell's cautious remarks, combined with comments from other central bank policymakers this week, rattled expectation of 2 more rate cuts this year.

The cell and gene therapy sector has seen a few too many fits and starts, so …

  • The cell and gene therapy sector responds in its usual alternating trends as I have written “econs have been poison” to our universe
  • Again, investors feel some gains, “riding the skids of uncle algo and his electronic trading dwarfs” as the “the posse” alternate the cell and gene therapy sector’s being bought or sold into

 

September is in the front window: understand the “flow”

  • 9/24 – Wednesday closed positive with 28 positive, 11 negative and 1 flat
  • 9/23 – Tuesday closed negative with 7 positive, 32 negative and 1 flat
  • 9/22 - Monday closed positive with 31 positive, 9 negative and 0 flat

Last week:

  • 9/19 – Friday closed negative with 7 positive, 33 negative and 0 flat
  • 9/18 – Thursday closed positive with 33 positive, 6 negative and 1 flat
  • 9/17 – Wednesday closed negative with 10 positive, 30 negative and 0 flat
  • 9/16 – Tuesday closed positive with 29 positive, 9 negative and 2 flats
  • 9/15 – Monday closed negative with 17 positive, 22 negative and 1 flat

 

September has historically delivered pullbacks, yet, this year’s 2025 market has defied that pattern — climbing 35% since March with strong technical and fundamental tailwinds,

Q2 Earnings are in the rear-view mirror; we are about to start again … Q3!

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!”

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.

 

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. All investments are subject to risks. Investors should consider investment objectives.

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.  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.