September 11, 2023 4:36pm

Market breadth should keep investors cautious for the week until economic/inflation data releases, algos and electronic trading seek to disable the upside; I am still emphasizing sell into strength signals to offset the coming downdraft

Pre-open Indications: 5 Hits and 0 Miss

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The Dow closed UP +87.13 points or +0.25%, the S&P closed UP +29.97 points or +0.67% while the Nasdaq closed UP +156.37 points or +1.14%



We need to more than consider the economic environment - rising rates and inflation to comprehend the micro re “our” universe of cell and gene therapy companies …

Indexes closed higher in Monday’s trading on a quiet day ahead of what is sure to be a busy week.

Monday, investor/trading sentiment was helped by a Wall Street Journal report on Sunday saying there was a consensus among the Fed members not to raise rates at next week’s meeting. The report also cited a policy shift are seeing less urgency to add another rate hike later this year, as inflation data has been improving.

The Cboe Volatility Index briefly climbed 3.5% in early trading Monday, rising as high as 14.33, before returning back to Friday’s levels around 13.80. <CNBC>


Monday (9/11) … RegMed Investors’ (RMi) Opening Bell: “The September Effect. Refers to the historically weak stock market returns observed during the month of September. Cell and gene therapy stocks are barely up one week (3 of 5 sessions) into what's historically been their worst month of the year.” …


Pre-Open indications: 5 Hits < Blueprint Medicine (BPMC +$0.16), Beam Therapeutics (BEAM +$0.55), Intellia Therapeutics (NTLA +$0.38), Ionis Pharmaceuticals (IONS +$0.08), Sage Therapeutics (SAGE +$0.04)> and 0 Miss


RegMed/Stem/Cell and Gene Therapy’s 35 covered equities’ Advance/Decline (A/D) lines: what happened – differences …

  • Monday’s advance/decline line opened positive at 20 up/ 14 down and 1 flat, stayed positive with 25 up/ 10 down and 0 flat at the mid-day, ending with a positive close of 23 incliners, 12 decliners and 0 flat


Ebb and flow:

Q3: September – 1 holiday, 4 positive and 2 negative closes

·         August – 9 positive and 14 negative closes

·          July - 1 holiday, 12 positive and 8 negative close


Key Metrics:

The iShares NASDAQ Biotechnology (IBB) and the SPDR S&P ETF (XBI) indicators:

  • Monday, the IBB was up +0.65% and the XBI was up +0.22%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Monday was up +0.05 point or +0.36% at 13.90


Closing Down (12 of 12):

  • Ultragenyx Pharmaceuticals (RARE -$0.41),
  • Voyager Therapeutics (VYGR -$0.32),
  • Brainstorm Cell Therapeutics (BCLI -$0.10),
  • Adverum Biotechnologies (ADVM -$0.07 after Friday’s -$0.05),
  • uniQure NV (QURE -$0.05 after Friday’s +$0.18),
  • Graphite Bio (GRPH -$0.04),
  • Fate Therapeutics (FATE -$0.04),
  • Compass Therapeutics (CMPX -$0.03),
  • Precigen (PGEN -$0.03),
  • Agenus (AGEN -$0.01),
  • bluebird bio (BLUE -$0.01),
  • Cellectis SA (CLLS -$0.01)

Closing Up (10 of 23):

  • Alnylam Pharmaceuticals (ALNY +$2.29 after Friday’s +$0.33),
  • Vericel (VCEL +$1.35 after Friday’s -$0.18),
  • Prime Medicine (PRMC +$1.35 after Friday’s -$0.97),
  • CRISPR Therapeutics (CRSP +$1.13 after Friday’s +$0.60),
  • Caribou Biosciences (CRBU +$0.63),
  • Beam Therapeutics (BEAM +$0.55 after Friday’s +$0.40),
  • BioLife Solutions (BLFS +$ after Friday’s +$0.33),
  • Blueprint Medicine (BPMC +$0.43 after Friday’s +$2.74),
  • Intellia Therapeutics (NTLA +$0.38 after Friday’s +$0.18),
  • Verve Therapeutics (VERV +$0.36),


Q3/23 – September

  • (9/11) Monday closed positive with 23 incliners, 12 decliners and 0 flat


The BOTTOM LINE: I try to keep it simple … and short!

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

My version of the morning’s “indications” is about what you need to know; it’s what could happen or materialize after the opening and what might happen during the session


This week, the focus also turns to Consumer Price Index (CPI) inflation data due for release on Wednesday, a key input for investors trying to assess whether the Fed will ease up on interest rate hikes at its September meeting.


Another reiteration “too many factors are calling the ball on share pricing – sentiment, economics, earnings, and I believe the political aspect of the country’s leanings, polarization, and disparities of the debt ceilings arguments.”

The cell and gene therapy sector equity stayed positive on Monday after closing positive on Friday, Thursday’s negative close, Wednesday’s positive close following Tuesday’s dive post Monday’s holiday post the previous Friday’s positive close.


Another questionable or possibly bad:

FDA casts doubt on Alnylam Pharmaceuticals (ALNY) drug trial results for expanded usage. <Boston Globe>

·         The drug, AMVUTTRA™ (vutrisiran), an RNAi Therapeutic for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults; ALNY’s second best-selling, was initially approved in 2018 as a first-of-its-kind treatment for a rare genetic disease called polyneuropathy.

·         The FDA approval is based on positive 9-month results from the HELIOS-A P3 study, where AMVUTTRA significantly improved the signs and symptoms of polyneuropathy, with more than 50% of patients experiencing halting or reversal of their disease manifestations.<more to come>


Right up front, “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!”

Being “greedy when others are fearful” is easier said than done

When a cell and gene therapy sector equity sells-off to or below a buy point, investors face a tough decision: hold tight, exit or trim the position. There's not necessarily a "right" answer. Sometimes the stock will bounce right back, others will keep falling — perhaps after briefly bouncing. A more-cautious approach may make more sense in the current volatile market.


The top three (3) performing in the session:

Monday: Alnylam Pharmaceuticals (ALNY), CRISPR Therapeutics (CRSP), Prime Medicine (PRMC)

Friday: Blueprint Medicine (BPMC) - again, Ionis Pharmaceutrals (IONS) – again and Sage Therapeutics (SAGE)

While The worst three (3) in the session:

Monday: Voyager Therapeutics (VYGR), Brainstorm Cell Therapeutics (BCLI) and Adverum Biotechnologies (ADVM)

Friday: Prime Medicine (PRMC), AxoGen (AXGN) and Vericel (VCEL) - again


I am definitely considered a contrarian depending on the session – one has to be a watcher of the ups and downs as well as measurer of sentiment. I am also a NO trust investor but, a validate and verify journalist/analyst.

The NO spin zone! U.S. public shareholders deserve accountability …


Harvard Apparatus Regenerative Technology (HRGN) formerly Biostage (OTCQB: BSTG) … as of 7/20/23 -- so many issues according to the 8-K and 10-K!     

Still labeled a … Going Concern

·         HRGN has incurred substantial operating losses since its inception, and as of June 30, 2023 had an accumulated deficit of approximately $88.5 million and will require additional financing to fund future operations.

·         HRGN- WHO and WHICH U.S. investors would INVEST in a BASICALLY Chinese company with their history??

·         As they continue pumping the price “pump share pricing and promote volume” just like a Ponzi scheme???


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 its 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.