September 19, 2023 4:40pm

Before fed decision as the path of inflation and monetary policy evolves

Pre-open Indications: 4 Hits and 1 Miss

The cell and gene therapy sector is defined by the words, “When you’re on a roller coaster, the only thing you can be sure of is you’ll end up back where you started”

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The Dow closed DOWN -106.57 points or -0.31%, the S&P closed DOWN -9.58 points or -0.22% while the Nasdaq closed DOWN -32.05 points or -0.23%



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 dived on Tuesday awaiting the Fed's policy meeting, as grocery delivery app Instacart's ($42.00) Nasdaq debut.

Recent economic data has signaled that core inflation is crawling toward the Fed's 2% target, though crude prices gaining for three consecutive weeks to around 10-month highs remains a concern.

  • The Fed will also offer economic forecasts on Wednesday. Investors will watch for commentary around the path of inflation and future of monetary policy.

Economic Data Docket: U.S. homebuilding plunged to more than a three year-low in August as a resurgence in mortgage rates weighed on demand for housing, but a surge in permits suggested new construction remained supported by a dearth of homes on the market.

  • The decline in housing starts reported by the Commerce Department on Tuesday was the largest in a year and occurred across the board, suggesting that an anticipated housing market recovery was still far off.


Tuesday (9/19) … RegMed Investors’ (RMi) Opening Bell: “Sector share pricing is disconnected from everything. Instead of dwelling on not buying the “depleted” or not waiting long enough to take profit; I suggest thinking about where your portfolio is most vulnerable>” …


Pre-Open indications: 4 Hits < Blueprint Medicine (BPMC -$0.86), Intellia Therapeutics (NTLA -$0.65), Beam Therapeutics (BEAM +$0.19), CRISPR Therapeutics (CRSP -$0.22) and 1 Miss < Alnylam Pharmaceuticals (ALNY -$4.11)>


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

  • Tuesday’s advance/decline line opened negative at 13 up/ 18 down and 4 flats, stayed negative at the mid-day with 14 up/ 20 down and 1 flat, ending with a negative close of 17 incliners, 18 decliners and 0 flats
  • Monday’s advance/decline line opened negative at 9 up/ 25 down and 1 flat, stayed negative with 8 up/ 26 down and 1 flat at the mid-day, ending with a negative close of 11 incliners, 22 decliners and 2 flats


52-week low:

  • Alnylam Pharmaceuticals (ALNY) at $175.66
  • Solid Biosciences (SLDB) at $2.88
  • Cellectis SA (CLLS) at $1.64
  • Sangamo Therapeutics (SGMO) at $0.84


Ebb and flow:

Q3: September – 1 holiday, 6 positive and 6 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:

  • Tuesday, the IBB was up +0.37% and the XBI was up +0.05%
  • Monday, the IBB was down -1.07% and the XBI was down -1.50%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Tuesday was up +0.12 point or +0.86% at 14.11
  • Monday was up +0.29 point or +2.10% at 14.08


Closing Down (10 of 18):

  • Alnylam Pharmaceuticals (ALNY -$4.11 after Monday’s -$5.22)
  • Blueprint Medicine (BPMC -$0.86 after Monday’s +$1.57),
  • Intellia Therapeutics (NTLA -$0.65 after Monday’s -$0.80),
  • Vericel (VCEL -$0.28),
  • CRISPR Therapeutics (CRSP -$0.22 after Monday’s -$2.94),
  • Fate Therapeutics (FATE -$0.20 after Monday’s +$0.35),
  • Precigen (PGEN -$0.12),
  • Solid Biosciences (SLDB -$0.12),
  • Voyager Therapeutics (VYGR -$0.11 after Monday’s +$0.19),
  • Harvard Apparatus RN (HRGN -$0.09 after Monday’s $0.00)

Closing Up (10 of 17):

  • MiMedx (MDXG +$0.28 after Monday’s +$0.03),
  • uniQure NV (QURE +$0.26 after Monday’s -$0.57),
  • Caribou Biosciences (CRBU +$0.19 after Monday’s -$0.61),
  • Beam Therapeutics (BEAM +$0.19 after Monday’s -$0.74),
  • Sage Therapeutics (SAGE +$0.15 after Monday’s -$0.72),
  • Prime Medicine (PRMC +$0.15 after Monday’s -$0.44),
  • Verve Therapeutics (VERV +$0.14 after Monday’s +$0.03),
  • BioLife Solutions (BLFS +$0.11),
  • Regenxbio (RGNX +$0.08 after Monday’s +$0.03)
  • Ultragenyx Pharmaceuticals (RARE +$0.08 after Monday’s -$1.37),


Q3/23 – September

  • Tuesday closed negative with 17 incliners, 18 decliners and 0 flat
  • Monday closed negative with 11 incliners, 22 decliners and 2 flats


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.”

Contributing to today’s (9/19) downdraft … fear of inflation and its resulting market forces:

Another hit to investors as inflation with a plunge in U.S. homebuilding last month underscored the balancing act the Fed faces in presenting its outlook on interest rates and the economy this week.

Traders and investors are avoiding big bets ahead of the Fed's meeting this week on Tuesday and Wednesday.

The cell and gene therapy sector equities got “lifted” by algos/electronic trading on Tuesday after Monday’s depression even further than Friday after popping positive on Thursday, having dived negative on Wednesday having stayed positive on last Tuesday’s close.


As I have written, too many factors are calling the ball on share pricing – algorithms and electronic trading, here and there sentiment, economics, upcoming Q3 earnings.

I STILL believe the political aspect of the country’s leanings, polarization, and disparities of the debt ceilings arguments are contributing to the roller coaster ride for share pricing actions.

It’s still about the economy … STUPID as investors congest a raft of economic reports pointing to … tamer core inflation data and a spending consumer.

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:

Tuesday: MiMedx (MDXG), uniQure NV (QURE) and Caribou Biosciences (CRBU)

Monday: Blueprint Medicines (BPMC), Fate Therapeutics (FATE) and Voyager Therapeutics (VYGR)

While The worst three (3) in the session:

Tuesday: Alnylam Pharmaceuticals (ALNY) – 4x, Blueprint Medicines (BPMC) and Intellia Therapeutics (NTLA)

Monday: Alnylam Pharmaceuticals (ALNY) – 3x, CRISPR Therapeutics (CRSP) and Ultragenyx Pharmaceuticals (RARE) – 3x


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 will NEED to raise additional funds to fund its operations. 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??? Notice the volume today – 5,398 shares traded <3-month average = 1,498 shares> to close FLAT?

·         Question, did you notice how it barely trades unless volume is “pump” – is it by DST, run by the president of HRGN, Hong Yu and Mrs. Mrs. bin Zhao of Weston, Mass – funded by Lui Dong Hai, chairman of Dixintong Technology Group (D. Phone, the largest smartphone retailer in China) the husband of Mrs. bin Zhao??

·         Question #2, Is the current or future investment coming directly or indirectly from those associated with two (2) directors of BSTG, Jason Jing Chen (chairman of BSTG’s board of directors who resides in Beijing, China and is employed by a subsidiary of Dixintong technology Group – D. Phone), Ting Li (Donghai Securities Co., Ltd) - all reside in China – what are their affiliations - especiallt to the Chinese security service - MSS??


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.