September 14, 2023 4:43pm

Snap crackle and pop, there were low cent winners after Wednesday’s losers as September spins cell and gene therapy sector with 6 positive, 3 negative closes and 1 holiday – so far

Pre-open Indications: 3 Hits and 0 Miss

News: Alnylam Pharmaceuticals (ALNY -$18.59) stock tumbled Thursday after a split advisory panel recommended the FDA approve its heart disease treatment. But panelists suggested Onpattro would only be useful for patients who worsen while receiving Pfizer's (PFE) tafamidis, which sells as Vyndaqel and Vyndamax. Patients treated with Onpattro showed improvements in symptoms. But PFE's drug has a proven benefit on mortality.

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The Dow closed UP +331.58 points or +0.96%, the S&P closed UP +37.66 points or +0.84% while the Nasdaq closed UP +112.47 points or +0.81%



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 were up having experiences August’s producer price index showing core PPI was held in check last month which comes after August’s consumer price index on Wednesday showed core CPI, which excludes food and energy, came in slightly above expectations on a monthly basis.

Economic Data Docket: The August reading of the producer price index came in hotter than expected. It rose 0.7%, more than the 0.4% increase anticipated by economists. However, excluding food and energy, core PPI increased 0.2%, in line with the estimate.

  • August retail sales came in better than expected, jumping 0.6% against a 0.1% increase expected by economists. Excluding autos, retail sales rose 0.6% last month, more than the forecasted 0.4% increase.


Thursday (9/43) … RegMed Investors’ (RMi) Opening Bell: “the known unknowns. Prepare for the August producer price index, a measure of wholesale inflation.”


Pre-Open indications: 3 Hits < Alnylam Pharmaceuticals (ALNY -$18.59), CRISPR Therapeutics (CRSP +$1.92), Intellia Therapeutics (NTLA +$0.51)> and 0 Miss


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

  • Thursday’s advance/decline line opened positive at 17 up/ 13 down and 5 flats, kept positive at the mid-day with 21 up/ 11 down and 3 flats, ending with a positive close of 18 incliners, 15 decliners and 2 flats


Ebb and flow:

Q3: September – 1 holiday, 6 positive and 3 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:

  • Thursday, the IBB was up +0.38% and the XBI was down -0.10%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Thursday was down -0.66 point or -4.90% at 12.82


Closing Down (10 of 15):

  • Alnylam Pharmaceuticals (ALNY -$18.59 after Wednesday’s $0.00 due trading stop)
  • Ultragenyx Pharmaceuticals (RARE -$1.70 after Wednesday’s -$0.45, Tuesday’s +$0.67 and Monday’s -$0.41),
  • Sage Therapeutics (SAGE -$1.17 after Wednesday’s -$0.78 and Tuesday’s +$1.79),
  • Vericel (VCEL -$1.02 after Wednesday’s +$0.20, Tuesday’s +$2.46 and Monday’s +$1.35),
  • Blueprint Medicine (BPMC -$0.56 after Wednesday’s -$0.88, Tuesday’s -$0.74 and Monday’s +$0.43),
  • BioLife Solutions (BLFS -$0.36 after Wednesday’s +$0.01),
  • Brainstorm Cell Therapeutics (BCLI -$0.11),
  • Verve Therapeutics (VERV -$0.09 after Wednesday’s -$0.47, Tuesday’s +$0.39 and Monday’s +$0.36),
  • Editas Medicine (EDIT -$0.07 after Wednesday’s -$0.53 and Tuesday’s -$0.17),
  • Sangamo Therapeutics (SGMO -$0.06 after Wednesday’s +$0.06),

Flat (2):

  • Agenus (AGEN)
  • Bluebird bio (BLUE)

Closing Up (10 of 18):

  • CRISPR Therapeutics (CRSP +$1.92 after Wednesday’s -$1.01, Tuesday’s -$0.70 and Monday’s +$1.13),
  • Intellia Therapeutics (NTLA +$0.51 after Wednesday’s -$1.65, Tuesday’s -$1.10 and Monday’s +$0.38),
  • Ionis Pharmaceuticals (IONS +$0.49),
  • Beam Therapeutics (BEAM +$0.11 after Wednesday’s -$1.15),
  • MiMedx (MDXG +$0.09),
  • Caribou Biosciences (CRBU +$0.05 after Wednesday’s -$0.50, Tuesday’s -$0.29 and Monday’s +$0.63),
  • Mesoblast (MESO +$0.04),
  • AxoGen (AXGN +$0.04),
  • Adverum Biotechnologies (ADVM +$0.04)


Q3/23 – September

  • Thursday closed positive with 18 incliners, 15 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.”

My version of the morning’s “indications” is about what you need to know; it’s what could happen or materialize and what did happen at the close of the session


The cell and gene therapy sector equity popped positive on Thursday, having dived negative on Wednesday, stayed positive on Tuesday after Monday’s positive close Friday’s positive close and last Thursday’s negative close.

Cell and gene therapy sector popped even as a monthly increase in inflation in more than a year Thursday, as the producer price index came in hotter than expected

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

I 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.

Thursday's reading on retail sales for the same month came in stronger than they were in July, underscoring how the US consumer has remained resilient despite rising interest rates. Sales grew 0.6% on the month, compared with 0.1% expected, picking up steam as people shelled out more for gas.


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:

Thursday: CRISPR Therapeutics (CRSP), Ionis Pharmaceutrals (IONS) and Intellia Therapeutics (NTLA)

Wednesday: Regenxbio (RGNX), Vericel (VCEL) and uniQure NV (QURE)

Tuesday: Alnylam Pharmaceuticals (ALNY) - again, Vericel (VCEL) and Ionis Pharmaceutrals (IONS)

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


While The worst three (3) in the session:

Thursday: Alnylam Pharmaceuticals (ALNY), Ultragenyx Pharmaceuticals (RARE) and Sage Therapeutics (SAGE)

Wednesday: Intellia Therapeutics (NTLA) - again, Beam Therapeutics (BEAM) and CRISPR Therapeutics (CRSP) - again

Tuesday: Intellia Therapeutics (NTLA), Blueprint Medicines (BPMC) and CRISPR Therapeutics (CRSP)

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


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???


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.