December 19, 2023 5:39pm

Cell and gene therapy lives up with an unpredictability signature

News: uniQure N.V. (QURE -$1.34) updated interim data including up to 30 months of follow-up from 39 patients enrolled in the ongoing U.S. and European Phase I/II clinical trials of AMT-130 for the treatment of Huntington’s Disease. Ionis Pharmaceuticals (IONS -$0.40) signed a license agreement with Otsuka Pharmaceutical. Per the terms, Otsuka Pharmaceutical will acquire exclusive rights to market its investigational late-stage hereditary angioedema (HAE) therapy, donidalorsen, in the EU. bluebird bio (BLUE -$0.62 or -20.33% to $2.43 as 37.592 million shares trade) $150 million stock offering blossoms or blunders with NO pricing notice to shareholders.

Pre-open Indications: 1 Hit and 1 Miss

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

The sector is … still what it is, until it isn’t and even then, it doesn’t seem to be … that is after taking a deep breath and holding it

 

The Dow closed UP +251.90 points or +0.68%, the S&P closed UP +27.81 points or +0.59% while the Nasdaq closed UP +98.03 points or +0.66%

 

Henry’omics:

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 achieved yet another upside move … still, there are some concerns ahead for investors as they turn to a new year.

Economic Data Docket: Home construction and homebuilders stocks rose, continuing their recent rally as falling Treasury yields bolster the outlook for the housing market.

 

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

  • Tuesday’s advance/decline line was positive at the open with 26 incliners, 6 decliners and 3 flats, stayed positive at the mid-day with 24 declined, 9 incliners and 2 flats, ending with a positive close of 26 incliners, 8 decliners and 1 flat 

 

Pre-open Indications: 1 Hit <Sage Therapeutics (SAGE +$1.07)> 1 Miss <Intellia Therapeutics (NTLA +$1.67)>  

 

52-week Low:

  • bluebird bio (BLUE) at $2.43 (-$0.62 or -20.33% to $2.43 after news of $150 million stock offering as 35.147 million shares sell. NOTICE: NO pricing release to INFOM shareholders

 

Ebb and flow of MY covered sector cell and gene therapy session daily “endings”:

Q4:  December – 6 negative and 7 positive closes

  • November – 11 positives, 1 holiday and 10 negative closes
  • October – 12 negative and 10 positive closes

 

Key Metrics:

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

  • Tuesday, the IBB was up +1.60% and the XBI was up +2.54%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Tuesday was down -0.04 point or -0.32% at 12.52

 

Tuesday’s Closing Down (8 of 8):

  • uniQure NV (QURE -$1.34 after Monday’s -$0.31),
  • bluebird bio (BLUE -$0.62 after Monday’s -$0.22),
  • Ionis Pharmaceuticals (IONS -$0.40 after Monday’s +$1.01),
  • AxoGen (AXGN -$0.08),
  • Mesoblast (MESO -$0.04 after Monday’s +$0.03),
  • Graphite Bio (GRPH -$0.04 after Monday’s +$0.08),
  • Generation Bio (GBIO -$0.02),
  • Brainstorm Cell Therapeutics (BCLI -$0.0107),

Flat (1):

  • Harvard Apparatus GN (HRGN) WHY invest in this PIG!!

Tuesday’s Closing Up (10 of 26):

  • CRISPR Therapeutics (CRSP +$5.43 after Monday’s -$0.68
  • Ultragenyx Pharmaceuticals (RARE +$2.55),
  • Beam Therapeutics (BEAM +$2.06 after Monday’s -$0.97
  • Intellia Therapeutics (NTLA +$1.67 after Monday’s -$0.43),
  • Alnylam Pharmaceuticals (ALNY +$1.27 after Monday’s +$0.99),
  • Sage Therapeutics (SAGE +$1.07 after Monday’s -$0.51),
  • BioLife Solutions (BLFS +$1.02),
  • Verve Therapeutics (VERV +$0.78 after Monday’s -$0.34),
  • Prime Medicine (PRME +$0.60 after Monday’s +$0.08),
  • Vericel (VCEL +$0.57 after Monday’s -$2.53),
  • Editas Medicine (EDIT +$0.52 after Monday’s -$0.44).

 

Q4/23 – December

  • Tuesday closed positive with 26 incliners, 8 decliners and 1 flat
  • Monday (12/18) closed negative with 11 incliners, 24 decliners and 0 flat

 

The BOTTOM LINE: Musical chairs, the merry-go-round and even the spinning tea-cup rides capsulate the sector and its moves.  Right after as “uncle algo(rithms) and his electronic dwarfs came yet … again to speculate!

Tuesday’s backdrop:

  • Small cap stocks outperformed Tuesday as traders bet the assets can rebound next year after their underperformance this year. The Russell 2000 is up by 1.5%, and up by more than 11% this month. It’s advanced 14% this year????

 

“We remain cautious on risky assets and the broader macro-outlook due to the interest rate shock (over the past 18 months) that should negatively impact economic activity, fading consumer strength. Thus, even in an optimistic scenario, we believe upside is limited for risky assets, favoring cash and bonds over equities from a risk-reward standpoint.” Marko Kolanovic, the bank’s co-head of global research.

 

It's time to think ahead to December. It's usually an important month for the Nasdaq.

  • Don’t FORGET portfolio December tax selling and a bit of rebalancing … “Investors NEED to start formulating their portfolio outlook into next year.”
  • It might be prudent to harvest and cash in some chips following the past month’s dramatic rally.
  • And then comes January and with worries that the U.S. economy will be slowing down, the potential for continued Middle East violence and, of course, the real prospect of bitterly contested elections across all of the United States. <The Street>

The top three (3) performing in the session:

  • Tuesday: CRISPR Therapeutics (CRSP), Beam Therapeutics (BEAM) and Ultragenyx Pharmaceuticals (RARE)
  • Monday: Alnylam Pharmaceuticals (ALNY), Ionis Pharmaceuticals (IONS) and Fate Therapeutics (FATE)

The worst three (3) in the session:

  • Tuesday: uniQure NV (QURE), bluebird bio (BLUE) and Ionis Pharmaceuticals (IONS)
  • Monday: Vericel (VCEL), Beam Therapeutics (BEAM) and CRISPR Therapeutics (CRSP)

 

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

  • Right up front, “I also hate to be so negative or contrarian but, this is a NO spin zone and facts are its product; I can always be WRONG but … I am mostly EARLY!”

 

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.