December 8, 2023 6:13pm

Biotech, healthcare, cell and gene therapy sector are about to be possibly scammed for their patents by current administration

News: The FDA has approved Vertex Pharmaceuticals (VRTX) and CRISPR Therapeutics (CRSP -$5.67) co-developed Casgevy to treat sickle cell disease, a blood disorder that affects about 100,000 Americans; the first gene-editing treatment to be marketed in the country. However, the one-time treatment that could cost around $2 million per patient and the procedure is so complex, it will be limited to certain health facilities like academic medical centers.

Another but, BLUE finally got its sickle cell approval, yet also gets a black box cancer warning (the risk is probably same as VRTX), charges $1M more than VRTX, and doesn’t get the $100M pediatric voucher it needed. <Jason Mast, STAT>

 

Pre-open In Indications: 5 Hits and 1 Miss

Subscription is coming, it is not conscription but, an offer to join our collective of like-minded investors!  Join me … in the NO spin zone.

Never leave an investor uninformed!

 

After careful examination of the sector and breathe trends, I STILL come away more cautious. Having lived through the rise and multiple declines of “our” universe’s stock price.

Investors deserve share pricing explanations because they give us an illusion of portfolio control. I know what a company is supposed to look like, be like, and smell like to succeed; bottom line, investors own the right to exit or enter sector’s share pricing.

Investors must be better informed on what fluctuating economics and markets can do to an equity, or what impact indications or expectations can have.

 

The Dow closed UP +130.49 points or +0.36%, the S&P closed UP +18.78 points or +0.41% while the Nasdaq closed UP +63.98 points or +%

 

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 closed higher Friday as the November jobs report and University of Michigan consumer survey data signaled a resilient economy and cooling inflation, fueling hopes for a so-called soft-landing scenario.

All the major averages finished the week with gains… the S&P jumped 0.2%, the Dow finished marginally higher while the Nasdaq advanced 0.7%.

Economic Data Docket: November’s nonfarm payrolls report showed an unexpected drop in the unemployment rate. The jobless rate fell to 3.7% in November from 3.9% the prior month. It was expected to remain the same. The economy added 199,000 jobs, slightly ahead of the 190,000 estimates and well ahead of the 150,000 jobs added in October.

  • The University of Michigan survey showed inflation expectations drop and consumer sentiment jump in December to its highest level since July.

 

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

  • Friday’s advance/decline line was negative with 14 incliners, 20 decliners and 1 flat at the open, the mid-day stayed negative with 13 incliners, 21 decliners and 1 flat, ending with a negative close of 10 incliners, 25 decliners and 0 flat
  • Thursday’s advance/decline line was negative with 13 incliners, 21 decliners and 1 flat at the open, the mid-day flipped positive with 19 incliners, 16 decliners and 0 flat, ending with a positive close of 23 incliners, 12 decliners and 0 flat
  • Wednesday’s advance/decline line was positive with 22 incliners, 11 decliners and 2 flats at the open, the mid-day stayed positive with 24 incliners, 10 decliners and 1 flat, ending with a positive close of 21 incliners, 14 decliners and 0 flat
  • Tuesday’s advance/decline line was negative with 2 incliners, 31 decliners and 2 flats at the open, the mid-day stayed negative with 4 incliners, 31 decliners and 0 flat, ending with a negative close of 5 incliners, 29 decliners and 1 flat
  • Monday’s advance/decline line was positive at the open with 25 incliners, 6 decliners and 4 flats, flopped negative with 22 decliners/12 incliners and 1 flat, springing positive at the mid-day with 25 declined, 8 incliners and 2 flats, ending with a positive close of 26 incliners, 8 decliners and 1 flat

 

Pre-open In Indications: 5 Hits < Alnylam Pharmaceuticals (ALNY -$7.22), Blueprint Medicine (BPMC +$0.20), Ultragenyx Pharmaceuticals (RARE -$0.96), Solid Biosciences (SLDB -$0.70), Regenxbio (RGNX -$1.02)> and 1 Miss < Prime Medicine (PRME -$0.06)>

 

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

Q4:  December – 2 negative and 4 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:

  • Friday, the IBB was down -0.69% and the XBI was down -1.49%
  • Thursday, the IBB was up +0.71% and the XBI was up +1.23%
  • Wednesday, the IBB was up +0.78% and the XBI was up +0.94%
  • Tuesday, the IBB was down -0.40% and the XBI was down -0.49%
  • Monday, the IBB was up +0.69% and the XBI was up +1.75%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Friday was down -0.71point or -5.44% at 12.45
  • Thursday was up +0.090 point or +0.69% at 13.06
  • Wednesday was up +0.12 point or +0.93% at 12.97
  • Tuesday was down -0.23 point or -1.76% at 12.63
  • Monday was up +0.45 point or +3.56% at 13.08

 

Friday’s Closing Down (10 of 25):

  • Alnylam Pharmaceuticals (ALNY -$7.22 after Thursday’s +$2.24, Wednesday’s +$4.65, Tuesday’s -$2.50 and Monday’s +$1.36),
  • CRISPR Therapeutics (CRSP -$5.67 after Thursday’s -$0.93 after Wednesday’s +$0.54, Tuesday’s -$0.91 after Monday’s +$2.86
  • Beam Therapeutics (BEAM -$2.35 after Thursday’s -$0.08 after Wednesday’s +$0.42 after Tuesday’s -$1.31 after Monday’s -$0.01
  • bluebird bio (BLUE -$1.95 after Thursday’s -$0.02 after Wednesday’s +$0.50),
  • Regenxbio (RGNX -$1.02 after Thursday’s +$0.82),
  • Ultragenyx Pharmaceuticals (RARE -$0.96 after Thursday’s +$0.31 after Wednesday’s -$0.90, Tuesday’s +$0.79 after Monday’s +$1.09),
  • Sage Therapeutics (SAGE -$0.88),
  • Ionis Pharmaceuticals (IONS -$0.78 after Thursday’s -$0.47 after Wednesday’s -$0.06, Tuesday’s -$1.46 after Monday’s -$0.17),
  • Intellia Therapeutics (NTLA -$0.76 after Thursday’s -$0.08 and Wednesday’s -$0.04),
  • Solid Biosciences (SLDM -$0.77 after Thursday’s +$2.34 after Wednesday’s -$0.33, Tuesday’s +$0.31 and Monday’s +$0.52),

 

Friday’s Closing Up (10 of 10):

  • BioLife Solutions (BLFS +$0.54 after Thursday’s -$0.32, Wednesday’s -$0.24, Tuesday’s -$0.58 after Monday’s +$0.62),
  • Blueprint Medicine (BPMC +$0.20 after Thursday’s +$1.36, Wednesday’s -$0.89, Tuesday’s +$0.59 and Monday’s +$0.70)
  • Cellectis SA (CLLS +$0.16 after Thursday’s -$0.07),
  • AxoGen (AXGN +$0.09),
  • MiMedx (MDXG +$0.08),
  • Harvard Apparatus GN (HRGN +$0.05 after Thursday’s -$0.05 and Wednesday’s +$0.32)? Who would buy this pig?
  • Sangamo Therapeutics (SGMO +$0.0275),
  • Precigen (PGEN +$0.01 after Thursday’s +0.02, Wednesday’s -$0.07 after Tuesday’s $0.00),
  • Compass Therapeutics (CMPX +$0.01),
  • Bellicum Pharmaceuticals (BLCM +$0.0008 after Thursday’s -$0.0247),

 

Q4/23 – December

  • Friday (12/8) closed negative with 10 incliners, 25 decliners and 0 flat
  • Thursday closed positive with 23 incliners, 12 decliners and 0 flat
  • Wednesday closed positive with 21 incliners, 14 decliners and 0 flat
  • Tuesday closed negative with 5 incliners, 29 decliners and 1 flat
  • Monday (12/4) closed positive with 26 incliners, 8 decliners and 2 flats
  • Friday (12/1) closed positive with 30 incliners, 3 decliners and 2 flats

 

The BOTTOM LINE: Today, Friday reinforces my words ...“I remain a skeptic, as electronic trading remains the impetus to, I believe a cell and gene therapy sector’s artificial high.

I warned that markets have been too optimistic about rate cuts and maintain investors should consider getting defensive” … if dead wood or too struggling share pricings are in the portfolio; especially those desperately needing a financing, lacking a partner, restructuring and needing a financing or just wallowing in the market …

… “Investors NEED to start formulating their portfolio outlook into next year.”

Being that I have concerns over the upside moves that usually end in downward sells while the risk/reward profile doesn’t always compel elevated and “dramatic” i.e., sudden equity pricing.

It might be prudent to harvest and cash in some chips following the past month’s dramatic rally.

 

What’s behind the numbers:

Stocks are in a ‘catch-22’ situation, JPMorgan strategist says … The strategist is not optimistic on the 2024 outlook. In his bullish scenario, he expects stocks can outperform bonds or cash by roughly 5%, but in the event of a recession, he expects they will underperform cash by about 20%

  • Even if there isn’t a recession in 2024, it’s hard to imagine a sustainable stock rally without a meaningful lowering of interest rates, according to Marko Kolanovic, chief global markets strategist at JPMorgan.
  • “This is a catch-22 situation, in which risk assets can’t have a sustainable rally at this level of monetary restriction, and there will likely be no decisive easing unless risky assets correct (or inflation declines due to, for example, weaker demand, thus hurting corporate profits),” Kolanovic wrote on Friday.
  • “This would imply that we would need to first see some market declines and volatility during 2024 before easing of monetary conditions and a more sustainable rally,” Kolanovic said. <CNBC>

 

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

  • Don’t FORGET portfolio December tax selling and a bit of rebalancing
  • 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:

  • Friday: BioLife Solutions (BLFS), Blueprint Medicine (BPMC) and Cellectis SA (CLLS)
  • Thursday: Solid Biosciences (SLDB), Alnylam Pharmaceuticals (ALNY) – 4x and Blueprint Medicine (BPMC)
  • Wednesday: Alnylam Pharmaceuticals (ALNY) – 3x, Verve Therapeutics (VERV) and CRISPR Therapeutics (CRSP)
  • Tuesday: Alnylam Pharmaceuticals (ALNY) – 2x, Ionis Pharmaceuticals (IONS) -2x and Beam Therapeutics (BEAM)
  • Monday: CRISPR Therapeutics (CRSP), Alnylam Pharmaceuticals (ALNY) and Ultragenyx Pharmaceuticals (RARE)

The worst three (3) in the session:

  • Friday: Alnylam Pharmaceuticals (ALNY), CRISPR Therapeutics (CRSP) and Beam Therapeutics (BEAM)
  • Thursday: CRISPR Therapeutics (CRSP), Ionis Pharmaceuticals (IONS) and BioLife Solutions (BLFS)
  • Wednesday: Vericel (VCEL), Ultragenyx Pharmaceuticals (RARE) – 2x and Blueprint Medicine (BPMC) -2x
  • Tuesday: Ultragenyx Pharmaceuticals (RARE), Blueprint Medicine (BPMC) and Solid Biosciences (SLDB)
  • Monday: Ionis Pharmaceuticals (IONS), Cellectis SA (CLLS) and Fate Therapeutics (FATE)

 

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.