December 12, 2023 7:58pm
Called out on first base, Monday and second, Tuesday; who’s on for the third, Wednesday?
News: Caribou Biosciences (CRBU -$0.11 with +$0.19 or +3.36% aftermarket) FDA feedback re CB-010 P3 randomized controlled trial for CB-010; on an allogeneic anti-CD19 CAR-T cell therapy in development for patients with second-line relapsed or refractory large B cell lymphoma (r/r LBCL). CRBU’s proposed comparator arm of platinum-based immunochemotherapy followed by high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) is acceptable. Blueprint Medicines (BPMC +$4.01 with +$0.30 or +0.35% aftermarket) the European Commission has approved AYVAKYT® (avapritinib) for the treatment of adult patients with indolent systemic mastocytosis (ISM) with moderate to severe symptoms inadequately controlled on symptomatic treatment. AYVAKYT is the first and only approved therapy for people living with ISM in Europe.
Pre-open Indications: 2 Hits and 3 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 +173.01 points or +0.48%, the S&P closed UP +21.26 points or +0.46% while the Nasdaq closed UP +100.91 points or +0.70%
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 …
Tuesday, indexes popped, hitting their highest intraday levels since January 2022.
Economic Data Docket: The consumer price index in November increased 3.1% from 12 months earlier, down from 3.2% in October.
- On a month-on-month basis, consumer prices ticked up 0.1% last month, compared with estimates of remaining unchanged.
RegMed/Stem/Cell and Gene Therapy’s 35 covered equities’ Advance/Decline (A/D) lines: what happened – differences …
- Tuesday’s advance/decline line was negative at the open with 5 incliners, 27 decliners and 3 flats, stayed negative at the mid-day with 12 declined, 23 incliners and 0 flat, ending with a negative close of 10 incliners, 25 decliners and 0 flat
- Monday’s advance/decline line was negative at the open with 4 incliners, 28 decliners and 3 flats, stayed negative at the mid-day with 12 declined, 23 incliners and 0 flat, ending with a negative close of 13 incliners, 21 decliners and 1 flat
Pre-open Indications: 2 Hits < Prime Medicine (PRME -$0.58), bluebird bio (BLUE -$0.58)> 3 Miss < Blueprint Medicine (BPMC +$4.01 on news), CRISPR Therapeutics (CRSP -$2.16), Intellia Therapeutics (NTLA -$0.20)>
Ebb and flow of MY covered sector cell and gene therapy session daily “endings”:
Q4: December – 4 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:
- Tuesday, the IBB was up +1.09% and the XBI was up +1.55%
The CBOE Volatility Index (VVIX: INDEX) tracked:
- Tuesday was down -0.56 point or -4.43% at 12.07
Tuesday’s Closing Down (10 of 25):
- CRISPR Therapeutics (CRSP -$2.16 after Monday’s -$4.26
- Beam Therapeutics (BEAM -$0.61 after Monday’s +$0.25
- Prime Medicine (PRME -$0.58 after Monday’s -$0.35),
- Verve Therapeutics (VERV -$0.29 after Monday’s -$0.38),
- bluebird bio (BLUE -$0.28 after Monday’s +$0.21),
- Regenxbio (RGNX -$0.25 after Monday’s -$0.19),
- Sage Therapeutics (SAGE -$0.22),
- Voyager Therapeutics (VYGR -$0.21 after Monday’s -$0.20),
- Intellia Therapeutics (NTLA -$0.20 after Monday’s -$0.67),
- BioLife Solutions (BLFS -$0.17 after Monday’s -$0.39),
Tuesday’s Closing Up (10 of 10):
- Blueprint Medicine (BPMC +$4.01 after Monday’s +$7.01)
- Alnylam Pharmaceuticals (ALNY +$2.96 after Monday’s +$0.88),
- Ultragenyx Pharmaceuticals (RARE +$2.81 after Monday’s +$0.16),
- Ionis Pharmaceuticals (IONS +$0.28 after Monday’s +$0.49),
- Fate Therapeutics (FATE +$0.12 after Monday’s +$0.04),
- Agenus (AGEN +$0.12),
- Mesoblast (MESO +$0.04),
- Generation Bio (GBIO +$0.02 after Monday’s +$0.07),
- uniQure NV (QURE +$0.01),
- Homology Medicine (FIXX +$0.0032),
Q4/23 – December
- Tuesday closed negative with 10 incliners, 25 decliners and 0 flat
- Monday (12/11) closed negative with 13 incliners, 21 decliners and 1 flat
The BOTTOM LINE: The Nasdaq and S&P 500 have moved out to 2023 highs, but not decisively. It's a little like letting the cat out, but it's a few steps past the door. Yes, it's outside, but it's not on a big adventure yet and could come right back in. <IBD>
- Reiterating … “I remain a skeptic, as electronic trading remains the impetus to, I believe a cell and gene therapy sector’s artificial high” … as proven today yet again!
- I warned that sector portfolios containing cell and gene therapy sector equities should consider getting defensive” … “Investors NEED to start formulating their portfolio outlook into next year.”
Cell and gene therapy sector equities are facing resistance at their highs and lows of the year, without a news driving the upside, our universe is unlikely for the near-to-intermediate term. <ME>
Tuesday’s backdrop:
- Indexes started off mixed after November CPI inflation data but gradually improved during the session.
- The Nasdaq hit a 20-month high, finally pushing past its July peak.
- The small-cap Russell 2000 dipped 0.1% but pared morning losses.
- The 10-year Treasury yield fell 3 basis points to 4.205%.
- The CBOE Volatility Index, or VIX, slumped once again, hitting the lowest point since early January, a sign of excessive bullishness.
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: Blueprint Medicine (BPMC) -2x, Alnylam Pharmaceuticals (ALNY) -2x and Ultragenyx Pharmaceuticals (RARE)
- Monday: Blueprint Medicine (BPMC), Alnylam Pharmaceuticals (ALNY) and Ionis Pharmaceuticals (IONS)
The worst three (3) in the session:
- Tuesday: CRISPR Therapeutics (CRSP) -2x, Beam therapeutics (BEAM) and Prime Medicine (PRME)
- Monday: CRISPR Therapeutics (CRSP), Solid Biosciences (SLDB) and Intellia therapeutics (NTLA)
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.
