November 4, 2024 5:04pm

To de-risk markets and a binary sector from perception; needed is forward motion

News: Ionis Pharmaceuticals (IONS -$0.32) FDA acceptance of NDS (New Drug Application) for donidalorsen for prophylactic treatment of HAE (an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older); PDUFA date set for 8/21/25.

Never leave an investor uninformed!  

On point, short on words, long on facts and being judicious!

It’s hard to be right so often, it’s about defining insight. Who speaks out while standing in-front, beside and behind investors – RMi

 

RegMed Investors (RMi) Research Note: Q3/24 earnings reporting dates, net losses, cash positions, revenue and runway outcomes … https://www.regmedinvestors.com/articles/13441

Monday’s … RegMed Investors’ (RMi) pre-open: How investors can best navigate the sector and market ahead? … https://www.regmedinvestors.com/articles/13682

RegMed Investors (RMi) - Q3/24 Cell and Gene Therapy Earnings Scorecard Results… https://www.regmedinvestors.com/articles/11628  

 

Monday: The Dow closed DOWN -257.59 points or -0.61%, the S&P closed DOWN -16.11 points or -0.28% while the Nasdaq closed DOWN -59.93 points or 0.33-%

  • Indexes dumped on Monday as investors prepped for the presidential election and a potential Fed rate cut later this week …

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 …

  • Bracing for the latest rate decision from the Fed on Thursday.      

Monday’s advance/decline line at the open was positive with 24 incliners, 9 decliners and 2 flats; ending with a negative close at the close of 15 incliner, 18 decliners and 2 flats

  • Cell and gene therapy sector jumped after negative on Friday, 11/1 having dived (last Thursday, Wednesday and Tuesday) after a positive close on Monday

Metrics:  Monday, the IBB was up +0.05% and the XBI was down -0.05% while the VIX was up +0.10 points or +0.46% at 21.98

 

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

Q4/24 November – 1 negative and 1 positive closes       

  • October: 8 positive and 15 negative sessions

Q3/24

  • September – 10 positive and 11 negative closes
  • August: 1 neutral, 10 positive and 11 negative closes
  • July: 1 market holiday. 1 day off, 6 negative, 1 neutral and 12 positive closes

 

Monday’s Closing Down (10 of 18):

  • Alnylam Pharmaceuticals (ALNY -$3.96 after Friday’s +$7.32),
  • Moderna (MRNA -$0.97 after Friday’s +$0.27),
  • Voyager therapeutics (VYGR -$0.35),
  • Ionis Pharmaceuticals (IONS -$0.32 after Friday’s +$0.37),
  • uniQure NV (QURE -$0.30),
  • Sage Therapeutics (SAGE -$0.24 after Friday’s -$0.03),
  • Sangamo Therapeutics (SGMO -$0.14),
  • Brainstorm Cell Therapeutics (BCLI -$0.09 after Friday’s -$0.01),
  • Solid Biosciences (BCLI -$0.09),
  • Mesoblast (MESO -$0.07),

Flat (2):

  • Compass Therapeutics (CMPX)
  • Homology Medicine (FIXX)

Monday’s Closing Up (10 of 15):

  • BioLife Solutions (BLFS +$1.49 after Friday’s +$0.67),
  • Beam Therapeutics (BEAM +$1.43),
  • Blueprint Medicine (BPMC +$1.18 after Friday’s +$3.19),
  • Lenz Therapeutics (LENZ +$0.50 after Friday’s +$0.97),
  • Vericel (VCEL +$0.38 after Friday’s -$0.05),
  • Intellia Therapeutics (NTLA +$0.33 after Friday’s +$0.59),
  • Fate therapeutics (FATE +$0.33),
  • AxoGen (AXGN +$0.25 after Friday’s -$0.05).
  • MiMedx (MDXG +$0.20),
  • Harvard Apparatus RT (OTCQB: HRGN +$0.15 after Friday’s -$0.05),

 

The BOTTOM LINE:  new month, 2nd session …more earnings’ sessions to “kick” November!

All 3 of the major averages ended the day in negative territory in anticipation of the 2024 presidential election tomorrow.

  • November has two market dynamics overlapping this year — market volatility attributed to pre-election jitters and seasonality drivers.

 

Quote to ponder, “US equity funds saw their biggest weekly outflows in over a month last week, totaling $5.83 billion, as Wall Street contends with market volatility and has begun pricing in the Federal Reserve's next interest rate decision to come later this week.” <Yahoo Finance>

Reiterating, A quote to ponder, “We're thinking more volatility next week, particularly, as the election goes because ... It's unlikely we get a result Tuesday night. That may extend for some time. The Fed meeting is [on] Thursday instead of Wednesday. We'll have to see what the Fed does. They'll probably cut by just a quarter and set themselves up for maybe another cut in December, depending upon the economic data continues to unfold, especially as we get through the weather and strike-related data." < US Bank Wealth Management senior investment strategist Rob Haworth>

 

I CONTINUE to WARN about earnings’ season of concern, "I’m just not sure what's going to reignite share pricing SUSTAINABILTY as earnings season is about to … HIT with LPS (loss-per-share) expectation and consensus. "

  • Although, the wide dispersion of potential outcomes in elections, interest rates, and geopolitical situations globally has created volatility.

Looking ahead, brace for more market volatility!

 

Cell and gene therapy sector equities closed POSITIVE again on Monday after closing positive on November’s 1st session

  • After a traumatic month and weeks of ups and down sessions

 

More sector LPS (loss-per-share) earnings are due 

  • FOCUS and be aware on those with development partners, runways and ATM usage

Also, be aware that portfolio managers will be addressing rotations as year comes to an end trying to be careful to spread them out over the last few months in Q4.

I keep writing about uncertainty and skepticism … and coming realities.

  • Even with the potential for some market hiccups along the way, the good news is Q4 has historically skewed positively, even as sector earnings kicked the bucket down the road!

 

Ranking the end of October:      

  • 11/4 - Monday's advance/decline line ended with a negative close of 15 incliner, 18 decliners and 2 flats
  • 11/1 - Friday's advance/decline line ended with a positive close of 26 incliner, 7 decliners and 2 flats

 

The top three (3) performing in the session:    

  • Monday: BioLife Solutions (BLFS), Beam Therapeutics (BEAM) and Blueprint Medicine (BPMC)
  • Friday: CRISPR Therapeutics (CRSP), Alnylam Pharmaceuticals (ALNY) and Blueprint Medicine (BPMC)

The worst three (3) in the session: 

  • Monday: Alnylam Pharmaceuticals (ALNY), Moderna (MRNA) and Voyager therapeutics (VYGR)
  • Friday: Agenus (AGEN), AxoGen (AXGN) and Harvard Apparatus RT (OTCQB: HRGN)

 

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 it’s 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.