June 20, 2025 4:43pm

As the sector slammed into the newest bottom; every “dump” is for different reason, so expecting it is routine

The latest shake-up at the FDA forced out the top 2 officials in charge of reviewing cell and gene therapies. Nicole Verdun, who directs the FDA's Office of Therapeutic Products, and her deputy, Rachael Anatol, were placed on administrative leave. Verdun's exit adds uncertainty to the cell and gene therapy space. The OTP is under the Center for Biologics Evaluation and Research. Vinay Prasad recently took over as director at CBER after Peter Marks < the former director of the FDA's Center for Biologics Evaluation and Research> resigned amid a feud with health secretary, Kennedy Jr.

The Harvard Apparatus RT (OTCQB: HRGN) the pump of share pricing is BACK in with 5475 shares trading flat ($0.00) after weekly session barely or the usual no shares trading. If I had to guess <usually right> today’s investor meeting did NOT meet expectation <as usual>. Post Thursday’s holiday, Wednesday’s share pricing $0.00 after Tuesday’s +$0.05 <+995 shares traded> and Monday’s $0.00). Back to my admonition, a Ponzi scheme!

Never leave an investor uninformed! 

TGIF

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

My mission is to provide clear, actionable guidance on a regular basis to help investors and traders navigate the uncertain and often irrational financial markets.

I put hours of effort to create reporting, while leveraging my 40 years of operating. investigative and research experiences to analyze the key market-moving events and distill that into a cogent outlook.

 

Friday’s RegMed Investors’ (RMi) pre-open: walking back the cat … https://www.regmedinvestors.com/articles/13967

Thursday was a market holiday

Wednesday night’s RegMed Investors (RMi) Closing Bell: a sector of flash bang pricing movements … https://www.regmedinvestors.com/articles/13966

RegMed Investors (RMi) Research Note: Harvard Apparatus GT (OTCQB: HRGN): PONZI Scheme at its best or was convicted Bernie Madoff also resurrected … https://www.regmedinvestors.com/articles/13812

 

Friday: The Dow closed UP +35.18 points or +0.08%, the S&P closed DOWN -13.03 points or -0.22% while the Nasdaq closed DOWN -98.86 points or -0.51%

  • Indexes slipped a day after holiday as traders weigh next moves by the Fed and Trump re Middle east i.e. Iran
  • This comes after Fed Chair Powell said the central bank was in no hurry to cut benchmark rates and will remain data dependent, especially as it remains unclear how President Trump’s tariffs will impact the economy.
  • For the week, the S&P 500 was 0.2% lower, the Dow eked a gain of +0.2% on the week, while the Nasdaq advanced +0.2%.

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

  • The Philadelphia Federal Reserve manufacturing business outlook for June came in at -4, worse than the estimate of -2, as forecast by economists. The prices paid index fell 18 points to 41.4, the lowest since February.
  • Bearishness toward the outlook for stocks over the next six months spiked to 41.4% of respondents after a one-week decline to 33.6% last week, according to the latest weekly survey by the American Association of Individual Investors. The historical average over the length of the survey is 31.0%. Bullish sentiment dropped to 33.2% from 36.7% last week, and remains below the historic average of 37.5% for the 18th week out of the past 19, the AAII said.

Friday’s advance/decline line opened barely negative with 15 incliners, 16 decliners and 4 flats ending with a negative close of 14 incliners, 18 decliners and 3 flats    

Metrics:  Friday, the IBB was down -0.26%, the XBI was down -0.28% while the VIX was down -1.36 points or -6.13% at 20.81

 

Q2/25 – June – 1 market holiday, 1 neutral, 5 negative and 9 positive closes

  • May – 1 market holiday, 10 negative and 11 positive closes
  • April – 11 positive and 10 negative closes

 

Friday Closing UP (10 of 14) 

  • Moderna (MRNA +$0.50 after Thursday’s holiday, Wednesday’s -$0.15 after Tuesday’s -$0.45 after Monday’s -$0.67),
  • AxoGen (AXGN +$0.44 after Thursday’s holiday,  Wednesday’s -$0.24 after Tuesday’s -$0.22),
  • Ionis Pharmaceuticals (IONS +$0.40 after Thursday’s holiday, Wednesday’s +$0.86 after Tuesday’s +$0.91 and Monday’s -$0.35),
  • Agenus (AGEN +$0.31 after Thursday’s holiday, Wednesday’s -$0.31, Tuesday’s -$0.36 and Monday’s +$0.44),
  • Prime Medicine (PRME +$0.27 after Thursday’s holiday and Wednesday’s +$0.19),
  • Vericel (VCEL +$0.24 after Thursday’s holiday and Wednesday’s +$0.28),
  • Sage Therapeutics (SAGE +$0.17),
  • Solid Biosciences (SLDB +$0.14),
  • Blueprint Medicine (BPMC +$0.08 after Thursday’s holiday and Wednesday’s -$0.11),
  • Cellectis SA (CLLS +$0.07),

Flat (3)

  • bluebird bio (BLUE) P/E acquired
  • Harvard Apparatus RT (OTCQB: HRGN)- a Ponzi scheme
  • Homology Medicine (FIXX)

Friday’s Closing DOWN (10 of 18): 

  • Alnylam Pharmaceuticals (ALNY -$2.62 after Thursday’s holiday and Wednesday’s +$3.61),
  • Mesoblast (MESO -$1.25 after Thursday’s holiday, Wednesday’s -$0.08 after Tuesday’s -$0.53 and Monday’s +$0.52),
  • uniQure NV (QURE -$0.89 after Thursday’s holiday, Wednesday’s +$0.31 after Tuesday’s -$0.32 after Monday’s -$0.23),
  • Intellia Therapeutics (NTLA -$0.40),
  • BioLife Solutions (BLFS -$0.30 after Thursday’s holiday, Wednesday’s -$0.22 after Tuesday’s -$0.55 and Monday’s +$0.26),
  • Beam Therapeutics (BEAM -$0.23 after Thursday’s holiday, Wednesday’s +$0.32, Tuesday’s +$0.05 and Monday’s -$0.44),
  • Ultragenyx Pharmaceuticals (RARE -$0.21 after Thursday’s holiday, Wednesday’s +$0.69 after Tuesday’s -$0.45 and Monday’s -$0.38),
  • CRISPR Therapeutics (CRSP -$0.18 after Thursday’s holiday, Wednesday’s +$1.24 after Tuesday’s +$1.61 and Monday’s +$0.22),
  • Regenxbio (RGNX -$0.14 after Thursday’s holiday, Wednesday’s -$0.09 after Tuesday’s -$0.50 and Monday’s -$0.11),
  • Editas Medicine (EDIT -$0.13 after Thursday’s holiday and Wednesday’s +$0.21),

 

The BOTTOM LINE: the cell and gene therapy sector got a Friday injection of negative energy…

  • And, I did NOT smell an abundance of sentiment in the morning!!

The cell and gene therapy sector closed the session negative on Friday as investors navigated a flurry of developments across multiple fronts.

  • A Fed governor floated the possibility of interest rate cuts by July, and President Trump put off a decision on whether he would authorize a US strike in Iran.
  • Fed governor Chris Waller floated the possibility of rate cuts in July, arguing recent inflation data has been tame even amid the introduction of Trump's tariffs. The central bank held interest rates steady this week, and Federal Reserve Chair Jerome Powell reiterated that policymakers are not rushing to ease, leading to a fresh attack from Trump. <Yahoo Finance>

 

This week, 6/16 – 6/20 started with a Monday positive close … followed by Tuesday’s negative close … and a Wednesday’s positive close, Thursday’s market holiday and Friday’s negative close.

  • The week of 6/9 – 6/13; Friday, the cell and gene therapy sector stayed in negative territory following Thursday's trading session ended with a negative territory, after May's Producer Price Index (PPI) report following Wednesday's negative close after May's Consumer Price Index (CPI) report post Monday’s neutral close.
  • The cell and gene therapy sector popped Friday after Thursday’s reverses on Thursday from a negative open with a barely positive close after Wednesday’s positive close – although slipping …
  • Following upsides on Tuesday and Monday) after its “napping and waking” in the May share pricing doldrums initiated by a sweetener of BPMC getting an acquired by BMY, MRNA regulatory approval and BNTX’s partnership with BMY.

As I also wrote, about June… Some believe in a “June Swoon;” however, June will be no better or worse than any other month. Although, I consider the so-called summer rally after the peripatetic or wandering.”

  • Although historically, June (in the past) has been a slow or weak month – I/we just saw a tremendous start (6/2) with partnership, acquisition and regulatory news 
  • Also, ASCO opens this month with probably a lot of news flow attracting attention of funds such as hedges and electronic traders.

There are always some big ifs, especially given some of the headlines that could emanate after a past few months of news flatulence.

June ‘25: understand the “flow” …

  • 6/20 - Friday closed negative with 14 positive, 18 negative and 3 flats
  • 6/19 – Thursday was a market holiday
  • 6/18 – Wednesday closed positive with 21 positive, 11 negative and 3 flats
  • 6/17 - Tuesday closed negative with 10 positive, 23 negative and 2 flats
  • 6/16 - Monday closed positive with 20 positive, 11 negative and 4 flats
  • 6/13 - Friday closed negative with 5 positive, 25 negative and 5 flats
  • 6/12 – Thursday closed negative with 7 positive, 23 negative and 5 flats
  • 6/11 - Wednesday closed negative with 6 positive, 25 negative and 4 flats
  • 6/10 – Tuesday closed positive with 17 positive, 15 negative and 3 flats
  • 6/9 – Monday closed neutral with 16 positive, 16 negative and 3 flats
  • 6/6 – Friday closed positive with 28 positive, 4 negative and 3 flats
  • 6/5 – Thursday closed positive with 16 positive, 15 negative and 4 flats
  • 6/4 – Wednesday closed positive with 18 positive, 13 negative and 4 flats
  • 6/3 - Tuesday closed positive with 24 positive, 8 negative and 3 flats
  • 6/2 - Monday closed positive with 25 positive, 7 negative and 3 flats

 

“I 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!”

  • If I have learned one thing as a former research analyst in a venture and public fund, operating executive, x-FBI, x-military officer and an adjunct (MBA) business school professor now a journalist; my life and your portfolio are largely tied to knowledge of price movements and questioning pricing targets and more.

 

Why do I keep repeating, so investors can make the connection …

The top three (3) performing in the session:   

  • Friday: Moderna (MRNA), AxoGen (AXGN) and Ionis Pharmaceuticals (IONS)
  • Thursday was a market holiday
  • Wednesday: Alnylam Pharmaceuticals (ALNY), Lenz Therapeutics (LENZ) and CRISPR Therapeutics (CRSP)
  • Tuesday: Verve Therapeutics (VERV), CRISPR Therapeutics (CRSP) and Ionis Pharmaceuticals (IONS)
  • Monday: Sage Therapeutics (SAGE), Alnylam Pharmaceuticals (ALNY) and Intellia Therapeutics (NTLA)

The worst three (3) in the session: 

  • Friday: Mesoblast (MESO), uniQure NV (QURE) and Alnylam Pharmaceuticals (ALNY)
  • Thursday was a market holiday
  • Wednesday: Agenus (AGEN), AxoGen (AXGN) and Verve Therapeutics (VERV)
  • Tuesday: BioLife Solutions (BLFS), Mesoblast (MESO) and Regenxbio (RGNX)
  • Monday: Vericel (VCEL), Moderna (MRNA) and Beam Therapeutics (BEAM)

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.