September 20, 2022 8:06am

The bar is getting lower … as investors ditch vaccine stocks after Biden says pandemic is over waiting for the Fed to sing

News: Avrobio (AVRO +$0.05) the FDA has granted rare pediatric disease designation to AVR-RD-04, an investigational gene therapy for the treatment of cystinosis, a life-threatening disease that causes progressive multi-organ damage, including early, acute kidney disease progressing to end-stage kidney disease. Alnylam Pharmaceuticals (ALNY +$0.53) the European Commission (EC) has granted marketing authorization for AMVUTTRA® (vutrisiran), an RNAi therapeutic for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy.

Indications: 1 Positive Indication, 1 Negative Indications and 1 Pump/Promote (BSTG – the usual suspect)

The cell and gene therapy sector shows more signs of downside movement alternating to continued weakness.

No tunnel vision here, this analyst/journalist gets into the weeds of daily share pricing and root causes


Remember that overnight and pre-open actions in futures don't necessarily translate into actual trading in the coming day’s session.


Dow futures are DOWN -0.36% or (-111 points), S&P futures are DOWN -0.44% (-17 points) and NASDAQ futures are DOWN -0.54% (-65 points) early in the pre-open – so far,


Stock futures are slipping Tuesday,

European markets were struggling,

Asia-Pacific markets were up as Japan’s inflation accelerated and China kept its loan prime rate on hold.



Indexes snapped a two (2) session losing streak on Monday in a volatile trading session ahead of the Fed’s two-day policy meeting that kicks off Tuesday.

The Dow closed UP +197.26 points (+0.64%) the S&P closed UP +26.56 points (+0.69%) while the Nasdaq closed UP +86.62 points (+0.76%)

Ahead of Tuesday's open, Dow Jones futures rose 0.2% vs. fair value. S&P 500 futures gained 0.25% and Nasdaq 100 futures traded 0.3% above fair value.

Economic Data Docket: August housing starts on Tuesday and initial jobless claims on Thursday.


RegMed Investors’ (RMi) closing bell: “investors are traumatized as cell and gene therapy equities waiver as markets discount the hope of cures as costs such as BLUE’s treatment cost breaks the bank on cost of gene therapy and potential of re-imbursement” …


Ebb and flow:

Q3/22 – September – 1 holiday, 7 positive and 5 negative closes

•             August – 1 neutral, 11 positive and 11 negative closes

•             July - 1 holiday, 10 negative and 10 positive closes


Companies in my headlights – It’s your decision; I provide ideas and context: INDICATIONS

Positive Indication:

Ultragenyx (RARE) closed down -$0.24 to $45.79 with a positive +$1.78 or +3.89% pre-open indication,


Negative Indications:

BioLife Solutions (BLFS) closed up +$0.64 to $23.76 after Friday’s -$2.82, Thursday’s -$0.17 with a negative -$0.31 or -1.30% pre-open indication,


Puff/Pump and Promote: Maintaining SELL

Biostage (OTCQB: BSTG) closed up +$0.10 with 9,718 shares traded after Friday’s +$1.19 with 2,660 shares traded, Thursday’s -$0.19 with 717 shares traded, Wednesday’s +$0.15 with 2,101 shares traded, Tuesday’s -$0.30 with 500 shares traded and last Monday’s -$0.10 with 442 shares traded <3-month average = 1,806>,

  • Questions need to be answered and they NEVER are for shareholders; as the First Amendment of the U.S. Constitution does guarantee the “freedom of speech, or of the press” … but I guess NOT to respond?
  • How many non-citizens of Chinese nationality are employed at BSTG – 3 managers/directors of 5 and 3 of 5 board directors?
  • Who and WHAT are funding the “spikes” in volume and share price?
  • What is DST Capital?  Is DST Capital really managed by Mrs. bin Zhao of Weston, Mass and Hong Yu, president of BSTG?  Is LIU Dong-hai chairman of D. Phone, one of the largest smartphone retailers in China and Dixintong Technology group; the ultimate funder of DST Capital?
  • Are Chinese communist bureaucrats from Beijing, China directing the company’s activities with BSTG being their corporate “concubine”?


The BOTTOM LINE:  Are we, investors due for another DEEP dive in our cell and gene therapy universe as indexes WEAKEN?

I try to keep it simple … and short as I love my coverage list – yet, the truth will set investors free from electronic and algorithm control!

When a cell and gene therapy sector equity sells-off to or below a buy point, investors face a tough decision: hold tight, exit or trim the position. There's not necessarily a "right" answer. Sometimes the stock will bounce right back, others will keep falling — perhaps after briefly bouncing. A more-cautious approach may make more sense in the current volatile market.

Investors are going to need to prepare for another reporting cycle to confirm whether or not a bottom is even close to happening.

As I continually question, “The real question that should be asked is how many companies are at the end of sentiments …  leash? Start by looking at cell and gene therapy companies trading below cash!” 

When it comes time to invest or even hold onto an investment; I’d say … focus on what percentage ownership of stock … NOT options CEOs and management teams own versus their salary and bonus.

As I have written, “I devote a lot of time to the direction of the sector to reckon the geography of my coverage group.”

That doesn't mean you should flee entirely to cash, but investors make sure gains don't evaporate thus … be quick to drop losing positions.

Whether information or intelligence is good, bad or somewhere in between; RMi’s daily report is a primer that may say little or a lot; yet it serves as insurance that all indications are being examined and evaluated.


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.

All investments are subject to risks. Investors should consider investment objectives.

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.

Henry McCusker, the editor and publisher of RegMed Investors does not hold or have positions securities referred to in this publication.