September 15, 2021 7:41am

Sector News: Sage Therapeutics (SAGE – pre-open +$2.40 or +5.50%) the U.S. FDA has granted Fast Track Designation to SAGE-718 for development as a potential treatment for Huntington’s disease (HD). Fast Track is a process designed to facilitate the development and review of new treatments for serious conditions with unmet medical need such as HD.

Pre-open indications: BUY: 4; SELL: 1; Maintain SELL: 1

My version of the morning’s “indications” is about what you need to know; it’s what could happen or materialize after the opening and what might happen during the session

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


Dow futures are DOWN -0.04% (-13 points), S&P futures are UP +0.07% (+3 point) and NASDAQ futures are UP +0.17% (+26 point)


U.S. stock futures are mixed and bouncing on Wednesday,

European markets were slightly lower as U.K. inflation soared to a nine-year high in August,

Asia-Pacific markets were lower, as investors reacted to the release of Chinese economic data with Japan and Australia also falling.


Data Docket: Mortgage applications to purchase a home jumped 7% last week from the previous week. The average contract interest rate for 30-year fixed-rate mortgages with conforming loan balances ($548,250 or less) remained unchanged at 3.03%.



Yesterday, indexes closed lower Tuesday, giving up gains earlier in the session after a better-than-feared inflation reading and falling back into September’s depth.

September has historically been the worst month for markets as it also ends Q3.


Sector News (continued): Sage Therapeutics (SAGE) - HD is an autosomal dominant genetic disorder that impacts the brain and by nature numerous generations of a family. Cognitive decline is often one of the earliest signs of the disease and this decline, in addition to other symptoms, results in a devastating impact on independence, general functioning, and quality of life.


If you didn’t remember what happen at Tuesday night’s close and the quarter’s “number’s” impact, you won’t be prepared for today’s session:

  • Tuesday’s evening’s recap: “key word for today’s session – fragility. Stem, cell and gene therapy stocks crashed; markets showed the depths of the downside with the sector following as yesterday’s gains are today’s pain” …


  • September, 1 holiday, 3 positive and 6 negative close
  • August - 12 positive and 10 negative close
  • July: 6 positives, 1 holiday and 15 negative closes

Q2/21 Earnings releases …  … to date:


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

The Biostage (BSTG) Chronicles - Maintaining Sell – notice how the shares trade with the “pump/promote”?

Biostage (BSTG) closed down -$0.27 to $3.56 with 6,551 shares traded after Monday’s +$0.04 with 26,150 shares traded, Friday’s -$0.19 to $3.79 with 22,124 shares traded, Thursday’s +$0.66 to $3.98 with 6,062 shares traded, Wednesday’s +$0.57 to $3.32 with 7,833 shares traded and last Tuesday’s -$0.75 to $2.75 with 6,705 shares traded

Question#1: Being able to trade a stock doesn't mean it is worth the share price; an equity that has WHAT is BSTG’s value proposition, after all the share price pumping – NO clinical trial after a 1.5-year-old IND?

Questiob#2: WHAT is the end game of “pumping” the share price as the float is MINIMAL compared to the ever-OUTSTANDING shares? 

WHY do I keep analyzing/commenting negatively on Biostage (BSTG): When one sees an inextricable wrong and morally repulsive scenario; it takes courage, resolve and patience to stay the course of asking the questions without response!


Pre-open Indications:  who and what’s lookin’ which way …


Applied Genetic Technologies (AGTC) closed down -$0.16 to $3.30 and has a positive +$0.14 or +4.24% pre-open indication.

Maintaining BUY:

Cellectis SA (CLLS) closed down -$0.44 to $13.86 and has a positive +$1.03 or +7.43% aftermarket indication.

CRISPR Therapeutics (CRSP) closed down again -$1.70 to $116.30 after Monday’s -$2.74, Friday’s -$0.72, Thursday’s +$2.20, Wednesday’s -$1.25 after being down last Tuesday-$1.45 to $120.51 and has a positive +$0.99 or +0.85% pre-market indication,

Sage Therapeutics (SAGE) closed down -$1.71 to $43.60 and has a positive +$2.40 or +5.50% aftermarket indication. <see above news>



BioLife Solutions (BLFS) closed down -$0.77 to $51.06 and has a negative -$2.03 or -3.97% aftermarket indication.


The BOTTOM LINE: Not yielding, I keep reinforcing the theme that increased stock market volatility suppresses the stem, cell and gene therapy sector; yet the more oversold – the greater the capacity to selectively … rebound as an avenue to profiting.

I maintain, the recent stem, cell and gene therapy sector investors should be a bit more defensive, limiting new buys and perhaps curtailing overexposure.

Or it could say buying opportunities are here today and maybe tomorrow but G O N E soon!

Theme is uncertainty, more likely to me: skepticism …

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. 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.

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 in securities referred to in this publication.