September 3, 2020 8:11am

As gains and pains get pared, The US Centers for Disease Control and Prevention has told public health officials around the U.S. to prepare to distribute a potential coronavirus VACCINE as soon as late October.

Pre-open indications: 2 BUYs < Applied Genetic Technologies (AGTC) has a positive +$0.73 or +14.17% pre-market indication and Mesoblast (MESO) has a positive +$0.78 or +4.20% pre-market indication > and 5 SELLs

The Biostage (BSTG) Chronicles – WHY haven’t clinical trials begun after a five (5) month period with an IND’s approval (3/20), investors should ask chief scientific officer, William Fodor, PhD (?) <Read more>

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Dow futures are DOWN -0.07% (-20 points), S&P futures are DOWN -0.37% (-13 points) and NASDAQ futures are DOWN -1.02% (-126 points)


Index futures were lower on Thursday as investors paused on the heels of healthy gains but, not for “our” universe of RegMed, cell and gene therapy companies;

European markets advanced as investors monitored key economic data from around the world as the pan-European Stoxx 600 added +1.2% in early trade;

Asia Pacific markets were mixed as South Korean and Japanese markets led gains while mainland Chinese shares declined as the MSCI Asia ex-Japan index dipped 0.11%.


Data Docket:New filings for jobless claims totaled 881,000 last week, better than the 950,000 Dow Jones estimate. The number reflects an improving labor market as well as a change in the methodology used by the Labor Department. Continuing claims fell to 13.3 million, a drop of more than 1.2 million from the previous week. <The number reflects an improving labor market as well as a change in methodology from the Labor Department to address seasonal factors.>

  • Australian Bureau of Statistics showed exports declining -4% month-on-month. Imports, meanwhile, saw a +7% increase in July as compared to the previous month.
  • China’s services sector expanded again in August, according to a private survey. The Caixin/Markit services PMI came in at 54.0, as compared to July’s reading of 54.1.



More about the title, “Members of the White House Coronavirus Task Force, including US Food and Drug Administration Commissioner Dr. Stephen Hahn, have said recently it's possible the FDA could authorize an experimental Covid-19 vaccine before large P3 trials are complete, if data shows a vaccine was safe and effective.

  • Three vaccines are currently in P3 trials in the United States: those developed by Moderna and the National Institute of Allergy and Infectious Diseases; Pfizer and BioNTech; and AstraZeneca and the University of Oxford.


Wednesday night’s post title – “what’s beneath all the sector selling: profit taking, lack of confidence, sentiment which has a snap-off button based on algorithmic rules and it doesn’t take much to disregard fundamentals”  

  • The Nasdaq closed UP +116.78 (+0.98%);
  • The IBB closed up +1.47% and XBI also closed up +0.98%;
  • Sector volume was LOW with 3 of the 18-upside having higher than the 3-month average volume and the 2 of 25-downside having higher than the 3-month average volume;
  • The CBOE Volatility Index (VVIX: INDEX) was up +0.45 points or +1.72% at 26.57;
  • Wednesday’s percentage (%) of the 18-upside were +0.19% (NTLA) to +7.66% (BCLI) while the 25-downside ranges from -0.22% (CLLS) to -4.66% (CLBS); 

Q3 so far:

  • September, 2 negative closes
  • August, 10 positive closes and 11 negative closes
  • July -11 positive and 11 negative closes with 1 holiday


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

Maintaining Sell:

Biostage (BSTG) closed up +$0.03 to $1.48 after Tuesday’s -$ 0.05 to $1.45, Monday’s +$0.02 to $1.50 and Friday’s -$0.46 or -23.71% to $1.48 with 71,846 shares traded (the highest in YEARS),

Analysts ask questions … and usually doesn’t get a response from this company. Wonder WHY … what is the “HIDE”?

  • Question #1 – WHY have the clinical trials not been started?
  • Question#2: WHAT is the hold-up on trial initiation, patient recruitment hasn’t even started?
  • Question#3: WHAT is the role of the chief scientific officer, William Fodor, PhD in relation to the IND filing, its completeness with NO clinical initiatives yet to start?
  • Question#4: the depth of his involvement in the musical chairs and revolving executive doors at Biostage?


Athersys (ATHX) closed up +$0.135 to $2.175 after Tuesday’s $2.04, Monday’s $2.18 and last Friday’s $2.13 and has a positive +$0.01 or +0.23% aftermarket indication. ALWAYS sell the highs; 

CRISPR Therapeutics (CRSP) closed up +$0.51 to $93.93 after Tuesday’s $93.42, Monday’s $93.46, last Friday’s $90.71 and has a negative -$0.43 or -0.46% aftermarket indication – overbought;

Editas Medicine (EDIT) closed up +$1.13 to $36.16 after Tuesday’s $35.03, Monday’s $35.23 and last Friday’s $34.96 and has a positive +$0.15 or +0.41% aftermarket indication. Pricing is fickle and subject to trading;

Ionis Pharmaceuticals (IONS) closed up +$0.79 to $55.06 after Tuesday’s $54.27, Monday’s $54.50 and last Friday’s $52.79 and has a negative -$0.29 or -0.53% aftermarket indication after buying the shares of Akcea Therapeutics (AKCA) they did not own (24%) at $18.50 in all cash deal;

Maintaining BUY:

Applied Genetic Technologies (AGTC) closed up +$0.01 to $5.15 after Tuesday’s (9/1) flat at $5.14 Monday’s $5.14 and last Friday’s 5.01. AGTC has a positive +$0.73 or +14.17% pre-market indication;

Mesoblast (MESO) closed down -$0.39 to $18.56 after Tuesday’s -$0.41 to $18.95 and has a positive +$0.78 or +4.20% pre-market indication reflecting past news of receiving ethics approval to include Australian hospitals in the P3 randomized controlled trial of remestemcel-L in ventilator-dependent COVID-19 patients with acute respiratory distress syndrome (ARDS). This study is being conducted by the US NIH–funded Cardiothoracic Surgical Trials Network, and cleared by the US FDA.


The BOTTOM LINE: It might be time to take deep breathe, let it out and ignore the market until Tuesday, the rest of the week has NO real rudder.

I am STILL forecasting a “BAD” Q3 reporting outcome … as well as a correction in the markets which would also take down the sector.

The advice I continually state … “Skim if you can trim, buy if it will fly and sell if compelled!”


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.