November 11, 2020 7:56am

Remember our Veterans to those who have served this nation and those who stand to duty today. Remember those who sacrificed their lives and are no longer with us …

Pre-open indications: 4 BUYs and 8 SELLs

News:  Applied Genetic Technologies (AGTC) reported positive data from its ongoing P1/2 clinical program in patients with X-linked retinitis pigmentosa (XLRP). Also, Mesoblast (MESO) announced that the randomized controlled P3 trial of remestemcel-L in patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection had received a recommendation to continue from the independent Data Safety Monitoring Board (DSMB) following completion of the trial’s second interim analysis.

What I provide is an “intelligence daily” to ensure that shareholders are kept apprised based on a 24-hour surveillance of “our” universe, the RegMed/cell and gene therapy sector and its surrounding markets

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Dow futures are UP +0.68% (+194 points), S&P futures are UP +0.76% (+27 points) and NASDAQ futures are UP +1.15% (+134 points)

 

U.S. equity futures rose on Wednesday set to gain after news of an effective Pfizer (PFE) Covid-19 vaccine;

European stocks were modestly higher over a forthcoming coronavirus vaccine with the pan-European Stoxx 600 rising 0.5% in early trade;

Asia-Pacific stocks were mixed with following overnight declines for the tech sector while Hong Kong-listed shares of Chinese tech firms were among the hardest hit in Wednesday trade after China’s State Administration for Market Regulation announced on Tuesday a set of draft guidelines aimed at curbing monopolistic behavior on internet platforms. MSCI’s broadest index of Asia-Pacific shares outside Japan was fractionally higher.

 

Data Docket: Mortgage applications to purchase a home fell 3% for the week and were 16% higher than a year ago. The annual comparison is now shrinking steadily. Refinance applications rose 1% for the week and were 67% higher annually.

 

Henry’omics:

Futures are up again on continuing spread of news of a PFE “treatment: <not fully disclosed> as they were yesterday and the advance/decline (A/D) did show evidence after a slow start.

Supposedly, the news caused investors to move out of technology names and stay-at-home stocks and into cyclical stocks that hinge upon a recovering economy, causing Nasdaq names to underperform as the week started.

However, more news of Eli Lilly’s (LLY) antibody drug was cleared by the FDA for emergency use late Monday; this drug could be used to treat mild-to-moderate cases of Covid-19 in patients who are older than 12 years old.

The bigger issue: the seven-day average of daily new cases Monday was 108,964, a 37% increase from a week ago. <Johns Hopkins University>

 

Tuesday night’s recap: RegMed Investors’ (RMi) closing bell: “rotation, rations and then exhibits causation of an upside. This market will rotate until the end of the year, this will NOT be an easy economic transition”

  • The Nasdaq closed DOWN -159.93 points (-1.37%)
  • The IBB closed up +0.40% and XBI closed up +1.50%
  • Sector volume was the usual LOW with 8 of the 22-upside having higher than the 3-month average volume with the increased volume of 6 of 11-downside having higher than the 3-month average volume;
  • The CBOE Volatility Index (VVIX: INDEX) was down -0.95 points or -3.69% at 24.80;
  • Tuesday’s percentage (%) of the 22-upside were +0.16% (IONS) to +11.11% (BSTG with only 200 shares traded) while the 11-downside of -0.46% (PSTI) to -23.21% (VYGR);

Q4’s: November, so far: 6 positive and 1 negative closes

  • Q4’s October: 1 neutral, 11 positives with 1 negative closes
  • Q3: July through September: 1 neutral, 28 positive and 34 negative closes with 2 holidays

 

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

Maintaining Sell:

Biostage (BSTG) closed up +$0.15 to $1.50 with 200 shares traded after Monday’s -$0.25 to $1.35 with 2.235 shares traded, Friday’s +$0.23 to $1.60 with 635 shares traded, Thursday’s -$0.10 to $1.37 and last Wednesday’s flat at $1.47).

  • Question#1: WHAT is the status of the PPP loan through B of A; with 1 U.S. director and three (3) foreign Chinese national directors, two (2) U.S. employees and three (3) foreign (Chinese) national green card employees – WILL U.S laws complicate ANY forgiveness?

 

SELL from BUY:

bluebird bio (BLUE) closed up +$0.15 to $46.61 after Monday’s +$0.57 to $46.46, Friday’s -$0.62 to $45.89, Thursday’s -$9.72 to $48.83, Wednesday’s +$4.00 and has a NEGATIVE -$0.35 or -0.76% aftermarket indication following earnings release;

 

BUY:

Applied Genetic Technologies (AGTC) reported positive data from its ongoing P1/2 clinical program in patients with X-linked retinitis pigmentosa (XLRP). Visual sensitivity, visual acuity and safety data were reported for 12-month timepoints for Groups 2 and 4, and 6-month time points for Groups 5 and 6. Eight of the 11 patients in Groups 5 and 6 would meet the eligibility criteria for AGTC’s future XLRP trials, and five of these eight (62%), met the definition for response based on an improvement of at least 7 decibels in at least 5 loci. AGTC plans to initiate its Skyline trial by enrolling approximately 12 additional patients total in Group 2 (1.2E+11 vg/mL) and Group 5 (1.1E+12 vg/mL). AGTC remains on track to initiate enrollment in its planned Vista trial in 1Q 2021.

Alnylam Pharmaceuticals (ALNY) closed down -$2.43 to $125.05 after Monday’s $127.48, Friday’s $130.73, Thursday’s $137.86, and last Wednesday’s $139.49 with a POSITIVE +$0.49 or +0.395 aftermarket indication;

Homology Medicine (FIXX) closed down -$0.26 to $9.61 after Monday’s $9.87, Friday’s $9.50, Thursday’s $12.00 and last Wednesday’s $11.03 with a POSITIVE +$0.21 or +2.19% aftermarket indication;

Mesoblast (MESO) closed up +$1.07 to $11.61 after Monday’s -$1.19 to $10.54, Friday’s $11.73, Thursday’s $11.89 and last Wednesday’s $11.42, with a POSITIVE +$0.51 or +4.39% aftermarket indication. MESO announced that the randomized controlled P3 trial of remestemcel-L in patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection had received a recommendation to continue from the independent Data Safety Monitoring Board (DSMB) following completion of the trial’s second interim analysis. The analysis was performed on the trial’s first 135 patients, 45% of the total target of up to 300 randomized patients, with the DSMB recommending continuation after reviewing the trial’s primary endpoint, all-cause mortality within 30 days of randomization and all safety data. The key secondary endpoint is days alive off mechanical ventilatory support within 60 days of randomization.

 

SELL:

CRISPR Therapeutics (CRSP) closed down -$0.95 to $98.70 after Monday’s $99.65, Friday’s $102.66, Thursday’s $103.34 and last Wednesday’s $95.51 with a NEGATIVE -$0.20 or -0.20% aftermarket indication

Global Blood Therapeutics (GBT) closed down -$0.55 to $37.80 after Monday’s +$0.14 to $38.35, Friday’s -$22.11 to $38.21, Thursday’s $60.32 and last Wednesday’s $61.88 with a NEGATIVE -$0.20 or -0.53% aftermarket indication;

Intellia therapeutics (NTLA) closed up +$0.78 to $29.51 after Monday’s $28.73, Friday’s $28.06, Thursday’s $28.48 and last Wednesday’s $27.17 with a NEGATIVE -$0.06 or -0.20% aftermarket indication

Pluristem (PSTI) closed down -$0.04 to $8.66 after Monday’s $8.70, Friday’s $9.83, Thursday’s $10.14 and last Wednesday’s $9.80 with a NEGATIVE -$0.45 or -5.20% aftermarket indication;

Ultragenyx (RARE) closed up +$3.76 to $117.48 after Monday’s $113.72, Friday’s $111.42, Thursday’s $114.41 and last Wednesday’s $113.53 with a NEGATIVE -$1.42 or -1.21% aftermarket indication;

Verastem (VSTM) closed up +$0.12 to $1.43 after Monday’s $1.31, Friday’s $1.22, Thursday’s $1.28 and last Wednesday’s $1.25 with a NEGATIVE -$0.03 or -2.10% aftermarket indication

 

The BOTTOM LINE: Short and non-sweetened …

A short-lived rally as the Nasdaq closed down not quite sparking hope of a return to a normality and economic activity?

Let go of momentum driven stocks – cut holdings with a profit, volatility will strengthen. Don’t just sit on “some’ gains – fill your portfolio with cash and “powder” for coming lows!

Realities are … beginning to set-in re financial disasters of the economy and slow recovery.

 

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.