Indication intelligence, analysis and sector perception

RegMed Investors’ (RMi) pre-open: declines stretch share pricing as uncertainty inclines

December 8, 2020 8:07am

Headlines are forecasting challenging health and economic timing

Pre-open indications: 4 BUY and 2 SELLs

News: uniQure N.V. (QURE) presented initial data from its pivotal, P3 HOPE-B gene therapy trial of etranacogene dezaparvovec, an investigational adeno-associated virus five (AAV5)-based gene therapy for the treatment of patients with severe and moderately severe hemophilia B.

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 market.

Dow futures are DOWN -0.40% (-120 points), S&P futures are DOWN -0.49% (-18 point) and NASDAQ futures are DOWN -0.37% (-47 points)

Stock futures declined early Tuesday as negotiations for additional fiscal aid (NOT stimulus) and coronavirus infections and hospitalizations incline;

European stocks were lower as talks between the U.K. and EU continue to yield little progress, with time running out to agree on a deal while the pan-European Stoxx 600 index was -0.2% lower in early deals;

Asia-Pacific markets traded mixed as major indexes in Japan and South Korea fell, while Australia, India and Indonesia were up;

Henry’omics:

The increase in COVID-19 infections, coupled with the uncertainty around additional fiscal aid, knocked the Dow and S&P 500 off record levels on Monday.

The Dow declined -0.5%, the S&P 500 dived -0.2% and the Nasdaq rose +0.5%.

Never forget gravity is a force of nature and markets.

News (continued): uniQure N.V. (QURE) presented initial data from its pivotal, P3 HOPE-B gene therapy trial for patients with severe and moderately severe hemophilia B.

This is the first data set to be reported from a P3 gene therapy study in hemophilia B and, with 54 patients, the largest set of patients receiving a single gene therapy investigational product to be reported to date;
Data show 91% reduction in reported bleeds requiring treatment, with 87% of patients reporting no such bleeds during the 26 weeks after dosing
Durable increases in Factor IX activity maintained for up to 18 months irrespective of pre-existing neutralizing antibodies
Etranacogene dezaparvovec was well-tolerated with no treatment-related serious adverse events

An Update: RegMed/Cell and Gene Therapy Earnings Scorecard Q3/20 LPS Results https://www.regmedinvestors.com/articles/11628

Monday’s night’s recap: RegMed Investors’ (RMi) closing bell: “a slip and fall as I had warned. Risk and profit-taking as ASH presentations upped the ante of share pricing” … https://www.regmedinvestors.com/articles/11666

The Nasdaq closed UP +55.71 points (+0.45%);
The IBB closed up +0.01% and XBI closed up +0.93%;
Sector volume was LOW with 9 of the 14-upside having higher than the 3-month average volume with the increased volume of 9 of 20-downside having higher than the 3-month average volume;
The CBOE Volatility Index (VVIX: INDEX) was up +0.51 points or +2.45% at 21.30;
Monday’s percentage (%) of the 14-upside were +0.38% (SAGE) to +37.80% (FATE) while the 20-downside of -0.07% (RENE.L) to -9.71% (BLCM);

Q4:

Q4’s December, so far: 1 neutral, 1 negative and 3 positive closes

Q4’s November: 16 positive and 3 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 down -$0.07 to $1.35 with 5,098 shares traded after Friday’s +$0.07 to $1.42 with 3,514 shares traded, Thursday’s -$0.00 to $1.35 with 2,418 shares traded, Wednesday’s -$0.01 to $1.36 with 8,574 shares traded and last Tuesday’s +$0.01 to $1.36 with 902 shares traded;

Question#1: WHY NO communication re clinical trial strategy or just anything re froward motion? Is there a language gap or message deficiency by key management?

Maintaining BUY:

Applied Genetic Technologies (AGTC) closed down -$0.14 to $4.55 after Friday’s +$0.02 to 44.69, Thursday’s -$0.33 to $4.67, Wednesday’s +$0.18 to $5.00 and last Tuesday’s $4.82, with NO aftermarket indication but … a sincere belief that it is OVERSOLD and I LOVE BOTTOMS;

Global Blood Therapeutics (GBT) closed down -$2.50 to $41.35 after Friday’s -$0.05 to $43.85, Thursday’s -$0.88 to $43.90, after Wednesday’s -$3.40 to $44.78 and last Tuesday’s +$2.27 to $48.18 with a POSITIVE +$0.15 or +0.36% aftermarket indication

Editas Medicine (EDIT) closed up +$1.26 to $34.49 after Thursday’s +$1.67, Wednesday’s-$0.34 and last Tuesday’s +$1.31 with a POSITIVE +1.40 or +3.49% aftermarket indication;

SELL:

CRISPR Therapeutics (CRSP) closed up +$2.18 to $149.72 after Friday’s +$7.08 to $147.54, Thursday’s +$8.92, Wednesday’s +$1.96 and last Tuesday’s +$2.66 with a NEGATIVE 3.72 or -2.48$ aftermarket indication;

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BUY on News:

UniQure NV (QURE) closed down -$2.83 to $47.26 after Friday’s $50.09 with NO aftermarket or pre-market indication but, news:

The BOTTOM LINE: What goes UP, comes DOWN; news gets sold into and spurs share price appreciation … its like throwing dice in a crap game or a casino … some sessions.

The key stumbling headline or block that endangers short-term risk to markets are led by Democratic congressional leader’s demand for a multi-trillion-dollar stimulus package.

Senate Majority Leader Mitch McConnell continued to tout his own plan, endangering prospects for a compromise. McConnell’s top priority -- federal limits on Covid-19 related lawsuits against businesses -- has emerged as the key potential deal-breaker.

Talks have stalled re a year-end “deal”.

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.

35 companies, 1 interpreter!

Insight, foresight and recommendation

My motto … never leave an investor uninformed! I say today what others won’t, so you can do what others can’t.

My name is Henry McCusker; I endorse these opinions under my own name and with a subscription based membership.

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Editor and Publisher ... Henry McCusker enters his tenth (10th) year at RegMed Investors with past experience in sell-side analysis, buy-side management, corporate management and due diligence.

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The information included above as well as individual companies and/or securities mentioned should be construed as guidance in RMi reviews.

The facts stated and the opinions given in this publication are based on data and information considered to be reliable and have been carefully worked into my qualitative analyses and prognoses. However, no guarantee can be given as to their fairness, accuracy or completeness.

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