October 16, 2020 8:00am

More weakness is just around the corner, “our” stem, cell and gene therapy universe is sensitive to fluctuating waves of investor sentiment

Pre-open indications: 3 BUYs and 3 SELLs

News: Alnylam Pharmaceuticals (ALNY) has news of that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of lumasiran, an investigational RNAi therapeutic targeting the hydroxyacid oxidase 1 (HAO1) mRNA – encoding glycolate oxidase (GO) – in development for the treatment of primary hyperoxaluria type 1 (PH1). If approved by the European Commission (EC), lumasiran will be marketed in Europe under the brand name OXLUMO™.

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

Subscription is coming, it’s not conscription but, an offer to join our collective of like-minded investors!  My gift to you, I've kept RMi subscription FREE during these COVID-19 and volatile times

Dow futures are UP +0.27% (+77 points), S&P futures are UP +0.27% (+9 points) and NASDAQ futures are UP +0.48% (+57 points)

 

Futures were stretching higher on Friday as stocks attempt to snap a three-day losing streak;

European markets were up as the pan-European Stoxx 600 climbed +0.8% by mid-morning;

Asia-Pacific markets mostly decline as coronavirus fears surge again;

 

Data Docket: Retail sales data, due at 8:30 a.m. ET, will offer an update on the recovery in consumer spending. Economists polled expect retail sales to rise by 0.7% in September, following a 0.6% rebound in August. Excluding autos, sales were expected to rise by 0.4%.

  • E.U. data, August’s balance of trade figure and September’s inflation rates for the euro zone are expected at 10 a.m. London time.

 

Henry’omics:

Major averages suffered their third straight day of losses on Thursday, their longest losing streak in nearly a month.

Market’s weakness this week came amid the uncertainties around further coronavirus stimulus as well as fears of a worsening pandemic around the world. <CNBC>

Some positive news, for once, Pfizer (PFE)said it would apply for emergency use of its coronavirus vaccine as soon as it reaches certain safety milestones that it expects to have in late November.

 

Thursday night’s post: RegMed Investors’ (RMi) closing bell: “what’s the next catalyst for the sector and markets … https://www.regmedinvestors.com/articles/11591

  • The Nasdaq closed DOWN -54.86 points (-0.47%);
  • The IBB closed down -2.27% and XBI closed up +0.19%
  • Sector volume was the usual LOW with 4 of the 17-upside having higher than the 3-month average volume with the increased volume of 2 of 15-downside having higher than the 3-month average volume;
  • The CBOE Volatility Index (VVIX: INDEX) was up +0.57 points or +2.16% at 26.97;
  • Thursday’s percentage (%) of the 17-upside were +0.02% (ALNY) to +7.07% (PGEN) while the 15-downside ranges from -0.89% (SGMO) to -11.86% (CLLS);

Q4’s October, so far: 1 neutral, 6 positive and 4 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 -$0.02 to $150 with 100 shares traded after Wednesday’s +$0.02 with 368 shares traded, Tuesday’s flat and last Monday’s -$0.01 to $1.50.  Question#1: WHY are there NO real share pricing moves as the company continues to execute private placements – is the answer self-evident? WHEN is a CRO being hired to initiate clinical trials? WHERE are the peer reviewed scientific papers supporting the IND platform?

BUY:

Alnylam Pharmaceuticals (ALNY) closed up +$0.03 to $143.94 (it had been up +$1.62 during the session) and has news of that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of lumasiran, an investigational RNAi therapeutic targeting the hydroxyacid oxidase 1 (HAO1) mRNA – encoding glycolate oxidase (GO) – in development for the treatment of primary hyperoxaluria type 1 (PH1). If approved by the European Commission (EC), lumasiran will be marketed in Europe under the brand name OXLUMO™.PH1 is an ultra-rare orphan disease characterized by excessive oxalate production, which can lead to end-stage renal disease (ESRD) and other systemic complications. PH1 affects approximately 3.5 to 4 individuals per million in Europe and the United States.

Applied Genetic Technologies (AGTC) closed down -$0.06 to $5.36 after Wednesday’s $5.42, Tuesday’s $5.59, Monday’s $5.66 and last Friday’s $5.50 with no aftermarket indication. AGTC close out our 2020 fiscal year with a path toward initiating a P2/3 trial for our XLRP program, and to provide new preliminary data for the higher dose Group 5 in our P1/2 trial, which supports inclusion of that dose level in the P2/3. In addition, we remain on track to report additional data readouts from three clinical programs in Q4/2020. As of June 30, 2020, AGTC's cash, cash equivalents and investments totaled $80.5 million. AGTC believes these funds will be sufficient to allow AGTC to generate data from its ongoing clinical programs, initiate a P2/3 on XLRP trial and to fund currently planned R&D programs into the Q4/2021.

Maintaining BUY:

bluebird bio (BLUE) closed down again -$0.51 to $55.28 after Wednesday’s -$0.96 to $55.79, Tuesday’s -$1.64 to $56.75, Monday’s $58.39 and last Friday’s $57.60 with NO aftermarket indication;

SELL:

Fate Therapeutics (FATE) closed up +$1.14 to $48.10 after Wednesday’s $46.96, Tuesday’s $49.04, Monday’s $48.75 and last Friday’s $48.01 with a NEGATIVE -$0.63 or -1.32%;

Solid Biosciences (SLDB) closed down -$0.06 to $3.89 after Wednesday’s $3.95, Tuesday’s $3.74, Monday’s $3.86 and last Friday’s $3.96 with a NEGATIVE -$0.08 or -2.06% aftermarket indication.;

 

The BOTTOM LINE: Sentiment is “streaming” at extremes; the key is to sell into speculative highs and be on the look-out for accessing new lows.

I just want to be INTO very low risk equities re pricing (closer to lows to later ride the upside) - right now.

Markets do NOT reflect the uncertainty, pauses and pain in the economy and some issues re J&J’s single-dose COVID-19 vaccine being developed.

 

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.