April 7, 2020 8:45am

I don’t trust algorithms; they see no fundamentals, feel no sentiment, experience no symptoms nor speaks or hears no problems

Pre-open indications: HOLD and isolate

News: Alnylam Pharmaceuticals (ALNY) completed a rolling submission of a New Drug Application (NDA) and also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for lumasiran for the treatment of PH1 <read more>

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

Dow future are UP +3.35% (+753 points), S&P futures are UP +2.89% (+77 points) and NASDAQ futures are UP +2.81% (+226 points)

 

Stock futures pointed to an opening incline but, post the morning trade is a (?);

European markets traded higher as investors “hoped” the region will “flatten the peak” of the coronavirus outbreak (yet, Spain is seeing an uptick in deaths) with the pan-European Stoxx 600 jumping +2.5% in early trade;

Asia Pacific markets also advanced on hopes the spread of the global coronavirus may be slowing. Mainland Chinese stocks, which returned to trade following a Monday holiday, led gains among the region’s major markets. The Shenzhen composite surged while the Shenzhen component also jumped. Japan and South Korea popped higher, while Australia slipped lower

 

Henry’omics:

Stocks surged on Monday as a slew of coronavirus headlines pointed to a potential stabilization in the U.S. The Dow soared 1,600 points, posting its third biggest point gain ever. The S&P 500 jumped 7% to its highest level since March 13. With Monday’s rally, the S&P 500 bounced about 20% from its 52-week low on March 23.

Amid yesterday’s rally, the Cboe Volatility Index (.VVIX) fell -3.3% to 45.24, the lowest level in about two (2) weeks. Three (3) weeks ago, the VIX hit a record high of 82.69, surpassing the peak level during the financial crisis.

Alnylam Pharmaceuticals (ALNY) completed a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase (GO), in development for the treatment of primary hyperoxaluria type 1 (PH1).

  • PH1 is an ultra-rare, life-threatening disease impacting the kidneys and other vital organs; it affects infants, children, and adults.
  • In the U.S., lumasiran has previously received Pediatric Rare Disease Designation, Orphan Drug Designation, and Breakthrough Therapy Designation for the treatment of PH1, based on data showing a substantial reduction in urinary oxalate, the key toxic metabolite responsible for the clinical manifestations of the disease.

ALNY also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for lumasiran for the treatment of PH1. Lumasiran has been granted Priority Medicines (PRIME) Designation by the EMA as well as Orphan Drug Designation in the European Union.

  • Lumasiran has also been granted an accelerated assessment by the EMA which is awarded to medicines deemed to be of major public health interest and therapeutic innovation. Accelerated assessment potentially provides a reduced review timeline from 210 to 150 days once the MAA is filed and validated.

ReNeuron Group plc (AIM: RENE) has signed a research agreement with an unnamed major pharmaceutical company to explore the potential use of the Company's proprietary exosomes to deliver novel therapeutics.

The agreement follows RENE.L's strategy of collaborating with pharmaceutical and biotechnology companies to use its exosome technology as a novel delivery vehicle.  RENE.L's exosomes are derived from its CTX neural stem cell line and have the ability to cross the blood brain barrier and to be manufactured at scale.

  • The research collaboration will focus on the use of RENE.L's exosomes for the delivery of gene silencing sequences created by the pharmaceutical company. 
  • ReNeuron will be responsible for manufacturing exosomes and then loading them with the gene silencing sequences after which the pharmaceutical company will evaluate the loaded exosomes.  
  • ReNeuron will be paid by the pharmaceutical company for manufacturing and loading the exosomes in the initial phase of the collaboration.

 

The BOTTOM LINE: as I stated on Monday “Remain cautious … as the RegMed cell and gene therapy sector was totally oversold and has NOT been subject to upside news.”

  • I don’t trust this market upside, it’s something to SELL into IF it stays UP; if NOT HOLD in place.
  • Sector stocks have NOT fully priced-in a potential of an economic breakdown as the coronavirus pandemic shut down the U.S. economy.

 

Monday night’s title: “a stabilizing event is needed in infection and death rates. Next step, a re-test will allow the capital markets to regenerate and revitalize the economy.”

  • the NASDAQ closed UP +540.16 points (+7.33%);
  • the IBB closed up +5.14% and XBI also closed up +7.40%;
  • the volatility index was down -1.56 points or -3.33% at 45.24;
  • Monday opened positive at 33/2, stayed positive at the mid-day at 31/4 and closed positive at 33/2 of the 35 covered companies;
  • 6 out of the 33-upside had higher than the 3-month average volume;
  • 1 out of the 2-downside had higher than the 3-month average volume;

Q2:

  • April registered 2 negative and 2 positive closes

Q1:

  • March registered 11 negative, 1 neutral and 10 positive closes
  • February registered 9 negative, 9 positive closes, 3 vacation days and 1 holiday.
  • January registered 9 negative, 10 positive closes and 2 holidays.

 

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

HOLD in place, self-isolate your portfolio

News to BUY: Alnylam Pharmaceuticals (ALNY) which has news and has “rolled” to an upside in past two (2) sessions and ReNeuron (RENE.L with a positive pre-U.S. market indication of +$14.49 or +13.29%

 

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.