October 2, 2020 8:13am

Pre-open indications: 5 SELLs and 2 BUYs

News: bluebird bio (BLUE) the European Medicines Agency (EMA) accepted the marketing authorization application (MAA) for its investigational elivaldogene autotemcel (eli-cel, Lenti-D™) gene therapy for the treatment of patients with cerebral adrenoleukodystrophy (CALD). CALD is a fatal neurodegenerative disease primarily affecting young boys. Mesoblast (MESO) the FDA recommended that MESO conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD. <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

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 DOWN -1.55% (-429 points), S&P futures are DOWN -1.62% (-75 points) and NASDAQ futures are DOWN -2.32% (268 points)

 

Dow futures dropped Friday after President Donald Trump and first lady Melania Trump tested positive for coronavirus;

European stocks traded lower Friday morning as the pan-European Stoxx 600 index slipped -0.8% by late morning;

Asia Pacific markets were mostly closed in China, Hong Kong, Taiwan, South Korea and India on Friday for holidays while Japan’s Tokyo Stock Exchange returned to trade following a halting of trade yesterday caused by a hardware glitch.

 

Markets

Data Docket: the ongoing labor market recovery when September’s jobs report is released at 8:30 a.m. ET. The final jobs report ahead of the election is expected to show a slowdown from August’s levels. Economists are expecting 800,000 nonfarm payrolls added, down from 1.37 million in August.

 

Henry’omics:

Markets are uncertain after COVID-19 disclosure from the Trump family ... 

This is potentially a strong market negative. The key issue to my mind is has COVID-19 spread to the upper echelons of the U.S. government including the Senate leadership?

 

Thursday night’s post: RegMed Investors’ (RMi) closing bell: “some equities felt the love”

  • The Nasdaq closed UP +159.00 points (+1.42%);
  • The IBB closed up +0.93% and XBI closed up +1.32%
  • Sector volume was extremely LOW with 9 of the 21-upside having higher than the 3-month average volume with the 3 of 12-downside having higher than the 3-month average volume;
  • The CBOE Volatility Index (VVIX: INDEX) was up +0.33points or +1.25% at 26.70;
  • Thursday’s percentage (%) of the 21-upside were +0.04% (RGNX) to +70.44% (SLDB) while the 12-downside ranges from -0.19% (BLUE) to -5.61% (BCLI); 

Q4 so far: I negative close

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 -$0.03 to $1.57 after Wednesday’s +$0.05 to $1.60, Tuesday’s -$0.19 to $1.55, Monday’s +$0.04 to $1.74 and last Friday’s +$0.19 to $1.70. Question#1: WHERE is William Fodor, PhD, the CSO and WHAT role does he play with NO clinicals happening or even on the horizon? Question#2: WAS the IND completely and TRUTHFULLY submitted? Question#3: the last section of the IND asks financial disclosures be met – WERE THEY – he signed it?

 

SELL into Strength:

BioLife Solutions (BLFS) closed up again z=$0.48 to $29.42 after Wednesday’s +$0.28 to $28.94, Tuesday’s +$1.63 to $28.66, Monday’s +$0.78 to $27.03 and last Friday’s $26.25 with NO aftermarket indication. Chart is “peaky” and has a 52-week +89.20% - time to let some go;

Fate Therapeutics (FATE) closed up again +$0.64 to $40.61 after Wednesday’s +$0.57 to $39.97 after Tuesday’s -$1.10 to $39.40 and Monday’s +$2.70 to $40.50 and last Friday’s $37.80 with NO aftermarket indication;

 

BUY:

bluebird bio (BLUE) closed down -$0.10 to $53.85 and then announced that the European Medicines Agency (EMA) accepted the company’s marketing authorization application (MAA) for its investigational elivaldogene autotemcel (eli-cel, Lenti-D™) gene therapy for the treatment of patients with cerebral adrenoleukodystrophy (CALD). CALD is a fatal neurodegenerative disease primarily affecting young boys.

Pluristem (PSTI) closed down -$0.51 to $10.02 and has a positive +$0.18 or +1.80% pre-market indication (after an aftermarket indication of +0.62 or +6.19%);

 

SELL:

Mesoblast (MESO) closed flat at $18.56 and has a NEGATIVE -$7.16 or 38.58 pre-market indication on news that the US FDA has issued a Complete Response Letter to its Biologics License Application (BLA) for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD). While the Oncologic Drugs Advisory Committee (ODAC)1 of the FDA voted 9:1 that the available data support the efficacy of remestemcel-L in pediatric patients with SR-aGVHD, the FDA recommended that MESO conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD. As there are currently no approved treatments for this life-threatening condition in children under 12, Mesoblast will urgently request a Type A meeting with the FDA, expected within 30 days, to discuss a potential accelerated approval with a post-approval condition for an additional study.

Solid BioSciences (SLDB) closed up +$1.43 to $3.46 and has a NEGATIVE -$0.14 or -4.05% pre-market indication

 

 

The BOTTOM LINE:  NOT trusting ANYTHING today!

The president’s diagnosis added more uncertainty to the election, an event that was already weighing on the market and keeping traders on edge as they attempted to evaluate the possible outcomes.

Shares of stocks tied to the economy reopening fell in pre-market trading as the news highlighted the risk of a second wave of the coronavirus and raised fears that maybe lawmakers would slow the pace at which they relaxed coronavirus measures. <CNBC>

 

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.