January 2, 2020 4:59pm

News: Mesoblast Limited (ASX: MSB; NASDAQ: MESO) has filed its rolling Biologics License Application (BLA) for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). Intrexon has changed its name and relocated assets to Precigen (XON). <Read more>

Updates: Also my “covered list” dropped to 36: gone are BMRN, merged or reversed AST, OSIR, HSGX, ONVO OSIR and ONCE and dropped: BTX, CUR and KOOL


 

News to start the year:

Mesoblast Limited (ASX:MSB; Nasdaq: MESO) receipt of the  filing of clinical efficacy and safety data for remestemcel-L in its rolling Biologics License Application (BLA) for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). The final module will be filed during January, and Mesoblast will request an expedited FDA review of the BLA under the product candidate’s existing Fast Track designation. If approved, remestemcel-L is planned to be launched in the US in 2020.

Intrexon is now Precigen (XON) and will encompass Intrexon's wholly-owned healthcare subsidiaries Precigen, ActoBio Therapeutics, Exemplar Genetics, and its majority ownership interest in Triple-Gene, as well as equity and royalty interests in therapeutics and therapeutic platforms from companies not controlled by Intrexon. Randal J. Kirk has been appointed Executive Chairman.  XON has also executed binding agreements to sell its smaller non-healthcare businesses for $65.2M plus certain contingent payment rights and entered into an agreement to sell $35M of its common stock.  The proceeds from these transactions, combined with the company's cash and short-term investments on hand at 12/31/19, approximates $175 million thus attaining Intrexon's year-end objective.

 

The Dow closed UP +331.31 points (+1.16%), the S&P closed UP +27.07 points (+0.84%) and the NASDAQ closed UP +119.58 points (+1.33%)

 

The iShares NASDAQ Biotechnology (IBB) and the SPDR S&P ETF (XBI) indicators:

  • Thursday the IBB closed down -0.62% while and XBI closed down -0.51%
  • Wednesday was a holiday
  • Tuesday the IBB closed up +0.54% while and XBI closed up +0.54%
  • Monday the IBB closed down -1.38% while and XBI closed down -1.49%

 

The Advance/Decline (A/D)  line scenario of 45 covered companies:

  • Thursday the close was negative with an A/D line of 15/19 , 2 flats of 36,
  • Wednesday the markets were closed,
  • Tuesday the close was positive with an A/D line of 24/11, 3 flats, 2 reversed merged (HSGX & ONVO), 2 dropped (BTX and CUR) and 3 acquired (ONCE, AST & OSIR);
  • Monday the close was negative with an A/D line of 9/28, 1 flat, 2 reversed merged (HSGX & ONVO), 2 dropped (BTX and CUR) and 3 acquired (ONCE, AST & OSIR);

 

Henry’omics:

Indexes rose to all-time highs on Thursday, although the cell and gene therapy sector got “rotated”, as the strong rally in 2019 continued in the first trading day of the New Year.

Thursday’s gains come after markets booked a strong 2019 performance on Tuesday, with the S&P 500 rising 28.9% in the year. That was the broad index’s biggest annual gain since 2013, when it surged 29.6%. The Dow, meanwhile, climbed 22.3% while the Nasdaq Composite skyrocketed more than 35% <CNBC>.

As my “Data Docket” stated, weekly jobless claims came in at 222,000, slightly below an estimate of 225,000.

 

 First business session of the New Year ste the "tone" going forward as many say the first five (5) sessions are an indicator!

 

Decliners:

  • Regenxbio (RGNX -$1.98 after Tuesday’s +$0.36);
  • CRISPR Therapeutics (CRSP -$1.58 after Tuesday’s -$0.94 and Monday’s -$4.17);
  • uniQure NV (QURE -$1.40);
  • bluebird bio (BLUE -$1.38);
  • Global Blood Therapeutics (GBT -$0.92);

Incliners:

  • Sage Therapeutics (SAGE +$0.97 after Tuesday’s+$0.60 and Monday’s-$1.76);
  • Cellectis SA (CLLS +$0.69 after Tuesday’s -$0.15);
  • ReNeuron (RENE.L +$0.50 after Tuesday’s +$9.50 and Monday’s +$2.50);
  • Ionis Pharmaceuticals (IONS +$0.48);
  • Mesoblast (MESO +$0.47);

 

The percentage (%) indicators:

  • Thursday’s range of the 15 upside was +0.34% (RENE.L) to +11.05% (BLCM) while the 19 downside ranged from -0.02% (BOLD) to -8.19% (AGTC); 
  • Wednesday was a holiday; 
  • Tuesday’s range of the 24 upside was +0.05% (RARE) to +16.22% (BLCM) while the 11 downside ranged from -0.05% (BMRN) to -4.96% (VSTM); 
  • Monday’s range of the 9 upside was +0.09% (ADVM) to +10.31% (CLBS) while the 28 downside ranged from -0.03% (GBT) to -9.02% (BLCM); 

 

Upside volume stats:  to compare

  • Thursday: 4 out of the 15 upside had higher than the 3 month average volume;
  • Wednesday was a holiday;
  • Tuesday: 6 out of the 24 upside had higher than the 3 month average volume;
  • Monday: 2 out of the 9 upside had higher than the 3 month average volume;

Downside volume stats:

  • Thursday: 7 out of the 19 downside had higher than the 3 month average volume;
  • Wednesday: markets were closed
  • Tuesday: 7 out of the 11 downside had higher than the 3 month average volume;
  • Monday: 10 out of the 28 downside had higher than the 3 month average volume;

 

2 flat – ADRO and BSTG

 

January’s sessions:

Thursday closed NEGATIVE with 19 decliners, 15 advancers and 2 flats;

Wednesday markets were closed;

 

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.