June 4, 2019 6:06pm

Not about sentiment, it’s just filling the widened share pricing gaps; sustainability beware!

News: Cesca Therapeutics (KOOL +$0.0061) executed a 1-for-10 reverse stock split of its common stock, another way to regain NASDAQ compliance and seek just another financing. Caladrius Biosciences (CLBS -$0.02) completed enrollment and dosing in the P2 ESCaPE-CMD study for CLBS16) in patients with coronary microvascular dysfunction with data expected at the end of 2019. BioMarin Pharmaceuticals (BMRN +$1.71) announced today that Vimizim® for the treatment of patients with mucopolysaccharidosis type IVA (MPS IVA), also known as Morquio A syndrome which is the first treatment in China approved for this condition.

FDA protects public health: A U.S. District Judge of Florida granted the government’s motion for summary judgment against … <read more>; the court held that the defendants in that case adulterated and misbranded  stem cell drug products made from a patient’s adipose tissue .

Pre-open indications: 6 HITs and 0 MISS

The sector is what it is, until it isn’t and even then it doesn’t seem to be …


 

 

When you point one finger, there are three fingers pointing back at you!

 

Markets and indexes:

  • The Dow closed up +512.40 points or +2.06% to 25,332.18

  • The S&P closed up +58.82 points or +2.14% at 2,803.77

  • The NASDAQ was 194.10 points or +2.65% to 7,527.12

 

Henry’omics:

Sector equities surged on Tuesday … it’s NOT about sentiment; it’s just a dramatic response to being oversold and May’s downside market.

… As markets climbed back from a big rout in the past month, after Fed Chairman Powell signaled the central bank was open to easing monetary policy to save the economy and as trade tensions eased amid comments by China and Mexico.

 

Pre-open post: “still a delicate balance of headline significance of placing trades as the “machines” determine the direction of the sector. Futures on the Dow, S&P and NASDAQ were seen higher.”

 

Tuesday marked the best single-day performance for markets since Jan. 4, when the Dow rose 3.3%, the S&P 500 gained 3.4% and the NASDAQ jumped 4.3%.

Support was also tied to renewed hopes tensions between the U.S. and its major trading partners would die down.

Stocks have been battered over the past month. The S&P 500 is down more than 5% in that time period while the Dow has lost 4.6%. The NASDAQ is down more than 8% in the past month.

 

FDA initiated action …

Cell-based regenerative medicine holds significant medical opportunity, but those in this field who do not operate in compliance with the law can potentially cause serious harm to patients,” said Acting FDA Commissioner Ned Sharpless, M.D. “We support sound, scientific research and regulation of cell-based regenerative medicine. The FDA has advanced a comprehensive policy framework to promote the development and approval of regenerative medicine products.

But at the same time, the FDA will continue to take action—such as issuing warning letters or initiating court cases against clinics that abuse the trust of patients and endanger their health with inadequate manufacturing conditions or by manufacturing and promoting products in ways that make them drugs under the law, but which have not been proven to be safe or effective for any use. It is our responsibility to promote and protect public health, and we take this responsibility seriously.”

https://www.fda.gov/news-events/press-announcements/federal-court-issues-decision-holding-us-stem-cell-clinics-and-owner-adulterated-and-misbranded-stem?utm_campaign=060419_PR_Federal%20court%20issues%20decision%20in%20US%20Stem%20Cell%20clinics%20case&utm_medium=email&utm_source=Eloqua

 

Pre-open indications: 6 HIT and 0 MISS

  • BioMarin Pharmaceuticals (BMRN) closed up +$1.71 – hit;
  • CRISPR Therapeutics (CRSP) closed up +$1.27 – hit;
  • Editas Medicine (EDIT) closed up +$0.07 – hit;
  • Intellia Therapeutics (NTLA) closed up +$0.44 – hit;
  • uniQure NA (QURE) closed up +$6.10 – hit;
  • ReNeuron (RENE.L) closed down -$5.00 – hit;

 

Tuesday’s advance/decline line scenario of 45 covered companies:  

  • The open was positive with the A/DL at 27/14, 2 flats and 2 acquired (AST & OSIR);
  • The mid-day was positive with an A/DL of 31/11 and 1 flat and 2 acquired;
  • The close was positive with an A/DL of 32/10 and 1 flat and 2 acquired;

 

Upside volume stats:  review the numbers, there is a message …

  • Tuesday: 10 out of the 32 upside had higher than the 3 month average volume;
  • Monday: 4 out of the 25 upside had higher than the 3 month average volume;

Downside volume stats: here is where the session landing is expressed …

  • Tuesday: 4 out of the 10 downside had higher than the 3 month average volume;
  • Monday: 7 out of the 17 downside had higher than the 3 month average volume;

 

Cell and gene therapy company’s worst-performers were:

  • Tuesday: RENE.L (-$5.00), AGTC (-$0.20), STML (-$0.100, BCLI (-$0.03) and ADRO (-$0.02);
  • Monday:  RENE.L (-$5.00), SAGE (-$2.72), GBT (-$2.32), ADRO (-$1.31) and VYGR (-$2.12);

Sector equities posting gains were:

  • Tuesday: BLUE (+$7.02), SAGE (+$6.10), QURE (+$6.10), RARE (+$2.85) and VYGR (+$1.93);
  • Monday: QURE (+$5.33), $BLUE (+$2.50), RGNX (+$1.90), RARE (+$1.21) and MDXG (+$0.84);

 

The week’s percentage (%) indicators: 

  • Tuesday’s range of the 32 upside was +0.34% (EDIT) to +9.44% (QURE) while the 10 downside ranged from -0.68% (CLBS) to -5.69% (HSGX);
  • Monday’s range of the 25 upside was +0.01% (ONCE) to +18.46% (MDXG) while the 17 downside ranged from -0.21% (BMRN) to -40.31% (ADRO);

1 flat – BSTG with 2 acquired (AST & OSIR) and the Spark Therapeutics’ (ONCE) acquisition by Roche still being delayed

 

The iShares NASDAQ Biotechnology (IBB) indicator:

  • Tuesday closed up +1.93%;
  • Monday closed up +1.08%;

 

June’s sessions:

Tuesday closed POSITIVE with 10 decliners, 32 advancers, 1 flat and 2 acquired (AST & OSIR);

Monday closed POSITIVE with 17 decliners, 25 advancers, 1 flat and 2 acquired (AST & OSIR);

Q2/19 so far:

  • In May, there were 14 negative, 1 holiday and 8 positive closes;
  • In April, there has been 10 positive and 11 negative closes;

 

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.