August 30, 2017 5:50pm

 

… The FDA approved Novartis’ (NVS) cellular therapy CAR-T treatment;

The accelerated approval ahead of the PDUFA date is for all young people under 25 patients with a form of acute lymphoblastic leukemia but at a cost of a onetime $475 K treatment

 

Pre-open indications: 4 hits and 3 miss:

Out and about: Verastem (VSTM +$0.42), MiMedx (MDXG +$0.57), Spark Therapeutics (ONCE +$0.55) and Stemline (STML +$0.40) are a few of the day winners while losers were Juno Therapeutics (JUNO -$3.52), Cellectis SA (CLLS -$0.45) and Bellicum Pharmaceuticals (BLCM -$0.29)

 

It’s called premium content for a reason … I define insight  from a real-time perspective discussing equity share pricing, attractiveness and support levels as stock pricing changes by the hour … if not the minute!

Others don’t even come close!

 

I answer one question, in which company should investors commit and keep their money.

 

 

Wednesday’s results have implications to Thursday’s sector activity as a daily report may say little or a lot and it serves as insurance that all indications are being examined and evaluated!

 

 

Henry’omics:

From the pre-open’s investor’s newsletter “… probability is my key word. And I am sticking to a downside view, the drama of an acquisition momentum and low to moderate volume leaves little to imagination.”

  • And it was true until the Novartis (NVS) moves today’s sector … As the FDA approved Novartis’ (NVS) gene therapy CAR-T treatment.  The accelerated approval ahead of the PDUFA date is for all young people under 25 patients with a form of acute lymphoblastic leukemia but at a cost of a onetime $475 K treatment.

In CAR-T cell therapy, every single dose of a treatment is unique and completely personalized to individual patients. That’s because the technology involves extracting a patient’s immune cells, using genetic technology to make them home in on (and destroy) cancerous cells, and then re-inserting these powerful new cancer killers into the patient.

  • On Wednesday, the FDA also expanded approval of Roche’s (ROG) +0.04% Genentech’s rheumatoid arthritis drug Actemra to treat CAR-T cell-induced CRS; nearly 70% of patients had CRS completely resolved in two weeks using one or two doses of Actemra, the FDA said.

Gilead (GILD) shares surged 5.5% in extremely heavy midday trade, making it among the biggest gainers in the biotech sector.

 

Some cell therapy companies working in the cellular therapy space saw a stock boost on Wednesday, including bluebird Bio (BLUE +$10.10 ) with shares soaring 8.86% in heavy trade, and Adaptimmune Therapeutics (ADAP) +$0.10% with shares rising 3.66%.

By contrast, Juno Therapeutics (JUNO -$3.52%) stock dropped 8.03%, Cellectis SA (CLLS -$0.45) declined -1.57% and Bellicum Pharmaceuticals (BLCM -$0.29) dropped -2.87%.

Novartis (NVS -$0.88) shares declined 1.05% in heavy trading. Novartis shares have risen 2.8% over the last three months, compared with a 1.6% rise in the S&P 500 SPX, +0.50%

 

Be ready for a blow-back ...!

 

 

Pre-open indications: 4 hits and 3 miss:

  • Applied Genetic Technologies (AGTC) closed flat +$0.00 – hit;
  • Bellicum Pharmaceuticals (BLCM) closed down -$0.29 – hit;
  • Biostage (BSTG) closed down -$0.00 – hit;
  • bluebird bio (BLUE) closed up +$10.10 – miss;
  • Cellectis SA (CLLS) closed down -$0.45 – miss;
  • Juno Therapeutics (JUNO) closed down -$3.52 – hit;
  • Sangamo Therapeutics (SGMO) closed up +$0.05 – miss;

 

 

The advance/decline line scenario of 43 SCGT & RT covered companies:   

·         The first hour was negative with an A/DL of 14/25 and 4 flats;

·         The mid-day was positive with an A/DL of 29/11 and 3 flat;

·         The close was positive  with an A/DL of 26/14 and 3 flat;

 

 

Daily analytics:

U.S. stocks rose Wednesday afternoon, with a pair of strong economic reports putting the S&P 500 on track for its fourth straight daily increase, though ongoing tensions between the U.S. and North Korea has fostered turbulent trade.

Major indexes had opened lower, but they turned slightly higher, with the NASDAQ seeing particular strength thanks to gains in biotech names.

·         The Dow was off 20 points, or 0.4%, at 21,884,

·         The S&P 500 index was up by 9 points, or 0.4%, to 2,455.

·         The NASDAQ was 51 points higher at 6,353, a rise of 0.8%.

 

 

The CBOE Volatility Index (VIX) widely considered the best gauge of fear in the market; traded at 11.22, down -4.10% …

  • Tuesday traded at 10.71, up +3.45% after Monday traded at 11.34, up +0.09% following Friday trading at 11.24, down -8.09% after Thursday traded 12.23, down -0.16% … after last Wednesday traded at 11.91, up +4.93%

 

 

Welcome to another day of the sector’s roller coaster …

… The iShares Russell 2000 (IWM) indicated:

·         Wednesday was up +0.63%

·         Tuesday +0.02%

·         Monday +0.44%

·         Friday +0.29%

·         Thursday +0.32%

·         Last Wednesday -0.18%

… The iShares NASDAQ Biotechnology (IBB) indicated:

·         Wednesday was up +2.05%

·         Tuesday +0.29%

·         Monday +1.88%

·         Friday -0.58%

·         Thursday +1.20%

·         Last Wednesday -0.44%

 

 

The count - decliners versus gainers:

……. look at the differences in the spreads as decliners jump and %

·         Wednesday’s decliners ranged from -0.03% <KITE -$0.05> to -8.03% <JUNO -$3.52> in 14  equities;

·         Tuesday’s decliners ranged from -0.06% <KITE -$0.10> to -7.49% <QURE -$0.64> in 16  equities;

·         Monday’s decliners ranged from -0.06% <MDXG -$0.01> to -5% <CUR -$0.06> in 14  equities;

·         Friday’s decliners ranged from -0.24% <BCLI -$0.01> to -9.89% <OPXA +$0.09> in 21  equities;

·         Thursday’s decliners ranged from -1.35% <RENE.L -$0.025> to -9.78% <IMUC -$0.04> in 11 equities;

·         Last Wednesday’s decliners ranged from -0.31% <CYTX -$0.001> to -5.13% <RENE.L -$0.10> in 18 equities;

 

Versus

… Look at the percentage’s (%) and spreads …

·         Wednesday’s gainers ranged from +0.33% <OSIR +$0.02> to +16.67% <ISCO +$0.20> in 26 equities;

·         Tuesday’s gainers ranged from +0.50% <OSIR +$0.03> to +20.09% <JUNO +$7.33> in 24 equities;

·         Monday’s gainers ranged from +0.48% <RGNX +$0.10> to +28% <KITE +$38.95> in 21 equities;

·         Friday’s gainers ranged from +0.47% <SGMO +$0.05> to +8.70% <CYTX +$0.03> in 17 equities;

·         Thursday’s gainers ranged from +0.60% <HSGX +$0.01> to +9.09% <ADVM +$0.23> in 26 equities;

·         Last Wednesdays gainers ranged from +0.08% <CLLS +$0.02> to +25.24% <BSTG +$0.067> in 21 equities;

 

 

Some of MY working trend lines or indications:

… The greatest volume to the downside:  JUNO, KITE, NWBO, IMUC and BLCM

… Upside volume was weighted to:  VCEL, MDXG, BLUE, SGMO, and ATHX

… Biggest $ downside:  JUNO, CLLS, BLCM, MESO and CLBS

… Largest $ upside:  BLUE, ADRO, MDXG, ONCE and VSTM

… Flat:  AST, AGTC and RENE.L

 

 

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.