March 14, 2016 6:35am

 

The stem, cell and gene therapy regenerative medicine sector muddles along with undramatic volume and melodramatic volatility

 

Some days, it seems that volume increases when prices decline and rises as share pricing increases.

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I say today what others won't, so you can do what others can't; whether information or intelligence is good, bad or somewhere in between – it defines the who, when, where, which and what of it …

 

 

Dow futures are DOWN -0.1% and NASDAQ futures are also DOWN -0.1%

 

U.S. markets are setting up for a choppy session on Monday, with stock futures swinging in and out of losses as investors stay cautious ahead of the closely watched Federal Reserve meeting this week.

European equities were higher in morning trade, following a positive lead set in Asia, as investors looked ahead to a raft of central bank meetings and rate decisions this week.

Asia markets traded higher across the board, extending gains from last week following the announcement of fresh stimulus measures from the European Central Bank (ECB).

 

Data docket: Monday is also a quiet day on the data front, with no major releases on the calendar.

 

 

The stem, cell and gene therapy RegMed sector closed POSITIVE on Friday, NEGATIVE on Thursday, POSITIVE on Wednesday, NEGATIVE on Tuesday and POSITIVE on last Monday.

 

Last five (5) days (of 43 covered companies):

·         Friday closed POSITIVE with 7 decliners, 34 advancers and 2 flats;

·         Thursday closed NEGATIVE with 27 decliners, 15 advancers and 1 flat;

·         Wednesday closed POSITIVE with 19 decliners, 23 advancers and 1 flat;

·         Tuesday closed NEGATIVE with 32 decliners, 9 advancers and 2 flats;

·         Last, Monday closed POSITIVE with 12 advancers, 31 advancers and 1 flat;

 

 

The stem, cell and gene therapy regenerative medicine (SCGT&RM) sector opened up, stayed positive at the mid-day and closed positive on Friday!

  • Keeping Friday’s hat on … “There is one thing that everyone needs, and that's interpretation and translation of intelligence, not just news or information  - we get too much!”

Reflecting on the title … history shows that lack of volume in itself is not a valid reason to sell.

  • The sector is unquestionably higher after Friday’s positive move; however, pricing sustainability needs a broader appeal!

The alternating closes, advance/decline lines with lackluster volume ultimately inhibits upside continuous trends and multiplies sell-off tendencies!

 

 

You’ve made it to the office, turned on the monitor having just gotten your coffee and it hits you - what could be Monday’s trades?

  • bluebird bio (BLUE) closed UP +$3.28 to $48.22 on 1.46 M share volume <3 month average = 1.375 M shares>. News has been limited and March’s historical pricing started at $50.51 jumped to a high of $55.12 and has edged back and forth in the high $40’s. Friday’s close after-market indication was -$0.19. Interest has been alternating on this carousel horse – SELL;
  • Capricor (CAPR) closed UP +$0.06 to $2.16.  Financial results/earnings conference call is Thursday, 3/17/16 at 4:30 pm – do achievements correlate to the current spending patterns? The question is can CAPR’s cash position and “runway” side-step the lack of capital market access while it is also in the running for an $3.38 M from the CIRM. California bond holders must have a concern in a pending grant!  The award is subject to final approval being given by the Application Review Subcommittee of the Independent Citizens' Oversight Committee of CIRM and the satisfaction of other conditions. Pre- Q4/15 result’s patterns project a depreciating share price – SELL;
  • Juno Therapeutics (JUNO) closed UP +$0.91 to $40.00. Some CAR-T results have been stunning, as one Novartis AG therapy wiped out an aggressive blood cancer in 93% of children and young adults who received it -- and 18 of 59 patients were cancer-free after 12 months. Treatments from JUNO have shown similar promise. The after-market indication is +$0.28 – BUY;
  • Vericel (VCEL) closed UP +$0.38 to $4.33 after Thursday’s upside of +$1.83. The value of VCEL appreciated after results from a P2b trial involving 114 patients met the main goal of a treatment for heart failure. After such a rapid appreciation in the past days, speculators will take profits.   Friday’s after-market indication was +$0.07. Speculators will be seeking the “vig” from the rapid appreciation post the $10 M credit facility and $5 M term loan agreement with Silicon Valley Bank.  Another trial will be too costly for the cash starved company without access to the capital markets.  VCEL should focus on their revenue directed "acquired" programs from Sanofi as the therapeutic trial continuation will drain the cash "pool" –  SELL;
  • Spark Therapeutics (ONCE) closed UP +$1.94 to $33.82. Their past year was one of significant growth, progress and accomplishment for ONCE that has set the stage for expansion and advancement of its pipeline and to submit its first Biologics Licensing Application (BLA) in 2016.  The successful conclusion of its pivotal P3 trial of its lead program, SPK-RPE65. Having raised more than $290 M from an IPO in January and follow-on offering in December, ONCE is in a strong position to exit 2016 with five (5) clinical programs. The after-market indication is +$0.08 – BUY;
  • Intrexon (XON) closed UP +$2.98 to $37.97. XON announced <Saturday> the FDA-CVM published preliminary findings-of-no-significant impact (FONSI) < A FONSI is issued when environmental analysis and interagency review during the EA process find a project to have no significant impacts on the quality of the environment.> on its self-limiting OX513A Aedes aegypti mosquito.  The US FDA's Center for Veterinary Medicine today released in the Federal Register this preliminary FONSI on Oxitec's (a subsidiary of XON) self-limiting OX513A Aedes aegypti mosquito for an investigational trial in the Florida Keys. The finding agrees with the draft environmental assessment submitted by Oxitec, that concludes a field trial of XON's genetically engineered OX513A mosquitoes in Key Haven, Florida, will not result in a significant impact on the environment – BUY;

 

Opinions expressed are those of the author and are subject to change, and are 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.

Henry McCusker, the editor and publisher of RegMed Investors does not hold or have positions in securities referred to in this publication.