September 21, 2016 5:17pm

… Did Yellen’s rate conference help healthcare for once and keeping Mylan (MYL) hearings from the air during Wednesday’s session?

 

Pre-open indication’s tally:  2 hits <ADVM and BLCM > and 2 miss < BLUE and KITE>

Out and about: BLUE, CAPR, CUR, FATE and NWBO

 

 

I answer one question; in which company should investors put, keep and commit their money!

 

Do you care what happened today, you should because it has implications to Thursday's sector activity?  

Subscribe or lose a portfolio advantage!

 

 

I say what others won't, so you can do what others can't!

There are two things that investors need - interpretation of news and translation of market metrics concerning the stem, cell, gene and regenerative therapy sector to substantiate share pricing.

 

 

U.S. stocks closed sharply higher on Wednesday after the Federal Reserve kept interest rates unchanged but hinted at the possibility of one rate hike later this year.

The NASDAQ closed UP +53.83 or +1.03% to 5,295.18 and the DOW closed UP +163.74 or +0.90% to 18,293.70.

 

 

A day in the life of the stem, cell, gene and regenerative therapy (SCGT & RT) sector – the advance/decline line scenario of our 43 covered companies:   

  • The open was positive with an A/DL of 27/14 and 2 flats;
  • The mid-day was negative with an A/DL of 12/30 and 1 flat;
  • The closing bell jumped positive with A/DL of 24/17 and 2 flats;

 

 

Henry’omics:

The stem, cell, gene and regenerative therapy (SCGT&RT) sector was positive at the opening bell, slipped negative at the mid-day with the sector closing positive.

I keep telling investors in the a.m. to check the indexes:  

  • The iShares Russell 2000 (IWM) indicated a positive open of +0.43% and was UP +1.45% at the close while the iShares Nasdaq Biotechnology (IBB) was NOT indicating this a.m. and closed UP +0.62% at the close.

The key is in staying in the moment and operating on a current assessment of NOT what has happened, but what might happen.

  • Retreating to what I wrote this a.m., we need optimism!  Until we get some illuminating news, the path of least resistance is lower …

I haven’t seen any good news re optimistic performance indications.

  • I am also a firm believer in short-term performance being an indicator for near-term signals.

And I don’t always think relative strength … is always a number in the moment …

  • The ever ending question is whether … support will last as pricing strengthens to the upside – it DOESN’T!

 

Call me cantankerous, contrarian or even a curmudgeon but at the least I get it right and investors make money!

 

 

Pre-open indication’s tally:  2 hit and 2 miss:

  • Adverum (ADVM) closed DOWN -$0.01 – hit;
  • Bellicum (BLCM) closed DOWN -$0.06 – hit;
  • bluebird bio (BLUE) closed UP +$0.04 – miss;
  • Kite Pharma (KITE) closed DOWN -$0.10 – miss;

 

 

Out and about:

bluebird bio (BLUE) closed UP +$0.04 to $73.81…

BLUE said that the European Medicines Agency (EMA) has granted access to its Priority Medicines (PRIME) scheme for LentiGlobin drug product in the treatment of patients with transfusion-dependent beta-thalassemia (TDT).

  • The PRIME initiative provides enhanced support and increased interaction to companies, with the goal of optimizing development plans and speeding regulatory evaluations to potentially bring innovative medicines to patients more quickly.
  • To be accepted for PRIME, a therapy must demonstrate potential to benefit patients with unmet medical need through early clinical data or nonclinical data.
  • Access to the PRIME initiative complements bluebird’s ongoing participation in the EMA’s Adaptive Pathways Pilot program, which also aims to expedite patient access to therapies with the potential to treat serious conditions with unmet need.
  • It uses the existing EU regulatory framework for medicines, including conditional approval.

PRIME designation will allow BLUE to further improve its communication with European regulators as we continue to refine an evidence generation plan in the context of adaptive biomedical innovation.

 

 

Capricor (CAPR) closed DOWN -$0.12 to $3.64 …

  • After CAPR closed its offering and concurrent registered direct offering; in this registered public offering, a total of 3,090,625 shares of CAPR's common stock were sold at an offering price of $3.20 per share;
  • The shares include 403,125 shares of common stock sold pursuant to the underwriters' over-allotment option, which option was exercised in full. In the registered direct offering, a total of 312,500 shares of CAPR's common stock were sold directly to Cedars-Sinai Medical Center at a price of $3.20 per share – its research partner.

 

 

Fate Therapeutics (FATE) closed DOWN -$0.01 to $3.18 …

  • The U.S. FDA granted FATE orphan drug status for its treatment of prevention of graft-versus-host disease in patients undergoing allogenic hematopoietic cell transplantation.
  • Regulators awarded the designation to the treatment, which has the generic name Protmune (Ex Vivo Programmed Mobilized Peripheral Blood) on 9/19.

Orphan drugs are entitled to seven years of market exclusivity if approved by the FDA for the treatment of a rare disease.

 

 

Neuralstem (CUR) closed FLAT at $0.00 to $0.31

  • Neuralstem Achieves 50% Enrollment in NSI-189 P2 Trial in Major Depressive Disorder (MDD)
  • The ongoing P2 MDD study is testing two doses (40mg QD and 40mg BID) of NSI-189, a small molecule in an oral tablet formulation. 
  • The multi-center, double-blind, placebo-controlled Phase 2 study plans to enroll a total of 220 moderately depressed patients at 12 trial sites.
  • The primary efficacy endpoint is a reduction in depression symptoms, as measured by the  Montgomery-Asberg Depression  Rating  Scale  (MADRS). 
  • Secondary endpoints include additional clinical outcomes and cognition improvement measures. 
  • The study duration is for 12 weeks with a separate observational study to monitor the responders for six months in order to assess NSI-189’s potential durability of benefits.

CUR’s survival should be their major concern …

 

 

Northwest Bio (NWB) closed DOWN -$0.069 to $0.63 …

NWBO’s Dr. Marnix Bosch, Chief Technical Officer, presented an updated analysis of the PI DCVax®-Direct Trial data at the 5th Annual SMi Cancer Vaccines Conference in London, England.

DC Vax-Direct was designed to treat inoperable solid tumors. 

  • The PI Trial treated patients with multiple inoperable metastatic tumors who had failed existing treatment regimens. 
  • These patients had failed as many as five or six different prior types of treatments, and had generally quite poor life expectancies when they entered the DCVax-Direct Trial. 
  • DCVax-Direct was directly injected, with image guidance, into just one of the patients' tumors and most patients received just three treatments. 
  • The Trial included 40 patients, with 39 evaluable, and covered more than a dozen diverse types of solid tumor cancers.

Some highlights of Dr. Bosch's update presentation today included:

  • The top 20% of these patients have so far exceeded 2 years of survival and are still alive. The longest survivor to date has reached nearly 3 years.  See Attachment A for details.
  • The top 30% of these patients (including pancreatic, melanoma, lung, ovarian, sarcoma and other cancers) as a combined group have an average survival to date of 26.7 months, compared with an average of expected survival times of 12.3 months.  Individually, these patients have also substantially exceeded their respective expected survival times. 

The continuing positive survival results correlate with underlying mechanisms of action and cellular and immune profiles, including phenotype analyses, relative production of a wide range of diverse cytokines by the dendritic cells.  Additional positive observations include T-cell infiltration, and PD-L1 expression.

  • 64% of the patients evaluable for PD-L1 checkpoint expression (14 of 22) showed either de novo or significantly increased expression of PD-L1 following DCVax-Direct treatment, indicating potential for combination of DCVax-Direct and checkpoint inhibitors.

 

 

Today’s Bottom Line:

Show me the stability of the sector; I need to buy a drink to handle this market …

 

 

Review my fear gauge or the CBOE Volatility Index (VIX):

  • Wednesday traded near 13.9, -2.6% lower;
  • Tuesday traded 15.9;
  • Monday traded near 15.3;
  • Friday traded near 16.2;
  • Thursday traded near 15.79 – 13% lower;
  • Last Wednesday traded 18.14 – 1.18% lower

 

 

Decliners:

  • Northwest Bio (NWBO) -9.87% after Tuesday’s +18.82 % after Monday’s +23.28% after Friday’s +12.59% after Thursday’s-18.81% after Wednesday’s +8.23% after last Tuesday’s;
  • Opexa (OPXA) -8.14%;
  • Capricor (CAPR) -3.19%;
  • Regenxbio (RGNX) -4.26% after Tuesday’s +5.28% after Monday’s 5.57%;
  • Brainstorm (BCLI) -3.97%

 

Advancers:

  • International Stem Cell (ISCO) +8.33%;
  • VistaGen (VTGN) +5.21%;
  • Juno Therapeutics (JUNO) +5.28%;
  • AxoGen (AXGN) +4.11%;
  • Asterias Biotherapeutics (NYSEMKT: AST) +3.68%

 

Flat:                                                            

  • BioLife Solutions (BLFS) at $1.83;
  • Biostage (BSTG) at $1.09;
  • ReNeuron (RENE.L) at $2.625;

                                                                                                                               

Volume spikes that stand out: 

  • Kite Pharma (KITE) 905.5 K shares traded <3 month average = 820 K shares>;
  • Asterias Biotherapeutics (NYSEMKT: AST) 692.9 K shares traded <3 month average =236 K shares>;

 

 

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.