December 12, 2017 7:39am

As I had stated, “the ASH data presentations raised more questions than answers”

 

… Reiterating, “There is just TOO MUCH short-term thinking and pricing in these last weeks! What will or which upside will stick? Sustainability has to be more than a session … this will be the key to the sector!”

And we learned yesterday … “Don’t get too comfortable with a number of those equities with an upside; pessimism is a protective and profitable shroud!”

 

Pre-open indications:  7 BUYs and 1 SELL

 

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Higher open expected

Dow futures are UP +0.11% (+26 points) and NASDAQ futures are DOWN -0.01% (-0.75 points)

 

U.S. stock index futures pointed to a slightly higher open on Tuesday, ahead of several economic data releases and the start of a two-day policy meeting by the U.S. Federal Open Market Committee (FOMC).

European stocks opened slightly higher, as investors monitored upcoming policy meetings from the U.S. Federal Reserve and the European Central Bank (ECB).

Asian markets closed slightly lower ahead of the Federal Reserve's December meeting.

 

Issues that will affect the trading day: A two-day monetary policy meeting by the U.S. Federal Open Market Committee is set to kick off

Data docket: producer price index (PPI) data are slated to come out at 8:30 a.m. ET, and the Monthly Treasury Statement — due out at 2 p.m. ET.

Issues on the political front: Trump being Trump

 

 

Henry’omics:

From Monday night’s closing bell post, “… ASH giveth and taketh … after a raft of announcements from companies presenting the American Society of Hematology annual meeting … BLUE (+$30.65) soars along with and STML (+$0.38) as ONCE (-$25.66), JUNO (-$8.41), BLCM (-$0.37), VSTM (-$0.73) and QURE (-$0.46) got hammered while FATE (-$0.03) limped until the session closed to pop +$0.30 or +7.25% with the IBB +0.15%, XLV +0.42% were up and the XBI was down -1.04%.”

Some investors might love biotech stocks for their lottery ticket-like returns when a company strikes medical gold. A lottery ticket, however, costs only costs a buck or two, while getting a cell therapy company wrong can hurt a lot more than that.

Consider yesterday’s issue with JUNO and ONCE after presenting data while bluebird (BLUE) blew everyone away … while VSTM, SGMO and RGNX got dwarfed!

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

 

 

The cell therapy sector’s record over 5 sessions (of 40 covered companies):

·         Monday closed NEGATIVE with 27 decliners, 12 advancers and 1 flat;

·         Friday closed NEUTRAL with 19 decliners, 19 advancers and 2 flats;

·         Thursday closed POSITIVE with 11 decliners, 24 advancers and 5 flats;

·         Wednesday closed NEGATIVE with 29 decliners, 7 advancers and 4 flats

·         Last Tuesday closed NEGATIVE with 21 decliners 18 advancers and 1 flat;

 

You’ve made it to the office, turned on the monitor, having just gotten your coffee and it hits you - what are today’s indications?

Watch list:

  • The iShares Nasdaq Biotechnology (IBB) is NOT indicating in Tuesday’s pre-market;
  • The SPDR S&P Biotech ETF (XBI) is NOT indicating in Tuesday’s pre-market;
  • The Health Care Select Sector SPDR ETF (XLV) is NOT indicating in Tuesday’s pre-open;
  • The iShares Russell 2000 (IWM) is indicating a POSITIVE +0.24% in Tuesday’s pre-open

 

Companies in my headlights:

Bellicum Pharmaceuticals (BLCM) closed down -$0.37 to $9.16 after Friday’s +$0.32 to $9.53 with 329.5 K shares traded <3 month average =454.3 K shares>.  BLCM announced results demonstrated that donor BPX-501 cells infused after transplant expanded in vivo and persisted over time, contributing to improved immune recovery for patients in the study as compared to historical controls from the same transplant center. Oversold with a positive aftermarket indication of +0.12 or +1.26%– Maintaining BUY;

bluebird bio (BLUE) closed up +$30.65 to $201.80 with 5.12 M shares traded after Friday’s +$3.25 to $171.15 with 727.2 K shares traded <3 month average = 777.4 K shares>. BLUE announced <expected> an offering with the shares down – $3.10 or – 1.54%. - BUY to SELL;

Fate Therapeutics (FATE) closed down -$0.03 to $4.14 after Friday’s -$0.02 to $4.17 which jumped +$0.28 or +6.71% to $4.45 after closing on news of the first subject has been treated in the APOLLO study of FATE-NK100 in women with ovarian cancer resistant to, or recurrent on, platinum-based treatment. Fate on Monday announced today that IND-enabling production of FT500 has commenced at University of Minnesota, Molecular and Cellular Therapeutics, a state-of-the-art, FDA-registered Good Manufacturing Practice (GMP) facility. Jeffrey S. Miller, M.D., Professor of Medicine, Deputy Director of the Masonic Cancer Center, University of Minnesota presented an overview today at the 59th American Society of Hematology Annual Meeting and Exposition of the clinical translation of FT500, a first-of-kind natural killer (NK) cell cancer immunotherapy generated from a self-renewing clonal master pluripotent cell line (MPCL). The clonal MPCL was created from a single induced pluripotent stem cell (iPSC) using the Company’s proprietary iPSC product platform. The Company expects to file an Investigation New Drug (IND) application in the first quarter of 2018 for the clinical testing of multiple dosing cycles of FT500 in combination with FDA-approved checkpoint inhibitor therapies for advanced solid tumors in the outpatient setting. The aftermarket indication is a positive +$0.30 or +7.25% - Maintaining BUY;

Juno Therapeutics (JUNO) closed down -$8.41 to $50.24 after Friday’s +$1.92 to $58.65 with 2.37 M shares traded <3 month average = 2.20 M shares> after Thursday’s +$2.17 to $56.73 with 1.18 M shares traded after Wednesday’s +$1.36 to $54.56 after last Tuesday’s -$1.46 to $53.20 with 1.45 M shares trading. November started at $78.56 had a high of $82.06 and a low of $68.25 on 11/14 while October ended at $80.90 having started at $89.37. The aftermarket indication is a POSITIVE +$0.70 or +1.39% – Maintaining BUY;

Pluristem (PSTI) closed down -$0.05 to $1.42. News is always a rebounder as PSTI received a GMP certification and manufacturer/importer authorization from Israel’s Ministry of Health (MOH). The GMP certificate was granted upon successful audit of PSTI’s facilities. The MOH approval is required for Pluristem to continue manufacturing its cell therapies for use in ongoing pivotal studies and will also facilitate readiness of manufacturing for marketing of placental cell therapies worldwide. This MOH authorization fulfills the requirements set by the World Health Organization (WHO) and also falls under the provision of the CAA agreement between Israel and the EU, which will also serve to qualify PSTI’s facilities for marketing in the EU as well – BUY;

uniQure (QURE) closed down -$0.46 to $17.36 after last Friday’s $17.82, Thursday’s $17.02 and Wednesday’s $15.00 and last Tuesday’s $15.27. QURE surged almost 4% in premarket trade Monday, after the company reported positive results in an early-stage trial of a treatment for hemophelia B. QURE has been added to the NASDAQ Biotechnology Index (NBI). The addition is part of NBI's annual review of biotechnology and pharmaceutical companies listed on the NASDAQ Stock Market that meet NBI's eligibility criteria. UniQure will be added to the NBI effective prior to market open on Monday, 12/18/17. The pre-market indication is a positive +$1.53 or +9.59% – BUY;

Regenxbio (RGNX) closed down -$2.25 to $29.50 after Friday’s +$1.45 to $31.75 with 325.7 K shares traded <3 month average = 366 K shares> after Thursday’s +$0.85 to $30.30 with 391.8 K shares traded after Wednesday’s +$1.25 to $29.45 with 198.9 k shares traded <3 month average = 362.9 K shares>. December started out at $28.90 following Novembers end at $28.10 and start at $28.00 with a low of $26.00 and a high of $29.70. On Thursday, The aftermarket indication is a positive +$1.08 or +3.68%–SELL to BUY;

Stemline Therapeutics (STML) closed up +$0.38 to $15.23 with 375.8 K shares traded <3 month average = 280.3 K shares>. The pre-market indication is a negative -$1.15 or -7.74% - SELL;

Verastem (VSTM) closed down -$0.73 to $3.60 after Friday’s +$0.36 to $4.33 with 1.29 M shares traded <3 month average = 752.2 K shares>. ASH news, Duvelisib achieved a statistically significant improvement in Overall Response Rate (ORR) and significantly reduced lymph node burden in the vast majority of patients. These data are encouraging for patients with CLL/SLL who progress or relapse following initial treatment.” These clinical results were further bolstered by important pre-clinical findings showing duvelisib’s cell killing activity in vitro and its ability to promote beneficial changes within the in vivo tumor microenvironment.” The aftermarket indication is a positive +$0.15 or +4.17% – Maintaining BUY;

 

 

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.