June 28, 2017 6:14pm
Returns on the back of a downslide
The sector responds to volatility
Just when I thought appreciation would disappear, a whipsaw
Pre-open indications re-cap: 2 hit and 2 miss,
As the IBB was up +1.93%, XBI +2.56%, XLV +0.53% and IWM jumped +1.53% as the VIX was down -9.13%,
Out and about:
The USPTO has provided to Kite Pharma (KITE) a Notice of Intent to issue an Ex Parte Reexamination Certificate that confirms the patentability of amended claims presented in U.S. Patent No. 7,741,465, known as the Eshhar ‘465 patent. The Eshhar ‘465 patent, exclusively licensed by KITE in 2013, protects the axicabtagene ciloleucel franchise and may impact competitive CAR-T therapies
Aduro Biotech’s (ADRO) First Patient Dosed in P2 clinical trial of CRS-207 in Combination with KEYTRUDA® (pembrolizumab) for the treatment of patients with previously treated Malignant Pleural Mesothelioma
I answer one question, in which company should investors commit and keep their money.
Wednesday’s results have implications to Thursday’s sector activity.
A daily report may say little or a lot and its final judgement may be inconclusive; yet it serves as insurance that all indications are being examined and evaluated.
The advance/decline line scenario of 43 SCGT & RT covered companies:
· The open was positive with an A/DL of 29/11 and 3 flats;
· The mid-day was positive with an A/DL of 34/6 and 3 flats;
· The close was positive with an A/DL of 31/9 and 3 flat;
Pre-open indications re-cap: 2 hit and 2 miss
- Biostage (BSTG) closed up +$0.00 – hit;
- bluebird bio (BLUE) closed up +$2.20 – hit;
- Histogenics (HGNX) closed down -$0.01 – miss;
- Osiris (OSIR) closed up +$0.43 – miss;
Henry’omics:
From the pre-open’s investor’s newsletter …” I had stated “Safety is sitting on the sidelines”; I could NOT have been more wrong as a spring-back moved the oversold …
Revisiting the week so far:
The cell therapy sector’s record over the last 6 sessions (of 43 covered companies):
· Wednesday closed POSITIVE with 9 decliners, 31 advancers and 3 flats;
· Tuesday closed NEGATIVE with 32 decliners, 10 advancers and 1 flat;
· Monday closed POSITIVE with 15 decliners, 26 advancers and 2 flats;
· Friday closed POSITIVE with 14 decliners, 24 advancers and 5 flats;
· Thursday closed POSITIVE with 12 decliners, 27 advancers and 4 flats
· The previous Wednesday closed POSITIVE with 13 decliners, 27 advancers and 3 flats;
Out and about:
The USPTO has provided to Kite Pharma (KITE) a Notice of Intent to issue an Ex Parte Reexamination Certificate that confirms the patentability of amended claims presented in U.S. Patent No. 7,741,465, known as the Eshhar ‘465 patent. The Eshhar ‘465 patent, exclusively licensed by Kite in 2013, protects the axicabtagene ciloleucel franchise and may impact competitive CAR-T therapies …
· “This notice by the USPTO outlining its intent to confirm the Eshhar patent further asserts the pioneering role of Dr. Zelig Eshhar in developing CAR-T technology,” said Arie Belldegrun, MD, FACS, Chairman, President and Chief Executive Officer of Kite. “Our significant patent portfolio, combined with our positive data and industry-leading manufacturing process, reinforces our position as one of the foremost companies in cell therapy.”
· The Eshhar ‘465 patent term continues to June 2027, not including certain potential extensions. Kite’s growing intellectual property portfolio now encompasses more than 200 patent assets relating to its broad cell therapy pipeline and manufacturing excellence.
· Axicabtagene ciloleucel is the first engineered cell therapy to be reviewed by the U.S. Food and Drug Administration (FDA) in aggressive non-Hodgkin’s lymphoma (NHL). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 29, 2017.
KITE closed UP +$4.82 to $102.87, a +4.92% increase …
Aduro Biotech, Inc. (ADRO), first patient has been dosed in the P2 clinical trial in malignant pleural mesothelioma (MPM).
· ADRO’s LADD (live, attenuated double-deleted) based immunotherapy, in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy marketed by Merck (known as MSD outside the United States and Canada), for the treatment of patients with MPM whose disease progressed following prior treatment.
· The multicenter, single-arm, open-label P2 study is designed to evaluate the safety and efficacy of CRS-207 with pembrolizumab in adults with previously treated MPM.
· The trial will be conducted at up to 10 sites and will enroll approximately 35 patients who have failed one to two prior treatments.
· The primary efficacy endpoint is objective response rate, defined as the proportion of patients with either complete or partial responses. For additional information about the study, please visit www.clinicaltrials.gov (NCT03175172).
ADRO closed UP +$0.20 to $11.15 a +1.83% increase
Daily analytics:
The NASDAQ rose 1.4% to 6,234. The S&P 500 index SPX, +0.88% climbed 0.9% at 2,440, representing the benchmark's best daily rise since April 24. The Dow gained 0.7% at 21,454. Those moves come a day after equities saw their worst selloff in more than a month … the small-cap Russell 2000 RUT, +1.55% nearly closed at a record, finishing up about 1.5% on the day, and highlighting the broad-based nature of the rally.
… The CBOE Volatility Index (VIX) widely considered the best gauge of fear in the market, 10.05 … DOWN -9.13%
· Tuesday traded above 11.07 … up +11.72% after Monday traded near 9.7, breaking below 10 for the first time since June 9, Friday’s near 10.02 … down -4.39%, Thursday’s near 10.5 and last Wednesday near 10.75 – DOWN -1.01%
Welcome to another day of the sector’s roller coaster …
… The iShares Russell 2000 (IWM) indicated a close of:
· Wednesday traded UP +1.53%
· Tuesday -0.88%
· Monday+0.12%
· Friday+0.66%
· Thursday +0.38%
· Last Wednesday -0.25%
… The iShares NASDAQ Biotechnology (IBB) indicated a close of:
· Wednesday traded UP +1.93%
· Tuesday -2.88%
· Monday -0.32%
· Friday+0.20%
· Thursday +1.27%
· Last Wednesday +4.12%
The count - decliners versus gainers:
……. look at the differences in the spreads as decliners jump and %’s migrate……….
· Wednesday’s decliners ranged from -0.56% <HSGX> to -4.63% <ADVM> in 9 equities;
· Tuesday’s decliners ranged from -0.32% <BTX> to -9.95% <CUR> in 32 equities;
· Monday’s decliners ranged from -0.23% <KITE> to -3.93% <NWBO> in 15 equities;
· Friday’s decliners ranged from -0.31% <FATE> to -11.36% <BSTG> in 14 equities;
· Thursday’s decliners ranged from -0.38% <MDXG> to -5.95% <ATHX> in 12 equities;
· Last Wednesday’s decliners ranged from -0.13% <OSIR> to -4.23% <VTGN> in 13 equities;
Versus
………… look at the percentage’s (%) and their decreases …….
· Wednesday’s gainers ranged from +0.22% <CLBS> to +9.67% <FCSC> in 31 equities;
· Tuesday’s gainers ranged from +0.55% <VTGN> to +14.49% <FCSC> in 10 equities;
· Monday’s gainers ranged from +0.08% <XON> to +10.41% <CAPR> in 26 equities;
· Friday’s gainers ranged from +0.28% <XON> to +7.49% <JUNO> in 24 equities;
· Thursday’s gainers ranged from +0.31% <FATE> to +14.74% <NWBO> in 27 equities;
· Last Wednesday’s gainers ranged from +0.38% <ONVO> to +12% <ATHX> in 27 equities;
Some of MY working trend lines or indications for Tuesday:
… The greatest volume to the downside: CYTX, ADVM, AGTC, PSTI and VSTM
… Upside volume was weighted to: BLUE, JUNO, KITE, SGMO and MDXG
… Biggest $ downside: ADVM, VSTM, BLFS, CYTX and PSTI
… Largest $ upside: JUNO, CLLS, XON, MDXG and OSIR
… Flat: BCLI, VTGN 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.
