December 26, 2017 5:45pm

Overall the sector is scattered yet Fate (+$0.67), JUNO (+$0.41), ONCE (+$0.37), AXGN (+$0.30) and RGNX (+$0.35) led advances

While the NASDAQ was down -23.7 or -0.34% while the IBB was up +0.50 or +0.47%

 

Out and about:

Biostage (OTCQB: BSTGD) opened at $1.29 dropping -$0.375 or -29.1% to $0.915 after the projected $1.32 post the 1-to-20 reverse split – talk about having faith in this management team!

Organovo Holdings (ONVO) the FDA granted orphan drug designation for the Company’s treatment of alpha-1 antitrypsin deficiency (A1AT) with its 3D bio-printed liver therapeutic tissue while …

Mesoblast (MESO) received FDA Regenerative Medicine Advanced Therapy Designation for Its Cell Therapy in Heart Failure Patients with Left Ventricular Assist Devices. 

Tuesday’s results have implications to Wednesday’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 newsletter, “…what may come this week? Not much … make tracks with your laggards, especially those with a financing due. My view: volatility and turbulence should cause an upsurge of risk exposure in sector equities, only news will set them free – if then, as all we have seen is selling into events, lately

Reiterating, “What’s for the week – clean-up, be careful of what ails your portfolio – it might be time to DUMP the consistent laggards and those who have a financing in the “cards”, you are holding! Although trading is expected to be thin this week - as many traders are still away for the Christmas break.”

Tread carefully with low volume upsides ...

 

The advance/decline line scenario of 40 SCGT & RT covered companies:   

·         The open was positive with an A/DL of 22/15 and 3 flat ;

·         The mid-day was positive with an A/DL of 20/18 and 2 flats;

·         The close was positive with an A/DL of 22/166 and 2 flat;

 

MY working trend lines or indications:

… The greatest volume to the downside:  RENE.L, MDXG, XON, NWBO and CUR

… Upside volume was weighted to:  IMUC, VTGN, FATE, VSTM and JUNO

… Biggest $ downside: BSTG (-$0.375), CLLS (-$0.32), ADRO (-$0.30), XON (-$0.22) and MDXG (-$0.20)

… Largest $ upside:  BLUE (+$1.55), FATE (+$0.67), QURE (+$0.63), JUNO (+$0.41) and ONCE (+$0.37)

… Flat:  ADVM and ONVO

 

 

Out and about:

Organovo (ONVO)

Organovo Holdings (ONVO) the FDA granted orphan drug designation for the Company’s treatment of alpha-1 antitrypsin deficiency (A1AT) with its 3D bio-printed liver therapeutic tissue …

With tens of thousands of patients being treated for inborn errors of metabolism (IEMs) in the U.S., and an annual cost per patient that exceeds $250,000 for drug therapy alone, these patient populations are in desperate need of new treatment options.”

… And is FLAT at $1.45

 

Mesoblast (MESO)

This RMAT designation allows for multi-disciplinary, comprehensive interactions with the FDA to support the efficient development of and potential accelerated approval pathway, in this case for Mesoblast’s allogeneic MPCs in the treatment of heart failure patients with LVADs.

The RMAT designation also offers eligibility for priority review. Once the biologics license application (BLA) for a product is approved, the FDA can require various post-approval confirmatory commitments.

Mesoblast also recently announced that the P3 trial of its mesenchymal stem cell (MSC) product candidate MSC-100-IV in children with steroid-refractory acute graft versus host disease (aGVHD) has completed enrollment. Top-line results are expected in 1Q18. In November 2016, the P3 trial was successful in a pre-specified interim futility analysis of the primary endpoint (Jason Kolbert, Maxim).

… MESO is UP +$0.10 to $5.90

 

Daily analytics:

The CBOE Volatility Index (VIX) widely considered the best gauge of fear in the market; Tuesday traded at 10.25, up +0.47% …

  • The previous Tuesday traded at 9.92, up +6.21% …

 

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

… The iShares Russell 2000 (IWM) indicated:

·         Closed up +0.04%

·         The previous Tuesday was down -0.76%

… The iShares NASDAQ Biotechnology (IBB) indicated:

·         Closed up +0.47%

·         The previous Tuesday was down -0.24%

 

 

The count - decliners versus gainers:

……. look at the differences in decliners:

·         Last Tuesday’s decliners ranged from -0.47% <BLFS -$0.03> to -29.1% <BSTG -$0.375> in 16 equities;

·         Last Tuesday’s decliners ranged from -0.11% <CLLS -$0.03> to -% <NWBO -$0.0423> in 20 equities;

Versus

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

·         Tuesday’s gainers ranged from +0.30% <SGMO +$0.05> to +11.94% <FATE +$0.67> in 22 equities

·         Tuesday’s gainers ranged from +0.18% <JUNO +$0.08> to +5.88% <QURE +$1.01> in 17 equities

 

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.