April 26, 2021 5:10pm

News: FDA has removed Voyager Therapeutics (VYGR +$0.77 with -$0.03 aftermarket indication) clinical hold to proceed with its planned P1/2 clinical trial investigational new drug application for VY-HTT01, a gene therapy candidate for Huntington's disease (HD). Applied Genetic Technologies’ (AGTC +$0.09 with -$0.13 aftermarket indication) Mark Shearman, Ph.D., Chief Scientific Officer, has resigned from the company to pursue another opportunity

Pre-open indication performance: 13 HITs and 3 MISS <while profit was made in selling>

Who is feeding your portfolio profits - I challenge the status quo to achieve what most believe is impossible: each week break down tactical ways to … earn!

RMi outlines the daily dose of facts and objectivity!

The Dow closed DOWN -61.92 points (-0.18%); the S&P closed UP +7.45points (+0.18%) while the Nasdaq closed UP +121.97 points (+0.87%)



The Dow slipped; the S&P traded slightly higher as the Nasdaq climbed

As I stated in this a.m.’s title, Investors are due for a busy week ahead between a Fed meeting, the debut of President Biden’s “American Families Plan,” more inflation data and the initiation of cell and gene therapy sector earnings reporting.


Data docket: new orders for capital goods rebounded less than expected in March. The Commerce Department said orders for non-defense capital goods excluding aircraft rose 0.9% last month, missing an estimate of a 2.2% increase.


RegMed/Stem/Cell and Gene therapy’s 35 covered equities’ Advance/Decline (A/D) lines: progressions and regressions

  • Monday opened positive at 20/12, 2 flat and 1 acquired, stayed positive at the mid-day to 30/3, 1 flat and 1 acquired, closing positive at 31/2, 1 flat and 1 acquired;
  • Friday opened positive at 18/14, 2 flats and 1 acquired, strayed negative at the mid-day to 8/25, 1 flat and 1 acquired, closing negative at 16/17, 1 flat and 1 acquired;


RegMed Investors’ (RMi) pre-open: “RegMed Investors’ (RMi) pre-open: a busy week is ahead. Beware the Ides of Q1 Earnings season beginning” …  https://www.regmedinvestors.com/articles/11882


Pre-open indication results:  13 HITs < Biostage (BSTG -$0.00 at $1.10 with 407 shares traded); Cellectis SA (CLLS +$0.96), Homology Medicine (FIXX +$0.12), uniQure NV (QURE +$2.67); SELL into Strength: Applied Genetic Technologies (AGTC +$0.09), Chinook Therapeutics (KDNY +$0.30), Adverum Biotechnologies (ADVM +$0.46), CRISPR Indication (CRSP +$9.17),   Editas Medicine (EDIT +$2.17), Pluristem (PSTI +$0.12) – profit was made, MiMedx MDXG -$0.58), Mesoblast (MESO -$0.16)> and 3 MISS <Vericel (VCEL +$4.46), Precigen (PGEN +$0.15), Voyager Therapeutics (VYGR +$0.77) – profit was also made >


There are clear winners and losers

Jumping with share pricing momentum:

  • Crisper Therapeutics (CRSP), ReNeuron (RENE.L), Fate Therapeutics (FATE), Intellia Therapeutics (NTLA), Alnylam Pharmaceuticals (ALNY) to name 5 of the 31 inclining of the 35 covered

Hammered in today’s market:

  • MiMedx (MDXG), Mesoblast (MESO) to name 2 of the 2 declining of the 35 covered


Key metrics:

  • Sector volume was LOW with 9 of the 31-upside having higher than the 3-month average volume with the volume of 1 of 2-downside having higher than the 3-month average volume;
  • Monday’s percentage (%) of the 31-upside were +0.47% (AXGN) to +16.49% (VYGR) while the 2-downside ranges from -1.93% (MESO) to -5.17% (MDXG);


Monday’s (10 of 31) incline

  • ReNeuron (RENE.L +$9.50 after Friday’s flat)
  • CRISPR Therapeutics (CRSP +$9.17 after Friday’s +$0.66);
  • Fate Therapeutics (FATE +$5.67 after Friday’s +$1.11);
  • Intellia Therapeutics (NTLA +$6.50 after Friday’s +$3.69);
  • Alnylam Pharmaceuticals (ALNY +$6.18 after Friday’s -$1.05);
  • Ultragenyx (RARE +$5.00 after Friday’s +$1.00);
  • Vericel (VCEL +$4.46 after Friday’s +$1.96);
  • uniQure NV (QURE +$2.67 after Friday’s -$0.68);
  • Editas Medicine (EDIT +$2.17 after Friday’s +$0.62);
  • Sage Therapeutics (SGMO +$1.93 after Friday’s +$1.75);

Monday’s (2 of 2) decliners:

  • MiMedx (MDXG -$0.58 after Friday’s +$0.57);
  • Mesoblast (MESO -$0.16 after Friday’s -$0.23);

Closing: 1 – Biostage (BSTG) and 1- Stemline Therapeutics (STML – acquired)


COVID-19 updates:

  • The Biden administration is slated to relax federal public health guidance on wearing masks outdoors as soon as this week.

Monday’s COVID Data Tracker <Million>:

  • Cases: 31,883 M
  • Death rate totaled 569,272 <Johns Hopkins University>
  • Vaccinations:  231 M


Stats: comparisons tell a story in line with the title

The iShares NASDAQ Biotechnology (IBB) and the SPDR S&P ETF (XBI) indicators:

  • Monday, the IBB closed up +1.92% and XBI closed up +3.47%
  • Friday, the IBB closed up to +0.42% and XBI closed down -0.18%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Monday was up +0.31 points or +1.79% at 17.64
  • Friday was down -1.38 points or -7.38% at 17.33

Upside volume: low

  • Monday: 9 out of the 31-upside had higher than the 3-month average volume;
  • Friday: 1 out of the 16-upside had higher than the 3-month average volume;

Downside volume: low

  • Monday: 1 out of the 2-downside had higher than the 3-month average volume;
  • Friday: 0 out of the 17-downside had higher than the 3-month average volume;

Percentage (%) movement/range statistics: LOW % with limited pricing drops as upside maintains

  • Monday’s percentage (%) of the 31-upside were +0.47% (AXGN) to +16.49% (VYGR) while the 2-downside ranges from -1.93% (MESO) to -5.17% (MDXG);
  • Friday’s percentage (%) of the 16-upside were +0.52% (CRSP) to +5.36% (MDXG) while the 17-downside ranges from -0.45% (BLUE) to -4.76% (BSTG);


April, the beginning of Q2/21:

Monday (4/26) closed positive with 31 advancers, 2 decliners, 1 flat and 1 acquired

Friday closed negative with 16 advancers, 17 decliners, 1 flat and 1 acquired


The BOTTOM LINE: Earnings are about to take center stage over the next weeks, there is a lot of anticipation of what's to come I don’t feel that many cell and gene therapy sector won’t beat any expectations.

Q1/21 earnings are being announced, MiMedx (MDXG) on Wednesday 4/28, Alnylam Pharmaceuticals (ANY) on Thursday, 4/29, Sage therapeutics (SAGE) on Tuesday, 5/4, AxoGen (AXGN) and Vericel (VCEL) on Wednesday, 5/5 and Athersys (ATHX) on Thursday, 5/6.

What if I was to tell you the single biggest determinant of your success, is your skill at questioning?

If I have learned one thing as a former journalist, turned pundit, turned public markets investor, cell and gene therapy sector equity investor, it is that one’s life and your bank account are largely tied to questioning.

As Descartes said, "I think, therefore I am."

Sector momentum remains “fluid” and any pricing more uncertain as earnings’ season declines induce more downside risks but, hopefully a few rebounds.

I’m STILL a “beware or the cautious man” whose focus has always been “warning analysis” … earnings’ season is NOT over … my advice, trim and skim any new highs if one can!”

My time frame of measurement is Friday to Friday and been proved right again, don’t get complacent …


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.