October 14, 2021 5:40pm
News: Regenxbio (RGNX +$0.80) announced initial data from the Phase 2 ALTITUDE trial of RGX-314 for diabetic retinopathy (DR) without center-involved diabetic macular edema (CI-DME).
Pre-open indication results: 5 Hits and 1 MISS
My version of the session’s “indications” is about what you need to know; it’s what did happen after the opening, mid-day and to the close
An objective, fact and numbers-based narrative
The Dow closed UP +534.75 points (+1.56%); the S&P closed UP +74.46 points (+1.71%) while the Nasdaq closed UP +251.79 points (+1.73%)
Henry’omics:
Markets had its best day in months …
Indexes rallied Thursday; now on track to close the week higher, with the S&P 500 and the Dow roughly 2% off their record highs and the Nasdaq about 4% behind.
The 10-year Treasury yield fell 3 basis points to 1.52%, the third straight decline, providing a tailwind for the broader market rally and especially growth names.
Interesting notes: U.S. FDA staff says Moderna (MNDA) did not meet all criteria for COVID-19 boosters; data for MDNA's vaccine showed that a booster does increase protective antibodies, but the difference in antibody levels before and after the shot was not wide enough.
NEWS continued: Regenxbio (RGNX) - P2 ALTITUDE trial of RGX-314 for diabetic retinopathy (DR) without center-involved diabetic macular edema (CI-DME).
- Of the 15 patients dosed with RGX-314 in Cohort 1, five patients (33%) demonstrated a two-step or greater improvement from baseline on the disease severity scale at three months, compared to zero in the observational control group.
- One patient dosed with RGX-314 had a four-step improvement.
- In the seven patients who had NPDR (DR severity level 47-53) at baseline, three patients (43%) demonstrated a two-step or greater improvement.
- In the eight patients who had PDR (DR severity level over 61) at baseline, two patients (25%) demonstrated a two-step or greater improvement.
Economic Data Docket: A lower-than-anticipated number of weekly jobless claims added to the positive market sentiment. Initial unemployment insurance claims last week totaled 293,000 – the first time the tally fell below the 300,000 level during the pandemic-era.
- September’s producer price index was lighter than expected, also helping sentiment. Wholesale prices rose 0.5% from the month prior versus the 0.6% Dow Jones estimate.
RegMed/Stem/Cell and Gene therapy’s 35 covered equities’ Advance/Decline (A/D) lines: what’s happening …
- Thursday opened positive at 28/3, 3 flats and 1 acquired, stayed positive at the mid-day at 26/7, 1 flat and 1 acquired, ending with a positive close of 22/10, 2 flats and 1 acquired;
RegMed Investors’ (RMi) pre-open: “a lackluster sector, yet up. Three (3) sector positive closes in a row, 5 five (5) positive closes out of nine (9) sessions.” … https://www.regmedinvestors.com/articles/12138
Pre-open indication results: 5 Hits: < Biostage (BSTG +$0.00), Cellectis SA (CLLS +$1.08), Editas Medicine (EDIT +$1.08), Fate Therapeutics (FATE +$2.36); Sell into Strength: Vericel (VCEL +$1.51)> and 1 MISS < Brainstorm Cell therapeutics (BCLI -$0.01)>
Key Metric - volume:
- Sector volume was LOW with 3 of the 22-upside having higher than the 3-month average volume with INCREASED volume of 3 of 10-downside having higher than the 3-month average volume;
Largest downside volume:
- Voyager Therapeutics (VYGR -$0.13 – 3.198 m shares traded)
There are clear winners and losers
Jumping with share pricing momentum (10 of 22):
- Intellia therapeutics (NTLA +$6.42 after Wednesday’s -$2.73, Tuesday’s +$2.15 and Monday’s +$5.22),
- ReNeuron (RENE.L +$6.00 after Wednesday’s -$6.00, Tuesday’s +$2.50 and Monday’s +$20.70)
- Alnylam Pharmaceuticals (ALNY +$5.40 after Wednesday’s +$0.45, Tuesday’s -$1.09 and Monday’s +$0.83)
- Fate Therapeutics (FATE +$2.36 after Wednesday’s +$1.08, Tuesday’s +$2.52 and Monday’s +$1.62)
- CRISPR Therapeutics (CRSP +$1.93 after Wednesday’s -$5.82, Tuesday’s +$1.94 and Monday’s +$2.02),
- Vericel (VCEL +$1.51 after Wednesday’s +$1.16, Tuesday’s -$1.46 and Monday’s -$1.48)
- BioLife Solutions (BLFS +$1.13 after Wednesday’s +$0.42, Tuesday’s +$0.59 and Monday’s -$0.52)
- Editas Medicine (EDIT +$1.08 after Wednesday’s +$0.34 and Tuesday’s +$0.89),
- Cellectis SA (CLLS +$1.08 after Wednesday’s +$0.47),
- Ionis Pharmaceuticals (IONS +$0.93 after Wednesday’s -$0.45, Tuesday’s -$0.40 and Monday’s +$0.32),
Hammered in today’s market (10 of 10):
- AxoGen (AXGN -$0.23 after Wednesday’s -$0.25, Tuesday’s -$0.02 and Monday’s -$0.09),
- Voyager Therapeutics (VYGR -$0.13),
- Ultragenyx (RARE -$0.08 after Wednesday’s -$1.71, Tuesday’s +$1.80 and Monday’s -$0.65),
- Global Blood Therapeutics (GBT -$0.07 after Wednesday’s +$0.63, Tuesday’s +$1.07 and Monday’s +$0.70),
- Athersys (ATHX -$0.02),
- Bellicum Pharmaceuticals (BLCM -$0.02),
- Adverum Biotechnologies (ADVM -$0.01),
- Applied Genetic Technologies (AGTC -$0.01),
- Brainstorm Cell Therapeutics (BCLI -$0.01),
- Homology Medicine (FIXX -$0.01 after Wednesday’s -$0.37),
Closing Flat:
2 – Biostage (BSTG), Verastem (VSTM) and 1 - Stemline Therapeutics (STML) – acquired
Stats:
The iShares NASDAQ Biotechnology (IBB) and the SPDR S&P ETF (XBI) indicators:
- Thursday the IBB closed up +1.47% and XBI closed up +1.67%
The CBOE Volatility Index (VVIX: INDEX) tracked:
- Thursday was down -1.78 points or -9.55% at 16.86
October, the first month of Q3/21:
Thursday closed positive with 22 advancers, 10 decliners, 2 flats and 1 acquired
The BOTTOM LINE: Enjoy the highs …
A "watch-out" - the Nasdaq jumped above its 21-day moving average and last week's highs, moving to just shy of its 50-day line. The S&P 500 and Dow Jones bounced back above their 21-day lines and closed just above the 50-day line.
Coming, EPS (earnings-per-share) risk; but, eyeing muted returns for the rest of 2021 after quarterly releases.
I’m still welcoming the upside but, warn of “harm” coming to share pricing.
Once again, a large number of stem, cell and gene therapy stocks showed strength within lackluster volume at best.
There are a lot of headwinds out there as we embark on corporate earnings, and traders will be looking for any and all indications of guidance.
Reiterating, “the stem, cell and gene therapy sector is still seen as vulnerable to extreme moves in either direction, overbought and oversold categories as risk stimulates the susceptibility!”
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!”
WHY do I keep analyzing Biostage (BSTG): When one sees an inextricable wrong and morally repulsive scenario; it takes courage, resolve and patience to stay the course of asking the questions without response!
Who is defining the metrics for investors and keeping you notified of the sector and market fluctuations? What I provide is a trusted source of share pricing intelligence – it’s more than opinion, I deal in the facts and numbers that back them up.
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.
Regulation Analyst Certification (Reg AC): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.
