December 20, 2021 4:52pm

An oversold “Santa Rally” yet, I had written this a.m., I was NOT in a Santa Mood” and will stay that way until years-end

Pre-open indication results: 6 HITs, 6 MISS

News: bluebird bio (BLUE +$0.09), the FDA has placed a partial clinical hold on patients below the age of 18 in its lovo-cel sickle cell gene therapy program. The temporary halt is due to an investigation by the company into an adolescent patient who has suffered persistent, non-transfusion-dependent anemia following treatment with lovo-cel, now 18 months after the treatment. "This patient is clinically well and there is no evidence of malignancy or clonal predominance." Editas Medicine (EDIT +$0.32) the FDA has cleared the IND for EDIT-301 for the treatment of transfusion-dependent beta thalassemia (TDT), enabling the Company to initiate a Phase 1/2 clinical study of EDIT-301 in TDT patients.

If I have learned one thing as a former research analyst, venture and public markets investor to a journalist; it is that your life and your bank account are largely tied to your questioning of price movements and targets.

Who else is tracking a broad representative of cell and gene therapy equities – with facts supported by real numbers?

The Dow closed DOWN -433.28 points (-1.23%); the S&P closed DOWN -52.62 points (-1.14%) while the Nasdaq closed DOWN -188.74 points (-1.24%)



The major averages are coming off a negative week …

The major indexes each fell -1% on Monday as the newfound omicron variant is dramatically increasing and the mechanics of the “Build Back Better ACT” which should have been rejected.

  • Sen. Joe Manchin decision/stand will likely kill the $1.75 trillion social spending and climate policy bill as it stands now.
  • The House passed the package last month with a $2.2 trillion price tag. But the Congressional Budget Office (CBO) said the plan would cost about $4.5 trillion — and add $3 trillion to the federal deficit — if its programs were extended over 10 years, the same period as the proposed revenue streams.


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

  • Monday opened negative at 1 up/32 downs, 2 flat and 1 acquired, flipped positive at the mid-day at 18/15, 1 flat and 1 acquired, ending with a neutral close of 16/16, 2 flats, and 1 acquired;
  • Friday opened negative at 8 ups/125 downs, 1 flat and 1 acquired, jumped positive at 10:30 a.m. at 30/8, 2 flats and 1 acquired, stayed positive at the mid-day at 30/13, 1 flat and 1 acquired, ending with a positive close of 27 up/7 downs and 1 acquired;


RegMed Investors’ (RMi) pre-open: “dive, dive and dive. A holiday-shortened week - sector rotation adds to the sector’s direction difficulty” …


Pre-open indication results: 6 HITs: <AxoGen (AXGN -$1.03), Cellectis SA (CLLS- $0.30), CRISPR Therapeutics (CRSP -$1.68), Intellia Therapeutics (NTLA -$5.59), Vericel (VCEL -$2.52), Verastem (VSTM -$0.06)> and 6 MISS: < Biostage (OTCQB: BSTG -$0.529), Alnylam Pharmaceuticals (ALNY +$3.72), BioLife Solutions (BLFS +$0.17), Editas Medicine (EDIT +$0.32), Fate Therapeutics (FATE +$1.36), Global Blood Therapeutics (GBT +$0.71)>


Key Metric - volume

Sector volume INCREASED with 11 of the 16-upside having higher than the 3-month average volume with INCREASED volume of 7 of 16-downside having higher than the 3-month average volume;


Note: Biostage (BSTG) closed up On Monday +$0.53 with 425 shares traded after Friday’s down -$0.37 on Friday with 5,734 shares traded, Thursday’s flat with 371 shares traded after Wednesday’s flat with 3,281 shares traded, Tuesday’s flat with 500 shares traded and Monday’s 0 shares traded. Has he, David Green, the new interim CEO and chairman CONDONED the “pump and promote”?


Jumping with share pricing momentum (10 of 16):

  • Alnylam Pharmaceuticals (ALNY +$3.72 after Friday’s +$9.69),
  • Ultragenyx (RARE +$2.65 after Friday’s +$4.99),
  • Fate Therapeutics (FATE +$1.36 after Friday’s +$7.13),
  • Global Blood Therapeutics (GBT +$0.71 after Friday’s +$2.90),
  • uniQure NV (QURE +$0.63),
  • Biostage (BSTG +$0.529 after Friday’s -$0.37),
  • Regenxbio (RGNX +$0.46),
  • Editas Medicine (EDIT +$0.32),
  • BioLife Solutions (BLFS +$0.17 after Friday’s +$3.55),
  • bluebird bio (BLUE -$0.09),

Hammered in today’s market (10 of 16):

  • Intellia Therapeutics (NTLA -$5.59 after Friday’s +$13.64),
  • Vericel (VCEL -$2.52 after Friday’s +$5.26),
  • CRISPR Therapeutics (CRSP -$1.68 after Friday’s +$6.27),
  • AxoGen (AXGN -$1.03),
  • Cellectis SA (CLLS -$0.30),
  • Ionis Pharmaceuticals (IONS -$0.25 after Friday’s +$2.39)
  • Sage Therapeutics (SAGE -$0.20 after Friday’s +$2.55),
  • Pluristem (PSTI -$0.10),
  • Chinook Therapeutics (KDNY -$0.10),
  • Homology Medicine (FIXX -$0.08),


  • 2 – Athersys (ATHX), ReNeuron (RENE.L) and 1- Stemline Therapeutics (STML) – acquired



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

  • Monday the IBB closed down -0.94% and XBI closed up +0.18%
  • Friday, the IBB closed up +2.71% and XBI closed up +4.78%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Monday was up +1.30 points or + 6.03% at 22.87
  • Friday was up +1 points or +.86% at 21.57


December, the second month of Q4/21:

Monday (12/20) closed neutral with 16 incliner, 16 decliners, 2 flats and 1 acquired

Friday closed positive with 27 incliner, 7 decliners and 1 acquired


The BOTTOM LINE: An oversold bounce …

Monday’s sector movers were: Alnylam Pharmaceuticals (ALNY) as went – Friday, Ultragenyx (RARE), Global Blood Therapeutics (GBT) and again Fate Therapeutics (FATE) as went Friday

Friday’s trading action was marked by jumps in share pricing by Intellia therapeutics (NTLA), CRISPR Therapeutics (CRSP) which Monday were hammered, ReNeuron (RENE.L -$1.00) and was flat on Monday, Mesoblast (MESO -$0.23) – up on Monday +$0.10 and Bellicum Pharmaceuticals (BLCM -$0.012) - up on Monday +$0.09; Friday Athersys (ATHX) dived then, gained +$0.01 on Monday along with Caladrius Biosciences (CLBS) which also gained on Monday +$0.025 – which had barely hung in the Nasdaq on Friday.

Despite gains for the sector last week, direction is still unclear.

Reiterating, “the stem, cell and gene therapy sector is still seen as vulnerable to extreme low volume moves in either direction, as share pricing risk stimulates their 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.