November 30, 2020 7:59am

With rotation, migration and fluctuation

Pre-open indications: 1 BUY and 5 SELLs

News: Moderna (MRNA) will request emergency clearance from the FDA for its two-dose vaccine after new data confirms the vaccine is more than 94.1% effective in preventing Covid-19 and was safe. Verastem (VSTM) initiated a P2 registration-directed clinical trial of VS-6766, its RAF/MEK inhibitor, and defactinib, its FAK inhibitor, in patients with recurrent low-grade serous ovarian cancer (LGSOC).

What I provide is an “intelligence daily” to ensure that shareholders are kept apprised based on a 24-hour surveillance of “our” universe, the RegMed/cell and gene therapy sector and its surrounding markets

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Dow futures are DOWN -0.34% (-103 points), S&P futures are DOWN -0.12% (-4 points) and NASDAQ futures are UP +0.30% (+36 points)

 

Futures are fluctuating i.e. slipping (although the Nasdaq is barely positive) as monthly market gains are about to be harvested;

European markets are mixed as stocks pause with the U.K. and the European Union head into tense Brexit negotiations while the pan-European Stoxx 600 edged 0.1% above the flatline by late morning;

Asia-Pacific markets fell as investors digested the release of China’s official manufacturing Purchasing Managers’ Index (PMI) for November was “pegged” at 52.1 - the expectation was for 51.5. MSCI’s index of Asia-Pacific shares outside Japan declined -1.51%.

 

Henry’omics:

Despite the overnight weakness, major equity averages are poised to wrap up a strong month.

Small caps have been on a tear this month as investors piled into beaten-down value names. The Russell 2000 has rallied 20.6% so far in November, on track for its best month ever. <CNBC>

 

News (continued): Moderna (MRNA), the FDA’s review of MRNA’s vaccine is expected to take a few weeks. The agency will likely schedule an advisory committee meeting to review the vaccine on Dec. 17, Moderna said. It has already initiated rolling submissions with several regulatory agencies around the world, including the European Medicines Agency. Federal agencies are already sending vaccination plans around to staff. Five agencies have started telling employees they could receive Pfizer’s or Moderna’s Covid-19 vaccine in as little as eight weeks, a person with firsthand knowledge of those plans told CNBC on Nov. 20.

Verastem (VSTM): Results to date have demonstrated the clinical activity of VS-6766 and defactinib in KRAS mutant cancers, signaling potentially promising clinical results in low-grade serous ovarian cancer and in KRAS-G12V mutant non-small cell lung cancer," said Brian Stuglik, Chief Executive Officer of Verastem Oncology. "The start of our registration-directed trial in recurrent LGSOC is a significant milestone in our work to develop the backbone of therapy for RAS driven tumors, an area of minimal therapeutic results, significant toxicity and limited treatment options."

 

An Update: RegMed/Cell and Gene Therapy Earnings Scorecard Q3/20 LPS Results https://www.regmedinvestors.com/articles/11628     

 

Friday’s night’s recap: RegMed Investors’ (RMi) closing bell: “an early and another record close, as we inch towards a virus containment … https://www.regmedinvestors.com/articles/11653    

  • The Nasdaq closed UP +111.44 points (+0.92%);
  • The IBB closed up 3.07% and XBI closed UP +3.67%;
  • Sector volume was the usual LOW with 3 of the 30-upside having higher than the 3-month average volume with the increased volume of 1 of 4-downside having higher than the 3-month average volume;
  • The CBOE Volatility Index (VVIX: INDEX) was down -0.41 points or -1.93% at 20.84;
  • Friday’s percentage (%) of the 30-upside were +0.13% (PGEN) to +17.06% (VSTM) while the 4-downside ranges from -1.79% (RENE.L) to -8.62% (SAGE);

Q4’s: November, so far: 16 positive and 3 negative closes

  • Q4’s October: 1 neutral, 11 positives with 1 negative closes
  • Q3: July through September: 1 neutral, 28 positive and 34 negative closes with 2 holidays

 

Companies in my headlights – It’s your decision; I provide an idea and context:

Maintaining Sell:

Biostage (BSTG) closed down -0.04 to $1.36 with 1,200 shares traded following Thursday’s holiday after Wednesday’s flat with 900 shares traded, Tuesday’s flat at $1.40 with 1,200 shares traded and last Monday’s 1700 shares traded (1 down and 7 trading days at $1.40).

  • Question#1: WHAT and WHICH payables i.e. liabilities were “LOST, HIDDEN or DISPOSED-OF” to lighten the load of the balance sheet going forward, ask Shunfu Hu? <$6,021.80 (2/10/20). $20,000.00 (2/20/20) and $429,500.00 (1/22/20)?
  • Question#2: HOW does or will RMS US and the SEC categorize these “displacements”? Non-existing but, copies exist, isn’t it illegal to “fudge” Qs, Shunfu Hu, VP of busdev and operations and the interim CFO? Back-up in the hundreds of e-mails exist to support; Shunfu Hu isn’t that a felony under U.S. laws?

 

SELL into Strength:

Fate Therapeutics (FATE) closed up again +$0.79 to $57.92 after Thursday’s holiday, Wednesday’s +$1.86 to $57.13, Tuesday’s +$0.98 to $55.27 and last Monday’s+$1.64 to $54.29 with a NO aftermarket indication. A 52-week change of +308.46% and a short percentage (%) of float of -22.79%, There’s “room” to profit;

 

SELL into any Strength:

Athersys (ATHX) closed up =$0.13 to $1.90 with 1.941 M shares traded after Thursday’s holiday, Wednesday’s $1.77, Tuesday’s $1.58 and last Monday’s $1.56 with a NEGATIVE -0.02 or -1.05% aftermarket indication;

CRISPR Therapeutics (CRSP) closed up +$11.55 to $121.55 after Thursday’s holiday, Wednesday’s $110.00, Tuesday’s $109.99 and last Monday’s $110.00 with a POSITIVE +$1.62 or +1.335 aftermarket indication

Editas Medicine (EDIT) closed up +$1.89 to $31.34 after Thursday’s holiday, Wednesday’s $29.45, Tuesday’s $29.02 and last Monday’s $29.33 with a NEGATIVE -$0.09 or -0.29% aftermarket indication;

Verastem Oncology (VSTM) closed up +$0.29 to $1.99 and has a POSITIVE +0.07 or +3.52% pre-market indication following news of the initiation of a P2 registration-directed clinical trial of VS-6766, its RAF/MEK inhibitor, and defactinib, its FAK inhibitor, in patients with recurrent low-grade serous ovarian cancer (LGSOC).

 

BUY:

Sage Therapeutics (SAGE) closed down -$7.13 to $75.57 after Thursday’s holiday, Wednesday’s $82.70, Tuesday’s $79.88 and last Monday’s $77.97 with a POSITIVE +$0.53 or +0.73% aftermarket indication

 

The BOTTOM LINE: The sector is what it is … until it isn’t!

Reiterating, you never get hit by a bus that you saw ... I covered my portfolio for risk of inflated pricing.

Algorithms are circling …

 

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.