October 7, 2020 8:04am
Second stimulus bill talks were off the table until Trump tweeted some aid is now possibly back on
Pre-open indications: 2 BUYs and 3 SELLs
News: - Pluristem (PSTI) has received approval from the Israeli Ministry of Health to commence patient enrollment in Israel for the Company’s COVID-19 P2 clinical trial, under the protocol that was approved by the Paul Ehrlich Institute (PEI), Germany’s regulatory agency. A total of 40 patients hospitalized with severe COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS) will be enrolled at clinical sites in Israel and Germany. Pfizer Inc. (NYSE: PFE) and Sangam Therapeutics (SGMO) doses in the P3 AFFINE study of giroctocogene fitelparvovec (SB-525), an investigational gene therapy for hemophilia A patients.
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
Subscription is coming, it’s not conscription but, an offer to join our collective of like-minded investors! My gift to you, I've kept RMi subscription FREE during these COVID-19 and volatile times
Dow futures are UP +0.74% (+204 points), S&P futures are UP +0.70% (+24 points) and NASDAQ futures are UP +0.70% (+79 points)
Futures rebounded Wednesday from Tuesday’s slide after President Trump tweeted support for aid to airlines and other stimulus measures after he tweeted the White House was halting talks;
European stocks were mixed as the pan-European Stoxx 600 hovered just above the flatline in early trade;
Asia-Pacific stocks mostly advanced as MSCI’s broadest index of Asia-Pacific shares outside Japan gained +0.65%.
Data Docket: The Federal Open Market Committee will publish its meeting minutes from its September meeting at 2 p.m. ET on Wednesday. The FOMC made no action on interest rates in September, leaving them near zero.
Henry’omics:
Yesterday, the S&P 500 lost -1.4% and the Nasdaq -1.57% after a negative tweet re retracting the stimulus bill for democratic non-cooperation.
Tuesday night’s post: RegMed Investors’ (RMi) closing bell: RegMed Investors’ (RMi) closing bell: sector erases some gains as the last hour sealed the downside ... https://www.regmedinvestors.com/articles/11577
- The Nasdaq closed DOWN -177.88 points (-1.57%);
- The IBB closed down -1.21% and XBI closed down -0.79%;
- Sector volume was the usual LOW with 3 of the 11-upside having higher than the 3-month average volume with the increased volume of 4 of 23-downside having higher than the 3-month average volume;
- The CBOE Volatility Index (VVIX: INDEX) was up +0.10 points or +0.36% at 28.06;
- Tuesday’s percentage (%) of the 11-upside were +0.03% (GBT) to +6.60% (SAGE) while the 23-downside of -0.07% (BLUE) to -8% (SLDB)
Q4’s October, so far: 1 positive and 3 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 -$0.01 to $1.60 <after being up +$0.28> after Monday’s +$0.01 to $1.61, Friday’s +$0.03 to $1.60, Thursday’s -$0.03 to $1.57 and last Wednesday’s +$0.05 to $1.60 a. Question#1: WHAT is the status of the board of directors – NO audit board member; Question#2: WHY hasn’t thee bill or $429,500 (the final payment of a $1 million gift) to Connecticut Children’s (of which a BSTG board of director member, James Schmerling is the CEO) shown up in the payable’s entry – it has been months – copies exist; Question#3: WHERE is RMS, the accounting firm in establishing transparency in financials;
SELL into Strength:
BioLife Solutions (BLFS) closed up again +$0.46 to $29.50 after Monday’s +$0.44 to $29.04, Friday’s $28.60, Thursday’s $29.42 and last Wednesday’s $28.94 with NO aftermarket indication yet a vey “peaky” chart and a 52-week change of +87.11% - The new acquisition’s revenue won’t show up until Q4 in 2021 release.
Solid BioSciences (SLDB) closed down -$0.38 to $4.37 after Monday’s +$0.57 to $4.75, Friday’s +$0.72 to $4.18, Thursday’s+$1.43 to $3.46 and last Wednesday’s $2.03 with a NEGATIVE -$0.14 or -3.20% aftermarket (Friday) indication. 11 months ago, the U.S. FDA shut down Solid Biosciences' (SLDB) "IGNITE DMD" P1/2 clinical trial after one of the young patients involved in the trial suffered a "serious adverse event. Last week, the FDA has "lifted the clinical hold" on its trials, acknowledging that the company has "satisfactorily addressed all clinical hold questions. There is STILL work and patients to be treated.
BUY on News:
Pluristem Therapeutics (PSTI) closed down -$0.17 to $10.30 and has a POSITIVE +$0.65 or +6.31% pre-market indication and has news of a received approval from the Israeli Ministry of Health to commence patient enrollment in Israel for the Company’s COVID-19 Phase II clinical trial, under the protocol that was approved by the Paul Ehrlich Institute (PEI), Germany’s regulatory agency. A total of 40 patients hospitalized with severe COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS) will be enrolled at clinical sites in Israel and Germany.
Sangamo Therapeutics (SGMO) closed down -$0.08 to $9.70 with a POSITIVE +$0.18 or +1.86% pre-market indication on news of Pfizer Inc. (NYSE: PFE) and SGMO dosing in the P3 AFFINE study of giroctocogene fitelparvovec (SB-525), an investigational gene therapy for hemophilia A patients. AFFINE is a global P3, open-label, multicenter, single arm study that will evaluate the efficacy and safety of giroctocogene fitelparvovec in patients with moderately severe to severe hemophilia A. The primary endpoint is impact on annual bleed rate (ABR) through 12 months following treatment with giroctocogene fitelparvovec, compared to ABR on Factor VIII (FVIII) replacement therapy collected in the P3 lead-in study period. Participants will be analyzed throughout the 5-year study period following the single infusion to further assess the durability and efficacy.
The BOTTOM LINE: As I stated yesterday, profit now, a market storm is brewing.
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.
