RegMed Investors’ (RMi) closing bell: ASH defines the sector while trade initiatives explain the markets

December 3, 2018 5:29pm

Highlights: Global Blood Therapeutics (GBT +$15.08 or +47.81% to $46.62) shares jumped after the FDA agreed to allow GBT’s filing for its late-stage sickle cell disease, or SCD, candidate Voxelotor under an accelerated approval pathway. GBT will submit a NDA, for the pipeline asset under the pathway. bluebird bio (BLUE -$6.39 or -5.20% to $116.50) presented data that was mostly positive, with high expectations for group C (only treated with the 'refined' LentiGlobin). However, one serious adverse event (SAE) was reported from Group A; a case of myelodysplasic syndrome that isn't believed to be therapy related but could be due to the conditioning needed for therapy. Fate Therapeutics (FATE +$1.61 or +10.48% to $16.97) has secured an exclusive option to an intellectual property portfolio owned by the Max Delbrück Center for Molecular Medicine (MDC) covering novel humanized chimeric antigen receptor (CAR) constructs that uniquely and specifically bind B-cell Maturation Antigen (BCMA).

Pre-open indications: 3 HITs and 2 MISS

Some have stated, “I am the “weatherman” of the sector; forecasting and presenting conditions of the sector in a given period.”

RMi’s daily report may say little or a lot and its final judgement may be inconclusive; yet it serves as insurance that all indications are being examined and evaluated.

Daily analytics and metrics:

• The Dow closed UP + 287.97 points or +1.13% to 25,826.43
• The S&P closed UP +30.20 points or +1.09% to 2,790.37
• The NASDAQ was UP +110.98 points or +1.51% to 7,441.51

From the pre-open newsletter: “up, up to possibly stay up. Some hot and a lot of presentations at the 60th American Society of Hematology (ASH) Annual Meeting and Exposition focus the week,

The advance/decline line scenario of 45 covered companies:   

• The open was positive with an A/DL of 36/6 and 3 flats;
• The mid-day was positive with an A/DL of 29/15 and 1 flat;
• The close was positive with an A/DL of 32/10 and 3 flat;

Pre-open indications: 3 HITs and 2 MISS

• Editas Medicine (EDIT) closed up +$0.63 – hit;
• bluebird bio, Inc. (BLUE) closed down -$6.39 – miss;
• Bellicum Pharmaceuticals (BLCM) closed down -$0.02 – miss;
• Global Blood Therapeutics (GBT) closed up +$15.08 – hit;
• uniQure N.V. (QURE) closed a up +$1.22 – hit;

Monday’s highlights:

Global Blood Therapeutics (GBT +$15.08 or +47.81% to $46.62) shares traded at a 3 month high. The FDA has agreed to allow GBT’s filing for its late-stage sickle cell disease, or SCD, candidate Voxelotor under an accelerated approval pathway. GBT will submit a NDA, for the pipeline asset under the pathway. GBT’s voxelotor reasonably reduces strokes in SCD patients, the FDA has accepted the transcranial doppler, or TCD, flow as the primary endpoint in a post-approval confirmatory study to demonstrate stroke risk reduction. The accelerated approval under Subpart H is allowed for drugs that treat serious or life-threatening illnesses and provide meaningful therapeutic benefit to patients over existing treatments.

bluebird bio (BLUE -$6.39 or -5.20% to $116.50) presented data that was mostly positive, with high expectations for group C (only treated with the 'refined' LentiGlobin). However, one serious adverse event (SAE) was reported from Group A; a case of myelodysplasic syndrome that isn't believed to be therapy related but could be due to the conditioning needed for therapy.

Fate Therapeutics (FATE +$1.61 or +10.48% to $16.97) has secured an exclusive option to an intellectual property portfolio owned by the Max Delbrück Center for Molecular Medicine (MDC) covering novel humanized chimeric antigen receptor (CAR) constructs that uniquely and specifically bind B-cell Maturation Antigen (BCMA). Under the agreement with MDC, FATE holds an exclusive option to exclusively license the portfolio for all cell products, including CAR NK- and T-cell products, derived from induced pluripotent stem cells (iPSCs).

Daily sector metrics:

… Greatest volume to the downside:  BLUE, HSGX, ONCE, MDXG and BLCM

… Upside volume was weighted to:  GBT, SGMO, VSTM, ADRO and FATE

… Weakness ($) to the downside:  BLUE (-$6.39), SLSB (-$0.83), ONCE (-$0.24), CLBS (-$0.17) and MESO (-$0.105)

… Best moves ($) to the upside … GBT (+$15.08), ALNY (+$3.13), BMRN (+$1.76), FATE (+$1.61) and FIXX (+$1.53)

The iShares NASDAQ Biotechnology (IBB) closed:

• Monday was UP +1.15% after indicating a POSITIVE +1.74% in the pre-market;
• Friday was UP +1.50% after NOT indicating in the pre-market;
• Thursday was down -0.05% after NOT indicating in the pre-market;
• Wednesday was up +2.71% after indicating a POSITIVE +0.66% in the pre-market;
• Tuesday was down -0.3% after NOT indicating in the pre-market;
• Last Monday was up +1.7% after NOT indicating in the pre-market;

Henry’omics:

Sector equities rose on Monday after U.S. President Trump and Chinese President Jinping agreed to a 90-day cease-fire in the trade war that has weighed heavily on global stock markets for most of 2018.

Leading the upside were GBT (+$15.08), ALNY (+$3.13), BMRN (+$1.76) and FATE (+$1.61) after Friday’s (+$1.26), while the losers were BLUE (-$6.39) after Friday’s dip of (-$2.25), SLDB (-$0.83) and ONCE (-$0.24).

Sector equities shucked the high of the opening as the mid-day trading dipped and skipped-up a notch at the close.

Tonight’s percentage (%) indicators:

• Review the range of the 32 upside from +0. % () to +% () while the 10 downside ranged from -0.44% (BLCM) to -5.20% (BLUE) with 3 flat close (AST, RENE.L and BTX).

Volume stat:

• 11 out of 32 upside had higher (than the 3 month average) volume
• 4 out of 10 downside experienced greater volume (than the 3 month average).

December sessions:

Monday (12/3) closed POSITIVE with 10 decliners, 32 advancers and 3 flats;

• In 22 sessions in November – there were 1 holiday, 10 positive closes, 1 neutral and 10 negative closes;
• In 23 sessions in October – there were 17 negative closes and 6 positive closes
• In 19 sessions in September – there were 10 negative closes and 9 positive close;
• In 21 August sessions – 6 had negative and 15 had positive closes

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.