BPC November 21 update

FDA approves AML treatments ABBV RHHBY PFE; ​Aquestive AQST -23% on court ruling

Price and Volume Movers

Aquestive Therapeutics (NASDAQ: AQST) shares closed down 23% to $10.22 following news that its partner Indivior lost a court ruling with the U.S. Court of Appeals ruling in favor of Dr. Reddy's Laboratories (DRL) overturning the preliminary injunction against DRL that had prevented DRL from selling its Suboxone generic. 

Pfizer Inc. (NYSE:PFE) announced that the FDA approved Daurismo (glasdegib) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years or older or who are not eligible for intensive induction chemotherapy.

Roche (OTCQX: RHHBY) and AbbVie (NYSE: ABBV) also announced that the FDA has granted approval for Venclexta for the same AML indication noted above. 

Heat Biologics (NASDAQ: HTBX) shares closed down 31% to $1.42 following the pricing of its underwritten public offering consisting of 8m shares combined with warrants to purchase 4m shares at a combined price to the public of $1.50.

Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume 


Kiniksa Pharmaceuticals, Ltd. (KNSA): $20.29; +24%.

Can-Fite BioPharma Ltd. (CANF): $1.61; +15%.

Vaxart, Inc. (VXRT): $2.85; +12%.

Stemline Therapeutics, Inc. (STML): $11.73; +11%.

Autolus Therapeutics Plc (AUTL): $45.71; +11%.


Bioblast Pharma Ltd. (ORPN): $1.36; -12%.

Onconova Therapeutics, Inc. (ONTX): $3.51; -11%.

Novan, Inc. (NOVN): $1.92; -10%.

Curis, Inc. (CRIS): $1.28; -9%.

Achaogen, Inc. (AKAO): $1.79; -8%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ABBV – AbbVie Inc.
First line unfit AML

Approved FDA approval announced November 21, 2018.
$103.9 billion

CYAD – Celyad SA
CYAD-101 - alloSHRINK
Colorectal cancer

Phase 1 Phase 1 data to presented at ESMO noted 1/6 partial responses and three with stable disease.
$169.8 million

MESO – Mesoblast Limited
MPC-150-IM - Class 2/3
Heart failure

Phase 3 Phase 3 enrolment to be completed 1Q 2019.
$528.8 million

PFE – Pfizer Inc.
Acute myeloid leukemia (AML)

Approved FDA approval announced November 21, 2018.
$237.7 billion

TBPH – Theravance Biopharma Inc.
Crohn's Disease

Phase 2 Phase 2 commencement of dosing announced November 21, 2018.
$983 million