BPC November 22 update

Upcoming stocks to watch ahead of ASH next weekend; Bitoech week in review

Weekly watchlist

The annual ASH meeting, regarded as the major hematology conference of the year, commences on December 1. A plateful of companies will be presenting at the meeting, with investor eyes no doubt nervously observing following poor stock performances following recent meetings coupled with a general downturn in biotech stocks. 

We highlight a dozen ASH abstracts to watch plus a couple other events scheduled for the upcoming week. A larger list of well over 50 presentations is noted in the BioPharmCatalyst FDA Calendar

First let’s review the shortened trading week which was largely absent of major biotech-related news due to Thanksgiving.

Aquestive Therapeutics (NASDAQ: AQST) shares saw a two-day loss across Tuesday and Wednesday of 37% 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.  

Sage Therapeutics, Inc. (NASDAQ: SAGE) announced Tuesday that FDA has extended the PDUFA date for Zulresso (brexanolone) injection for the treatment of postpartum depression (PPD) by three months to March 19, 2019. The extension is due to a recently submitted Risk Evaluation and Mitigation Strategies (REMS) program by Sage in response to the FDA’s request.

The FDA approved two indications for the treatment of newly-diagnosed acute myeloid leukemia (AML) in patients who are not eligible for intensive induction chemotherapy. Pfizer Inc. (NYSE:PFE) received approval for Daurismo (glasdegib) and Roche (OTCQX: RHHBY) and AbbVie (NYSE: ABBV) were granted approval for Venclexta.

Upcoming regulatory events for next week and a look ahead at ASH:

Drug Stage Catalyst Market Cap

AMGN – Amgen Inc.
AMG 420
Relapsed. Refractory (R/R) Multiple Myeloma (MM)

Phase 1 Phase 1 data ASCO June 2, 2019. Overall response rate 70% (7/10) in high dose, 13/42 response across all cohorts.
$107.4 billion

AUTL – Autolus Therapeutics plc
AUTO3 - (ALEXANDER)
Relapsed or refractory diffuse large B-celllymphoma (DLBCL)

Phase 1/2 Phase 1/2 data update due 3Q 2019.
$724.1 million

BLUE – bluebird bio Inc.
LentiGlobin - HGB-206
Sickle disease

Phase 1/2 Phase 1/2 updated data due at EHA June 16, 2019.
$7.5 billion

BLUE – bluebird bio Inc.
LentiGlobin - HGB-207 Northstar-2
non-β0/β0 transfusion-dependent thalassemia (TDT)

Phase 3 Phase 3 updated data due at EHA June 2019 noted 4/5 patients achieved transfusion independence.
$7.5 billion

CPRX – Catalyst Pharmaceuticals Inc.
Firdapse
Lambert-Easton Myasthenic Syndrome (LEMS)

Approved FDA approval announced November 28, 2018.
$419.6 million

GBT – Global Blood Therapeutics Inc.
GBT440
Sickle cell disease

NDA Filing NDA to be filed under accelerated approval 2H 2019. Data presented at EHA June 14, 2019 noted 51% patients showed a hemoglobin response.
$3.5 billion

HSGX – Histogenics Corporation
NeoCart
Cartilage defects in the knee

Phase 3 Development to be suspended - noted December 21, 2018.
$19.6 million

IMGN – ImmunoGen Inc.
IMGN632
Acute Myeloid Leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN)

Phase 1 Phase 1 updated data due 2019.
$370.8 million

JNJ – Johnson & Johnson
Daratumumab - MAIA
Newly Diagnosed Multiple Myeloma (NDMM)

Approved FDA Approval announced June 28, 2019.
$357.7 billion

LLY – Eli Lilly and Company
Larotrectinib (LOXO-101)
Solid tumors that harbor a TRK fusion.

Approved FDA Approval announced November 26, 2018.
$105.3 billion

MGNX – MacroGenics Inc.
Flotetuzumab
AML/MDS

Phase 1 Phase 1 interim data due 2H 2019.
$777 million

MGTA – Magenta Therapeutics Inc.
MGTA-456
Inherited Metabolic Disorders (IMD)

Phase 2 Phase 2 data noted all patients met primary endpoint.
$529.3 million

XLRN – Acceleron Pharma Inc.
Luspatercept
Myelodysplastic syndromes (MDS) cancer

PDUFA PDUFA date April 4, 2020.
$2.2 billion

XNCR – Xencor Inc.
XmAb14045
Acute Myeloid Leukemia (AML)

Phase 1 Phase 1 trial placed on partial clinical hold - February 20, 2019.
$2.5 billion