BPC August 31 update

Biotech catalysts for September; Biotech Week in Review

Weekly watchlist

The end of summer brought a quiet trading week of newsflow, with just a few price-moving events to highlight from the week that was. We also update our catalyst list for September.

The Medicines Company (NASDAQ: MDCO) shares closed the week up 20% to $41.96 following news that its first pivotal Phase 3 clinical trial, ORION-11, evaluating inclisiran in its treatment of cholesterol, met all primary and secondary endpoints. Detailed data will be presented at a late-breaking science session at the European Society of Cardiology’s ESC Congress on Monday, September 2 at 8:30 am CET / 2:30 am EDT.

Prothena Corporation plc (NASDAQ:PRTA) shares closed the week up 22% to $8.41, following the filing of a Schedule 13D by EcoR1 Capital on Monday, where it reported a $23.6% ownership stake of the company.

Amgen (NASDAQ:AMGN) announced that it has entered into an agreement with Celgene Corporation (NASDAQ:CELG) in connection with its pending merger with Bristol-Myers Squibb Company (NYSE:BMY) to acquire worldwide rights to Otezla, a treatment for psoriasis and psoriatic arthritis for $13.4b in cash. Amgen shares closed the week up 5% to $208.62.

Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN), which had been subject to rumors last week that Amgen may be interested in a buyout of the company, lost further ground on news the U.S. Patent and Trademark Office (PTO) will review patents of its blood disorder treatment, Soliris, following a challenge from Amgen. Shares closed the week down 13% to $100.74.


Biotech stock events for September:

Drug Stage Catalyst Market Cap

ADVM – Adverum Biotechnologies Inc.
ADVM-022
Wet age-related macular degeneration (Wet-AMD)

Phase 1 Phase 1 data from first cohort presented September 12, 2019. Range change in BCVA -9.1 to +5.1 letters.
$409.3 million

AIMT – Aimmune Therapeutics Inc.
AR101
Peanut Allergy

PDUFA PDUFA date late-January 2020. Advisory Committee meeting September 13, 2019 voted in favor of supporting approval.
$1.4 billion

AMGN – Amgen Inc.
AMG 510
Solid tumors

Phase 1 Phase 1 presentation at ESMO September 28, 2019, 4:52pm CEST.
$117.1 billion

ANAB – AnaptysBio Inc.
ANB019
Generalized pustular psoriasis

Phase 2 Phase 2 data due mid-2019.
$1.1 billion

AVEO – AVEO Pharmaceuticals Inc.
TIVO-3 - tivozanib
Third line treatment of patients with renal cell cancer

Phase 3 Phase 3 interim data noted overall survival of 16.4 months vs 19.7 months for sorafenib.
$156.1 million

AZRX – AzurRx BioPharma Inc.
MS1819-SD (OPTION)
Cystic fibrosis

Phase 2 Phase 2 data due September 2019.
$26.4 million

ENTA – Enanta Pharmaceuticals Inc.
EDP-305 ARGON-1
Non-alcoholic steatohepatitis (NASH)

Phase 2 Phase 2 initial data due 3Q 2019.
$1.4 billion

GTHX – G1 Therapeutics Inc.
G1T48
ER+, HER2- breast cancer

Phase 1/2 Phase 1/2 preliminary data due at ESMO September 29, 2019 12pm CEST.
$1.4 billion

LLY – Eli Lilly and Company
LOXO-292
RET-fusion non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other tumors

Phase 1 Phase 1/2 updated data presented at WCLC September 8, 2019. 68% Overall response rate.
$110.1 billion

MRNS – Marinus Pharmaceuticals Inc.
Ganaxolone
Refractory status epilepticus (RSE)

Phase 2 Data due by the end of 3Q 2019.
$75.2 million

NERV – Minerva Neurosciences Inc
MIN-202 (seltorexant) vs quetiapine
Major Depressive Disorder

Phase 2 Phase 2 data due 3Q 2019.
$333.7 million

NTRP – Neurotrope Inc.
Bryostatin
Alzheimer's disease

Phase 2 Phase 2 trial did not meet primary endpoint - September 9, 2019.
$13.1 million

URGN – UroGen Pharma Ltd.
VesiGel UGN-102
Low grade non-muscle invasive bladder cancer (LG-NMIBC)

Phase 2b Phase 2b initial data due September 24, 2019.
$756.3 million

XERS – Xeris Pharmaceuticals Inc.
Glucagon Rescue Pen
Severe hypoglycemia

Approved FDA Approval announced September 10, 2019.
$289.8 million