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 (OPTIC)
Wet age-related macular degeneration (Wet-AMD)

Phase 1 Phase 1 updated data from all four cohorts was well tolerated. Pivotal trial to commence mid-2021.
$1.2 billion

AIMT – Aimmune Therapeutics Inc.
PALFORZIA - AR101
Peanut Allergy

Approved FDA approval announced January 31, 2020.
$2.2 billion

AMGN – Amgen Inc.
AMG 510
Solid tumors

Phase 1 Phase 1 update at ASCO May 29, 2020. Objective response rate (ORR) was 12% (3/25) in 960 mg once-daily target dose cohort.
$145.1 billion

ANAB – AnaptysBio Inc.
ANB019
Generalized pustular psoriasis

Phase 2 Phase 2 further data due 4Q 2020.
$439 million

AVEO – AVEO Pharmaceuticals Inc.
Tivozanib
Third line treatment of patients with renal cell cancer

PDUFA PDUFA date March 31, 2021.
$161.3 million

AZRX – AzurRx BioPharma Inc.
MS1819 - OPTION 2
Cystic fibrosis

Phase 2b Phase 2b top line data due in 1Q 2021.
$23.2 million

ENTA – Enanta Pharmaceuticals Inc.
EDP-305 ARGON-2
Non-alcoholic steatohepatitis (NASH)

Phase 2 Phase 2b trial dosing is ongoing.
$926.5 million

GTHX – G1 Therapeutics Inc.
Rintodestrant (G1T48) and Ibrance
ER+, HER2- breast cancer

Phase 1/2 Phase 1/2 additional data due 4Q 2020.
$579 million

LLY – Eli Lilly and Company
LOXO-292
Medullary thyroid cancer (MTC)

Phase 3 Phase 3 trial initiation announced December 30, 2019.
$147.5 billion

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

Phase 3 Phase 3 trial to be initiated 3Q 2020 with data due 1H 2022.
$422.8 million

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

Phase 2 Phase 2b data noted quantitative advantage but no statistical separation between two arms. Company noted trial was not designed to detect statistical significance.
$147.1 million

NTRP – Neurotrope Inc.
Bryostatin
Alzheimer's disease

Phase 2 Phase 2 trial did not meet primary endpoint - September 9, 2019.
$28.8 million

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

Phase 2b Phase 3 trial planned for 2H 2020.
$495.3 million

XERS – Xeris Pharmaceuticals Inc.
Glucagon Rescue Pen
Severe hypoglycemia

Approved FDA Approval announced September 10, 2019.
$293.4 million