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

Phase 1 Phase 1 presentation of 24-week data from the second cohort and an update from first cohort of patients in the OPTIC trial due at the Angiogenesis Meeting, February 8, 2010 at 2:28 pm EST.
$698.2 million

AIMT – Aimmune Therapeutics Inc.
Peanut Allergy

PDUFA Advisory Committee meeting September 13, 2019 voted in favor of supporting approval. PDUFA date late-January 2020.
$2 billion

AMGN – Amgen Inc.
AMG 510
Solid tumors

Phase 1 Phase 1 update at ESMO noted 54% PR rate for NSCLC patients (960mg); 1/12 for CRC patients. Next update due in 2020.
$135 billion

ANAB – AnaptysBio Inc.
Generalized pustular psoriasis

Phase 2 Phase 2 interim data on first TWO patients announced September 30, 2019 with patients reaching primary endpoint. Further data due 2020.
$386.9 million

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

NDA Filing NDA to be filed in 1Q 2020. Will withdraw if overall survival data in 2Q 2020 yields an OS HR above 1.00.
$84.4 million

AZRX – AzurRx BioPharma Inc.
Cystic fibrosis

Phase 2 Phase 2 higher dose trial to be initiated early 2020 with data due mid-2020.
$27.2 million

ENTA – Enanta Pharmaceuticals Inc.
Non-alcoholic steatohepatitis (NASH)

Phase 2 Phase 2b trial to be initiated 2Q 2020.
$1 billion

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

Phase 1/2 Phase 1/2 data update and Phase 3 trial initiation due 2H 2020.
$800.1 million

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

Phase 3 Phase 3 trial initiation announced December 30, 2019.
$134.3 billion

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

Phase 2 Phase 3 trial to be initiated mid-2020.
$179.9 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.
$314.2 million

NTRP – Neurotrope Inc.
Alzheimer's disease

Phase 2 Phase 2 trial did not meet primary endpoint - September 9, 2019.
$16.9 million

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

Phase 2b Phase 3 trial planned for 2020.
$656.2 million

XERS – Xeris Pharmaceuticals Inc.
Glucagon Rescue Pen
Severe hypoglycemia

Approved FDA Approval announced September 10, 2019.
$162.2 million