BPC September 20 update

Biotech data releases left for 3Q; Biotech week in Review

Weekly watchlist

The upcoming week in the healthcare sector will see most eyes on the ESMO Congress, arguably Europe's leading medical oncology meeting, which commences late in the week (September 27 – October 01). We highlighted a few key events to watch in our preview two weeks ago. Aside from ESMO, a number of readouts slated for this quarter still remain on the calendar. Given that the last day of the quarter lies on Monday week, one would assume the majority of companies that have guided for data this quarter (or mid-2019) will release data in the upcoming week.

Next week we turn our focus to key catalysts to look forward to for the final quarter of 2019.

First, let’s review the week that was which saw an unusually quiet week of biotech news flow.

Alder BioPharmaceuticals (NASDAQ: ALDR) shares closed Monday up 84% to $18.50 on news that it will be acquired by H. Lundbeck A/S. Alder stockholders will receive an upfront payment of $18 per share in cash, along with one non-tradeable Contingent Value Right (CVR) that entitles them to an additional $2 per share upon approval of eptinezumab by the European Medicines Agency (EMA), representing a total potential consideration of $20.00 per share, for a total value of $1.95b.

Zynerba Pharmaceuticals Inc (NASDAQ: ZYNE) shares closed the week down 32% to $8.26 following the release of data from its Phase 2 open-label trial of Zygel (ZYN002) for the treatment of developmental and epileptic encephalopathies (DEE). Safety concerns were at the forefront, with 96% of patients experiencing a treatment emergent adverse event (TEAE) and 60% of patients experienced a treatment related adverse event. 10 of the 46 patients reported a serious adverse event (SAE).

Sienna Biopharmaceuticals, Inc. (NASDAQ:SNNA) announced that it has elected to file a voluntary petition to allow restructuring under Chapter 11 of the Bankruptcy Code. Shares slumped to close Tuesday down 74% to $0.18.

Aclaris Therapeutics, Inc. (NASDAQ: ACRS) shares closed the week up 38% to $1.42 following news released Monday that its Phase 3 THWART-2 clinical trial of A-101 45% Topical Solution for the treatment of common warts, met primary and secondary efficacy endpoints, achieving clinically and statistically significant clearance of common warts.

Biotech data releases to watch left for the quarter: ANAB ENTA MDCO MRNS NERV URGN

Drug Stage Catalyst Market Cap

ALNY – Alnylam Pharmaceuticals Inc.
Inclisiran - ORION-9
Hypercholesterolemia

Phase 3 Phase 3 data met all endpoints - September 25, 2019. Data November 18, 2019 noted LDL-C reductions of 50%.
$13.8 billion

ANAB – AnaptysBio Inc.
ANB019
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.
$380.4 million

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

Phase 2 Phase 2b trial to be initiated 2Q 2020.
$1.3 billion

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

Phase 2 Phase 3 trial to be initiated mid-2020.
$70.6 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.
$243.9 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.
$687.7 million