BPC May 29 update

Selection of key biotech catalysts slated for June; Biotech week in Review

Weekly watchlist

As we enter the final month of the first half of 2020, our focus this week is on remaining key catalysts slated for the month of June. Each week, we will highlight 14-15 catalysts, replacing completed events with new catalysts.

First, let’s review the shortened trading week with key price-moving healthcare news.

Adaptimmune Therapeutics (NASDAQ:ADAP) shares surged to close Friday up 128% to $11.07 following the release of data at the ASCO Virtual Meeting. In a Phase 1 trial of ADP-A2M4, 50% (8/16) of patients with synovial sarcoma exhibited partial responses.

Arvinas, Inc. (NASDAQ:ARVN) shares closed Friday down 26% to $33.27 following updated data at ASCO from the dose escalation portion of its Phase 1/2 clinical trial of ARV-110 in men with metastatic castration-resistant prostate cancer (mCRPC). Only 2 of 20 patients saw their PSA levels drop by more than 50%, falling short of expectations.

Minerva Neurosciences, Inc. (NASDAQ: NERV) shares slumped to close Friday down 72% to $3.71 on news that its Phase 3 trial of roluperidone to treat negative symptoms in schizophrenia did not meet its primary and key secondary endpoints.

Mersana Therapeutics, Inc. (NASDAQ:MRSN) shares rallied to close the week up 129% to $22.64 following interim data from its Phase 1 trial evaluating XMT-1536, in patients with ovarian cancer. Of the 20 patients that were evaluable for response, 2/20 (10%) achieved confirmed complete responses (CRs) and 5/20 (25%) achieved confirmed partial responses (PRs) for an objective response rate (ORR) of 35%.

argenx (NASDAQ:ARGX) announced its pivotal ADAPT trial of efgartigimod in generalized myasthenia gravis (gMG) patients met its primary endpoint. Shares closed the week up 39% to $219.30.

Arcus Biosciences, Inc. (NYSE: RCUS) announced a partnership with Gilead Sciences, Inc. (NASDAQ: GILD) to co-develop and co-commercialize current and future therapeutic product candidates in its pipeline. Arcus will receive $375m upon closing, consisting of a $175m upfront payment and a $200m equity investment from Gilead. Shares, however, closed the week down 12% to $31.35 as investors had hoped the company would be on the end of a buyout instead.


Selection of key biotech catalysts slated for June:

Drug Stage Catalyst Market Cap

AKRO – Akero Therapeutics Inc.
AKR-001
Nonalcoholic steatohepatitis (NASH)

Phase 2a Phase 2a dose groups all met primary endpoint - March 31, 2020. Further data released June 30, 2020 noted 48% of patients achieved at least a one-stage improvement in fibrosis without worsening of NAFLD activity score (NAS) and 28% achieved at least a two-stage improvement in fibrosis.
$946.8 million

AZN – Astrazeneca PLC
AZD1222 (ChAdOx1 nCoV-19)
COVID-19 vaccine

Phase 1 Phase 1 data due July 2020. Phase 3 data due August/September 2020.
$141.2 billion

BLU – BELLUS Health Inc.
BLU-5937
Chronic cough

Phase 2 Phase 2 data due July 2020.
$724.2 million

BYSI – BeyondSpring Inc.
Plinabulin + TAC (Trial 106)
Chemotherapy-induced neutropenia (CIN)

Phase 3 Phase 3 interim top-line data due met primary endpoint - June 15, 2020. Final analysis expected in 2H 2020
$444.7 million

CNST – Constellation Pharmaceuticals Inc.
CPI-0610 and ruxolitinib - Manifest
Myelofibrosis

Phase 2 Phase 2 update due at EHA June 12, 2020. 19 of 30 evaluable patients (63%) achieved SVR35 at 24 weeks.
$1.2 billion

EVOK – Evoke Pharma Inc.
Gimoti - EVK-001
Diabetic gastroparesis

Approved FDA Approval announced June 19, 2020.
$91.9 million

HRTX – Heron Therapeutics Inc.
HTX-011
Post operative pain

CRL CRL announced June 29, 2020.
$1.4 billion

INO – Inovio Pharmaceuticals Inc.
INO-4800
Coronavirus COVID-19 vaccine

Phase 1 Phase 1 interim data released June 30, 2020. 94% of Phase 1 trial participants demonstrated overall immune responses at Week 6 but no data on how many patients produced antibodies. Phase 2/3 trial to commence July/August 2020.
$3.4 billion

OBSV – ObsEva SA
Linzagolix OBE2109 - PRIMROSE 1
Uterine fibroids

Phase 3 Phase 3 data due July 6, 2020.
$274.2 million

OPK – Opko Health Inc.
Somatrogon (hGH-CTP)
Children - growth hormone deficiency

Phase 3 Phase 3 data met primary endpoint.
$2.4 billion

REGN – Regeneron Pharmaceuticals Inc.
Kevzara (Sarilumab)
Coronavirus COVID-19

Phase 3 Phase 3 trial did not meet primary endpoint - July 2, 2020.
$63.9 billion

SLNO – Soleno Therapeutics Inc.
Diazoxide Choline Controlled-Release (DCCR) - DESTINY PWS
Prader-Willi syndrome (PWS)

Phase 3 Phase 3 trial did not meet its primary endpoint - June 8, 2020.
$173.4 million

ZGNX – Zogenix Inc.
FINTEPLA (ZX008)
Dravet syndrom

Approved FDA approval announced June 25, 2020.
$1.6 billion

ZYNE – Zynerba Pharmaceuticals Inc.
Zygel ZYN002
Fragile X syndrome

Phase 2/3 Phase 2/3 trial did not meet primary endpoint - June 30, 2020.
$87.3 million