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 BALANCED trial data presented at AASLD meeting November 15, 2020. Phase 2a Cohort C (F4) readout and Phase 2b/3 initiation 1H 2021.
$1 billion

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

Phase 3 Phase 3 initial data met primary endpoint. 70% efficacy (90% and 60% across two dosing regimens) - UK and Brazil trial. Data from U.S. trial possibly due 1Q 2021.
$137.1 billion

BLU – BELLUS Health Inc.
BLU-5937 (SOOTHE)
Chronic cough

Phase 2b Phase 2b initiation announced December 8, 2020. Interim analysis expected in mid-2021, with top-line results expected 4Q 2021
$311 million

BYSI – BeyondSpring Inc.
Plinabulin + TAC (Trial 106) - Protective-2
Chemotherapy-induced neutropenia (CIN)

Phase 3 Phase 3 primary and secondary endpoints met - November 16, 2020.
$396.7 million

CNST – Constellation Pharmaceuticals Inc.
CPI-0610 and ruxolitinib - Manifest-2
Myelofibrosis

Phase 3 Phase 3 trial has been initiated.
$1.7 billion

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

Approved FDA Approval announced June 19, 2020.
$75.5 million

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

PDUFA CRL announced June 29, 2020. NDA resubmitted with new PDUFA date May 12, 2021.
$1.6 billion

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

Phase 2 Phase 2 part of Phase 2/3 trial is ongoing.
$1.6 billion

OBSV – ObsEva SA
Linzagolix OBE2109 - PRIMROSE 1
Uterine fibroids

Phase 3 Phase 3 data trial met primary endpoint - July 6, 2020. Placebo adjusted rates lower than competition.
$247.6 million

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

PDUFA BLA filing acceptance announced January 4, 2021. PDUFA date October 2021.
$3 billion

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

Phase 3 Phase 3 trial did not meet primary endpoint - July 2, 2020.
$57.9 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. Announced September 30, 2020 updated data noting that while there was a larger decrease from baseline to week 4 in placebo compared to DCCR subjects, from week 4 placebo subjects worsened, while DCCR subjects continued to improve (p=0.03).
$168.8 million

ZGNX – Zogenix Inc.
FINTEPLA (ZX008)
Dravet syndrom

Approved FDA approval announced June 25, 2020.
$1 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. Further trial to be initiated in 2021.
$106.6 million