BPC January 22 update

Biotech short-term events to watch; Biotech week in Review

Weekly watchlist

Following our recent previews of biotech stock catalysts to watch for the quarter as a whole, we look ahead at this week at events likely to occur during the next couple weeks.

As a caveat, of the stocks listed below, given that data from several ongoing COVID-19 vaccine trials are slated for release during the early part of the first quarter, some readouts might fall out of the two-week timeframe.

First, let’s review price-moving news in what was a relatively quiet week of news flow.

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) announced after the close of Friday's after hours session that the FDA approved Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). Lupkynis is the first FDA-approved oral therapy for LN.

Aclaris Therapeutics, Inc. (NASDAQ:ACRS) shares closed Tuesday up 220% to $18.83 following the release of data from its Phase 2 trial in patients with rheumatoid arthritis. The primary endpoint was safety and tolerability. Key secondary endpoints included the disease activity scores, DAS28-CRP and ACR20/50/70. ACR20/50/70 was observed at week 12 in 60%, 33% and 20%, respectively, of the 15 subjects in the treatment arm, and in 0% of the two subjects in the placebo arm. Analysts at SVB Leerink backed up the price surge by maintaining their outperform rating, and raising their price target from $4.50 to $21.

Minerva Neurosciences, Inc. (NASDAQ:NERV) announced Royalty Pharma plc (NASDAQ:RPRX) will acquire its royalty interest in seltorexant for an upfront payment of $60m and up to $95m in additional milestone payments. Shares closed the week up 21% to $3.28.

Gritstone Oncology, Inc. (NASDAQ:GRTS) shares closed the week up 324% to $27.11 on news it intends to initiate a Phase 1 COVID-19 vaccine trial this quarter. Currently in pre-clinical development, the company has entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID) to initiate clinical testing.

Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced that its Phase 2/3 trial of troriluzole as a symptomatic treatment in mild-to-moderate Alzheimer's disease (AD), did not meet the co-primary endpoints of the trial. Troriluzole did not statistically differentiate from placebo at 48 weeks on the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) in study participants. Shares closed the week down 6% to $79.67.

Merck KGaA and GlaxoSmithKline plc (NYSE: GSK) announced that their Phase 3 Lung 037 trial of bintrafusp alfa in the first-line treatment of patients with late-stage non-small cell lung cancer (NSCLC), will be discontinued following an Independent Data Monitoring Committee review which determined the trial was unlikely to meet the primary efficacy endpoint. The drug was trialled against Merck & Co's blockbuster immunotherapy, Keytruda.

Immutep Limited (NASDAQ:IMMP) announced that its partner, GlaxoSmithKline, has discontinued its Phase 2 clinical trial evaluating GSK2831781 in patients with active ulcerative colitis. The trial was stopped based on the assessment of clinical data as part of a planned interim analysis. Shares closed Friday down 4% to $3.20.

Drug Stage Catalyst Market Cap

AMGN – Amgen Inc.
AMG 510 - sotorasib (CodeBreak 100)
Non-small cell lung cancer (NSCLC)

PDUFA priority review PDUFA date under priority review August 16, 2021.
$130.4 billion

DVAX – Dynavax Technologies Corporation
Medigen with CpG 1018
COVID-19 vaccine

Phase 1 Phase 2 initiated January 2021.
$951.9 million

GSK – GlaxoSmithKline PLC
VIR-7831 / GSK418213 (COMET-ICE)
COVID-19 antibody

Phase 3 Phase 3 data due 1Q 2021.
$85.8 billion

JNJ – Johnson & Johnson
JNJ-78436735 (Ad26.COV2-S) - (ENSEMBLE)
COVID-19 vaccine (single dose)

Approved Phase 3 data released January 29, 2021. Efficacy rate 66% in overall population, 72% effective in U.S. and 57% in South Africa. EUA Approval by FDA announced February 27, 2021.
$418 billion

NVAX – Novavax Inc.
COVID-19 vaccine

Phase 3 Phase 3 U.K. interim data released January 28, 2021. 89.3% efficacy rate (95.6% effective against original COVID-19 strain and 85.6% against UK variant strain). Phase 2b South African trial noted 60% effective in HIV-negative patients, 49.4% in overall population. Phase 3 U.S. trial data due early April 2021.
$13.9 billion

RYTM – Rhythm Pharmaceuticals Inc.
Setmelanotide (basket)
POMC Heterozygous Deficiency Obesity, Alstrom Syndrome, POMC Epigenetic Disorders

Phase 2 Phase 2 data released January 26, 2021. 12 of 35 patients (34.3 percent) achieved the primary endpoint. Further data due 1H 2021.
$1.3 billion

VXRT – Vaxart Inc.
COVID-19 Vaccine

Phase 2 Phase 2 trial to be initiated 2Q 2021.
$781.6 million

ZYME – Zymeworks Inc.
HER2-Expressing Cancers

Phase 1 Phase 1 update January 27, 2021. 2/6 partial responses in the high dose three week dosing cohorts.
$1.7 billion