BPC June 11 update

June biotech event list updated; Biotech week in Review

Weekly watchlist

As we approach the midway point of 2020, we continue to update our selection of events slated to occur before the end of June. Each week we highlight 14-15 events of note, selected due to public interest (namely COVID-19) and/or potential price moving impact.

First, let’s review the week that was with latest key COVID-19 and other notable news.

COVID-19:

Johnson & Johnson (NYSE: JNJ) announced that it has accelerated the initiation of the Phase 1/2a clinical trial of its SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Initially scheduled to begin in September, the trial is now expected to commence in the second half of July. The company noted that it is committing to producing more than one billion doses globally through the course of 2021, provided the vaccine is safe and effective.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the initiation of the first clinical trial of REGN-COV2, its dual antibody cocktail for the prevention and treatment of COVID-19. The REGN-COV2 clinical program will consist of four separate study populations: hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected people in groups that are at high-risk of exposure (such as healthcare workers or first responders) and uninfected people with close exposure to a COVID-19 patient.

Moderna, Inc., (Nasdaq: MRNA) announced that it intends to initiate a Phase 3 trial of mRNA-1273, its vaccine candidate against COVID-19, in July. The primary efficacy analysis will be event-driven based on the number of participants with symptomatic COVID-19 disease. Assuming both efficacy and safety of the vaccine, the company remains on track to be able to deliver approximately 500m to 1b doses in 2021.

OTHER NEWS:

Reata Pharmaceuticals, Inc. (NASDAQ:RETA) shares closed Thursday up 28% to $167.68 on news that Blackstone Life Sciences will invest $300m in return for royalty payments on worldwide net sales of bardoxolone, currently being studied for chronic kidney disease in Alport syndrome and autosomal dominant polycystic kidney disease. An additional $50m will also be invested in 340,793 shares of Reata's common stock at $146.72 per share.

Viela Bio, Inc. (NASDAQ:VIE) announced Thursday that the FDA issued approval for Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients.

Soleno Therapeutics, Inc. (NASDAQ:SLNO) shares closed the week down 42% to $1.89 following news Monday that its Phase 3 trial evaluating once-daily Diazoxide Choline Controlled Release (DCCR) tablets for patients with Prader-Willi Syndrome (PWS) did not meet its primary endpoint.


Selection of June biotech stock events to watch:

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

CHMA – Chiasma Inc.
Mycapssa - OPTIMAL
Acromegaly

Approved FDA approval announced June 26, 2020.
$230.1 million

EPZM – Epizyme Inc.
Tazemetostat
Follicular lymphoma

Approved FDA approval announced June 18, 2020.
$1.2 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

KPTI – Karyopharm Therapeutics Inc.
Selinexor
Diffuse Large B-Cell Lymphoma (DLBCL)

Approved FDA Approval announced June 22, 2020.
$1.1 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

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

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