BPC June 19 update

Biotech stock events left slated for June; Biotech week in Review

Weekly watchlist

The final full week of the first half of 2020 lies ahead with several key biotech events still listed on the calendar, with COVID-19 treatment and early vaccine data readouts included. While most COVID events slated for June might not have large price moving effects due to the large market cap of the stocks concerned, promising data will no doubt give the general market a boost. First, let us review the week that was with notable events.

COVID-19:

Oxford University announced that a steroid called dexamethasone reduced death by 35% in hospitalised patients with severe respiratory complications of COVID-19 and by one fifth in other patients receiving oxygen only. There was no benefit among those patients who did not require respiratory support. Based on these results, 1 death would be prevented by treatment of around 8 ventilated patients or around 25 patients requiring oxygen alone. This makes it the first drug that has shown to significantly improve mortality in COVID patients.

FDA APPROVAL:

Evoke Pharma, Inc. (NASDAQ: EVOK) announced that the FDA approved Gimoti (metoclopramide) nasal spray for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Shares closed the after-hours session on Friday up 70% to $2.35.

Epizyme, Inc. (Nasdaq:EPZM) announced that the FDA approved Tazverik (tazemetostat) in patients with relapsed or refractory follicular lymphoma. Shares closed Thursday up 5% to $20.46.

Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) received approval for Crysvita (burosumab) for the treatment of fibroblast growth factor 23 (FGF23)-related hypophosphatemia in tumor-induced osteomalacia (TIO).

Nabriva Therapeutics plc (NASDAQ:NBRV) announced following the close of Friday’s after-hours session that the FDA issued a Complete Response Letter (CRL) for Conetpo for the treatment of complicated urinary tract infections (cUTI). The company cited manufacturing issues that could not be resolved due to the FDA's inability to conduct onsite inspections because of travel restrictions.

DATA:

Eli Lilly and Company (NYSE: LLY) announced that its Phase 3 trial of Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET), met the primary endpoint of invasive disease-free survival (IDFS), significantly decreasing the risk of breast cancer recurrence or death compared to standard adjuvant ET alone. Shares closed Tuesday up 16% to $163.71.

DEALS:

Alpine Immune Sciences, Inc. (NASDAQ: ALPN) announced a license agreement with AbbVie Inc. (NYSE: ABBV) for ALPN-101, a Phase 2-ready drug for systemic lupus erythematosus. Alpine will receive $60m in an upfront cash payment and is eligible to receive up to $805m in milestone payments. Shares closed Thursday up 125% to $10.95.

Ideaya Biosciences, Inc. (Nasdaq: IDYA) announced a partnership with GlaxoSmithKline plc (NYSE:GSK) for its Synthetic Lethality programs MAT2A, Pol Theta, and Werner Helicase programs. Ideaya will receive $100m upfront and a $20m equity purchase of its common stock. Shares closed the week up 86% to $14.70.

OTHER:

Biogen Inc. (NASDAQ:BIIB) shares closed down 8% to $260.30 on news that a U.S. District Court ruled in favor of Mylan, Inc. (NASDAQ:MYL) noting that Biogen’s ‘514 patent for its multiple sclerosis drug Tecfidera is invalid. Biogen's sales of Tecfidera in the U.S. for the 12 months ending April 30, 2020, were approximately $3.78b.

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

CHMA – Chiasma Inc.
Mycapssa - OPTIMAL
Acromegaly

Approved FDA approval announced June 26, 2020.
$230.1 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

LLY – Eli Lilly and Company
LY3127804
COVID-19

Phase 2 Phase 2 enrolling.
$192.5 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

XLRN – Acceleron Pharma Inc.
Sotatercept - STELLAR
Pulmonary arterial hypertension (PAH)

Phase 3 Phase 3 trial to be initiated by end of 2020.
$7.6 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