BPC June 05 update

Biotech week in Review; Biotech catalysts to watch in June

Weekly watchlist

Our list of events to watch over the next three weeks remains largely unchanged following a relatively quiet week of clinical readouts and regulatory events. Noted price moving and other news events from the week that was are noted below:

The White House announced as part of its Warp Speed program, five COVID vaccines that it sees as most likely to succeed. The five companies that have been selected are Moderna (MRNA), Astrazeneca (AZN), Johnson & Johnson (JNJ), Merck & Co. (MRK) and Pfizer (PFE). Notable companies not on the list that have made headlines recently include Inovio Pharmaceuticals, Inc. (NASDAQ:INO), Novavax, Inc. (NASDAQ: NVAX) and Sanofi (NASDAQ: SNY). Bloomberg did report later, however, that the White House is having discussions with an additional two companies. The Warp Speed program is reportedly aiming to have ready 300 million doses by the end of this year.

Mereo BioPharma Group plc (NASDAQ: MREO) announced Thursday the completion of a $70m private placement with institutional and accredited investors. The fundraising was led by healthcare fund, Orbimed. Mereo also announced plans to advance etigilimab (Anti-TIGIT) into a Phase 1b trial in 4Q 2020. Shares of the micro-cap company closed the week up 121% to $2.81.

Iterum Therapeutics plc (NASDAQ:ITRM) shares slumped to close the week down 64% to $1.53 on news its Phase 3 trial of sulopenem did not achieve statistical non-inferiority relative to ertapenem in its trial in patients with complicated urinary tract infection (cUTI). Data from its trial in uncomplicated urinary tract infection (uUTI) are due later this month.

Ocugen, Inc. (NASDAQ: OCGN) shares closed the week down 19% to $0.25 following its announcement to discontinue the Phase 3 trial of OCU300 for ocular Graft vs. Host Disease (oGVHD) due to results of interim analysis which indicated the trial was unlikely to meet its co-primary endpoints.

Novus Therapeutics, Inc. (NASDAQ:NVUS) announced top-line data from its Phase 2a clinical trial of OP0201 in acute otitis media (study C-006) did not meet the primary endpoint. Shares slid to close the week down 58% to $0.53.

Biotech catalysts to watch in June:

Drug Stage Catalyst Market Cap

AKRO – Akero Therapeutics Inc.
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.
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

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

EPZM – Epizyme Inc.
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.
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.
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

SRPT – Sarepta Therapeutics Inc.
Limb-girdle Muscular Dystrophy Type 2E (LGMD2E)

Phase 1/2 Phase 1/2 18-month functional results from Cohort 1 presented September 28, 2020.
$7.6 billion

ZGNX – Zogenix Inc.
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