BPC April 09 update

Key biotech stock clinical data readouts slated for release this quarter; Biotech week in Review

Weekly watchlist

In last week’s update we noted key biotech stock catalysts slated for April. Included in the list was a Phase 3 readout of Remdesivir, in patients with COVID-19. Gilead CEO Daniel O'Day released an open letter Friday with an update on ongoing trials. In the letter, he noted preliminary data from a Phase 3 trial of remdesivir in severe patients are due at the end of April. In May, initial data will be released from a placebo-controlled NIAID trial as well as data from a Gilead trial in patients with moderate symptoms. The Phase 3 trial in China was stopped due to stalled enrollment.

This week we look ahead at other key Phase 2 and 3 readouts slated for the quarter. First, let’s review the week that was with price-moving events.

Immunomedics, Inc. (NASDAQ: IMMU) announced its Phase 3 ASCENT trial of Sacituzumab govitecan for the treatment of metastatic triple-negative breast cancer, will be halted due to compelling evidence of efficacy. Shares closed the week up 109% to $19.64.

Millendo Therapeutics, Inc. (Nasdaq: MLND) shares closed the week down 71% to $1.42 following its announcement its pivotal Phase 2b ZEPHYR trial of livoletide as a potential treatment for Prader-Willi syndrome (PWS), did not meet the primary endpoint.

Menlo Therapeutics Inc. (Nasdaq: MNLO) announced top line data from two Phase 3 clinical trials evaluating oral serlopitant for the treatment of pruritus associated with prurigo nodularis, did not meet the primary endpoint of demonstrating statistically significant reduction in pruritus in patients treated with serlopitant compared to placebo. Shares closed the week down 54% to $1.20.

In COVID-19 news, INOVIO Pharmaceuticals, Inc. (NASDAQ:INO) became the third company to initiate human trials for a potential vaccine for COVID-19. Initial immune responses and safety data from the Phase 1 trial of INO-4800 are due by late summer this year. The other two companies to have initiated trials are Moderna and CanSino Biologics.

BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) shares closed the after-hours session Friday up 40% to $2.90 following news it has opened enrollment into a Phase 1 randomized, double-blind, placebo-controlled clinical trial to assess the safety, clinical impact and antiviral effects of galidesivir in patients with COVID-19.

Key biotech stock clinical data readouts slated for release this quarter (see last week’s update for April specific readouts).

Drug Stage Catalyst Market Cap

AKBA – Akebia Therapeutics Inc.
Vadadustat - INNO2VATE
Anemia related to chronic kidney disease who are undergoing dialysis (DD-CKD)

Phase 3 Phase 3 data met primary endpoints - May 5, 2020.
$1.7 billion

AVEO – AVEO Pharmaceuticals Inc.
TIVO-3 - tivozanib
Third line treatment of patients with renal cell cancer

Phase 3 NDA filing announced March 31, 2020. Overall survival data noted a hazard ratio of 0.97 - May 29, 2020.
$131.2 million

BIIB – Biogen Inc.
Alzheimer’s disease

BLA Filing BLA filing to be completed 3Q 2020.
$50.1 billion

CCXI – ChemoCentryx Inc.
Focal Segmental Glomerulosclerosis

Phase 2 Phase 2 trial did not meet primary endpoint - May 18, 2020.
$3.9 billion

CNST – Constellation Pharmaceuticals Inc.
CPI-0610 and ruxolitinib - Manifest (EHA)

Phase 2 Phase 2 update due at EHA June 12, 2020.
$1.5 billion

GILD – Gilead Sciences Inc.
Remdesivir (NIAID)
COVID-19 Coronavirus

Phase 3 Phase 3 data met primary endpoint - April 29, 2020 (placebo trial).
$97.6 billion

GLPG – Galapagos NV
Filgotinib - SELECTION
Ulcerative colitis

Phase 2/3 Phase 2b/3 data released May 20, 2020. 200mg dose met primary endpoint. 100mg did not meet clinical remission endpoint.
$13.1 billion

GOSS – Gossamer Bio Inc.
Eosinophilic asthma

Phase 2b Phase 2b top-line data 2H 2020.
$920.9 million

KDMN – Kadmon Holdings Inc.
KD025 - ROCKstar (KD025-213)
Chronic graft-versus-host disease (cGVHD)

NDA Filing Phase 2 top-line data noted statistically significant Overall Response Rates (ORRs) of 73% with 200 mg once daily. NDA filing 4Q 2020.
$710.5 million

MRNA – Moderna Inc.
Coronavirus COVID-19 vaccine

Phase 2a Phase 2a dosing has commenced - noted May 29, 2020. Phase 3 trial to start July 2020.
$22.8 billion

MYOK – MyoKardia Inc.
Mavacamten (MYK-461) - EXPLORER-HCM
Hypertrophic cardiomyopathy (HCM)

Phase 3 Phase 3 data met endpoints - May 11, 2020.
$4.8 billion

NERV – Minerva Neurosciences Inc
Roluperidone (MIN-101)

Phase 3 Phase 3 data did not meet primary endpoint - May 29, 2020.
$145.5 million

SNDX – Syndax Pharmaceuticals Inc.
HR+, HER2- breast cancer

Phase 3 Phase 3 did not meet overall survival primary endpoint - May 21, 2020.
$584.7 million

TGTX – TG Therapeutics Inc.
TG-1101 and TGR-1202 - UNITY-CLL study
Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin's Lymphoma (NHL)

Phase 3 Phase 3 PFS primary endpoint met. Trial to be stopped due to superior efficacy - May 5, 2020.
$2.1 billion