BPC March 26 update

​Bristol-Myers BMY receives FDA approval for ozanimod +6%; Intercept ICPT Advisory Committee meeting rescheduled to June

Price and Volume Movers

Bristol-Myers Squibb Company (NYSE: BMY) announced that the FDA approved Zeposia (ozanimod) for the treatment of adults with relapsing forms of multiple sclerosis (RMS). Shares closed up 6% to $52.25.

VBL Therapeutics (NASDAQ:VBLT) shares closed up 28% to $1.46. The company noted that interim analysis from its Phase 3 OVAL trial in patients with platinum-resistant ovarian cancer exhibited an overall CA-125 response rate in the first 60 randomized evaluable patients of 53%. An independent Data Safety Monitoring Committee (DSMC) has recommended the trial continue without modification.

Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) announced that amid the evolving COVID-19 pandemic, the FDA has rescheduled the previously announced Advisory Committee Meeting for their New Drug Application (NDA) for obeticholic acid (OCA) in liver fibrosis due to nonalcoholic steatohepatitis (NASH). The previous date of April 22, 2020 has now been moved to June 9, 2020. The PDUFA date remains at June 26, 2020.

Several other companies came out today with notifications of delays in their clinical trials. See the pipeline updates below for the major delays. One notable extension was bluebird bio, Inc. (NASDAQ:BLUE). The company noted that its planned completion of the submission of its Biologics License Application (BLA) for LentiGlobin for the treatment of β-Thalassemia has been delayed from the second half of 2020 to mid-2021.

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Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

AVEO Pharmaceuticals, Inc. (AVEO): $4.30; +41%.

PLx Pharma Inc. (PLXP): $2.70; +36%.

Bicycle Therapeutics plc (BCYC): $14.55; +27%.

EyeGate Pharmaceuticals, Inc. (EYEG): $4.50; +25%.

Clovis Oncology, Inc. (CLVS): $5.40; +22%.

DECLINERS:

Capricor Therapeutics, Inc. (CAPR): $1.42; -30%.

Pulmatrix, Inc. (PULM): $1.07; -12%.

Aprea Therapeutics, Inc. (APRE): $31.86; -12%.

IGM Biosciences, Inc. (IGMS): $43.00; -9%.

Millendo Therapeutics, Inc. (MLND): $5.40; -9%.

COVID-19 pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

BLUE – bluebird bio Inc.
LentiGlobin
β-Thalassemia

BLA Filing BLA filing to be completed mid-2021.
$3.5 billion

DRNA – Dicerna Pharmaceuticals Inc.
DCR-PHXC - PHYOX2
Primary hyperoxaluria (PH)

Phase 2/3 Phase 2/3 enrolment originally to be completed 2Q 2020 has been delayed due to COVID-19. Updated timeline due at a later date.
$1.6 billion

DRNA – Dicerna Pharmaceuticals Inc.
DCR-A1AT
Alpha-1 antitrypsin (A1AT) deficiency-associated liver disease

Phase 1/2 Phase 1/2 pause in enrolment at higher doses is likely due to COVID-19.
$1.6 billion

ENTA – Enanta Pharmaceuticals Inc.
EDP-305 ARGON-2
Non-alcoholic steatohepatitis (NASH)

Phase 2 Phase 2b trial initiation has been delayed due to COVID-19 - March 26, 2020.
$1 billion

ENTA – Enanta Pharmaceuticals Inc.
EDP-514
Hepatitis B virus (HBV)

Phase 1b Phase 1b trial to be initiated 2Q 2020.
$1 billion

EQ – Equillium Inc.
EQ001 - itolizumab
Asthma

Phase 1b Phase 1b enrolment has been paused due to COVID-19 - March 26, 2020.
$61 million

FREQ – Frequency Therapeutics Inc.
FX-322
Hearing loss

Phase 2a Phase 2a trial delayed due to COVID-19.
$575.6 million

ICPT – Intercept Pharmaceuticals Inc.
Ocaliva (Obeticholic acid (OCA)) - REGENERATE
Adult nonalcoholic steatohepatitis (NASH) patients.

PDUFA priority review Advisory Committee meeting set for June 9, 2020 has been postponed. New date TBA. PDUFA date June 26, 2020 will also be extended. Date TBC.
$2.4 billion

IRWD – Ironwood Pharmaceuticals Inc.
IW-3718
Gastroesophageal reflux disease (GERD)

Phase 3 Phase 3 data no longer due 2H 2020. Assessing COVID-19 situation and plans to provide an update on timing when it has more clarity.
$1.6 billion

MYOK – MyoKardia Inc.
Danicamtiv (MYK-491)
Dilated cardiomyopathy (DCM)

Phase 2a Phase 2 trial initiation has been delayed due to COVID-19.
$4.8 billion

MYOK – MyoKardia Inc.
MYK-224
Hypertrophic cardiomyopathy (HCM)

Phase 1 Phase 1 enrolment has been suspended due to COVID-19.
$4.8 billion

RVNC – Revance Therapeutics Inc.
DAXI (RT002)
Upper limb spasticity

Phase 2 Phase 2 enrolment has been paused due to COVID-19.
$1.2 billion

RVNC – Revance Therapeutics Inc.
DAXI (RT002)
Full Upper Face

Phase 2 Phase 2 data due 4Q 2020. Timeline update due later depending on COVID-19.
$1.2 billion

TBIO – Translate Bio Inc.
MRT5005
Cystic fibrosis

Phase 1/2 Phase 1/2 MAD data due initially 3Q 2020. Timeline might be delayed due to COVID-19. Update due at later date.
$1.3 billion

TRVN – Trevena Inc.
TRV250
Acute migraine

Phase 1 Phase 1 enrolment has been paused due to COVID-19 - noted March 26. 2020.
$139.3 million