BPC July 29 update

​Bristol Myers BMY and bluebird bio BLUE resubmit ide-cel BLA filing; Onconova ONTX data due later this quarter

Price and Volume Movers

Bristol Myers Squibb (NYSE:BMY) and bluebird bio, Inc. (NASDAQ:BLUE) announced the resubmission of their Biologics License Application (BLA) to the FDA for idecabtagene vicleucel (ide-cel; bb2121), for the treatment of adult patients with relapsed and refractory multiple myeloma. This submission follows a Refusal-to-file letter received in May earlier this year.

Onconova Therapeutics, Inc. (NASDAQ: ONTX) shares closed up 13% to $1.28 following news the required number of survival events for the pivotal Phase 3 INSPIRE trial has been reached. The company anticipates announcing top-line data by the end of this quarter.

Roche Group (OTCQX:RHHBY) announced that its Phase 3 COVACTA trial of Actemra (tocilizumab) did not meet its primary endpoint of improved clinical status in hospitalized adult patients with severe COVID-19 associated pneumonia.

Salarius Pharmaceuticals, Inc. (NASDAQ:SLRX) announced after hours that it has commenced an underwritten public offering of shares of its common stock.

Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) also announced after hours that it intends to offer and sell shares of its common stock in an underwritten registered public offering.

Spring Bank Pharmaceuticals, Inc. (NASDAQ:SBPH) announced it will merge with privately-held F-star Therapeutics, Limited. Following closing, which is expected to occur in late 2020, Spring Bank will be re-named F-star Therapeutics, Inc. and will trade under the ticker symbol "FSTX".

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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:

Adamis Pharmaceuticals Corporation (ADMP): $1.45; +31%.

Qualigen Therapeutics, Inc. (QLGN): $6.42; +27%.

OncoSec Medical Incorporated (ONCS): $4.70; +23%.

Mallinckrodt plc (MNK): $2.38; +21%.

Adial Pharmaceuticals, Inc. (ADIL): $1.75; +18%.

DECLINERS:

Alector, Inc. (ALEC): $16.31; -24%.

Spring Bank Pharmaceuticals, Inc. (SBPH): $2.08; -19%.

Celldex Therapeutics, Inc. (CLDX): $9.65; -13%.

Soligenix, Inc. (SNGX): $2.28; -13%.

iBio, Inc. (IBIO): $4.36; -11%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

BLUE – bluebird bio Inc.
ide-cel bb2121 - KarMMa
Relapsed/refractory multiple myeloma

BLA Filing Refusal-to-file letter received May 13, 2020. BLA refiled July 29, 2020.
$4.1 billion

DNLI – Denali Therapeutics Inc.
DNL758 (SAR443122)
COVID-19

Phase 1b Phase 1b trial initiation announced July 29, 2020.
$3.2 billion

EARS – Auris Medical Holding Ltd.
AM-125
Vertigo

Phase 2 Phase 2 interim analysis due 3Q 2020.
$5.3 million

GSK – GlaxoSmithKline PLC
VIR-7831
COVID-19 antibody

Phase 2/3 Phase 2/3 trial to commence August 2020. Initial data due by end of 2020.
$105.8 billion

GSK – GlaxoSmithKline PLC
Adjuvanted COVID-19 vaccine
COVID-19 vaccine

Phase 1/2 Phase 1/2 trial to commence September 2020. Late-stage trial to commence late-2020.
$105.8 billion

GSK – GlaxoSmithKline PLC
Otilimab
COVID-19

Phase 2a Phase 2a data due 1H 2021.
$105.8 billion

ONTX – Onconova Therapeutics Inc.
IV Rigosertib - INSPIRE
2nd-line HR-MDS (high risk myelodysplastic syndromes)

Phase 3 Phase 3 data due by the end of 3Q 2020.
$182 million

REGN – Regeneron Pharmaceuticals Inc.
Dupixent (dupilumab)
Asthma - 6-11 year-olds

Phase 3 Phase 3 data due 2H 2020.
$65.3 billion

RHHBY – Roche Holding Ltd ADR (Sponsored)
Actemra (COVACTA)
Coronavirus COVID-19

Phase 3 Phase 3 trial did meet primary endpoint - July 29, 2020.
$296.5 billion

RPTX – Repare Therapeutics Inc.
RP-3500
Solid tumors

Phase 1/2 Phase 1/2 dosing of first patient announced July 29, 2020.
$854.4 million

UTHR – United Therapeutics Corporation
Tyvaso - INCREASE
Pulmonary hypertension associated with interstitial lung disease (PH-ILD) (WHO Group 3)

sNDA Filing sNDA filing has been submitted - noted July 29, 2020.
$4.9 billion

VKTX – Viking Therapeutics Inc.
VK2809 VOYAGE
Non-alcoholic steatohepatitis (NASH) and fibrosis

Phase 2b Phase 2b enrolment to be completed 1H 2021.
$548.6 million

VKTX – Viking Therapeutics Inc.
VK0214
X-linked adrenoleukodystrophy

Phase 1 Phase 1 trial to be initiated 3Q 2020.
$548.6 million

VKTX – Viking Therapeutics Inc.
VK2809
NAFLD

Phase 2 Phase 2 additional data due at EASL August 28, 2020.
$548.6 million