BPC July 30 update

Sangamo SGMO license deal with Novartis NVS +15%; Lexicon LXRX sells rights to Xermelo +15%

Price and Volume Movers

Sangamo Therapeutics, Inc. (NASDAQ:SGMO) shares closed up 15% to $11.34 on the back of a licensing agreement with Novartis to develop gene regulation therapies for autism spectrum disorder (ASD) and other neurodevelopmental disorders. Under the collaboration agreement, Novartis will pay Sangamo $75m upfront. Sangamo is also eligible to earn up to $720m in milestone payments.

Roche Group (OTCQX: RHHBY) announced that the FDA approved Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients.

Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) announced that TerSera Therapeutics has purchased rights to Xermelo (telotristat ethyl), approved for the treatment of carcinoid syndrome diarrhea. Lexicon will receive $159m in cash at closing. Shares closed up 15% to $2.00.

Edesa Biotech, Inc. (NASDAQ:EDSA) shares closed up 82% to $9.45 following news it has filed an investigational new drug (IND) application with the FDA for the initiation of a Phase 2/3 trial of EB05, for the treatment of hospitalized COVID-19 patients.

Genocea Biosciences (NASDAQ:GNCA) released of preliminary data from its Phase 1/2a trial evaluating its neoantigen vaccine GEN-009, combined with immune checkpoint inhibitor-based regimens in patients with solid tumors. Three of five patients achieved separate RECIST responses after GEN-009 administration. Shares fell 31% to $3.45, essentially placing it back where it started the week ($3.60).

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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:

ADMA Biologics, Inc. (ADMA): $3.74; +32%.

Seelos Therapeutics, Inc. (SEEL): $1.25; +27%.

Cellectar Biosciences, Inc. (CLRB): $1.66; +21%.

Tiziana Life Sciences PLC (TLSA): $12.37; +19%.

Tonix Pharmaceuticals Holding Corp. (TNXP): $1.34; +18%.

DECLINERS:

Spectrum Pharmaceuticals, Inc. (SPPI): $3.10; -20%.

Capricor Therapeutics, Inc. (CAPR): $7.54; -19%.

Adamis Pharmaceuticals Corporation (ADMP): $1.23; -15%.

Oncternal Therapeutics, Inc. (ONCT): $2.87; -13%.

Salarius Pharmaceuticals, Inc. (SLRX): $1.12; -11%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AIMT – Aimmune Therapeutics Inc.
AR101 POSEIDON
Peanut Allergy

Phase 3 Phase 3 data due 2021.
$926.8 million

BPMC – Blueprint Medicines Corporation
Pralsetinib (BLU-667)
First-line RET-fusion non-small cell lung cancer (NSCLC)

PDUFA priority review PDUFA date under priority review November 23, 2020.
$4.2 billion

EBS – Emergent Biosolutions Inc.
CHIKV-VLP
Chikungunya virus

Phase 2 Phase 3 trial to be initiated in 2021.
$6.8 billion

ETON – Eton Pharmaceuticals Inc.
ET-104
Neurological indication

NDA Filing NDA filing announced July 30, 2020.
$132.3 million

EXEL – Exelixis Inc.
IMspire150 - cobimetinib, atezolizumab and vemurafenib
BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma

Approved FDA approval announced July 30, 2020.
$6.7 billion

GLPG – Galapagos NV
ISABELA - GLPG1690
Idiopathic pulmonary fibrosis

Phase 3 Phase 3 futility analysis due 1H 2021.
$12.4 billion

INFI – Infinity Pharmaceuticals Inc.
IPI-549 + Tecentriq and Abraxane and IPI-549 + Tecentriq and Avastin (MARIO-3)
Front-line triple negative breast cancer (TNBC); Renal cell cancer (RCC)

Phase 2 Phase 2 enrollment completion is expected in the RCC cohort by the end of 2020 and the TNBC cohort by the end of 1Q 2021.
$69.2 million

LLY – Eli Lilly and Company
LY-CoV555 (BLAZE-1/2)
COVID-19 Antibody

Phase 2/3 Phase 2 enrollment to be completed in September with initial data due soon thereafter and full data due 4Q 2020. Phase 3 trial initiation announced August 3, 2020.
$145.6 billion

MGNX – MacroGenics Inc.
MGD019
Solid tumors

Phase 1 Phase 1 data to be presented at ESMO September 19-21, 2020.
$1.4 billion

NTRP – Neurotrope Inc.
Bryostatin-1
Alzheimer's disease

Phase 2 Phase 2 dosing to commence late-3Q or early-4Q 2020.
$27.2 million

OPK – Opko Health Inc.
Somatrogon (hGH-CTP)
Children - growth hormone deficiency

BLA Filing BLA filing due fall of 2020.
$3.2 billion

QURE – uniQure N.V.
AMT-061 (HOPE-B)
Hemophilia B

Phase 3 Phase 3 26-week data due by the end of 2020.
$1.8 billion

RTRX – Retrophin Inc.
Sparsentan
IgA nephropathy

Phase 3 Phase 3 data due 2H 2021.
$931.6 million

VRTX – Vertex Pharmaceuticals Incorporated
Elexacaftor, tezacaftor and ivacaftor
Children ages 6 to 11 years who have two F508del mutations and one F508del mutation and one minimal function mutation

Phase 3 Phase 3 data and sNDA filing due 2H 2020.
$70.2 billion