BPC November 08 update

AnaptysBio ANAB shares plummet 72% on dermatitis data; FibroGen FGEN +10% on MACE data

Price and Volume Movers

Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) announced the FDA approved REBLOZYL (luspatercept) for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. The approval was issued before the official PDUFA date of December 4, 2019.

AnaptysBio, Inc. (Nasdaq: ANAB) announced that its Phase 2b ATLAS trial of etokimab in moderate-to-severe atopic dermatitis failed to meet the primary endpoint of the trial. Shares slumped to close down 72% to $10.18.

Dermira, Inc. (NASDAQ: DERM) shares rallied to close up 18% to $8.23 in reaction to the news released by AnaptysBio. Its lead pipeline candidate, lebrikizumab, is currently in a Phase 3 trial for atopic dermatitis, with data due 1H 2021.

Clovis Oncology, Inc. (NASDAQ: CLVS) shares closed up a further 36% to $5.88, adding to Thursday’s gain of 21%. Shares rallied in response to its third-quarter earnings report where it noted net product revenue for the first nine months of 2019 was $103.7m compared to $65m for same period in 2018.

Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) shares closed up 14% to $23.62 following its presentation of data from Cohort 2 of the ongoing Phase 2 lifileucel metastatic melanoma study (C-144-01) at the Society for Immunotherapy of Cancer (SITC) meeting. The company noted an objective response rate (ORR) of 35%.

FibroGen, Inc. (NASDAQ:FGEN) shares rallied to close up 10% to $41.62 following the release of pooled analyses of data from six global pivotal Phase 3 trials investigating roxadustat, as a treatment for anemia in chronic kidney disease (CKD). In the Non-Dialysis Dependent (NDD) patient population risks of MACE (Major Adverse Cardiovascular Event), MACE+, in roxadustat patients were comparable to placebo and comparable or in some cases better than that of epoetin alfa in patients on dialysis.

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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:

RAPT Therapeutics, Inc. (RAPT): $28.10; +26%.

Viela Bio, Inc. (VIE): $33.00; +22%.

Adamas Pharmaceuticals, Inc. (ADMS): $5.63; +20%.

Puma Biotechnology, Inc. (PBYI): $8.88; +18%.

Aclaris Therapeutics, Inc. (ACRS): $1.95; +15%.

DECLINERS:

Therapix Biosciences Ltd. (TRPX): $1.76; -28%.

SELLAS Life Sciences Group, Inc. (SLS): $5.75; -15%.

Ocugen, Inc. (OCGN): $1.00; -14%.

EyePoint Pharmaceuticals, Inc. (EYPT): $1.45; -13%.

Capricor Therapeutics, Inc. (CAPR): $2.20; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ABBV – AbbVie Inc.
IMBRUVICA (ibrutinib) and rituximab
Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

sNDA Filing sNDA filing announced November 8, 2019.
$127.9 billion

ANAB – AnaptysBio Inc.
ANB020 - etokimab
Moderate-to-severe adult atopic dermatitis

Phase 2b Phase 2b data failed to meet primary endpoint - November 8, 2019.
$322.3 million

AXGT – Axovant Gene Therapies Ltd.
AXO-Lenti-PD - SUNRISE-PD
Parkinson's disease

Phase 1/2 Phase 1/2 three-month data due 1H 2020.
$106.2 million

CTXR – Citius Pharmaceuticals Inc.
CITI-002
Hemorrhoids

Phase 2a Phase 2b trial planned for 2020.
$12.4 million

FGEN – FibroGen Inc
Roxadustat
Anaemia in Chronic Kidney Disease

NDA Filing NDA filing due 4Q 2019.
$3.3 billion

IMV – IMV Inc.
DPX-Survivac and epacadostat (DeCidE1)
Ovarian cancer

Phase 1/2 Phase 2 top-line data due 1Q 2020.
$119.2 million

INMB – INmune Bio Inc.
XPro1595
Alzheimer’s disease

Phase 1/2 Phase 1 trial to commence 4Q 2019 with data due 2H 2020.
$43.1 million

IOVA – Iovance Biotherapeutics Inc.
LN-144 - lifileucel
Refractory metastatic melanoma

Phase 2 Phase 2 pivotal cohort enrolment to be completed 1Q 2020. Cohort 2 data noted 41% ORR in patients refractory to anti-PD1/L1 - November 21, 2019.
$2.8 billion

NEOS – Neos Therapeutics Inc.
NT0502
Sialorrhea

Phase 1 Phase 1 trial to commence 1Q 2020.
$76.1 million

OVID – Ovid Therapeutics Inc.
OV101 - NEPTUNE
Adolescents with Angelman syndrome

Phase 3 Phase 3 data due mid-2020.
$107.1 million

PFE – Pfizer Inc.
Avelumab - JAVELIN Gastric 100
Gastric cancer

Phase 3 Phase 3 endpoint not met - November 8, 2019.
$208.9 billion

SEEL – Seelos Therapeutics Inc.
SLS-002
Post-traumatic stress disorder (PTSD)

Phase 1 Phase 1 initial data due 1Q 2020.
$23.1 million

SELB – Selecta Biosciences Inc.
SEL-212 (COMPARE) - Head to head trial vs Krystexxa
Tophaceous gout

Phase 2 Phase 2 interim data due 1Q 2020 and full data mid-2020.
$65.5 million

TNXP – Tonix Pharmaceuticals Holding Corp.
Tonmya
Post-traumatic stress disorder (PTSD)

Phase 3 Phase 3 interim analysis 1Q 2020 with top-line data due 2Q 2020.
$2 million

XLRN – Acceleron Pharma Inc.
Luspatercept
Beta-thalassemia

Approved FDA Approval announced November 8, 2019.
$2.3 billion