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).

Approved FDA Approval announced April 21, 2020.
$159 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.
$439 million

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

Phase 1/2 Phase 1/2 6-month data from second dose cohort due 4Q 2020
$171.6 million

CTXR – Citius Pharmaceuticals Inc.
CITI-002
Hemorrhoids

Phase 2a Phase 2b trial planned for 2H 2020.
$57.7 million

FGEN – FibroGen Inc
Roxadustat
Anaemia in Chronic Kidney Disease

PDUFA PDUFA date December 20, 2020.
$4 billion

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

Phase 2 Phase 2 updated data at ASCO May 29, 2020. 5/19 patients (26%) achieved a PR with tumor regression.
$330.4 million

INMB – INmune Bio Inc.
XPro1595
Alzheimer’s disease

Phase 1b Phase 1b interim data released July 13, 2020. Additional data due 2H 2020.
$152.9 million

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

BLA Filing BLA filing due late-2020.
$5.3 billion

NEOS – Neos Therapeutics Inc.
NT0502
Sialorrhea

Phase 1 Phase 1 ascending dose trial initiation planned in 2H 2020.
$33 million

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

Phase 3 Phase 3 data due 4Q 2020.
$423.7 million

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

Phase 3 Phase 3 endpoint not met - November 8, 2019.
$203.5 billion

SEEL – Seelos Therapeutics Inc.
SLS-002-101
Healthy volunteers

Phase 1 Phase 1 DDI initial data released January 10, 2020 - generally safe and well-tolerated.
$36 million

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

Phase 2 Phase 2 top-line data due 3Q 2020.
$278.6 million

TNXP – Tonix Pharmaceuticals Holding Corp.
Tonmya (TNX-102 SL)
Post-traumatic stress disorder (PTSD)

Phase 3 Phase 3 enrolment to be stopped due to futility - February 5, 2020. Top-line data has been delayed - June 19, 2020. No updated timeline.
$120.8 million

XLRN – Acceleron Pharma Inc.
Luspatercept
Beta-thalassemia

Approved FDA Approval announced November 8, 2019.
$6.4 billion