BPC June 27 update

​Zogenix ZGNX shares higher following NDA resubmission plans; DOVA receives FDA Approval +27%

Price and Volume Movers

Zogenix, Inc. (NASDAQ: ZGNX) shares closed up 21% on news that it intends to resubmit its New Drug Application (NDA) for Fintepla (ZX008, fenfluramine) for the treatment of seizures associated with Dravet syndrome in 3Q 2019. The company was previously issued a Refusal to file Letter (RTF) in April, 2019.

Dova Pharmaceuticals, Inc. (NASDAQ: DOVA) shares closed up 27% to $13.46 following its announcement the FDA approved a supplemental New Drug Application (sNDA) that expands the use of Doptelet (avatrombopag) to include the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Novavax, Inc. (NASDAQ: NVAX) shares closed up 11% to $6.16. The company announced that it intends to initiate a Phase 3 trial for its NanoFlu vaccine during the fall of this year with data due during 1Q 2020. Novavax noted that it intends to use the accelerated approval pathway for licensure, which will allow it to conduct a non-inferiority immunogenicity clinical trial against a licensed quadrivalent comparator, with a commitment to confirm efficacy post-licensure.

AstraZeneca (NYSE: AZN) announced that its Phase 3 trial CASPIAN trial with Imfinzi in 1st-line extensive-stage small cell lung cancer (SCLC), met its overall survival primary endpoint following interim analysis conducted by an Independent Data Monitoring Committee.

Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced that the FDA approved Soliris (eculizumab) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

Aclaris Therapeutics, Inc. (NASDAQ: ACRS) shares closed down 52% to $2.13 following news released after hours Wednesday that its Phase 2 clinical trial of ATI-502 (AA-201 Topical), in patients with alopecia areata (AA), did not meet its primary and secondary endpoints.

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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:

Atossa Genetics Inc. (ATOS): $2.58; +16%.

TG Therapeutics, Inc. (TGTX): $7.98; +14%.

Axsome Therapeutics, Inc. (AXSM): $25.39; +13%.

Palatin Technologies, Inc. (PTN): $1.11; +11%.

Evofem Biosciences, Inc. (EVFM): $6.60; +11%.

DECLINERS:

Oasmia Pharmaceutical AB (OASM): $1.34; -14%.

Spero Therapeutics, Inc. (SPRO): $11.11; -13%.

Acer Therapeutics Inc. (ACER): $3.45; -10%.

Acasti Pharma Inc. (ACST): $1.09; -9%.

Onconova Therapeutics, Inc. (ONTX): $2.97; -9%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ADXS – Advaxis Inc.
Axalimogene filolisbac - AIM2CERV Trial
High-risk, locally advanced cervical cancer

Phase 3 Phase 3 trial closed - noted June 27, 2019.
$11.7 million

ALXN – Alexion Pharmaceuticals Inc.
Eculizumab
Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)

Approved FDA Approval announced June 27, 2019.
$27.7 billion

APLS – Apellis Pharmaceuticals Inc.
APL-2 subcutaneous PEGASUS
Paroxysmal Nocturnal Hemoglobinuria (PNH)

Phase 3 Phase 3 data due December 2019.
$1.7 billion

ASMB – Assembly Biosciences Inc.
ABI-M201
Ulcerative Colitis

Phase 1b Phase 1b initiation of dosing announced June 27, 2019.
$342 million

ATOS – Atossa Genetics Inc.
Endoxifen
Mammographic breast density (MBD)

Phase 2 Phase 2 data met primary endpoint - June 27, 2019. High dropout rate noted.
$19.3 million

AZN – Astrazeneca PLC
Imfinzi + tremelimumab (CASPIAN)
Small cell lung cancer (SCLC)

Phase 3 Phase 3 interim analysis noted primary endpoint met - June 27, 2019.
$105.4 billion

BCRX – BioCryst Pharmaceuticals Inc.
BCX9930
Healthy subjects

Phase 1 Phase 1 commencement of enrolment announced June 27, 2019 with data due 4Q 2019.
$396.6 million

CHMA – Chiasma Inc.
Mycapssa - OPTIMAL
Acromegaly

Phase 3 Phase 3 data due mid-3Q 2019.
$198.7 million

DOVA – Dova Pharmaceuticals Inc.
Avatrombopag
Immune Thrombocytopenic Purpura (ITP)

Approved FDA Approval announced June 27, 2019.
$455.7 million

DRRX – DURECT Corporation
POSIMIR
Post-operative pain relief

NDA Filing CRL Feb 12 2014. NDA resubmission announced June 27, 2019.
$110.7 million

EVOK – Evoke Pharma Inc.
Gimoti - EVK-001
Female diabetic gastroparesis

NDA Filing CRL issued April 2, 2019. Meeting with FDA regarding NDA resubmission potentially to be held around July 26, 2019.
$24.4 million

IMGN – ImmunoGen Inc.
Mirvetuximab soravtansine
Cancer - ovarian cancer and relapsed endometrial cancer

Phase 3 Phase 3 top-line data released March 1, 2019 did not meet primary endpoint. Further Phase 3 trial to be initiated later in 2019 with data due 1H 2022.
$360.4 million

VTVT – vTv Therapeutics Inc.
Azeliragon
Mild Alzheimer’s disease with type 2 diabetes

Phase 2/3 Phase 2/3 initiation announced June 27, 2019 with top-line data due 4Q 2020.
$84.4 million

ZIOP – ZIOPHARM Oncology Inc
Ad-RTS-hIL-12 plus veledimex plus Libtayo
Refractory glioblastoma multiforme (GBM)

Phase 2 Phase 2 initiation announced June 27, 2019.
$920.8 million