BPC July 02 update

Amarin AMRN raises guidance +16%; Unum UMRX early stage trial placed on clinical hold -23%

Price and Volume Movers

Dova Pharmaceuticals, Inc. (NASDAQ: DOVA) shares closed up 13% to $16.21 following an analyst upgrade by Evercore ISI to an outperform rating.

Amarin Corporation plc (NASDAQ:AMRN) shares rallied to close up 16% to $22.37 on news that it is increasing revenue guidance for 2019 and planning to further increase its commercial expansion efforts for Vascepa by doubling the size of its current sales force. Guidance increased from $350m to $380m-$420m.

Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) announced that following discussions with the FDA, its Phase 2 trial of LN-145 in advanced cervical cancer may be sufficient to support a Biologics License Application (BLA), set to be submitted in 2H 2020.

Unum Therapeutics Inc. (NASDAQ: UMRX) shares are trading down 23% to $1.69 after hours on news the FDA has placed a clinical hold on its Phase 1 trial (ATTCK-20-2) evaluating ACTR087 in combination with rituximab patients with relapsed/refractory CD20+ B cell non-Hodgkin lymphoma. The clinical hold was initiated on news one patient experienced serious adverse events that included Grade 3 neurotoxicity and cytomegalovirus (CMV) infection, and Grade 4 respiratory distress.

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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:

Oasmia Pharmaceutical AB (OASM): $1.46; +30%.

Corvus Pharmaceuticals, Inc. (CRVS): $5.02; +21%.

Karyopharm Therapeutics Inc. (KPTI): $6.54; +16%.

Immunic, Inc. (IMUX): $12.59; +12%.

Acasti Pharma Inc. (ACST): $1.27; +9%.

DECLINERS:

Xenetic Biosciences, Inc. (XBIO): $9.02; -18%.

Diffusion Pharmaceuticals Inc. (DFFN): $2.36; -16%.

Atreca, Inc. (BCEL): $14.93; -14%.

Evelo Biosciences, Inc. (EVLO): $7.69; -13%.

Evofem Biosciences, Inc. (EVFM): $4.95; -12%.

Pipeline updates:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AKRO – Akero Therapeutics Inc.
AKR-001
Nonalcoholic steatohepatitis (NASH)

Phase 2a Phase 2a data due 1Q 2020.
$583.4 million

CALA – Calithera Biosciences Inc.
Telaglenastat (CB-839) + palbociclib
KRAS-mutated colorectal cancer (CRC) and KRAS-mutated non-small cell lung cancer (NSCLC)

Phase 1/2 Phase 1/2 initiation announced July 2, 2019.
$144.7 million

CYAD – Celyad SA
CYAD-01 and FOLFOX - SHRINK
Colorectal cancer

Phase 1 Phase 1 data to be presented at SITC November 8, 2019 7:00 am.
$131.9 million

DRNA – Dicerna Pharmaceuticals Inc.
DCR-A1AT
Alpha-1 antitrypsin (A1AT) deficiency-associated liver disease

Phase 1/2 Phase 1/2 trial to commence 3Q 2019.
$1.1 billion

ENTX – Entera Bio Ltd.
EB613
Osteoporosis

Phase 2 Phase 2 data due 2020.
$27.8 million

FCSC – Fibrocell Science Inc.
FCX-007 - DEFI-RDEB
Recessive dystrophic epidermolysis bullosa

Phase 3 Phase 3 data due 4Q 2020.
$28.9 million

IOVA – Iovance Biotherapeutics Inc.
LN-145
Cervical cancer

Phase 2 Phase 2 update due at ASCO June 1, 2019, 8am. Data released May 31, 2019 noted ORR 44%; CR 11%. BLA filing due 2H 2020.
$2.4 billion

KTOV – Kitov Pharma Ltd.
NT-219
Squamous cell carcinoma of the head & neck (SCCHN)

Phase 1 Phase 1/2 trial to be initiated 1Q 2020.
$14.6 million

LPTX – Leap Therapeutics Inc.
DKN-01 + KEYTRUDA
Esophagogastric adenocarcinoma

Phase 1/2 Phase 1/2 data August 6, 2019 noted 50% ORR.
$27.6 million

LPTX – Leap Therapeutics Inc.
DKN-01 and Paclitaxel
Endometrial Cancer

Phase 2 Phase 2 updated data September 20, 2019 at IGCS.
$27.6 million

PRQR – ProQR Therapeutics N.V.
QR-421a - STELLAR
Usher Syndrome Type 2

Phase 1/2 Phase 1/2 interim data due 1Q 2020.
$251 million

PSTI – Pluristem Therapeutics Inc.
PLX-PAD
Muscle injury following hip fracture

Phase 3 Phase 3 data due 2H 2020.
$56 million

RTTR – Ritter Pharmaceuticals Inc.
RP-G28
Lactose intolerance

Phase 3 Phase 3 data failed to meet primary endpoint - September 12, 2019.
$2.8 million

TCON – TRACON Pharmaceuticals Inc.
TRC253
Prostate cancer

Phase 1/2 Phase 2 data due 2H 2020.
$10.5 million

UMRX – Unum Therapeutics Inc.
ACTR087 + rituximab (ATTCK-20-2)
Non-Hodgkin Lymphoma (NHL)

Phase 1 Phase 1 trial placed on clinical hold - July 2, 2019. However, continues to plan to report data at the end of 2019.
$45.7 million