BPC June 07 update

​Biohaven BHVN spikes 20% on reports of conference withdrawal; Sesen SESN conference call Monday

Price and Volume Movers

Biohaven Pharmaceutical Holding Company Ltd. (NASDAQ: BHVN) shares spiked higher in afternoon trading on reports that the company has withdrawn from presenting at next week’s Goldman Sachs Global Healthcare conference. Traders inferred that the withdrawal might be as a result the company is soon to be acquired. The company has yet to make any comment. Shares closed up 20% to $67.01.

Biogen (Nasdaq: BIIB) announced that it has completed its acquisition of Nightstar Therapeutics (Nasdaq: NITE). Trading in Nightstar shares has been halted and the cancellation of listing is expected to become fully effective on 17 June 2019.

PTC Therapeutics, Inc. (NASDAQ: PTCT) announced that the FDA approved its supplemental New Drug Application (sNDA) for Emflaza (deflazacort) to expand its labeling to include patients with Duchenne muscular dystrophy who are between 2- and 5-years-old. Emflaza was first approved by the FDA in February 2017 for the treatment of Duchenne in patients 5-years and older.

Sesen Bio(Nasdaq: SESN) announced that it will host a conference call on Monday, June 10, 2019 at 8:00 a.m. ET to provide an update on its pre-BLA meeting with the FDA on June 6, 2019.

La Jolla Pharmaceutical Company (Nasdaq: LJPC) shares closed higher at $12.86, adding a further 26% to Thursday’s 92% gain. The company announced yesterday that it met the primary endpoint following interim analysis from its Phase 2 trial of LJPC-401 in patients with hereditary hemochromatosis (HH).

Genocea Biosciences (NASDAQ: GNCA) shares, which closed down 12%, are trading down a further 7% after hours to $4.94 after filing to offer up to $50m of common stock.

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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:

Avadel Pharmaceuticals plc (AVDL): $2.30; +20%.

CRISPR Therapeutics AG (CRSP): $42.88; +15%.

Celsion Corporation (CLSN): $1.87; +14%.

INSYS Therapeutics, Inc. (INSY): $1.31; +14%.

ContraVir Pharmaceuticals, Inc. (CTRV): $7.98; +13%.

DECLINERS:

Axovant Gene Therapies Ltd. (AXGT): $4.48; -21%.

Aeterna Zentaris Inc. (AEZS): $2.07; -16%.

Evolus, Inc. (EOLS): $14.49; -14%.

Unum Therapeutics Inc. (UMRX): $2.92; -12%.

Outlook Therapeutics, Inc. (OTLK): $1.90; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALBO – Albireo Pharma Inc.
Odevixibat (A4250)
Biliary atresia

Phase 3 Phase 3 trial planned for 2020.
$297.2 million

ALBO – Albireo Pharma Inc.
Odevixibat (A4250) - PEDFIC- 1
Progressive familial intrahepatic cholestasis (PFIC)

Phase 3 Phase 3 top-line data due mid-2020.
$297.2 million

ARQL – ArQule Inc.
ARQ 531
B-cell malignancies

Phase 1 Phase 1 data at EHA June 14, 2019 noted 66% (4/6) ORR in CLL patients.
$1.1 billion

AXSM – Axsome Therapeutics Inc.
AXS-05 STRIDE-1
Treatment resistant depression

Phase 3 Phase 3 data due 2H 2019.
$847.7 million

AXSM – Axsome Therapeutics Inc.
AXS-05 ADVANCE-1
Agitation in patients with Alzheimer’s disease (AD)

Phase 2/3 Phase 2/3 top-line data due 1H 2020.
$847.7 million

AXSM – Axsome Therapeutics Inc.
AXS-07 - MOMENTUM
Migraine

Phase 3 Phase 3 top-line data due 2H 2019.
$847.7 million

AXSM – Axsome Therapeutics Inc.
AXS-05 -GEMINI
Major Depressive Disorder

Phase 3 Phase 3 trial initiation announced June 24, 2019 with data due 2H 2019.
$847.7 million

AXSM – Axsome Therapeutics Inc.
AXS-12
Narcolepsy

Phase 2 Phase 2 top-line data due 2H 2019.
$847.7 million

DTIL – Precision BioSciences Inc.
PBCAR0191
Relapsed or refractory B-cell precursor acute lymphoblastic leukemia and R/R non-hodgkin lymphoma

Phase 1/2 Phase 1/2 interim data due 1Q 2020.
$474.4 million

PTCT – PTC Therapeutics Inc.
Emflaza
Duchenne muscular dystrophy (age 2-5)

Approved FDA Approval announced for label expansion June 7, 2019.
$2.7 billion

XOMA – XOMA Corporation
Vicinium
Non-muscle invasive bladder cancer (NMIBC)

BLA Filing BLA filing due 4Q 2019. Updated data August 8, 2019 noted pooled CR rates of 17%-40%.
$149.4 million