BPC July 10 update

​Amneal AMRX shares fall 36% on lower profit forecast; Offerings for Sunesis SNSS Eyenovia EYEN

Price and Volume Movers

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) shares closed down 36% to $4.36 following its announcement of a restructuring plan and news that it has cut its profit forecast from around $600m-$650m for 2019 to $425m-$475m. The company cited the uncertain supply of epinephrine auto-injector from its third-party supplier during the high seasonal third quarter, as well as delays in key product approvals and launches including generic NuvaRing.

Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) shares are trading down 29% to $0.60 after hours on news that it intends to offer and sell shares of its common stock and convertible preferred stock in underwritten public offerings.

Eyenovia, Inc. (NASDAQ: EYEN) also announced it intends to offer and sell shares of its common stock in an underwritten public offering. Shares closed down 14% and have fallen a further 8% after hours to $2.85.

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced that the FDA has accepted its New Drug Application (NDA) for opicapone, as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing OFF episodes. The PDUFA target action date is April 26, 2020.

Ohr Pharmaceutical, Inc. (NASDAQ: OHRP) shares closed up 15% to $4.25 following news its proposed merger with NeuBase Therapeutics, Inc. was approved by its stockholders, which will result in stockholders of NeuBase becoming majority holders of the combined company. Ohr and NeuBase expect the closing of the merger to occur during the week of July 15, 2019.

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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:

Intec Pharma Ltd. (NTEC): $4.17; +12%.

ContraVir Pharmaceuticals, Inc. (CTRV): $4.12; +10%.

Curis, Inc. (CRIS): $2.04; +10%.

Soleno Therapeutics, Inc. (SLNO): $2.96; +9%.

Can-Fite BioPharma Ltd. (CANF): $3.12; +7%.

DECLINERS:

Pfenex Inc. (PFNX): $6.14; -16%.

Karuna Therapeutics, Inc. (KRTX): $19.67; -16%.

Atreca, Inc. (BCEL): $16.44; -14%.

Oasmia Pharmaceutical (OASM): $2.26; -13%.

DiaMedica Therapeutics Inc. (DMAC): $4.01; -11%.

Pipeline updates:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

BHVN – Biohaven Pharmaceutical Holding Company Ltd.
Rimegepant
Acute treatment of migraine

NDA Filing NDA filing submitted 2Q 2019.
$2.3 billion

EQ – Equillium Inc.
EQ001
Asthma

Phase 1b Phase 1b trial initiation announced July 10, 2019 with top-line data due 2H 2020.
$95.4 million

GSK – GlaxoSmithKline PLC
Dolutegravir + lamivudine TANGO
HIV

Phase 3 Phase 3 data released July 10, 2019 met primary endpoint.
$103 billion

HZNP – Horizon Therapeutics Public Limited Company
Teprotumumab
Thyroid Eye Disease (TED)

BLA Filing BLA filing announced July 10, 2019.
$4.3 billion

LGND – Ligand Pharmaceuticals Incorporated
Captisol-enabled (CE) Iohexol program
Contrast-induced Nephropathy

Phase 1 Phase 1 top-line data met primary endpoint - July 10, 2019.
$2.3 billion

MRK – Merck & Company Inc. (new)
MK-8591
HIV

Phase 2 Phase 2b 48-week data to be presented July 24, 11:00-12:30 CDT at IAS 2019.
$208.8 billion

NBIX – Neurocrine Biosciences Inc.
Opicapone
Parkinson's disease

PDUFA PDUFA date April 26, 2020.
$8 billion

SNDX – Syndax Pharmaceuticals Inc.
SNDX-5613
Relapsed/refractory (R/R) acute leukemias

Phase 1/2 Phase 1/2 IND clearance announced July 10, 2019.
$245.8 million

SNY – Sanofi
Isatuximab
Refractory Multiple Myeloma

PDUFA PDUFA date April 30, 2020.
$104.4 billion