BPC January 30 update

​Eyenovia EYEN +25% on late-stage mydriasis data; AC Immune ACIU slides 66% on failed Alzheimer’s trial

Price and Volume Movers

Eyenovia, Inc. (NASDAQ: EYEN) shares closed up 25% to $3.29 following news it met the primary endpoint in its Phase 3 MIST-1 trial of MicroStat for the treatment of mydriasis (dilation of the pupil). The treatment showed a statistically superior mydriatic effect of MicroStat fixed combination of phenylephrine 2.5% and tropicamide 1% compared with either component formulation. 35 minutes post-administration, 94% of eyes in the MicroStat group demonstrated 6 mm or greater pupil dilation. This compared with 78% and 1.6% for the tropicamide-only and phenylephrine-only groups, respectively.

SCYNEXIS, Inc. (NASDAQ: SCYX) shares are trading up 93% to $1.39 after hours following the first interim efficacy analysis of its Phase 3 open-label trial evaluating oral ibrexafungerp as a salvage treatment in patients with difficult-to-treat mucocutaneous and invasive fungal infections. A Data Review Committee assessed the efficacy of ibrexafungerp in the first 20 treated patients and noted 11 out of 20 patients achieving a complete or partial response and six patients a stable disease response. 

AC Immune SA (NASDAQ:ACIU) announced today that Roche (RHHBY), the parent company of its collaboration partner, is discontinuing the CREAD 1 and CREAD 2 Phase 3 trials of crenezumab, for the treatment of Alzheimer’s disease (AD), following interim analysis conducted by the Independent Data Monitoring Committee (IDMC). The analysis indicated that crenezumab was unlikely to meet its primary endpoint of change from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score. Shares of AC Immune slumped on the data, closing down 66% to $3.65. 

Mylan (NASDAQ: MYL) shares spiked in late trading, closing up 7% to $30.82 following news of the FDA approval of Wixela, the first generic version of GlaxoSmithKline's inhaled respiratory drug Advair.

Trevena, Inc. (Nasdaq: TRVN) announced an offering with two healthcare-focused institutional investors of 10m shares at a price of $1 per share for proceeds of $10m. Shares closed down 12% to $1.12.

Pulmatrix, Inc. (NASDAQ: PULM) announced it intends to sell shares of its common stock in an underwritten public offering. Shares are trading down 5% to $0.17 after hours.

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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:

Alder Biopharmaceuticals, Inc. (ALDR): $14.12; +17%.

Onconova Therapeutics, Inc. (ONTX): $2.44; +17%.

CTI BioPharma Corp. (CTIC): $1.17; +15%.

Neurotrope, Inc. (NTRP): $4.40; +14%.

Adial Pharmaceuticals, Inc. (ADIL): $5.48; +14%.

DECLINERS:

Oramed Pharmaceuticals Inc. (ORMP): $2.95; -15%.

Leap Therapeutics, Inc. (LPTX): $2.17; -14%.

Innoviva, Inc. (INVA): $18.22; -9%.

Titan Pharmaceuticals, Inc. (TTNP): $1.20; -8%.

scPharmaceuticals Inc. (SCPH): $3.75; -8%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ACIU – AC Immune SA
Crenezumab - CREAD 1
Alzheimer’s disease

Phase 3 Phase 3 trial terminated following interim analysis indicating primary endpoint would not be met.
$318.9 million

AXSM – Axsome Therapeutics Inc.
AXS-12
Narcolepsy

Phase 2 Phase 2 trial initiation announced January 30, 2019 with top-line data due 2Q 2019.
$499.5 million

EYEN – Eyenovia Inc.
MicroStat
Mydriasis - pupil dilation

Phase 3 Phase 3 trial met primary endpoint - January 31, 2019. Data from second trial also met primary endpoint - February 25, 2019. Detailed data due at (ASCRS) meeting May 3-7, 2019.
$78.4 million

JNJ – Johnson & Johnson
Apalutamide
Metastatic castration-sensitive prostate cancer (mCSPC).

Phase 3 Phase 3 data met co-primary endpoints - January 30, 2019.
$366.2 billion

NVS – Novartis AG
OMB157 (ofatumumab)
Relapsing multiple sclerosis

Phase 3 Phase 3 data due 2H 2019.
$176.6 billion

NVS – Novartis AG
QAW039 (fevipiprant)
Asthma

Phase 3 Phase 3 data due 2H 2019.
$176.6 billion

NVS – Novartis AG
QVM149
Asthma

Phase 3 Phase 3 trial to be completed 3Q 2019.
$176.6 billion

NVS – Novartis AG
Lu-PSMA-617 VISION
Metastatic castration-resistant prostate cancer (mCRPC)

Phase 3 Phase 3 rPFS data due in 2020.
$176.6 billion

NVS – Novartis AG
PDR001
BRAFV600 mutant metastatic melanoma

Phase 3 Phase 3 data due 2H 2019.
$176.6 billion

NVS – Novartis AG
Entresto - PARALLEL-HF
Heart failure

Phase 3 Phase 3 first data due 2Q 2019.
$176.6 billion

NVS – Novartis AG
Cosentyx (secukinumab) - PREVENT
Non-radiographic axial spondyloarthritis

Phase 3 Phase 3 readout due 2019.
$176.6 billion

NVUS – Novus Therapeutics Inc.
OP0201
Acute Otitis Media - adults

Phase 1 Phase 1 data due April 2019.
$40 million

NVUS – Novus Therapeutics Inc.
OP0201 - C-006
Acute Otitis Media - children

Phase 1 Phase 2a dosing has commenced - noted February 19, 2019 data due 2H 2019.
$40 million

SCYX – SCYNEXIS Inc.
SCY-078 - oral (FURI)
Invasive candidiasis

Phase 3 Phase 3 open label interim data released January 30, 2019 - 11/17 partial or complete responses. Data to be presented at ECCMID April 16, 2019.
$82.7 million