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.


Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume


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%.


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.
$372.3 million

AXSM – Axsome Therapeutics Inc.

Phase 2 Phase 2 top-line data due 2H 2019.
$865.9 million

EYEN – Eyenovia Inc.
Mydriasis - pupil dilation

NDA Filing NDA filing due 2020.
$35.9 million

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

PDUFA sNDA filing announced April 29, 2019. Estimated PDUFA date February 28, 2020.
$357.7 billion

NVS – Novartis AG
OMB157 (ofatumumab)
Relapsing multiple sclerosis

Phase 3 Phase 3 data due 2H 2019.
$204.8 billion

NVS – Novartis AG
QAW039 (fevipiprant)

Phase 3 Phase 3 data due 2H 2019.
$204.8 billion

NVS – Novartis AG

Phase 3 Phase 3 trial to be completed 3Q 2019.
$204.8 billion

NVS – Novartis AG
Metastatic castration-resistant prostate cancer (mCRPC)

Phase 3 Phase 3 trial to be completed 2H 2020.
$204.8 billion

NVS – Novartis AG
BRAFV600 mutant metastatic melanoma

Phase 3 Phase 3 data due 2H 2019.
$204.8 billion

NVS – Novartis AG
Entresto - PARALLEL-HF
Heart failure

Phase 3 Phase 3 trial completed 1Q 2019.
$204.8 billion

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

Phase 3 Phase 3 data due 2H 2019.
$204.8 billion

NVUS – Novus Therapeutics Inc.
Acute Otitis Media - adults

Phase 1 Phase 1 data released April 22, 2019. Safety and tolerability objectives met.
$11.1 million

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

Phase 1 Phase 2a data due 1H 2020.
$11.1 million

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.
$67.1 million