BPC April 25 update

Upcoming PDUFA dates, data presentations and earnings slated for next week; Biotech week in Review

Weekly watchlist

The upcoming week sees several PDUFA dates followed by a number of presentations at the Academy of Neurology 71st Annual Meeting, which will commence late this week and conclude early the following week. We highlight some of these below together with other presentations and key companies reporting first quarter earnings.

First, let’s review the week that was in what was a relatively quiet week aside from the start of earnings season.

Alkermes plc (Nasdaq: ALKS) shares closed Thursday down 13% to $30.31 following its report of 1Q earnings. Total revenues for the quarter were $223.1m, compared to $225.2m for the same period last year. In particular, investors were concerned with revenue from its schizophrenia drug, Aristada. Revenue of $30m were recorded, compared with guidance issued in February for sales of approximately $40m.

Repligen Corporation (NASDAQ: RGEN) shares closed Friday up 20% to $68.89 on news it will acquire privately-held C Technologies, Inc. for approximately $240m, comprised of $192m in cash plus $48m in Repligen common stock. C Technologies recorded revenue of $23.7m in 2018, and is projected to generate $27-$29m in revenue (pro forma) in 2019.

ContraVir Pharmaceuticals, Inc (NASDAQ:CTRV) shares slid to close Thursday down 43% to $0.12 on the back of a public offering of shares and associated warrants at a price of $0.12 for each share and warrant, for total gross proceeds of approximately $2.14m.

Gritstone Oncology, Inc. (Nasdaq:GRTS) shares also fell sharply on news of its offering of 6.5m shares at a public offering price of $11.50 per share. Shares closed the week down 21% to $10.79.

Moleculin Biotech, Inc., (NASDAQ: MBRX) was a common example of a nano/mirco cap company announcing largely insignificant news, in the hope of garnering the attraction of day traders, and following it up with an offering to raise cash through the sale of shares and warrants, taking advantage of the price spike. On Monday the company announced in a press release that it would be announcing a “significant discovery for lung cancer” in a conference call later in the week. The press release saw its shares spike to close Monday up 168% to $2.98, only to slide the following by 47% to $1.59 on news of an offering of stock and warrants to raise $15m. The significant discovery ended up being insignificant news about its lead drug in mouse models for its lead drug Annamycin.

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Selection of 20 biotech companies reporting 1Q earnings:

M: NBIX

T: AMGN EXAS INCY LLY MRK PFE VRTX

W: ACAD ALNY AMRN ARQL EXEL GSK UTHR

Th: ACOR GILD IRWD PCRX SAGE

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PDUFA dates and data presentations slated for upcoming week:

Drug Stage Catalyst Market Cap

ADAP – Adaptimmune Therapeutics plc
MAGE-A4 (ADP-A2M4)
Soild tumors

Phase 1 Phase 1 update due 2H 2019.
$366.5 million

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

NDA Filing NDA filing submitted 2Q 2019.
$2.4 billion

BOLD – Audentes Therapeutics Inc.
AT132 - ASPIRO
X-Linked Myotubular Myopathy

Phase 1/2 Phase 1/2 data to be presented at WMS October 1-5, 2019.
$1.6 billion

CYTK – Cytokinetics Incorporated
Reldesemtiv (CK-2127107) - FORTITUDE-ALS
Amyotrophic lateral sclerosis (ALS)

Phase 2 Phase 2 data presented at AAN, May 5, 2019, failed to meet primary endpoint.
$639 million

GWPH – GW Pharmaceuticals Plc
Epidiolex GWPCARE2
Dravet Syndrome

Phase 3 Phase 3 data to be presented at AAN May 7, 2019.
$5.2 billion

HRTX – Heron Therapeutics Inc.
HTX-011
Post operative pain

CRL CRL announced May 1, 2019.
$1.4 billion

IONS – Ionis Pharmaceuticals Inc.
IONIS-SOD1Rx / BIIB067
Amyotrophic lateral sclerosis (ALS)

Phase 3 Phase 3 data due 2H 2020.
$9.5 billion

NBRV – Nabriva Therapeutics plc
Contepo
Complicated urinary tract infections (cUTI)

CRL CRL issued April 30, 2019.
$192.8 million

OVID – Ovid Therapeutics Inc.
OV101 - NEPTUNE
Adolescents with Angelman syndrome

Phase 3 Phase 3 trial to commence enrolment 3Q 2019. Data due mid-2020.
$99.4 million

SNY – Sanofi
Dengvaxia
Dengue

Approved FDA approval announced May 1, 2019.
$104.1 billion