BPC April 03 update

Offerings for AVEO PSTI SGMO; ABIO reverse split

Price and Volume Movers

AVEO Pharmaceuticals, Inc. (Nasdaq: AVEO) shares closed down 17% before falling an additional 21% after hours to $1.03. As noted in the BioPharmCatalyst daily update on March 27, shares had surged following a blog post on Seeking Alpha by apparent "hedge fund" BlueLion that AstraZeneca (AZN) was planning an imminent buyout of the company this quarter. The post has since been deleted but was sufficient to generate upward price action, closing at $1.58 yesterday compared with $0.57 prior to the blog post. Today, however, the company noted that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) might reverse its current marketing authorisation for tivozanib if interim overall survival data in August are negative. After hours, downward momentum continued following news it has commenced an underwritten public offering of its shares of common stock, together with warrants to purchase shares of common stock.

Sangamo Therapeutics, Inc. (Nasdaq: SGMO) announced that it has commenced an underwritten public offering of shares of its common stock. Shares, which rose 29% Tuesday, added a further 6% during normal trading hours. However, they have since pulled back following the after-hours offering, currently trading down 8% from the close to $12.02.

Pluristem Therapeutics Inc. (Nasdaq: PSTI) also announced today that it intends to offer and sell shares of its common stock and warrants in an underwritten public offering and shares of its common stock in a concurrent registered direct offering. Shares are trading down 13% to $0.75 after hours after closing down 9% during the normal session.

Advaxis, Inc. (Nasdaq: ADXS) shares closed down 31% to $4.05 following news after hours Tuesday of a public offering.

ARCA biopharma, Inc. (NASDAQ: ABIO) announced a 18-1 reverse split of its common stock is now effective and will trade on a post-split basis on April 4, 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:

Iovance Biotherapeutics, Inc. (IOVA): $11.80; +20%.

Celsion Corporation (CLSN): $2.41; +18%.

Sorrento Therapeutics, Inc. (SRNE): $4.38; +15%.

Adaptimmune Therapeutics plc (ADAP): $5.41; +15%.

Sunesis Pharmaceuticals, Inc. (SNSS): $1.52; +14%.

DECLINERS:

Pulmatrix, Inc. (PULM): $1.56; -23%.

PhaseBio Pharmaceuticals, Inc. (PHAS): $10.36; -14%.

TRACON Pharmaceuticals, Inc. (TCON): $1.48; -13%.

Precision BioSciences, Inc. (DTIL): $15.05; -10%.

Tenax Therapeutics, Inc. (TENX): $1.82; -8%.


Pipeline Database Updates

Drug Stage Catalyst Market Cap

ACHN – Achillion Pharmaceuticals Inc.
ACH-4471
C3 glomerulopathy (C3G)

Phase 2 End of Phase 2 meeting 4Q 2019.
$341.3 million

ACHN – Achillion Pharmaceuticals Inc.
ACH-4471
C3 glomerulopathy (C3G)

Phase 2 End of Phase 2 meeting 4Q 2019.
$341.3 million

ASND – Ascendis Pharma A/S
TransCon CNP
Achondroplasia

Phase 1 Phase 2 trial to be initiated 3Q 2019.
$5.3 billion

ASND – Ascendis Pharma A/S
TransCon
Hypoparathyroidism

Phase 2 Phase 2 top-line data due 4Q 2019.
$5.3 billion

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

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

GWPH – GW Pharmaceuticals Plc
Epidiolex GWPCARE2
Dravet Syndrome

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

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

Phase 3 Phase 3 data due 2H 2020.
$9.6 billion

MRUS – Merus N.V.
MCLA-117
Acute Myeloid Leukemia

Phase 1 Phase 1 initial data due 2H 2019.
$376.4 million

MRUS – Merus N.V.
MCLA-128
Breast cancer - HER2-positive MBC and ER+/HER2-low MBC

Phase 2 Phase 2 update due 2H 2019.
$376.4 million

MRUS – Merus N.V.
MCLA-158
Colorectal cancer

Phase 1 Phase 1 emerging data due YE 2019.
$376.4 million

NVS – Novartis AG
Biosimilar pegfilgrastim
Pegfilgrastim biosimilar

PDUFA BLA filing resubmission announced April 3, 2019 in response to CRL issued in 2017. Estimated PDUFA date February 3, 2020.
$204.4 billion

OPNT – Opiant Pharmaceuticals Inc.
OPNT002
Alcohol Use Disorder

Phase 1 Phase 2 trial to be initiated later in 2019 with data due 2H 2020.
$52.5 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.
$98.9 million

PGNX – Progenics Pharmaceuticals Inc.
PyL
Prostate cancer

Phase 3 Phase 3 data due 1Q 2020.
$457.8 million

RARX – Ra Pharmaceuticals Inc.
RA101495 zilucoplan
Myasthenia Gravis (MG)

Phase 3 Phase 3 trial to commence 2H 2019.
$1.4 billion

SCYX – SCYNEXIS Inc.
SCY-078 - oral - CARES
Candida Auris

Phase 3 Phase 3 data presented at ECCMID April 13, 2019.
$67.1 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.
$67.1 million

TYME – Tyme Technologies Inc.
SM-88
Pancreatic cancer

Phase 2 Phase 2 updated data June 5, 2019 noted median overall survival data of 6.3 months.
$148.2 million