BPC August 29 update

​AstraZeneca AZN releases positive lupus data; AbbVie ABBV terminates Rova-T program

Price and Volume Movers

AstraZeneca (NYSE: AZN) announced that its Phase 3 TULIP 2 trial of anifrolumab for the treatment of systemic lupus erythematosus (SLE), met its primary endpoint, achieving a statistically-significant and clinically-meaningful reduction in disease activity versus placebo. The result reverses data from its previous TULIP 1 trial in August last year, which did not meet the primary endpoint.

Solid Biosciences Inc. (NASDAQ: SLDB) shares closed down 7% to $8.42 following news that Citi has downgraded its rating of the company to Sell, with a price target of $6.

AbbVie (NYSE: ABBV) announced that MERU, its Phase 3 trial evaluating Rova-T as a first-line maintenance therapy for advanced small-cell lung cancer (SCLC), demonstrated no survival benefit following interim analysis compared with patients on placebo. The MERU trial is being closed, and the Rova-T research and development program has been terminated.

TRACON Pharmaceuticals, Inc. (NASDAQ:TCON) shares closed up 6% to $0.57 following initiation of coverage by H.C.Wainwright with a Buy rating and a price target of $2.

Acasti Pharma Inc. (NASDAQ: ACST) shares closed up 6% to $1.81. B.Riley FBR initiated coverage with a Buy rating and a price target of $7.75.

EyeGate Pharmaceuticals, Inc. (NASDAQ: EYEG) announced a reverse stock split of its shares of common stock at a ratio of 1-for-15 will be effective upon the commencement of trading on August 30, 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:

LogicBio Therapeutics Inc.( LOGC): $9.58; +29%.

Cidara Therapeutics, Inc. (CDTX): $1.78; 19%.

DiaMedica Therapeutics Inc. (DMAC): $2.88; +16%.

Aeterna Zentaris Inc. (AEZS): $2.40; +15%.

Applied Genetic Technologies Corporation (AGTC): $2.98; +15%.

DECLINERS:

Plus Therapeutics, Inc. (PSTV): $16.81; -13%.

Mallinckrodt Public Limited Company (MNK): $3.08; -13%.

Salarius Pharmaceuticals, Inc. (SLRX): $8.67; -10%.

Diffusion Pharmaceuticals Inc. (DFFN): $1.96; -8%.

Soligenix, Inc. (SNGX): $1.02; -7%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ABBV – AbbVie Inc.
Rova-T (MERU)
First-line Small Cell Lung Cancer

Phase 3 Phase 3 trial demonstrated no survival benefit at interim analysis - October 29, 2019.
$105.9 billion

AGLE – Aeglea BioTherapeutics Inc.
Pegzilarginase (AEB1102)
Arginase I deficiency

Phase 3 Phase 3 trial initiation announced June 3, 2019 with data due 1Q 2021.
$252.7 million

AKTX – Akari Therapeutics Plc
Coversin
Atopic keratoconjunctivitis

Phase 1/2 Phase 1/2 Part B data due 4Q 2019.
$38.4 million

AKTX – Akari Therapeutics Plc
Coversin
Bullous Pemphigoid

Phase 2 Phase 2 further data due at EADV Congress, October 10, 2019.
$38.4 million

CANF – Can-Fite Biopharma Ltd Sponsored ADR (Israel)
Piclidenoson (CF101)
Rheumatoid arthritis

Phase 3 Phase 3 continues to enrol as of August 29, 2019.
$8.2 million

CANF – Can-Fite Biopharma Ltd Sponsored ADR (Israel)
Piclidenoson (CF101)
Psoriasis

Phase 3 Phase 2/3 trial did not meet primary endpoint late March 2015. Additional Phase 3 trial initiation announced August 2018 continues to enrol as of August 29, 2019.
$8.2 million

CANF – Can-Fite Biopharma Ltd Sponsored ADR (Israel)
Namodenoson (CF102)
Non-alcoholic steatohepatitis (NASH)

Phase 2 Phase 2 data due 4Q 2019.
$8.2 million

ESPR – Esperion Therapeutics Inc.
Bempedoic Acid/ Ezetimibe (1002-058)
LDL-C and type 2 diabetes

Phase 2 Phase 2 trial met primary endpoint - August 29, 2019.
$985.5 million

KTOV – Kitov Pharma Ltd.
NT-219
Squamous cell carcinoma of the head & neck (SCCHN)

Phase 1 Phase 1/2 trial to be initiated 1Q 2020.
$15.9 million

MESO – Mesoblast Limited
MPC-150-IM - Class 2/3
Heart failure

Phase 3 Phase 3 data due 1H 2020.
$669 million

MESO – Mesoblast Limited
MPC-06-ID
Chronic low back pain

Phase 3 Phase 3 data due mid-2020.
$669 million

OPK – Opko Health Inc.
hGH-CTP
Children - growth hormone deficiency

Phase 3 Phase 3 data due 4Q 2019.
$1.3 billion

TGTX – TG Therapeutics Inc.
TG-1101 - ULTIMATE I
Multiple Sclerosis

Phase 3 Phase 3 data due in the middle to 2H 2020.
$609.3 million

TGTX – TG Therapeutics Inc.
TG-1101 (ublituximab)
Relapsing forms of Multiple Sclerosis (RMS)

Phase 2 Phase 2 long term follow up data presented at ECTRIMS, September 12, 2019.
$609.3 million