BPC August 01 update

Vanda VNDA and Acadia ACAD shares rally on earnings; Offerings for ARCT AGRX CORV

Price and Volume Movers

Vanda Pharmaceuticals (NASDAQ:VNDA) shares rallied to close up 27% to $15.79 on the back of better than expected second quarter earnings. Total product sales were up 25% year-over-year. Citigroup also upgraded its rating on the stock from neutral to buy with a price target of $19.

Acadia Pharmaceuticals (NASDAQ: ACAD) shares closed up 17% to $28.67, also following a stronger than expected earnings report. Revenues for the quarter grew to $83.2m, an increase of $46% over the same quarter last year.

Eton Pharmaceuticals, Inc (Nasdaq: ETON) announced that its partner, Aucta Pharmaceuticals, received notice that its New Drug Application for ET-105 has been accepted for review by the FDA with a PDUFA date of March 17, 2020. ET-105 is a formulation of lamotrigine, for which Aucta is seeking approval as an adjunct therapy for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome.

Arcturus Therapeutics (NASDAQ: ARCT) announced an intra-day offering, which saw shares drop sharply during lunch trading, closing the session down 15% to $11.58. The company intends to raise $10.9m (gross) in a registered direct offering of 945,653 shares at a purchase price of $11.50 per share.

Agile Therapeutics, Inc. (Nasdaq: AGRX) announced that it intends to offer and sell shares of its common stock in an underwritten public offering. Shares are trading down after hours 11% to $0.98.

Correvio Pharma Corp. (NASDAQ: CORV) shares are trading down 14% to $1.60 after hours following news it also will be proceeding with a public offering.


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

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

ADVANCERS:

Unum Therapeutics Inc. (UMRX): $2.33; +18%.

Selecta Biosciences, Inc. (SELB): $2.08; +16%.

TCR2 Therapeutics Inc. (TCRR): $17.90; +15%.

Zafgen, Inc. (ZFGN): $1.03; +13%.

Evofem Biosciences, Inc. (EVFM): $5.41; +11%.

DECLINERS:

Clovis Oncology, Inc. (CLVS): $8.87; -16%.

DelMar Pharmaceuticals, Inc. (DMPI): $1.52; -15%.

22nd Century Group, Inc. (XXII): $1.36; -14%.

Checkpoint Therapeutics, Inc. (CKPT): $2.29; -13%.

Acorda Therapeutics, Inc. (ACOR): $6.07; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ACIU – AC Immune SA
ACI-35.030
Alzheimer’s Disease

Phase 1/2 Phase 1b/2 trial initiation announced August 1, 2019.
$363.5 million

AGIO – Agios Pharmaceuticals Inc.
AG-270
Solid tumors

Phase 1 Phase 1 data to be presented at AACR-NCI-EORTC International Conference October 26-30, 2019
$2.5 billion

ARGX – argenx SE
Efgartigimod (ARGX-113)
Myasthenia gravis (MG)

Phase 3 Phase 3 data due 2H 2020.
$5.2 billion

BLPH – Bellerophon Therapeutics Inc.
INOpulse delivery device
Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD)

Phase 2b Phase 2b completion due year-end 2019 with pivotal cohort 3 (Phase 3) initiation due 1Q 2020.
$45.7 million

BPMC – Blueprint Medicines Corporation
Avapritinib BLU-285 - PATHFINDER
Advanced Systemic mastocytosis (SM)

Phase 2 Phase 2 enrolment to be completed 2H 2019. NDA filing due 1Q 2020.
$4.1 billion

CBIO – Catalyst Biosciences Inc.
Dalcinonacog alfa – DalcA
Hemophilia B

Phase 2b Phase 2b top-line data due 4Q 2019 with final data due in 2020.
$83.2 million

CLVS – Clovis Oncology Inc.
Rucaparib - TRITON2
Castrate-resistant prostate cancer (mCRPC)

Phase 2 Phase 2 updated data due at ESMO late-September, 2019.
$306.1 million

CNCE – Concert Pharmaceuticals Inc.
CTP-692
Schizophrenia

Phase 1 Phase 2 trial to be initiated 4Q 2019. Phase 1 data to be presented at the ECNP Annual Congress, September 7-10, 2019.
$248.9 million

ETON – Eton Pharmaceuticals Inc.
EM-105
Lennox-Gastaut syndrome, epilepsy

PDUFA PDUFA date March 17, 2020.
$100.5 million

FOLD – Amicus Therapeutics Inc.
CLN6 Gene Therapy
Batten disease

Phase 1/2 Phase 1/2 additional data due 2019.
$2.6 billion

GLYC – GlycoMimetics Inc.
GMI-1070 (rivipansel)
Vaso-occlusive crisis of sickle cell disease

Phase 3 Phase 3 data failed to meet endpoints - August 2, 2019.
$146.9 million

INSM – Insmed Inc.
INS1007
Bronchiectasis

Phase 2 Phase 2 top-line data due early 2020.
$1.5 billion

ISEE – IVERIC bio Inc.
IC-100
Rhodopsin-mediated autosomal dominant retinitis pigmentosa (RHO-adRP)

Phase 1/2 Phase 1/2 trial to be initiated 2H 2020.
$45.2 million

LJPC – La Jolla Pharmaceutical Company
LJPC‑401
Hereditary Hemochromatosis

Phase 2 Phase 2 top-line data due 4Q 2019.
$264.8 million