BPC January 06 update

aTyr LIFE shares close up 43% on license deal; Osmotica OSMT Intra-Cellular ITCI offerings

Price and Volume Movers

aTyr Pharma, Inc. (NASDAQ:LIFE) shares closed up 43% to $6.11 following news of a license agreement with Kyorin Pharmaceutical Co., Ltd. for the development and commercialization of ATYR1923, for interstitial lung diseases, in Japan. aTyr will receive $8m upfront and is eligible to receive up to an additional $167m in milestone payments.

Osmotica Pharmaceuticals plc (NASDAQ:OSMT) announced the commencement of a proposed public offering of 6m shares. Shares closed down 16% to $5.83.

Intra-Cellular Therapies, Inc. (Nasdaq:ITCI) announced after hours a public offering of 10m shares. Shares are currently trading down 5% to $29.16 after hours.

Merck (NYSE: MRK) announced that its Phase 3 KEYNOTE-604 trial investigating Keytruda in combination with chemotherapy met one of its dual primary endpoints of progression-free survival (PFS) in the first-line treatment of patients with extensive stage small cell lung cancer (ES-SCLC). The trial’s other primary endpoint of overall survival was no met.

Xeris Pharmaceuticals, Inc. (NASDAQ:XERS) shares are trading up 21% to $6.98 after hours following the release of top-line data from the in-clinic stage of its Phase 2 trial of its ready-to-use (RTU) glucagon for the prevention of hypoglycemia during and after moderate-to-high intensity aerobic exercise in adults with Type 1 diabetes mellitus (T1D). No p-values compared with placebo were noted but the company noted that a mini dose "was adequate to maintain normal blood glucose levels during prolonged, moderate-to-intense aerobic exercise."

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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:

Aridis Pharmaceuticals, Inc. (ARDS): $5.94; +26%.

Kala Pharmaceuticals, Inc. (KALA): $4.84; +26%.

Soligenix, Inc. (SNGX): $1.83; +26%.

Clearside Biomedical, Inc. (CLSD): $2.39; +24%.

Tonix Pharmaceuticals Holding Corp. (TNXP): $1.55; +23%.

DECLINERS:

Savara Inc. (SVRA): $3.47; -15%.

Applied Therapeutics, Inc. (APLT): $26.71; -11%.

Cassava Sciences, Inc. (SAVA): $8.63; -11%.

Cortexyme, Inc. (CRTX): $43.88; -10%.

Trillium Therapeutics Inc. (TRIL): $1.14; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALEC – Alector Inc.
AL101
Healthy volunteers

Phase 1 Phase 1 initiation of dosing announced January 6, 2020.
$1.6 billion

BPMC – Blueprint Medicines Corporation
Fisogatinib and CS1001
Hepatocellular Carcinoma

Phase 1/2 Phase 1b/2 trial initiation announced January 6, 2020.
$3.3 billion

CPRX – Catalyst Pharmaceuticals Inc.
Firdapse
Spinal Muscular Atrophy (SMA) Type 3

Phase 2 Phase 2 data due 1H 2020.
$432.8 million

CYTK – Cytokinetics Incorporated
CK-3773274 - Redwood-HCM
Hypertrophic cardiomyopathy (HCM)

Phase 2 Phase 2 trial initiation announced January 6, 2020.
$749 million

EIGR – Eiger BioPharmaceuticals Inc.
Pegylated interferon lambda + ritonavir (RTV)-boosted lonafarnib (LNF) - LIFT
Hepatitis delta virus (HDV)

Phase 2 Phase 2 additional data expected at EASL and AASLD 2020
$340.2 million

EIGR – Eiger BioPharmaceuticals Inc.
Lonafarnib
Hutchinson-Gilford Progeria Syndrome (HGPS)

NDA Filing NDA rolling submission commenced December 16, 2019. To be completed 1Q 2020.
$340.2 million

INO – Inovio Pharmaceuticals Inc.
VGX-3100 - REVEAL-1
Cervical dysplasia

Phase 3 Phase 3 data due 4Q 2020.
$384 million

INO – Inovio Pharmaceuticals Inc.
INO-5401 + cemiplimab
Glioblastoma (GBM)

Phase 1/2 Phase 1/2 overall survival data due 2020.
$384 million

MRK – Merck & Company Inc. (new)
Keytruda KN-604
Small cell lung cancer (SCLC)

Phase 3 Phase 3 data met PFS primary endpoint; overall survival primary endpoint not met - January 6, 2020.
$225.5 billion

NERV – Minerva Neurosciences Inc
Roluperidone (MIN-101)
Schizophrenia

Phase 3 Phase 3 data due 2Q 2020.
$330.9 million

PFE – Pfizer Inc.
Bavencio (Avelumab) - JAVELIN Bladder 100
Bladder cancer

Phase 3 Phase 3 trial met overall survival primary endpoint - January 6, 2020.
$225.3 billion

PLXP – PLx Pharma Inc.
VAZALORE
Aspirin - cardiovascular and stroke patients patients

sNDA Filing sNDA filing due 2Q 2020.
$40.3 million

PTGX – Protagonist Therapeutics Inc.
PTG-300
Hereditary hemochromatosis

Phase 2 Phase 2 initiation announced January 6, 2020.
$202.1 million

SLNO – Soleno Therapeutics Inc.
Diazoxide Choline Controlled-Release (DCCR) - DESTINY PWS
Prader-Willi syndrome (PWS)

Phase 3 Phase 3 data due 1H 2020.
$171.7 million

SRNE – Sorrento Therapeutics Inc.
STI-002
Remicade (infliximab) biosimilar

BLA Filing BLA filing due 2020.
$703.1 million