BPC August 05 update

​Allakos ALLK shares soar 111% on mid-stage data; Intra-Cellular ITCI PDUFA date extension

Price and Volume Movers

Allakos Inc. (Nasdaq: ALLK) shares soared to close up 111% to $65.26 following the release of data from its Phase 2 trial of AK002 in patients with eosinophilic gastritis and/or eosinophilic gastroenteritis. All arms showed clinically meaningful and statistically significant benefits compared to placebo on all prespecified primary and secondary endpoints. The company took advantage of the price surge when it announced after hours a public offering of $200m of shares of its common stock.

Intra-Cellular Therapies, Inc. (Nasdaq:ITCI) shares closed up 8% to $8.85. Following news last month that its Advisory Committee had been cancelled, Intra-Cellular provided an update today noting that the FDA has extended the PDUFA date for its New Drug application (NDA) for lumateperone for the treatment of schizophrenia, by three months to December 27, 2019. The extension follows additional information requested by the FDA related to toxicology findings in previous animal studies.

GlycoMimetics, Inc. (NASDAQ: GLYC) shares slumped to close down 69% to $2.80 following news released late-Friday by Pfizer Inc. (NYSE:PFE) that their Phase 3 trial of rivipansel (GMI-1070) in patients with sickle cell disease (SCD), did not meet its primary or key secondary efficacy endpoints.

Roche (OTCQX: RHHBY) announced that its Phase 3 IMvigor130 trial of Tecentriq (atezolizumab) plus chemotherapy, met its co-primary endpoint, exhibiting a statistically significant reduction in the risk of disease worsening or death (PFS) in people with previously untreated locally advanced or metastatic urothelial carcinoma (mUC) compared with chemotherapy alone.

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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:

KemPharm, Inc. (KMPH): $1.27; +21%.

MediWound Ltd. (MDWD): $2.89; +12%.

ImmunoGen, Inc. (IMGN): $2.50; +12%.

Lexicon Pharmaceuticals, Inc. (LXRX): $1.33; +11%.

Minerva Neurosciences, Inc. (NERV): $6.97; +8%.

DECLINERS:

Kezar Life Sciences, Inc. (KZR): $4.27; -18%.

Calithera Biosciences, Inc. (CALA): $3.56; -15%.

Immutep Limited (IMMP): $1.27; -15%.

Galmed Pharmaceuticals Ltd. (GLMD): $4.89; -14%.

Kala Pharmaceuticals, Inc. (KALA): $5.05; -13%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALNY – Alnylam Pharmaceuticals Inc.
Givosiran
Acute hepatic porphyrias

Approved FDA approval announced November 20, 2019.
$13.8 billion

ARVN – Arvinas Inc.
ARV-471
ER+ positive / HER2- negative breast cancer

Phase 1 Phase 1 initial data presented October 23, 2019. Further data due 2H 2020.
$1.5 billion

CCXI – ChemoCentryx Inc.
Avacopan - CCX168 (ADVOCATE)
Associated vasculitis (AAV)

Phase 3 Phase 3 data met primary endpoints - November 25, 2019.
$1.8 billion

CLSN – Celsion Corporation
ThermoDox - OPTIMA
Hepatocellular carcinoma - liver cancer

Phase 3 Phase 3 interim efficacy November 4, 2019 - trial to continue as planned. Second analysis 2Q 2020.
$33 million

EGRX – Eagle Pharmaceuticals Inc.
Fulvestrant
Breast cancer

Phase 3 Pilot trial planned, to be followed by pivotal trial.
$771.5 million

EVFM – Evofem Biosciences Inc.
Amphora - AMPREVENCE
Prevention of urogenital Chlamydia trachomatis infection in women

Phase 2/3 Phase 2b data met primary endpoint - December 2, 2019.
$322.1 million

FOMX – Foamix Pharmaceuticals Ltd.
FMX103
Papulopustular rosacea

PDUFA PDUFA date June 2, 2020.
$187.4 million

GALT – Galectin Therapeutics Inc.
GR-MD-02
Non-alcoholic steatohepatitis (NASH) with cirrhosis

Phase 3 Phase 3 trial to be initiated 1Q 2020 with top-line data due 4Q 2022.
$170.1 million

ITCI – Intra-Cellular Therapies Inc.
Lumateperone
Schizophrenia

PDUFA PDUFA date extended by three months to December 27, 2019. No advisory committee meeting expected.
$563.7 million

KDMN – Kadmon Holdings Inc.
KD025 - ROCKstar (KD025-213)
Chronic graft-versus-host disease (cGVHD)

Phase 2 Phase 2 trial met primary endpoint - November 11, 2019. Primary analysis due 1Q 2020.
$583.6 million

LLY – Eli Lilly and Company
Galcanezumab
Chronic and episodic migraine

Phase 3 Phase 3 trial met primary endpoint - August 5, 2019.
$114.9 billion

NERV – Minerva Neurosciences Inc
MIN-202 (seltorexant) vs quetiapine
Major Depressive Disorder

Phase 2 Phase 2b data noted quantitative advantage but no statistical separation between two arms. Company noted trial was not designed to detect statistical significance.
$243.9 million

NTRP – Neurotrope Inc.
Bryostatin
Alzheimer's disease

Phase 2 Phase 2 trial did not meet primary endpoint - September 9, 2019.
$15.4 million

PGNX – Progenics Pharmaceuticals Inc.
PyL
Prostate cancer

Phase 3 Phase 3 data due by end of 2019.
$442.5 million