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Catalysts Ahead: Will These 4 Pharma Stocks Hit Or Miss The Mark?

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Biotech stocks are driven by regulatory and clinical trial catalysts. Knowledge about the timing of FDA decisions and release of clinical trial results will help trade biotech stocks with some margin of safety around the catalyst events.

The following are some of the biotech stocks with near-term catalysts.

1. AnaptysBio Inc. (ANAB)

AnaptysBio is a clinical-stage antibody development company advancing therapeutic antibody product candidates focused on unmet medical needs in inflammation.

The Company's wholly-owned product pipeline includes Etokimab (ANB020) for the treatment of atopic dermatitis, eosinophilic asthma and chronic rhinosinusitis with nasal polyps, and ANB019 for the treatment of rare inflammatory diseases called generalized pustular psoriasis (GPP) and palmoplantar pustulosis (PPP).

In addition, the Company has a number of drug candidates that have entered the clinic under its immuno-oncology-focused collaboration with TESARO and inflammation-focused collaboration with Celgene.

Watch out for…

-- Top-line data from a phase IIb multi-dose study of Etokimab in adult patients with moderate-to-severe atopic dermatitis, referred to as the ATLAS trial, is expected in the second half of 2019.
-- Top-line data from a phase II trial of Etokimab in adult patients with chronic rhinosinusitis with nasal polyps, dubbed ECLIPSE, is expected in the second half of 2019.
-- Top-line data from a phase II trial of ANB019 in patients with generalized pustular psoriasis, or GPP, known as the GALLOP trial, due in mid-2019, are awaited.

ANAB closed Thursday's trading at $54.40, up 1.28%.

2. Curis Inc. (CRIS)

Curis is a biotechnology company developing innovative therapeutics for the treatment of cancer.

The Company has three drugs candidates in its pipeline - Fimepinostat in a phase II clinical trial in patients with MYC-altered diffuse large B-cell lymphoma and in a phase I trial in patients with MYC-altered solid tumors; CA-170, being investigated in a phase I clinical trial in patients with advanced solid tumors or lymphomas, and CA-4948 in a phase I clinical trial in patients with non-Hodgkin's lymphoma.

Expected 2019 Catalysts…

-- Initial data from phase II trial of Fimepinostat with Venetoclax combination regimen in diffuse large B-cell lymphoma (DLBCL), including patients with Double-Hit/Double-Expressor Lymphoma is expected in the second half of 2019.
-- Initial efficacy data from phase I CA-4948 dose-escalation study in patients with Non-Hodgkin lymphoma that was due mid-year 2019 is pending.
-- Initial efficacy data from CA-170 phase I trial in patients with mesothelioma (high VISTA expressors) is anticipated in the second half of 2019.

CRIS closed Thursday's trading at $2.30, up 1.32%.

3. Deciphera Pharmaceuticals Inc. (DCPH)

Deciphera Pharmaceuticals Inc. (DCPH) is a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance.

The Company's lead drug candidate is Ripretinib, an orally administered kinase switch control inhibitor being developed for the treatment of gastrointestinal stromal tumors, advanced systemic mastocytosis, gliomas, and other solid tumors, under phase III development.

Also in the pipeline are Rebastinib, which is under two chemo combo trials - one with Paclitaxel and the other with Carboplatin; and DCC-3014, under a phase I study in patients diagnosed with Tenosynovial giant cell tumors.

Watch out for…

-- Top-line data from a pivotal phase III clinical study of Ripretinib in fourth-line and fourth-line-plus gastrointestinal stromal tumor (GIST) patients, dubbed INVICTUS, due in mid-2019 is awaited.
-- Another phase III clinical study comparing Ripretinib to Sunitinib for the treatment of second-line GIST patients who have previously received Imatinib, dubbed INTRIGUE, is underway.
-- Data from Part 1 of phase I/II study of Rebastinib with Paclitaxel is expected in the second half of 2019.

DCPH closed Thursday's trading at $22.48, up 1.72%.

5. Immunic Inc. (IMUX)

Immunic is a clinical-stage biopharmaceutical company developing oral immunology therapies for chronic inflammatory and autoimmune diseases including ulcerative colitis, Crohn's disease, relapsing-remitting multiple sclerosis, and psoriasis.

The Company's lead development program is IMU-838, which is under phase II trials for ulcerative colitis and relapsing-remitting multiple sclerosis.

IMU-838 is an orally available small-molecule inhibitor of Dihydroorotate Dehydrogenase, an enzyme that is identified as a drug target in cancer and immunological disorders.

Also in the pipeline are IMU-935 for the treatment of autoimmune diseases such as psoriasis, and IMU-856, a new oral treatment option for ulcerative colitis and Crohn's disease, both of which are in preclinical testing.

Watch out for…

-- Interim dosing analysis of phase II trial of IMU-838 in patients with ulcerative colitis, dubbed CALDOSE-1, is expected in the third quarter of 2019. Top-line data is expected to be available in the first quarter of 2021.
-- A phase II trial of IMU-838 for the treatment of relapsing-remitting multiple sclerosis, dubbed EMPhASIS, is underway and is expected to be completed in the first half of 2020. Top-line data is anticipated to be available during the third quarter of 2020.
-- A phase II trial of IMU-838 for the treatment of active Crohn's disease, dubbed CALDOSE-2, is expected to be initiated during the second half of 2019.
-- A phase I trial of IMU-935 in healthy volunteers and psoriasis patients is expected to begin during September 2019.
-- A phase I trial of IMU-856, a potential therapy for inflammatory bowel disease, is expected to be initiated in the first half of 2020.

IMUX closed Thursday's trading at $13.29, down 2.71%.

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