AKAO Abuzz, PRVB On High Pulse, Mark Your Calendar For INNT

pharmaup dec10

The following are some of today's top gainers in the pharma/biotech sector.

1. Innovate Biopharmaceuticals Inc. (INNT)

Gained 38.39% to close Monday's (Dec.10) trading at $3.10.

News: No news

Upcoming event:

Investor update on capital plan for the celiac disease clinical program and NASH development strategy is scheduled for December 17, 2018.

Clinical Trials & Near-term Catalysts:

-- A phase 2b efficacy clinical trial of Larazotide acetate for celiac disease has been successfully completed, and the Company is preparing to launch the Phase 3 registration clinical trials for celiac disease in the first half of 2019.

2. Achaogen Inc. (AKAO)

Gained 20.86% to close Monday's trading at $1.68.

News: The Center for Devices and Radiological Health (CDRH) of the FDA has provided clearance for the Thermo Scientific QMS Plazomicin Immunoassay. The assay is jointly developed by Thermo Fisher Scientific and Achaogen.

Results of the assay will be used to assist in the management of patients receiving Plazomicin therapy.

Plazomicin, marketed as ZEMDRI in the United States, was approved by the FDA in June 2018 for the treatment of adults with complicated urinary tract infections, including pyelonephritis, due to certain Enterobacteriaceae.

3. Provention Bio Inc. (PRVB)

Gained 17.19% to close Monday's trading at $2.59.

News: No news

Clinical Trials & Near-term Catalysts:

-- A phase 1b clinical trial of PRV-300 in moderate-to-severe ulcerative colitis, dubbed PULSE, is underway. Top-line data from PULSE are expected in the second quarter of 2019.
-- On November 5, 2018, Provention and Amgen announced a licensing and co-development agreement for PRV-015 (Amgen's AMG 714), being developed for the treatment of gluten-free diet non-responsive celiac disease (NRCD). Under the terms of the agreement, Provention will conduct and fund a Phase 2b trial in NRCD and lead the next phase of development and regulatory activities for the program.

4. Sutro Biopharma Inc. (STRO)

Gained 16.46% to close Monday's trading at $11.96.

News: No news

Recent event:

On September 27, 2018, the Company went public on The Nasdaq Global Market offering its shares at a price of $15.00 each.

Clinical Trials & Near-term Catalysts:

-- A phase I trial of STRO-002 in patients with Ovarian and Endometrial cancers is expected to begin in early 2019.
-- A phase I clinical trial of STRO-001 enrolling separate dose escalation cohorts for myeloma and B-cell lymphoma is underway.

5. Kiniksa Pharmaceuticals Ltd. (KNSA)

Gained 15.65% to close Monday's trading at $24.98.

News: No news

Clinical Trials & Near-term Catalysts:

-- Report additional open-label phase II proof-of-concept clinical trial data of Rilonacept in recurrent pericarditis and close enrollment in the trial later this year.
-- Initiate phase III study for Rilonacept in recurrent pericarditis later this year.
-- On December 6, 2018, the FDA requested additional information regarding the delivery device to be used in the phase II clinical trial of Mavrilimumab in giant cell arteritis. The investigational new drug application (IND) for the phase II clinical trial for Mavrilimumab in giant cell arteritis has been placed on clinical hold.
-- Initiate phase IIa/IIb clinical trial of KPL-716 in prurigo nodularis in the first quarter of 2019.

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