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April 28, 2014
09:16 EDTXOMAXOMA finalizes plan for gevokizumab Phase 3 clinical program in PG
XOMA announced that based on its meeting with the FDA, the company is finalizing its plans for a gevokizumab Phase 3 program in pyoderma gangrenosum, or PG, a rare neutrophilic dermatosis of painful expanding necrotic skin ulcers. During the meeting, the Company and the FDA reviewed the data generated from XOMA's pilot trial in six PG patients. The pilot study was designed to determine if gevokizumab, an IL-1 beta modulating antibody, should be explored in pivotal studies in patients with active PG. XOMA is incorporating the FDA's verbal and written responses regarding the clinical design of the studies into a final Phase 3 program, which it will submit to the Agency for any final comments. The Phase 3 program is expected to include two double-blind, placebo-controlled clinical studies, each of which is designed to enroll approximately 60 patients with active PG. The primary endpoint is complete wound closure of the target ulcer at approximately four months. XOMA anticipates conducting these parallel studies in the United States and several other countries.
News For XOMA From The Last 14 Days
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October 1, 2015
11:06 EDTXOMAXOMA price target raised to $1.50 from $1 at Piper Jaffray
Piper Jaffray analyst Edward Tenthoff raised his price target for XOMA (XOMA) to $1.50 after the company partnered a preclinical TGF-beta antibody with Novartis (NVS) for $37M upfront and up to $480M in milestones. The payment brings XOMA's pro forma cash to $88M, enabling the company to advance its endocrine antibody pipeline, including lead candidate XOMA 358 for hyperinsulinism disorders, Tenthoff tells investors in a research note. The analyst keeps a Neutral rating on the name. The stock is up 20c to 95c in early trading.
09:20 EDTXOMAOn The Fly: Pre-market Movers
HIGHER: XOMA (XOMA), up 55.7% after announcing an agreement for anti-TGFb program with Novartis (NVS)... Sarepta Therapeutics (SRPT), up 10.6% after announcing additional clinical efficacy and safety data from the company's Phase IIb program of eteplirsen... Huntsman (HUN), up 3.8% after announcing a $150M share repurchase program... Mellanox (MLNX), up 3.2% after raising third quarter revenue guidance. DOWN AFTER EARNINGS: McCormick (MKC), down 3.4%. ALSO LOWER: Capstone Turbine (CPST), down 26.5% after announcing that its preliminary second quarter earnings were notably below management's expectations and analysts' consensus estimates... Concho Resources (CXO), down 3.9% after 7.7M share Spot Secondary priced at $92.50... AGCO (AGCO), down 3.5% after being downgraded to Sell from Neutral at UBS.
07:37 EDTXOMAXOMA announces agreement for anti-TGFb program with Novartis
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