Key Developments: BioCryst Pharmaceuticals Inc (BCRX.O)
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17 May 2013
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Latest Key Developments (Source: Significant Developments)
Biocryst Pharmaceuticals Inc Announces Chairman Change-Form 8-K
Biocryst Pharmaceuticals Inc reported in its Form 8-K that on February 6, 2013, Zola Horovitz, Ph.D., announced his retirement from the Board of Directors of BioCryst Pharmaceuticals, Inc. Dr. Horovitz, the current non-executive Chairman of the Board of Directors, has served on the Board since August 1994. Upon Dr. Horovitz’s resignation, George Abercrombie, who has served on the Board of Directors since October 2011, will serve as the non-executive Chairman. Full Article
Biocryst Pharmaceuticals Inc and Presidio Pharmaceuticals Mutually Terminate Merger Transaction
Biocryst Pharmaceuticals Inc and privately held Presidio Pharmaceuticals, Inc. announced the mutual termination of the Merger Agreement and the related Investor Financing Agreement entered into on October 17, 2012. Although the original rationale for the merger had merit, the parties determined that terminating the merger was in the best interest of both companies and their respective shareholders at this time. The termination of the transaction has been approved by the Boards of both companies. In association with the termination, both parties will release each other from all obligations with respect to the proposed transaction. Each company will bear its own legal and transaction fees. Full Article
Biocryst Pharmaceuticals Inc and Presidio Pharmaceuticals to Merge
Biocryst Pharmaceuticals Inc and Presidio Pharmaceuticals Inc announced that the companies have signed a definitive merger agreement for Presidio to be acquired by BioCryst in an all-stock transaction. The transaction has been approved by the Boards of both companies. The transaction values Presidio at approximately $101 million, based on October 17, 2012 closing BioCryst share price of $4.11 per share. The transaction is expected to close in the first quarter of 2013. Full Article
BioCryst Pharmaceuticals, Inc. Announces Positive Results From Two Ulodesine Phase 2 Trials In Patients With Gout
BioCryst Pharmaceuticals, Inc. announced avorable 52-week safety results and sustained efficacy from the extension phase of its randomized Phase 2b trial of ulodesine added to allopurinol in patients with gout who had failed to reach the serum uric acid (sUA) therapeutic goal of <6 mg/dL on allopurinol alone, as well as positive Phase 2 safety results in patients with mild to moderate renal impairment. In the original 12-week study, 279 patients were randomized. The extension to 52 weeks, in which 119 patients entered the final extension phase, concludes the Phase 2b trial and Phase 2 development program for ulodesine. Patients continued their blinded, randomized therapy of ulodesine at doses of 5 mg, 10 mg and 20 mg and placebo once-daily. Allopurinol 300 mg once-daily was administered in all study arms. The results of the 52-week, blinded Phase 2b safety extension trial confirm that ulodesine continues to be generally safe and well-tolerated in gout patients who inadequately responded to allopurinol alone, many of which had multiple co-morbidities. No clinical adverse event signals were observed that distinguished ulodesine from placebo, either by type or by rate at the doses tested. No opportunistic or unusual infections were observed and no signal for other organ toxicities was detected. No fatal or life-threatening adverse events were observed in any of the treatment groups. Full Article
BioCryst Pharmaceuticals, Inc. Presents Results From Its BCX4208 Gout Program At The Annual European Congress Of Rheumatology
BioCryst Pharmaceuticals, Inc. announced that additional safety and efficacy results from its BCX4208 gout program will be presented at the Annual European Congress of Rheumatology hosted by the European League Against Rheumatism (EULAR) in Berlin, Germany on June 7 & 8, 2012. Three posters summarize pharmacokinetic (PK), safety and efficacy results from BioCryst’s Phase 2b trial of BCX4208 added to allopurinol in patients with gout who had failed to reach the serum uric acid (sUA) therapeutic goal of <6.0 mg/dL on allopurinol alone. BCX4208, A Enzyme Inhibitor for Chronic Management of Gout Shows a Low Risk of Potential Drug-Drug Interactions” concludes that BCX4208 undergoes renal elimination, is not metabolized by liver cells and does not induce, or inhibit, CYP isoforms or common drug transporters. Therefore, BCX4208 should have a low risk of drug-drug interactions with medications commonly prescribed to patients with gout. Long-term Safety of BCX4208 Added to Allopurinol in the Chronic Management of Gout: Results of a Phase 2 24-week Blinded Safety Extension and Vaccine Challenge Study” concludes that BCX4208 was safe and generally well-tolerated when added to allopurinol. Patients showed no signal for infections and generated a healthy immune response to vaccination. BCX4208 Added to Allopurinol Increases Response Rates in Patients with Gout who Fail to Reach Goal Range Serum Uric Acid on Allopurinol Alone Full Article
BioCryst Pharmaceuticals, Inc. Announces Promising Results from Preclinical Studies of BCX5191 for Hepatitis C
BioCryst Pharmaceuticals, Inc. announced favorable preclinical results for BCX5191, a novel adenine nucleoside analog targeting viral RNA polymerase for the potential treatment of hepatitis C. BioCryst has successfully completed in vitro and in vivo studies in which BCX5191 exhibited potent and selective pan-genotypic antiviral activity against the hepatitis C polymerase enzyme. BCX5191 showed no inhibition of human RNA polymerase and no evidence of toxicity from standard in vitro screens. Full Article
BioCryst Pharmaceuticals, Inc. Announces Positive Results from Ongoing BCX4208 Phase 2B Study in Patients with Gout
BioCryst Pharmaceuticals, Inc. announced long-term results from the extension phase of its randomized Phase 2b study of BCX4208 added to allopurinol in patients with gout who had failed to reach the serum uric acid (sUA) therapeutic goal of <6 mg/dL on allopurinol alone. The results of this 24-week, blinded safety extension confirm that BCX4208 was generally safe and well-tolerated, and sustained sUA control over time. Patients generated healthy immune responses to a vaccine challenge at 16 or 20 weeks of BCX4208 treatment. Following the successful outcome of this 24-week analysis, BioCryst is preparing for end of Phase 2 regulatory discussions to take place in the coming months. In the original 12-week study, 279 patients were randomized and 160 patients entered the extension phase. Patients continued their blinded, randomized therapy of BCX4208 at doses of 5 mg, 10 mg, 20 mg, 40 mg and placebo once-daily. Allopurinol 300 mg once-daily was administered in all study arms. This longer-term safety profile of BCX4208 is consistent with the 12-week primary analysis results originally reported in October 2011. BCX4208 added to allopurinol was generally safe and well-tolerated at all doses studied, and responses to vaccines indicated healthy immune function. The types and rates of adverse events through 24 weeks, including infections, were similar between the groups treated with BCX4208 and placebo. No opportunistic or unusual infections were observed. Full Article
BioCryst Pharmaceuticals, Inc. Announces Positive Top-Line Results From BCX4208 Phase 2B Gout Study In Patients Not Responding To Allopurinol Alone
BioCryst Pharmaceuticals, Inc. announced positive top-line results from its Phase 2b randomized, double-blind, dose-response study of BCX4208 in gout patients who had failed to reach the clinically important serum uric acid (sUA) goal of <6 mg/dL on allopurinol alone. The study randomized 279 patients to five study arms: BCX4208 at doses of 5 mg, 10 mg, 20 mg, 40 mg and placebo, administered once-daily for 12-weeks. Allopurinol 300 mg once-daily was administered in all study arms. The primary endpoint of the study was the proportion of patients with sUA <6 mg/dL at day 85. The primary endpoint of the study was successfully achieved. When added to allopurinol 300 mg, BCX4208 was superior to allopurinol plus placebo (p=0.009 overall). BCX4208 doses evaluated in the study showed response rates ranging from 33% to 49%, compared to 18% for placebo. Adding BCX4208 to allopurinol was generally safe and well-tolerated at all doses studied. Both the frequency and types of adverse events, including infections, were similar between the groups treated with BCX4208 and placebo. No opportunistic or unusual infections were reported in either the BCX4208 treated groups or placebo. As expected, a dose-dependent effect on lymphocyte counts was observed and this effect appeared to plateau within 12 weeks of treatment. No patients from the placebo, 5 mg or 10 mg cohorts discontinued study drug due to confirmed lymphocyte or CD4+ cell counts below certain pre-specified thresholds. Full Article
BRIEF-Biocryst shares jump 10 percent in premarket
NEW YORK, April 1 - BioCryst Pharmaceuticals Inc : * Shares jump 10 percent in premarket trading
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