BioCryst Pharmaceuticals, Inc.
 (BCRX)

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  • Mon, Feb. 8, 12:46 PM
    | Mon, Feb. 8, 12:46 PM
  • Mon, Feb. 8, 9:19 AM
    | Mon, Feb. 8, 9:19 AM | 14 Comments
  • Mon, Feb. 8, 7:04 AM
    • Micro cap BioCryst (NASDAQ:BCRX) is down 56% premarket on light volume in response to its announcement that its Phase 2/3 clinical trial, OPus-2, assessing avoralstat (formerly BCX4161) for the prevention of hereditary angioedema (HAE) attacks failed to beat placebo.
    • The study recruited HAE patients with a historical attack frequency of more than 0.45 attacks/week. Subjects were randomized to receive either 300 mg or 500 mg of avoralstat or placebo three times per day for 12 weeks. The primary endpoint was the difference in attack frequency compared to placebo.
    • The number of patients receiving 500 mg of avoralstat, 300 mg of avoralstat or placebo was 38, 36 and 36, respectively. Average attacks per week for the three cohorts were 0.63, 0.71 and 0.61, respectively.
    • CEO Jon Stonehouse says, OPus-2 was a well-designed and executed trial that gave us a clear answer: this dosage form of avoralstat is not a viable formulation to move forward. While we are disappointed in the study results, we learned that meaningful better exposure is needed for avoralstat to succeed. We expect results from a relative bioavailability study testing a novel solid dosage form of avoralstat by mid-year. The primary goals of this study are to achieve much higher exposures and twice daily dosing. Our other opportunity to achieve higher exposure from an oral kallikrein inhibitor is with BCX7353 - we expect results from [a dose ranging study] in HAE patients by year end.
    • HAE is a rare inherited condition characterized by excessive swelling in the extremities, face, genitalia and airway, which can be life-threatening. A peptide called bradykinin is the mediator of acute swelling attacks in HAE sufferers. Avoralstat inhibits plasma kallikrein, an enzyme that plays a key role in bradykinin production.
    • Management will host a conference call this morning at 8:00 am ET to discuss the data.
    • Previously: BioCryst slumps 22% on risk of delay of avoralstat NDA (Oct. 8, 2015)
    | Mon, Feb. 8, 7:04 AM | 5 Comments
  • Oct. 9, 2015, 12:43 PM
    | Oct. 9, 2015, 12:43 PM | 6 Comments
  • Oct. 8, 2015, 12:45 PM
    | Oct. 8, 2015, 12:45 PM | 1 Comment
  • Oct. 8, 2015, 11:09 AM
    • BioCryst Pharmaceuticals (BCRX -22.4%) heads south on almost triple normal volume in response to its update on the clinical development status of avoralstat (formerly BCX4161) for hereditary angioedema (HAE).
    • Patient enrollment is complete in the Phase 2 OPuS-2 study, a 12-week, three-arm, parallel cohort trial designed to assess the safety and efficacy of avoralstat, 300 mg and 500 mg, administered three times per day compared to placebo. The primary efficacy endpoint is the average angioedema attack rate versus placebo. The estimated study completion date is early 2016.
    • The company wants to defer a two-year carcinogenicity study in rats, something that is typically required at the time of the regulatory application. The European Medicines Agency (EMA) has agreed to defer it as a post-filing commitment, but the FDA has yet to make a decision. If it declines BioCryst's request then the NDA filing would be delayed until 2018 because the carcinogenicity study will not commence until early 2016. The company intends to address the issue during its End-of-Phase 2 meeting with the FDA early next year.
    • HAE is a rare inherited condition characterized by excessive swelling in the extremities, face, genitalia and airway, which can be life-threatening. A peptide called bradykinin is the mediator of acute swelling attacks in HAE sufferers. Avoralstat inhibits plasma kallikrein, an enzyme that plays a key role in bradykinin production.
    | Oct. 8, 2015, 11:09 AM
  • Jun. 19, 2015, 5:36 PM
    | Jun. 19, 2015, 5:36 PM | 5 Comments
  • May 1, 2015, 5:36 PM
    • Top gainers, as of 5:15 p.m.: NNVC +16.2%. NYT +4.8%. DO +3.1%. BCRX +2.7%. SRPT +2.6%.
    • Top losers, as of 5:15 p.m.: MACK -3.9%. ITEK -3.8%. BLX -3.7%. SALT -2.0%. DCI -2.0%.
    | May 1, 2015, 5:36 PM | 1 Comment
  • Apr. 1, 2015, 9:13 AM
    | Apr. 1, 2015, 9:13 AM | 1 Comment
  • Mar. 31, 2015, 5:36 PM
    | Mar. 31, 2015, 5:36 PM | 3 Comments
  • Mar. 31, 2015, 9:13 AM
    | Mar. 31, 2015, 9:13 AM | 1 Comment
  • Feb. 6, 2015, 5:37 PM
    | Feb. 6, 2015, 5:37 PM
  • Jan. 22, 2015, 12:12 PM
    • Thinly-traded micro cap NanoViricides (NNVC +20.5%) moves up in early trading on higher volume albeit on modest turnover of 230K shares. Before the open, the company announced that it shipped several anti-Ebola nanoviricide drug candidates to an unnamed "hi-security bio-containment facility" for evaluation.
    • The company states that it progressed from design to synthesis of the drug candidates in only four months using its rapid design platform.
    • Related tickers: (TKMR +0.2%)(BCRX -2.9%)(HEB -3.2%)(INO -2.3%)(SRPT -0.4%)(CMRX -1.4%)(ABIO -1.6%)
    | Jan. 22, 2015, 12:12 PM | 1 Comment
  • Dec. 22, 2014, 6:55 AM
    • The FDA approves BioCryst Pharmaceuticals' (NASDAQ:BCRX) Rapivab (peramir injection) for the treatment of adult (18 years and older) patients with acute uncomplicated influenza who have been symptomatic for no more than two days.
    • Rapivab is a neuraminidase inhibitor that is administered as a single 600 mg dose intravenously over 15 to 30 minutes.
    • Shares are up 12% premarket on light volume.
    | Dec. 22, 2014, 6:55 AM
  • Nov. 17, 2014, 12:06 PM
    • Nano cap Aethlon Medical (OTCQB:AEMD +29.8%) jumps on massive turnover of 10M shares in response to its report of the successful treatment of a critically-ill Ebola patient in Germany with its Hemopurifier bio-filtration device. In a post-treatment analysis, the device captured 242M Ebola viruses. The patient is expected to make a full recovery.
    • The Hemopurifier targets the broad-spectrum elimination of viruses and immunosuppressive proteins from the blood.
    • The stock has more than tripled since mid-October when the first treatment with the Hemopurifier was reported.
    • Some of the members of the trading behavior-characterized Ebola Small Cap Index have completed their round trips. (HEB +1.2%)(TKMR +5.1%)(NLNK +2.5%)(NNVC -3.8%)(INO -8.5%)(OTCQB:GOVX)(SRPT -0.7%)(CMRX +4.4%)(PLX -1%)(NSPH -0.2%)(BCRX +0.7%)(LAKE +1.3%)(APT +0.2%)(VSR -0.7%)(SMED -2.7%)
    | Nov. 17, 2014, 12:06 PM | 19 Comments
  • Oct. 23, 2014, 9:57 PM
    • The physician - who lives in Upper Manhattan - had returned to NYC ten days ago after treating Ebola patients in West Africa. Late in the trading session today, stocks gave back some of their big gains on a report he had been hospitalized with Ebola-type symptoms.
    • City officials are at work tracing the doctor's contacts to determine who else may be at risk, and his girlfriend is being tested for the disease.
    • S&P 500 (NYSEARCA:SPY) futures are lower by 0.5%.
    • Ebola Small-cap Index: HEB. TKMR, NLNK, NNVC, INO, OTCQB:GOVX, SRPT, CMRX, PLX, NSPH, BCRX, LAKE, APT, VSR, SMED.
    | Oct. 23, 2014, 9:57 PM | 53 Comments
Company Description
Biocryst Pharmaceuticals Inc is a biotechnology company. The Company designs, optimizes and develops novel small molecule drugs that block key enzymes involved in the pathogenesis of diseases.
Sector: Healthcare
Industry: Biotechnology
Country: United States