BioCryst Pharmaceuticals, Inc.
 (BCRX)

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  • Fri, Feb. 12, 7:38 AM
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    • Quidel (NASDAQ:QDEL) downgraded to Hold from Buy by Canaccord. Price target lowered to $18 (18% upside) from $22.
    • BioCryst Pharmaceuticals (NASDAQ:BCRX) downgraded Neutral from Overweight by JP Morgan. Price target lowered to $5 (201% upside) from $16.
    | Fri, Feb. 12, 7:38 AM | 9 Comments
  • 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
  • Dec. 10, 2015, 2:59 AM
    • New Ebola cases have surfaced in Liberia, the worst hit of all Ebola-affected nations, suggesting that the fight against the disease could take months, or even years, to fully eliminate.
    • Recent scientific studies and case reports indicate the Ebola virus can persist in survivors' bodily fluids months longer than previously thought.
    • Liberia has already been declared Ebola-free (42 days pass without a new episode of hemorrhagic fever) twice this year, only to see new cases appear.
    • Previously: Sierra Leone declared free of Ebola (Nov. 08 2015)
    • Ebola-related stocks: JNJ, GSK, HEB, BCRX, NLNK, NNVC, INO, OTCQB:GOVX, SRPT, CMRX, PLX, NSPH, LAKE, APT, VSR, SMED
    | Dec. 10, 2015, 2:59 AM | 15 Comments
  • Nov. 5, 2015, 10:47 AM
    • BioCryst Pharmaceuticals (BCRX -6.5%) Q3 results: Revenues: $11M (+243.8%); R&D Expense: $20.1M (+54.6%); SG&A: $2.7M (+50.0%); Operating Loss: ($13.2M) (-13.8%); Net Loss: ($14.6M) (-67.8%); Loss Per Share: ($0.20) (-66.7%); Quick Assets: $118.1M (+3.7%).
    • 2015 Guidance: Net operating cash use: $8M - 18M; Operating expenses: $75M - 95M.
    | Nov. 5, 2015, 10:47 AM
  • Nov. 5, 2015, 6:57 AM
    • BioCryst Pharmaceuticals (NASDAQ:BCRX): Q3 EPS of -$0.20 in-line.
    • Revenue of $10.99M (+239.2% Y/Y) beats by $4.22M.
    | Nov. 5, 2015, 6:57 AM
  • Nov. 4, 2015, 5:30 PM
  • 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
  • Sep. 1, 2015, 11:54 AM
    • In a regulatory filing, BioCryst Pharmaceuticals (BCRX -1.3%) discloses that the Biomedical Advanced Research and Development Authority within the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR/BARDA) has exercised its option under its agreement with the company to authorize $4.2M plus an additional $1.2M to fund various activities related to the continued development of BCX4430, a drug candidate for the potential treatment of more than 20 RNA viruses including Ebola and Marburg.
    • The additional support increases the total value of the contract to $36.2M.
    • Previously: BioCryst Pharma snags advanced development project for RNA pathogens (March 31)
    | Sep. 1, 2015, 11:54 AM
  • Aug. 7, 2015, 7:40 AM
    • BioCryst Pharmaceuticals (BCRX -4.1%) Q2 results: Revenues: $25.8M (+999%); R&D Expense: $16.5M (+48.6%); SG&A: $3.5M (+75.0%); Operating Income: $5.3M (+145.7%); Net Income: $4.9M (+133.6%); EPS: $0.06 (+126.1%); Quick Assets: $130.4M (+14.5%).
    • 2015 Guidance: Net operating cash use: $18M - 28M; Operating expenses: $75M - 95M.
    | Aug. 7, 2015, 7:40 AM
  • Aug. 7, 2015, 6:52 AM
    • BioCryst Pharmaceuticals (NASDAQ:BCRX): Q2 EPS of $0.06 beats by $0.28.
    • Revenue of $25.84M (+1657.8% Y/Y) beats by $18.74M.
    | Aug. 7, 2015, 6:52 AM
  • Aug. 6, 2015, 5:30 PM
    | Aug. 6, 2015, 5:30 PM | 5 Comments
  • Jul. 2, 2015, 9:07 AM
    • Onconova (NASDAQ:ONTX) upgraded to Overweight from Neutral with a $6 (131% upside) price target (up from $3) by Piper Jaffray.
    • BioCryst Pharmaceuticals (NASDAQ:BCRX) upgraded to Buy from Neutral with a $19 (30% upside) price target (up from $12) by Bank of America.
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    | Jul. 2, 2015, 9:07 AM | 10 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