Fri, Feb. 20, 7:15 AM
- The World Health Organization (WHO) approves the use of a 15-minute point-of-care test developed by Corgenix Medical (OTCQB:CONX) to detect the presence of the Ebola virus. The company developed the assay with funding assistance of the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation.
- Procurement and roll-out in Africa will begin in a few weeks pending the completion of administrative procedures with the U.S. FDA.
- Ebola-related tickers: (NYSE:MRK) (NASDAQ:NLNK) (NYSEMKT:IBIO) (NASDAQ:NVAX) (NYSE:GSK) (NYSE:JNJ) (NASDAQ:TKMR) (NYSEMKT:HEB) (NASDAQ:BCRX) (NASDAQ:SRPT) (NASDAQ:CMRX) (NASDAQ:ABIO) (OTCQB:AEMD) (OTCPK:BVNRY) (NASDAQ:INO) (OTCQX:RHHBY)
Wed, Feb. 18, 8:20 AM
- BioCryst Pharmaceuticals (BCRX +0.7%) Q4 results: Revenues: $5.4M (-49.1%); R&D Expense: $18.5M (+19.4%); G&A: $2M (+42.9%); Operating Loss: ($15.2M) (-141.3%); Net Loss: ($11.7M) (-116.7%); Loss Per Share: ($0.16) (-77.8%).
- FY2014 results: Revenues: $13.6M (-21.4%); R&D Expense: $51.8M (+23.6%); G&A: $7.5M (+25.0%); Operating Loss: ($45.8M) (-49.2%); Net Loss: ($45.2M) (-50.2%); Loss Per Share: ($0.68) (-23.6%); Quick Assets: $32.6M (+999%).
- 2015 Guidance: Cash burn: $65M - 80M; operating expenses: $75M - 95M.
Wed, Feb. 18, 6:58 AM| 1 Comment
Tue, Feb. 17, 5:30 PM
Wed, Feb. 11, 3:38 AM
- President Obama is expected to announce plans today to withdraw most of the U.S. troops assigned to combat the Ebola outbreak in West Africa, where they had been deployed to assist with supply logistics, construction and training.
- The return of the troops comes as the number of new infections drops in the region - from 1,000 new suspected, probable and confirmed Ebola cases a week in October to about 150 a week in recent reports.
- Ebola-related stocks: JNJ, GSK, HEB, BCRX, NLNK, NNVC, INO, TKMR -0.5% AH
Fri, Feb. 6, 5:37 PM
Mon, Jan. 26, 7:49 AM
- The FDA grants Fast Track status to BioCryst Pharmaceuticals' (NASDAQ:BCRX) plasma kallikrein inhibitor BCX4161 for the treatment of hereditary angioedema. The product candidate is currently in Phase 2/3 development. Clinical trial results are expected by the end of this year.
- Fast Track designation allows for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
Thu, Jan. 22, 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%)
Wed, Jan. 14, 7:31 AM
- Europe's Committee for Orphan Medicinal Products (COMP) issues a positive opinion on BioCryst Pharmaceuticals' (NASDAQ:BCRX) application for Orphan Drug designation for BCX4161 for the treatment of patients with hereditary angioedema (HAE). The European Commission will make the final decision on the application.
- BCX4161 is a plasma kallikrein inhibitor which, in turn, suppresses bradykinin production. Bradykinin is the mediator of acute swelling attacks in patients with HAE.
- The FDA designated BCX4161 an Orphan Drug several weeks ago.
- Previously: BioCryst plasma kallikrein an Orphan Drug for HAE (Dec. 24, 2014)
Mon, Jan. 5, 7:19 AM
Dec. 30, 2014, 1:53 AM
- A health-care worker infected with Ebola was admitted to a specialist unit in a Glasgow hospital yesterday after she returned from working with Ebola patients in Sierra Leone.
- She is the second Ebola patient to be treated in the country since the outbreak of the disease and will be transferred to the U.K.’s specialized high-isolation unit at the Royal Free Hospital in London as soon as possible.
- Ebola-related stocks are rising after-hours on the news: Tekmira (NASDAQ:TKMR) +1.7%; BioCryst Pharmaceuticals (NASDAQ:BCRX) +1.2%.
- Other related tickers: Hemipherx BioPharma (NYSEMKT:HEB); Inovio Pharmaceuticals (NASDAQ:INO); NewLink Genetics (NASDAQ:NLNK).
Dec. 24, 2014, 7:11 AM
- The FDA grants Orphan Drug status to BioCryst Pharmaceuticals' (NASDAQ:BCRX) BCX4161 for the prevention of acute attacks of angioedema in patients with hereditary angioedema (HAE).
- BCX4161 is a novel selective inhibitor of plasma kallikrein which, in turn, suppresses bradykinin production. Bradykinin is the mediator of acute swelling attacks in patients with HAE.
- Among the benefits of the Orphan Drug designation is a seven-year period of market exclusivity if approved.
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. 18, 2014, 12:56 PM
- The FDA's PDUFA date for its review of BioCryst Pharmaceuticals' (BCRX +0.6%) New Drug Application (NDA) for peramivir for the treatment of adult patients with acute uncomplicated influenza is December 23.
- Previously: BioCryst Pharma +12% after FDA accepts NDA for peramivir (Feb. 25, 2014)
Dec. 15, 2014, 8:02 AM
- The first patient has been dosed in a Phase 1 study assessing the safety, tolerability and pharmacokinetics of BioCryst Pharmaceuticals' (NASDAQ:BCRX) BCX4430 for the treatment of hemorrhagic fever caused by viruses such as Ebola and Marburg. The trial will enroll up to 88 healthy volunteers who will receive a singe injection of BCX4430 in part one of the trial and will receive it over seven days in part two.
- BCX4430 is an RNA dependent-RNA polymerase inhibitor that has demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families.
- The National Institute of Allergy and Infectious Diseases, National Institutes of Health and the Department of Health and Human Services are funding the work.
- Related tickers: (NASDAQ:ABIO) (NASDAQ:TKMR) (NASDAQ:SRPT) (NYSEMKT:HEB) (NASDAQ:CMRX)
Dec. 5, 2014, 1:57 PM
- As expected, the Biotechnology Industry Organization (BIO) gives a resounding thumbs up in support of adding Ebola to the FDA Priority Review Voucher Program Act. Under the act, developers of a vaccine or treatment for a qualified tropical disease receive a voucher for FDA priority review for another product of its choice.
- Late Wednesday, the U.S. House of Representatives voted unanimously to add Ebola to the Act. Additional refinements to the legislation include making it easier for the Secretary of Health and Human Services to add to the list of qualified diseases, allowing the vouchers to be sold and transferred multiple times and shortening the timeline for notifying the FDA of the intention to use a priority review voucher.
- The changes bring the tropical diseases priority review voucher program more in line with the rare pediatric disease priority review voucher program.
- Ebola-related tickers: (GSK +0.2%)(JNJ +0.5%)(MRK +1%)(NLNK +2.2%)(TKMR -1.4%)(HEB +0.6%)(SRPT -0.8%)(BCRX +0.8%)(CMRX +3.2%)
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