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Sun, Jun. 26, 5:43 AM
- Research to be presented this week at a teratology conference in San Antonio suggests that serious joint problems, seizures, vision impairment and other medical issues can be added to the list of risks from Zika exposure in the womb.
- The new findings also confirm that even when Zika-exposed babies are born without microcephaly, developmental delays may appear in the weeks or months following birth.
- Related tickers: SNY, INO, AEMD, XON, CEMI, BCRX, TMO, CERS, OTCQB:GOVX
Mon, Jun. 20, 9:16 AM
Mon, Jun. 20, 6:59 AM
- Cerus (NASDAQ:CERS) enters into a 5-year agreement with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to support the development of the company's INTERCEPT Blood System for pathogen reduction of red blood cell (RBC) components, including blood-borne pathogens Zika, dengue and chikungunya.
- The contract includes a base period with committed funding of ~$30.8M with subsequent option periods that have could increase the amount to ~$180.5M to support clinical development, regulatory submissions, manufacturing and scale-up activities. Cerus and its partners are responsible for the co-investment of $14.5M.
- The company reported positive results from a European Phase 3 study in RBCs in January 2015 and from a U.S. Phase 2 in December 2014. An application for CE Mark registration should be filed later this year.
- INTERCEPT reduces the risk in transfusion-transmitted infection by inactivating a broad range of viruses, bacteria, spirochetes, parasites and leukocytes in platelet and plasma components. It accomplishes this via the use of a photoactive compound called amotosalen that "docks" between nucleic acid base pairs in the pathogen's DNA. When activated by ultraviolet light, it forms permanent cross-links between the helical strands of DNA that blocks further replication. Plasma and platelets are unaffected since they contain no functional DNA or RNA. The system has been in use in Europe since 2002 and the U.S. since 2014.
- Management will host a conference call this morning at 8:00 am ET to discuss the contract.
- Shares are up 12% premarket on robust volume.
Mon, May 23, 9:14 AM
- Health Canada approves Cerus' (NASDAQ:CERS) INTERCEPT Blood System for the ex vivo preparation of pathogen-reduced whole blood-derived or apheresis plasma to reduce the risk of transfusion-transmitted infection.
- INTERCEPT enhances the safety of donated blood components by inactivating a range of viruses, bacteria, spirochetes and parasites in addition to potentially harmful white blood cells.
- The system has been in use in Europe since 2002 and the U.S. since 2014.
Tue, May 3, 4:03 PM
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Wed, Mar. 16, 10:29 AM
- The FDA approves the use of Cerus Corp's (CERS -3.2%) INTERCEPT Blood System for the treatment of platelets suspended in 100% plasma, further extending the use of the pathogen killer with commonly used platelet collection methods. The system was originally cleared in December 2014 for platelets collected in a commercially available additive solution called InterSol, commonly used in Europe but still being introduced in the U.S.
- INTERCEPT reduces the risk in transfusion-transmitted infection by inactivating a broad range of viruses, bacteria, spirochetes, parasites and leukocytes in platelet and plasma components. It accomplishes this via the use of a photoactive compound called amotosalen that "docks" between nucleic acid base pairs in the pathogen's DNA. When activated by ultraviolet light, it forms permanent cross-links between the helical strands of DNA that blocks further replication. Plasma and platelets are unaffected since they contain no functional DNA or RNA.
Wed, Mar. 9, 6:39 AM
- Cerus (CERS) Q4 results: Revenues: $9.7M (+1.0%); R&D Expense: $7.2M (+38.5%); SG&A: $11.3M (+5.6%); Operating Loss: ($15M) (-16.3%); Net Loss: ($14.8M) (+26.7%); Loss Per Share: ($0.15) (+42.3%).
- FY2015 results: Revenues: $34.2M (-6.0%); R&D Expense: $25.6M (+17.4%); SG&A: $46M (+22.0%); Operating Loss: ($61.1M) (-37.3%); Net Loss: ($55.9M) (-44.1%); Loss Per Share: ($0.61) (unch); Quick Assets: $107.9M (+110.3%).
- No guidance given.
Tue, Mar. 8, 5:46 PM
Tue, Mar. 8, 4:04 PM
- Cerus (NASDAQ:CERS): Q4 EPS of -$0.15 beats by $0.01.
- Revenue of $9.7M (+1.3% Y/Y) in-line.
- Shares are down 6% after hours on increased volume.
Mon, Mar. 7, 5:35 PM
Wed, Feb. 17, 10:07 AM
- Micro cap Inovio Pharmaceuticals (INO +4%) is up in early trading on increased volume in response to its announcement of positive preclinical data for its Zika virus vaccine candidate. In the study, DNA constructs, synthetically generated with the company's SynCon vaccine technology, targeting multiple Zika virus antigens and administered using its CELLECTRA electroporation delivery technology induced robust and durable immune responses. Phase 1 testing is expected to commence before year end.
- Investors seeking to profit from a Zika-stoked up move need to be patient. Regulatory clearance for a vaccine, even with accelerated review, is probably two years away. Drugs to treat infection are further away still.
- Intrexon (XON +6.4%) has seen some recent bullish action (shares doubled from mid-January to early February) in apparent anticipation of the revenue potential of its genetically modified sterile male mosquitoes, OX513A, that produced a 95% reduction in the Aedes aegypti population, the type of mosquito that transmits Zika and Dengue, in a small study in northeast Brazil. Here, again, sobriety is key. The beneficial effects are only temporary (unless the sterile guys are repeatedly released over a wide area, a tall order since mosquitoes only travel ~200 yards so covering a large area would require substantial human and physical resources). Intrexon's pricing leverage will also be constrained because irradiated sterile mosquitoes perform just as effectively and they will be available free-of-charge. Both techniques have similar cost structures, about $400/1M mosquitoes.
- Zika Index: (XON +6.4%)(INO +5.9%)(CERS +1%)(SNY +0.8%)(NLNK -1.8%)
Wed, Feb. 17, 9:14 AM