Tue, May 12, 10:14 AM
- One consequence of the wind down of the Ebola outbreak in West Africa is that there is little chance that the vaccine trials going on there will show efficacy, according to the World Health Organization. Since the number of cases has dropped substantially, Liberia was declared Ebola-free on Saturday, Guinea reported seven cases last week while Sierra Leone reported only two, there may not be enough data to prove that people are actually protected.
- The FDA's Materials, Vaccines and Related Biological Products Advisory Committee is meeting today to discuss alternative approval paths for Ebola vaccines, considering situations like West Africa. One option for approval is the "animal rule" which grants licensure based on the results from animal studies that show the vaccine is reasonably likely to produce clinical benefit in humans.
- Previously: Ad Comm approaches for alternative development and licensure paths for Ebola vaccine candidates (May 8)
- Related tickers: (MRK -1.2%)(JNJ -0.5%)(GSK -1.2%)(NLNK -22.2%)(EBS -2.8%)
Tue, May 12, 9:16 AM
Tue, May 12, 8:08 AM
- NewLink Genetics (NASDAQ:NLNK) is off 20% premarket on average volume in apparent response to its announcement after yesterday's close that the Phase 3 trial evaluating algenpantucel-L in pancreatic cancer will continue following the second planned interim data analysis.
- Previously: NewLink on go with algenpantucel-L Phase 3 after 2nd interim analysis (May 11)
Mon, May 11, 5:44 PM
- NewLink Genetics (NASDAQ:NLNK) continues its pivotal 722-subject Phase 3 trial, called IMPRESS, evaluating algenpantucel-L in patients with resected (surgically removed) pancreatic cancer following the second planned interim data analysis. No modifications or sample size adjustments are necessary. The study is powered to determine efficacy based on 444 events.
- The primary endpoint is overall survival (OS) and the secondary endpoint is disease-free survival (DFS). Final data collection was targeted for March.
- Algenpantucel-L is an immunotherapeutic developed with the company's HyperAcute platform. The product candidates are composed of human cancer cells that are tumor specific, but not patient specific. The cells have been modified to express alpha-gal, a carbohydrate that stimulates the immune system.
- The FDA has designated algenpantucel-L an Orphan Drug for Fast Track review.
Mon, May 11, 5:40 PM
Sun, May 10, 7:06 AM
- The World Health Organization has declared Liberia free of Ebola, marking the end of a national outbreak that infected as many as 400 new victims a week at its peak.
- Liberia has now gone 42 days - twice Ebola's maximum incubation period - since the burial of its last confirmed patient without discovering a new case.
- The disease is still spreading in Sierra Leone and Guinea, though at a slower pace. According to WHO statistics, more than 11,000 people have died from the virus, with about half of them in Liberia.
- Ebola-related stocks: JNJ, GSK, HEB, BCRX, NLNK, NNVC, INO, TKMR, OTCQB:GOVX, SRPT, CMRX, PLX, NSPH, LAKE, APT, VSR, SMED.
Fri, May 8, 11:33 AM
- The FDA's Materials, Vaccines and Related Biological Products Advisory Committee meets Tuesday, May 12 to discuss the benefits and risks of various development and approval paths for Ebola vaccines.
- The committee will discuss three: 1) traditional approval based on clinical endpoint efficacy data, 2) accelerated approval and 3) approval under the "animal rule."
- Traditional approval is unlikely to be recommended due to the inability and unethical aspect of comparing the vaccine candidates to placebo and the difficulty of recruiting a sufficient number of subjects due to the significant decline in Ebola infection rates.
- Under accelerated approval, a surrogate endpoint that is reasonably likely to predict clinical benefit (e.g., immune response) may serve as the basis for licensure. In this scenario, post-approval studies would be required to verify and describe the vaccine's clinical benefit.
- The "animal rule" may apply if traditional studies are unfeasible or unethical and accelerated approval cannot be used. In this scenario, approval would based on the results from animal studies that show the vaccine is reasonably likely to produce clinical benefit in humans, provided that safety in humans has been established. Post-approval studies would be required here as well.
- Briefing information
- Related tickers: (MRK +1.5%)(JNJ +1.8%)(GSK +3.2%)(NLNK +3.1%)(EBS -1.6%)
Tue, May 5, 11:12 AM| Comment!
Tue, May 5, 7:13 AM
Tue, Apr. 14, 2:05 PM
- The Phase 3 segment of a Phase 2/3 trial, called STRIVE, evaluating the Ebola vaccine candidate, rVSV-ZEBOV-GP, has been initiated in Sierra Leone. The study will involve 6,000 health and front-line workers in several West African countries in the Basse Guinee region, which dealt with the most Ebola infections. The study in Guinea commenced a couple of weeks ago.
- rVSV-ZEBOV-GP was originally developed by the Public Health Agency of Canada. It licensed it to NewLink Genetics (NLNK) who, in turn, licensed it to Merck (MRK +2%).
- Previously: Phase 3 trials for Merck-NewLink Ebola vaccine start this week in Guinea (March 5)
Wed, Apr. 8, 1:38 PM
- Cytori Therapeutics (CYTX -1.5%) rated Buy with a $7 (425% upside) price target by Maxim Group.
- Sagent Pharmaceuticals (SGNT +9.2%) rated Buy with a $29 (13% upside) price target by Deutsche Bank.
- Mylan (MYL +15.6%) rated Overweight with a $70 (2% upside) price target by JP Morgan.
- Akorn (AKRX +3.7%) rated Buy with a $55 (11% upside) price target by Deutsche Bank.
- OvaScience (OVAS +1.4%) rated Outperform with a $60 (102% upside) price target by Oppenheimer.
- Impax Laboratories (IPXL +3.2%) rated Hold with a $50 (flat) price target by Deutsche Bank.
- Catamaran (CTRX) downgraded to Hold with a $61.50 (4% upside) price target by Jefferies.
- NewLink Genetics (NLNK +4.4%) downgraded to Hold with a $50 (11% downside risk) price target by Jefferies.
- Stryker (SYK +0.4%) downgraded to Underweight with a $92 (flat) price target by Barclays.
Thu, Apr. 2, 1:23 PM
- Retrophin (RTRX +3.7%) rated Outperform with a $48 (98% upside) price target by Leerink Partners.
- OvaScience (OVAS +8.7%) rated Outperform with a $60 (82% upside) price target by Oppenheimer.
- OxiGENE (OXGN -0.7%) rated Buy with a $6 (314% upside) price target by H.C. Wainwright.
- Esperion Therapeutics (ESPR -4.5%) rated Buy with a $140 (40% upside) price target by UBS.
- Trevena (TRVN -2.3%) rated Outperform with a $15 (110% upside) price target by Wedbush.
- NewLink Genetics (NLNK -2.3%) downgraded to Hold with a $50 (4% downside risk) price target by Jefferies.
- Stryker (SYK +0.2%) downgraded to Underweight with a $92 (1% upside) price target by Barclays.
- Universal Health Services (UHS +2.7%) downgraded to Underperform with a $98 (16% downside risk) price target by Sterne Agee.
Fri, Mar. 27, 9:19 AM
- The experimental Ebola vaccines from GlaxoSmithKline (NYSE:GSK) and NewLink Genetics (NASDAQ:NLNK) (NYSE:MRK) appear to be safe, based on interim results in a mid-stage trial in Liberia. The vaccines, administered as a single injection, are being evaluated for safety and efficacy on more than 600 people there. Based on the positive results, the study will now progress to the next phase of efficacy testing where additional volunteers will be injected with one of the vaccines or placebo to see if their immune systems produce anti-Ebola antibodies.
- The Ebola epidemic, its course winding down, has claimed more than 10,000 lives.
Thu, Mar. 5, 10:47 AM
- Phase 3 trials to assess the safety and efficacy of the experimental Ebola vaccine co-developed by Merck (MRK +0.2%) and NewLink Genetics (NLNK +0.8%) will commence in two days in Guinea according to a statement by the World Health Organization (WHO). The trials will be conducted in the Basse Guinee region which dealt with the most Ebola cases.
- A "ring vaccination" strategy will be employed whereby everyone who has been in contact with a newly diagnosed Ebola patient will be vaccinated, an approach used to eradicate smallpox in the 1970s.
- Trials of two vaccine candidates, Merck/NewLink and GlaxoSmithKline (GSK +0.1%), in Liberia appear to be working. No new cases have been reported for 13 days.
- Trials for Glaxo's offering will begin in Guinea when supplies are available.
Fri, Feb. 27, 12:20 PM
- According the the World Health Organization (WHO), a recommendation from the Strategy Advisory Group of Experts (SAGE), an independent advisory body, to commence the widespread introduction of an Ebola vaccine won't happen until at least August due to the timing of results from clinical trials.
- Liberia is currently testing vaccine candidates from GlaxoSmithKline and Merck-NewLink. Sierra Leone and Guinea will announce their plans soon.
- The steep decline in Ebola cases will make it more difficult to prove the efficacy of the experimental vaccines so some of the testing may have to be moved to Sierra Leone, according to the U.S. National Institutes of Health.
- More than 23,500 cases of Ebola have been reported in the three African countries, with more than 9,500 fatalities. Only 99 new confirmed cases were reported for last week.
- (GSK -0.6%)(MRK -0.5%)(NLNK +1.2%)(GILD -0.8%)
Thu, Feb. 26, 7:16 AM
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