LCI | Lannett | C-Topical | Local anesthesia | http://www.streetinsider.com/Corporate+News/Lannett+(LCI),+FDA+Reach+Agreement+Over+SPA+for+C-Topical+Phase+III/7054155.html | YES | n/a | n/a | |
nil | Lantheus | Flurpiridaz F18 | Myocardial perfusion imaging | http://www.lantheus.com/News-Press-2011-0311.html | Yes | http://www.clinicaltrials.gov/ct2/show/NCT01347710?term=Flurpiridaz+F18&rank=1 | Dec-12 | |
CSE:VELO | LifeCycle Pharma | LCP-Tacro | Kidney Transplant | http://www.news-medical.net/news/20100812/FDA-grants-LifeCycle-Pharma-SPA-for-LCP-Tacro-pivotal-Phase-3-study-in-de-novo-kidney-transplant-patients.aspx | Yes | http://www.clinicaltrials.gov/ct2/show/NCT01187953?term=LCP-tacro&rank=8 | Mar-13 | |
nil | Macrocure | CureXcell | Chronic diabetic ulcers | https://sos.cision.com/node/499686 | Yes | http://www.clinicaltrials.gov/ct2/show/NCT01421966?term=macrocure&rank=3 | Feb-15 | |
TSE:4508 | Mitsubishi Tanabe Pharma Co | Collategene | Advanced PAD | http://www.anges-mg.com/en/news/pdf/20121024.pdf | Yes | n/a | n/a | |
nil | Nanotherapeutics | Ramoplanin | C Diff | http://www.nanotherapeutics.com/products_pipeline_ramoplanin.php | Yes | n/a | n/a | |
NLNK | New Link Genetics | HyperAcute immunotherapy | Pancreatic cancer | http://www.linkp.com/products/hyperacute-pancreas.html | Yes | http://www.clinicaltrials.gov/ct2/show/NCT01072981?term=hyperacute+pancreas&rank=1 | Jan-14 | |
nil | NovaRx | Lucanix | Advanced NSCLC | http://www.prnewswire.com/news-releases/novarx-completes-enrollment-in-lucanix-pivitol-phase-iii-therapeutic-vaccine-trial-for-post-frontline-maintenace-therapy-in-non-small-cell-lung-cancer-159688685.html | Yes | http://www.clinicaltrials.gov/ct2/show/NCT00676507?term=NovaRx&rank=2 | Oct-12 | |
OXGI | Oncogenix | Custirsen | Cancer pain in mCRPC | http://oncogenex.com/physicians/custirsen-ogx-011 | Yes | http://www.clinicaltrials.gov/ct2/show/NCT01188187?term=Custirsen&rank=6 | Dec-13 | |
nil | Onconova | Estybon | Myelodysplastic Syndromes | http://www.eurekalert.org/pub_releases/2010-10/poc-oaf100410.php | Yes | http://www.clinicaltrials.gov/ct2/show/NCT01241500?term=onconova&rank=13 | Oct-13 | Interim analysis |
ONXX | Onyx Pharma | Carfilzomib | 2L MM +lenolidomide | http://www.onyx.com/view.cfm/626/onyx-pharmaceuticals-receives-fda-accelerated-approval-of-kyprolis-carfilzomib-for-injection- | Yes | http://www.clinicaltrials.gov/ct2/show/NCT01568866?term=carfilzomib&phase=2&rank=1 | Jan-15 | |
OREX | Orexigen | Contrave | Obesity | http://ir.orexigen.com/phoenix.zhtml?c=207034&p=irol-newsArticle&id=1656731 | Yes | http://www.clinicaltrials.gov/ct2/show/NCT01601704?term=orexigen&rank=1 | Sep-13 | |
OXGN | Oxigene | Zybrestat | Anaplastic Thyroid Cancer | http://investor.oxigene.com/releasedetail.cfm?ReleaseID=707372 | Yes | http://www.clinicaltrials.gov/ct2/show/NCT01701349?term=oxigene&rank=5 | Dec-16 | |
nil | Paratek | Omadacycline | ABSSSI | http://www.paratekpharm.com/press/032812_SPA_ECCMID_release.pdf | Yes | n/a | n/a | |
nil | Paratek | Omadacycline | CABP | http://www.paratekpharm.com/press/032812_SPA_ECCMID_release.pdf | Yes | n/a | n/a | |
n/a | Pervasis | Vascugel | Fistula/Graft failure prevention | http://www.prnewswire.com/news-releases/pervasis-receives-fda-fast-track-status-for-vascugel-to-prevent-arteriovenous-access-failure-in-patients-undergoing-hemodialysis-115553949.html | Yes | n/a | n/a | |
PXSL | Pharmaxis | Bronchitol | Bronchiectasis | http://www.prnewswire.com/news-releases/pharmaxis-concludes-special-protocol-assessment-with-fda-for-bronchitol-phase-3-trial-57511597.html | Yes | http://www.clinicaltrials.gov/ct2/show/NCT00669331?term=pharmaxis&phase=2&rank=4 | Jun-13 | |
nil | Polaris Group | ADI-PEG 20 | Advanced HCC | http://www.prnewswire.com/news-releases/fda-approves-special-protocol-assessment-for-phase-3-trial-of-polaris-groups-cancer-therapeutic-adi-peg-20-in-the-treatment-of-hepatocellular-carcinoma-118979494.html | Yes | http://www.clinicaltrials.gov/ct2/show/NCT01287585?term=Polaris+group&rank=1&submit_fld_opt= | Jun-13 | |
PVCT | Provectus | Rose Bengal | Melanoma | http://www.pvct.com/pressrelease.html?article=20121002 | pending | n/a | n/a | |
RPTP | Raptor | DR Cysteamine | Nephropathic Cystinosis | http://ir.raptorpharma.com/releasedetail.cfm?releaseid=633905 | Yes | http://www.clinicaltrials.gov/ct2/show/NCT01000961?term=raptor&rank=11 | Jun-11 | |
RPRX | Repros | Androxal | Hypogonadism | http://www.reprosrx.com/pr_20120912_repros_updates_androxal_phase_3.php | Yes | http://www.clinicaltrials.gov/ct2/show/NCT01534208?term=REPROS&rank=30 | Jul-13 |
Just my personal thoughts on biotech trading ideas. Not meant as investment advice. All views are my own.
Monday, 3 December 2012
SPA Directory Part 3: L-R
Here is the 3rd portion of the SPA Directory for companies L-R. As always I welcome your comments on any SPA agreements that are not shown here, especially active ongoing studies.
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Oncothyreon has a SPA on the Stimuvax trial. Results due early 1st qtr 2013.
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