Nefecon errreicht in Phase3 Studie den primären und sekundären Endpunkt
www.calliditas.se/en/...-pivotal-phase-3-nefigard-trial-3310/
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Nefecon errreicht in Phase3 Studie den primären und sekundären Endpunkt
www.calliditas.se/en/...-pivotal-phase-3-nefigard-trial-3310/
324 Mio. SEK Offering
www.calliditas.se/en/...f-approximately-sek-324-million-3615/
FDA verschiebt die Entscheidung um 3 Monate
"In March 2021 Calliditas filed for FDA approval using the Accelerated Approval Program, based on the proteinuria endpoint as previously discussed with the Agency, reflecting data from the 200 patients in Part A of the NefIgArd trial.
In its review of the NDA, the FDA has requested further analyses of the NeflgArd trial data which the company has provided to the FDA. The Agency has classified these analyses as a major amendment to the NDA. The amendment mainly provides additional eGFR and other related analyses as further support of the proteinuria data provided in the NDA submission. The FDA has therefore extended the PDUFA goal date to December 15, 2021."
www.calliditas.se/en/...sion-for-nefecon-nda-in-the-u-s-3809/
FDA Zulassung für Nefecon
Gestern nachbörslich bis auf 31$ hoch, heute vorbörslich bei 26$.
endpts.com/...y-disease-beating-two-competitors-to-the-punch/
75 Mio. $ ATM
www.calliditas.se/en/...hes-a-u-s-at-the-market-program-4194/
EU-Zulassung für Kinpeygo (IgA nephropathy)
www.calliditas.se/en/...ts-with-primary-iga-nephropathy-4205/
Nefecon (IgAN) Phase 3 Studie erreicht den primären Endpunkt
www.calliditas.se/en/...valuating-nefecon-in-iga-nephropathy/
sNDA wurde bei der FDA eingereicht
www.calliditas.se/en/...tration-for-full-approval-of-tarpeyo/
Wertung | Antworten | Thema | Verfasser | letzter Verfasser | letzter Beitrag | |
17 | CALT 33.50$ (+33%) | Vassago | Balu4u | 22.09.23 09:10 |