Biotek-snakken — April 2024
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En fabriksorienteret Complete Response Letter (CRL) kan typisk resultere i en forlængelse på 1 til 6 måneder, men i visse tilfælde kan forlængelsen vare op til 12 måneder eller mere.
"Receiving a complete response letter is not a rejection, but it introduces important business questions for product launch planning."
https://avalere.com/insights/what-is-a-complete-response-letter
(Avalere)
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Complete Response Letter (CRL) betyder en udfordring for Xbrane. De skal håndtere forsinkelsen, ekstra omkostninger men også en ekstra usikkerhed omkring godkendelse. Rent statistisk er høj godkendelsesraten for biosimilar ganske pæn. Har ikke Xbrane.
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Xbrane Biopharma: Ximluci – CRL
Redeye provides its initial comments on yesterday evening’s news that Xbrane has received a CRL from the FDA related to its Ximluci BLA. This means the FDA requires additional clarifications and a potential US approval will be delayed.
(Redeye)
"Given the available information, we believe that a realistic expectation for a new BsUFA date would be in the coming 6-9 months."
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Curasight får grønt lys til fase 2-forsøg mod prostatakræft https://www.proinvestor.com/investornyt/1148313/curasight-far-gront-lys-til-fase-2-forsog-mod-prostatakraeft
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Godmorgen
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Genovis AB: Genovis årsredovisning 2023 publicerad:
https://investor.genovis.com/wp-content/uploads/Genovis_AR_2023_Sv.pdf
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Calliditas Announces Positive NefIgArd Open Label Extension Results
Calliditas Therapeutics AB
Calliditas is a commercial stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs.
Calliditas Therapeutics AB (www.calliditas.se)
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Også muligt med et Kinpeygo-svar fra EMA i denne uge:
https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-22-25-april-2024_en.pdf
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God formiddag
Jeg så lige et indslag på Yahoo! Finance om ImmunityBio, som har fået FDA godkendelse af en ny behandling af blærekræft. Nogen der har fulgt selskabet? Formanden talte om, at de ville komme med en hel række behandlinger, baseret på en ny virkemåde. -
ImmunityBio's bladder cancer therapy wins FDA approval
The US Food and Drug Administration has approved ImmunityBio's (IBRX) bladder cancer therapy, a significant milestone for the company. ImmunityBio Executive Chairman Dr. Patrick Soon-Shiong, joins Market Domination alongside Yahoo Finance's health reporter Anjalee Khemlani to discuss the company's plans following this pivotal approval. Soon-Shiong says that Anktiva will be "the next generation of immuno-therapy." He claims the drug is the first of its kind to "generate complete remission that's completely durable" for 47 months and longer. Soon-Shiong believes the drug will serve as "a backbone" to "checkpoint inhibitors," a class of immunotherapy drugs. He envisions the drug's potential to target cancers regardless of their location within the body, describing it as "an opportunity to use this as a fundamental platform across all tumor types." Soon-Shiong says he, alongside other entities, collectively invested around $400 million in the company when the drug was first rejected. He further notes that additional investments totaling $100 million are forthcoming, stating, "the company is stable in terms of cash capabilities,"— hoping for a commercial launch of Anktiva in May. For more expert insight and the latest market action, click here to watch this full episode of Market Domination. This post was written by Angel Smith
Yahoo Finance (finance.yahoo.com)
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Calliditas: Supportive headline results from the Open Label Extension study
"Our Base Case is SEK 270 with a Bull case of SEK 390 and a Bear case of SEK 90."
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