Calliditas Gains Approval for China
Calliditas Announced Today: Nefecon receives market approval in China
Calliditas' China partner, Everest Medicines, today announced that Nefecon has received market approval from the Chinese regulatory agency NMPA for the treatment of IgAN.
China has the highest prevalence of IgAN with an estimated five million patients.
IgAN is common disease in China, while in the west it is consdered a rare disease. When I spoke to the company on this six months ago, the management was very bullish on China opportunity.
Calliditas' China partner, Everest Medicines, today announced that Nefecon has received market approval from the Chinese regulatory agency NMPA for the treatment of IgAN.
China has the highest prevalence of IgAN with an estimated five million patients.
IgAN is common disease in China, while in the west it is consdered a rare disease. When I spoke to the company on this six months ago, the management was very bullish on China opportunity.
NordicGuy
28.05.2024 kl 11:28
236
Calliditas up 88% after being acquired by the JApanese.
Vicore and Bioinvent next takeover candidates?
Vicore and Bioinvent next takeover candidates?
Mattelæreren
02.04.2024 kl 09:50
410
Utrolig gode nyheter fra Kina. Kina ( og flere land i Asia) er et av verden største markeder for Calliditas sitt produkt og salg der vil være gamechanger for Calliditas
Calliditas partner Everest Medicines förväntar sig att Nefecon kommer att bli kommersiellt lanserad på Fastlandskina, Hongkong och Singapore under 2024. Det uppger bolaget i samband med sin årsrapport. Calliditas har rätt till royalties på försäljningen.
Vidare uppger Everest Medicines att man räknar med att erhålla NDA-godkännanden för Nefecon i Taiwan och Sydkorea under 2024.
NDA är en förkortning för New Drug Application.
Nefecon används för att behandla IgAN hos vuxna med risk för sjukdomsprogression.
IgAN eller Bergers sjukdom, är den i västvärlden vanligaste formen av glomerulonefrit, en kronisk inflammatorisk njursjukdom.
Les også her:
https://www.everestmedicines.com/news/everest-medicines-announces-financial-results-for-full-year-ended-december-31-2023/4d941f08-9cf4-4d34-adf5-506dbb518404/?redirect=1
Calliditas partner Everest Medicines förväntar sig att Nefecon kommer att bli kommersiellt lanserad på Fastlandskina, Hongkong och Singapore under 2024. Det uppger bolaget i samband med sin årsrapport. Calliditas har rätt till royalties på försäljningen.
Vidare uppger Everest Medicines att man räknar med att erhålla NDA-godkännanden för Nefecon i Taiwan och Sydkorea under 2024.
NDA är en förkortning för New Drug Application.
Nefecon används för att behandla IgAN hos vuxna med risk för sjukdomsprogression.
IgAN eller Bergers sjukdom, är den i västvärlden vanligaste formen av glomerulonefrit, en kronisk inflammatorisk njursjukdom.
Les også her:
https://www.everestmedicines.com/news/everest-medicines-announces-financial-results-for-full-year-ended-december-31-2023/4d941f08-9cf4-4d34-adf5-506dbb518404/?redirect=1
Mattelæreren
08.03.2024 kl 11:23
528
dette er et medisinselskap som kommer til å bli en vinner i årene som kommer. Mange godkjenninger og patenter på plass. og salget øker. Kursmessig ligger den nå i startgropen.....
NordicGuy
02.01.2024 kl 15:44
885
Mattelæreren skrev Enig. Livsfarlig å selge seg ut av denne nå. Her kan mye positivt skje
Look at the graph. It is a volatile stock. Sold at 135-140. Now 125.
Would like to buy it back around 100 SEK.
Interestingly, CALTX is one of the most shorted stocks in Scandinavia
Would like to buy it back around 100 SEK.
Interestingly, CALTX is one of the most shorted stocks in Scandinavia
Mattelæreren
28.12.2023 kl 09:51
1010
Alias Mr X skrev Her tror jeg du bommer, forlengelse av patent er rett rundt hjørne🤞
Enig. Livsfarlig å selge seg ut av denne nå. Her kan mye positivt skje
Alias Mr X
28.12.2023 kl 09:19
1032
Her tror jeg du bommer, forlengelse av patent er rett rundt hjørne🤞
NordicGuy
28.12.2023 kl 09:00
1070
I sold my position in Calliditas at 140 SEK.
It is a volatile stock. I buy it back below 100. I have done this before.
It is a volatile stock. I buy it back below 100. I have done this before.
NordicGuy
21.12.2023 kl 08:14
1267
Redey on the FDA Approval
FDA has completed the review of Tarpeyo on time. With clear support from the 2-year post-approval study (NefIgArd Part B), Tarpeyo secures unconditional approval. Equally important is the label revision and, primarily, the broader label pointing to patients with a higher risk of rapid disease progression without referring to the previous 1.5 g/g UPCR limitation. The new label will support Tarpeyo’s market expansion. The timing is favorable as we await a new guideline draft from KDIGO within a month. We expect a positive >15% share market reaction compared with the local equity market.
NordicGuy
20.12.2023 kl 22:49
1310
BIG NEWS:
FDA grants full approval to Tarpeyo and removes label restriction
The FDA just granted full approval to Tarpeyo for the treatment of IgA Nephropathy (IgA N). This enables the company to market the drug much more broadly while giving it the final stamp of acknowledgment on its kidney protective properties.
FDA grants full approval to Tarpeyo and removes label restriction
The FDA just granted full approval to Tarpeyo for the treatment of IgA Nephropathy (IgA N). This enables the company to market the drug much more broadly while giving it the final stamp of acknowledgment on its kidney protective properties.
NordicGuy
11.12.2023 kl 15:55
1469
Pareto just published their take on today´s announcement:
This afternoon, Calliditas announced that it has received a Notice of Allowance from the US Patent and Trademark Office (USPTO) for a patent covering the composition of Tarpeyo.
According to the company, the new patent is expected to provide an extra 14 years of exclusivity for Tarpeyo in the US from 2029 to 2043.
Calliditas also plans to extend patent protection globally, filing applications in Europe and China.
We view this as positive news, although we need more details to assess if we can incorporate the full exclusivity extension into our valuation.
This afternoon, Calliditas announced that it has received a Notice of Allowance from the US Patent and Trademark Office (USPTO) for a patent covering the composition of Tarpeyo.
According to the company, the new patent is expected to provide an extra 14 years of exclusivity for Tarpeyo in the US from 2029 to 2043.
Calliditas also plans to extend patent protection globally, filing applications in Europe and China.
We view this as positive news, although we need more details to assess if we can incorporate the full exclusivity extension into our valuation.
NordicGuy
11.12.2023 kl 15:40
1480
JUst announnced:
Calliditas Receives Notice of Allowance for United States Patent Application Covering TARPEYO®
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 18/100,396 entitled “New Pharmaceutical Compositions.” This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed.
The allowed claims cover a method of treating IgA nephropathy with a composition that encompasses TARPEYO® (budesonide) delayed release capsules, developed under the name “NEFECON®”. Calliditas expects the resulting patent will be Orange Book-listable, with an anticipated expiration date in 2043. The patent, when issued, will be Calliditas’ second patent for TARPEYO in the United States.
Calliditas intends to file corresponding patent applications in additional territories around the world, including Europe and China.
“When issued, our new patent will significantly strengthen TARPEYO’s intellectual property protection, further improving its unique value proposition, and providing a basis for an active program of extending patent protection of the NEFECON® franchise globally,” said CEO Renée Aguiar-Lucander.
Calliditas Receives Notice of Allowance for United States Patent Application Covering TARPEYO®
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 18/100,396 entitled “New Pharmaceutical Compositions.” This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed.
The allowed claims cover a method of treating IgA nephropathy with a composition that encompasses TARPEYO® (budesonide) delayed release capsules, developed under the name “NEFECON®”. Calliditas expects the resulting patent will be Orange Book-listable, with an anticipated expiration date in 2043. The patent, when issued, will be Calliditas’ second patent for TARPEYO in the United States.
Calliditas intends to file corresponding patent applications in additional territories around the world, including Europe and China.
“When issued, our new patent will significantly strengthen TARPEYO’s intellectual property protection, further improving its unique value proposition, and providing a basis for an active program of extending patent protection of the NEFECON® franchise globally,” said CEO Renée Aguiar-Lucander.
NordicGuy
11.12.2023 kl 15:32
1489
I listened to the Calliditas CEO interview on Redeye (see the link in the conversation below).
The CEO said:
- In China IgAN is a common disease - five million Chinese suffer from the illness - a much higher percentage than in the West
- Early access program in China – huge demand by patients - there is NO OTHER treatment available
- Chinese patients get diagnosed earlier – it is a well-known and more established disease
- Calliditas will be on private pay for the first year.
- Regional governments selected this for review for reimbursement – it should happen in 2024
- Central government - most likely, it will be in review for reimbursement from 2025
The next catalysts due by 20/12/23
- FDA approval – the CEO was quite confident the FDA approval would be granted
- Calliditas has been selling in the US based on preliminary approval for about a year. The FDA approval would allow the company to market the drug fully.
THE CEO WAS VERY OPTIMISTIC FOR 2024
The CEO said:
- In China IgAN is a common disease - five million Chinese suffer from the illness - a much higher percentage than in the West
- Early access program in China – huge demand by patients - there is NO OTHER treatment available
- Chinese patients get diagnosed earlier – it is a well-known and more established disease
- Calliditas will be on private pay for the first year.
- Regional governments selected this for review for reimbursement – it should happen in 2024
- Central government - most likely, it will be in review for reimbursement from 2025
The next catalysts due by 20/12/23
- FDA approval – the CEO was quite confident the FDA approval would be granted
- Calliditas has been selling in the US based on preliminary approval for about a year. The FDA approval would allow the company to market the drug fully.
THE CEO WAS VERY OPTIMISTIC FOR 2024
NordicGuy
11.12.2023 kl 11:42
1534
Calliditas CEO interview with Redeye research:
https://www.redeye.se/research/964707/calliditas-interview-with-ceo-renee-aguiar-lucander
https://www.redeye.se/research/964707/calliditas-interview-with-ceo-renee-aguiar-lucander
heilo888
26.11.2023 kl 10:40
1679
Om inflasjonen og rentetoppen er nådd internasjonalt og markedet begynner å skue mot lavere renter vil det helt
klart påvirke biotech-sektoren positivt. Tror bunnen i biotech er passert og at man ser gradvis bedring utover i 2024 og 2025 .
Caltx er helt klart en aksje som vil nyte godt av utsiktene til lavere renter samtidig som salg og fortjeneste vil øke radikalt i de kommende par årene.
klart påvirke biotech-sektoren positivt. Tror bunnen i biotech er passert og at man ser gradvis bedring utover i 2024 og 2025 .
Caltx er helt klart en aksje som vil nyte godt av utsiktene til lavere renter samtidig som salg og fortjeneste vil øke radikalt i de kommende par årene.
Kraamz
26.11.2023 kl 08:46
1704
Spennende case dette da! Er 2024 året hvor Biotek går tilbake til "normalen" ?
heilo888
24.11.2023 kl 17:04
1747
Da klarte man perfekt å lukke gapet som oppstod i morges, og fikk kjøpt på kr 96 og under.
Det neste er godkjenning i USA 20. desember.
Har stor tro på at Caltx vil utvikle seg meget sterkt det kommende året nå når salget kommer i gang alle store markedene Europa, USA og Kina.
Et kjøp her nede vil være et sant kupp på litt sikt!
Det neste er godkjenning i USA 20. desember.
Har stor tro på at Caltx vil utvikle seg meget sterkt det kommende året nå når salget kommer i gang alle store markedene Europa, USA og Kina.
Et kjøp her nede vil være et sant kupp på litt sikt!
heilo888
24.11.2023 kl 10:50
1772
CALTX er vel etter det jeg har skjønt tungt shortet så blir spennende å se hvordan short-aktørene nå agerer.
Redigert 24.11.2023 kl 11:56
Du må logge inn for å svare
Mattelæreren
24.11.2023 kl 10:23
1789
Det er nesten vanskelig å fatte hvor gode nyheter dette er. Kina er verdenens største marked for CALTX sitt produkt. IgAN er en stor sykdom i Kina. dette er utrolig gode nyheter selv om det var ventet