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

CALTX er vel etter det jeg har skjønt tungt shortet så blir spennende å se hvordan short-aktørene nå agerer.

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!

Spennende case dette da! Er 2024 året hvor Biotek går tilbake til "normalen" ?

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.

Calliditas CEO interview with Redeye research:

https://www.redeye.se/research/964707/calliditas-interview-with-ceo-renee-aguiar-lucander

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

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.

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.

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.

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.

Dette er et flott selskap som fortjener litt oppmerksomhet 🙂👍

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.

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

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

Enorm kjøpsmulighet !!!

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.....

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