Markedet er veldig uenig med Pareto
Bryan Garnier 190 SEK
Jeffries med 337 SEK (60$ for 2 aksjer)
Kempen 300 SEK
Penser 300 SEK
Swedbank 140 SEK
Pareto 300 SEK
Redeye 280 SEK (125 - 450 SEK)
Carnegie 133 SEK
SEB med nytt kursmål 80 SEK og ville spekulasjoner ut fra ekstrapolering av rare datapunkter.
2 Likes
Traderne må få sitt. Mini 58 er wipet, kan det ut som, en del stop loss har antakelig gått rundt 70…
Bør vel få en rebound herfra?
Neste mini er nr 15 med stop loss på 60 ish. Mulig den også skal tas ut?
Pirato er bull - og deres kunder er største selger
Gjetter på dobbeltkommunikasjon de luxe her
Calliditas: Clarification of recent publication feedback
2022-10-20
10:51
The Calliditas share price reaction suggests that the Kidney International publication feedback should result in increased uncertainty. The results are mostly in line with should be expected and a negative reaction is mainly justified if some investors has inflated expectations. The current Calliditas valuation suggests that this is a small minority of investors.
Johan Unnerus
Tarpey has conditional approval to treat IgAN patients with elevated proteinuria of UPCR >1.5g/g. Elevated proteinuria is a well-established biomarker for the more advanced stages of IgAN, where the risk of disease progression and declining filtration of eGFR is elevated.
In the Kidney International publication, there are some interesting insights in terms of baseline characteristics and especially in terms of patient sub-group dynamics. In IgAN, we should expect (based on earlier published studies) that a group of diagnosed IgAN patients with low levels of proteinuria (measured by either UPCR or UACR) has a low level of eGFR disease progression. The rate of eGFR decline increases much faster for patients with elevated proteinuria. The eGFR decline is very modest for patient’s with proteinuria < 0.99 g/g and even less (near nil) deterioration when < 0.33 g/g. The accelerated eGFR decline kicks in for the patient group in the 1-2 g/g range and accelerates further for patients beyond >2 g/g. The 1.5 g/g hurdle on Tarpeyo’s label corresponds with a level where the risk of progression is distinctly higher. Some confirmatory points from the Kidney International publication:
- The positive eGFR impact over 9m and 12m is confirmed for the subgroup of patients with UPCR of > 1.5g/g (some 37% of the patients)
- The positive eGFR impact over 9m and 12m was limited for patients with UPCR of <1.5g/g (some 63% of the patients)
The average level of UPCR was 1.21-1.27 g/g; hence, most patients were below or in the very early stage of the UPCR range, where eGFR levels started to deteriorate faster. It is very difficult/impossible for Tarpeyo to show a positive eGFR effect among patients with no or very limited eGFR deterioration. A large minority of patients in this study had UPCR levels below 1.0 g/g, where Tarpey should have limited positive eGFR effects, especially over 9-12 months. Among relevant patients (UPCR 1.5g/g and above), we can expect even more significant benefits from Tarpeyo in terms of UPCR reduction and eGFR progression. In real life, this is also the >1.5 g/g patient cohort where specialists will and should prescribe a product like Tarpeyo. This includes both Tarpeyo naive patients and future repeat patients (when UPCR eventually bounces back to a higher level) in our view.
The cost-benefit rationale is also related to if the patients are at risk of experiencing eGFR deterioration or not. The Kidney International publication does not provide meaningful feedback on when the second dose of Tarpeyo should be administrated, nor the proportion of patients that should be subject to a repeat dose. We expect that Part B of the study will provide information in this respect (Q1 2023). Will this be after 15, 18 or 24 months and for what proportion of patients?
The publication does also introduce some question marks in our view. Some aspects are more challenging to understand:
- The Tarpeyo benefit is higher among European patients vs North American patients
We note that the number of US patients in the active arm is 17. This is a very small number of patients, and the proportion of patients with a UPCR of >1.5g/g is even lower, possibly as low as below 7. A natural explanation is that this number could be even lower (a disproportionate number of US early disease patients) or just a random result. This is also something to look out for in the extended study.
- The positive Tarpey effect is higher among men vs women.
This is difficult to understand, and we note that there is a high number of men in the study (66%). This is also something to look out for in the extended part B study.
The publication suggests that the positive Tarpey result would probably be even better among a more representative patient group (included in the label). The treatment profile also indicates that the Tarpey effect will be higher for patients with elevated UPCR levels ( above 1.5 g/g and most likely even higher among patients >2.0 g/g). On the other hand, the results (in the same disease progression group) could be slightly softer with a 50/50 male vs women split. The publication provides no clues to assessing the long-term eGFR effect nor o the dynamics related to when to initiate repeat Tarpeyo dosage.
Based on the current very modest valuation, few investors seem to expect a dramatic future market expansion beyond the current Tarpeyo label. As a result, this recent adverse share price reaction on the back of this publication is probably a dramatic overreaction that can be an excellent opportunity to invest in Calliditas ahead of further launch and study support.
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CALLIDITAS THERAPEUTICS
Volatil handel i Calliditas efter fas 3-data - vd kommenterar (Finwire)
2022-10-20 11:30
Igår föll forskningsbolaget Calliditas aktie 17 procent och idag fortsätter raset efter att ett mäklarhus tolkat fas 3-data för en subgrupp i studien på ett visst sätt. Datan presenterades i förrgår i en peer-reviewed vetenskaplig artikel i Kidney international.
Finwire hörde med Calliditas vd Renée Aguilar Lucander, som gav sin syn på mäklarfirmans kommentar.
“Problemet här är att det dragits slutsatser som inte går att dra baserat på den här datan. Jag har full förståelse för att det är komplext, men då kanske det är bra att få förklaringar på hur det fungerar. Det är ju tråkigt när det blir missförstånd och felaktigheter i sådana här situationer”, säger den verkställande direktören.
Enkelt förklarat gäller det en tolkning av data för en subgrupp med mindre sjuka patienter. Mäklarhuset antyder att Nefecon potentiellt kan ha negativa effekter i denna grupp.
En av huvudförfattarna för publikationen, som har tagit del av mäklarhusets tolkning, menar att tolkningen var “faktamässigt inkorrekt och ett grovt missförstånd av data”, säger Calliditas-chefen.
Aguilar Lucander lyfter även fram att den här datan har varit känd sedan tidigare och att såväl FDA som EMA tagit del av den när de gett sina villkorade godkännanden.
I mäklarhusets kommentar finns även antydningar om att Nefecon skulle utgöra en säkerhetsrisk.
“Det finns en spekulation i den här noten att det skulle finnas några säkerhetsrelaterade problem, men Nefecon har precis gått igenom FDA och det finns absolut inga säkerhetsrelaterade antydningar över huvud taget”, säger hon.
Filip Lindkvist
Nyhetsbyrån Finwire
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Oida, snakker vi tidenes rekyl?
Jeg har nå kjøpt mer, så antakeligvis ikke 
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Samme her 
Ok…finwire! Mer beroligende med en pressemelding fra calliditas!.. venter i spenning! 
Tok sjansen og økte!
Det er vel i utgangspunktet stilleperiode fra selskapet, uten at jeg vet alt hva det innebærer…
Da bør de heller ikke kommentere via andre kanaler…
Veldig spesielt det som skjer nå i CALTX.
EN analytiker forskutterer - på meget tynt grunnlag - black label for en pasientgruppe som uansett ikke er inkludert i den midlertidige godkjenningen fra FDA/EMA.
Så gjenstår det å se om oppklaringen fra VD som nettopp kom kan snu dette.
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Det er vel ca 1.9 mill aksjer short så gambler litt på et bestillingsverk her!
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Hele intervjuet:
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Denne historie gav en Mega mulighed, som jeg heldigvis fik udnyttet til det fulde. 
Jeg har økt med 37,5% i antall aksjer så da er jeg klar for oppgangen 
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Fedt 
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