Calliditas Therapeutics Scores Complete FDA Approval, Broader Label For Lead Kidney Disease Drug
Portfolio Pulse from Vandana Singh
Calliditas Therapeutics AB (NASDAQ:CALT) received full FDA approval for Tarpeyo, its treatment for IgAN, marking it as the first fully approved treatment for this condition based on kidney function. Tarpeyo, priced at $15,123 per month, is exclusively distributed through McKesson Corporation's (NYSE:MCK) specialty pharmacy, Biologics. Competitors like Travere Therapeutics Inc (NASDAQ:TVTX), Roche Holdings AG (OTC:RHHBY), Novartis AG (NYSE:NVS), and Vera Therapeutics Inc (NASDAQ:VERA) are developing treatments for IgAN. CALT shares rose 14.40% in premarket trading.
December 21, 2023 | 1:54 pm
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POSITIVE IMPACT
Calliditas Therapeutics received full FDA approval for its IgAN drug Tarpeyo, which is expected to significantly boost its adoption and sales.
Full FDA approval of Tarpeyo is a critical milestone for Calliditas, likely to increase investor confidence and drive stock prices up in the short term.
CONFIDENCE 90
IMPORTANCE 95
RELEVANCE 100
POSITIVE IMPACT
McKesson Corporation, through its specialty pharmacy Biologics, is the exclusive distributor of Tarpeyo, which may positively impact its revenue.
As the exclusive distributor of Tarpeyo, McKesson may see an increase in revenue from the drug's sales, positively affecting its stock in the short term.
CONFIDENCE 80
IMPORTANCE 60
RELEVANCE 70
NEUTRAL IMPACT
Novartis AG is developing an IgAN treatment, and the approval of Tarpeyo may influence the competitive landscape and urgency for NVS's product development.
Novartis is in the process of developing its own IgAN treatment, and while the approval of Tarpeyo changes the competitive environment, the direct short-term impact on NVS stock is uncertain.
CONFIDENCE 70
IMPORTANCE 50
RELEVANCE 50
NEUTRAL IMPACT
Roche Holdings AG, also in the race to develop an IgAN treatment, may need to consider the implications of Tarpeyo's approval on its own development efforts.
Roche is another competitor in the IgAN treatment market. The approval of Tarpeyo could affect the strategy for Roche's product, but the immediate impact on its stock is not clear.
CONFIDENCE 70
IMPORTANCE 50
RELEVANCE 50
NEUTRAL IMPACT
Vera Therapeutics, with its IgAN treatment in development, may experience indirect effects due to Tarpeyo's approval, potentially influencing its investment in R&D.
Vera Therapeutics is also working on an IgAN treatment. The market dynamics could shift with Tarpeyo's approval, but the short-term impact on VERA's stock is not definitive.
CONFIDENCE 70
IMPORTANCE 50
RELEVANCE 50
NEGATIVE IMPACT
Travere Therapeutics, with its competing IgAN drug Filspari priced lower than Tarpeyo, may face increased competition affecting its market share.
The approval of a competing drug at a higher price point could pressure Travere to adjust its strategy, potentially impacting its stock negatively.
CONFIDENCE 75
IMPORTANCE 70
RELEVANCE 60