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CALT Stock Pops on Major FDA News. What to Know.

Little-known Swedish biotech firm Calliditas Therapeutics (NASDAQ:CALT) is up nearly 40% today after reporting an accelerated approval process from the U.S. Food and Drug Administration (FDA) for its medication to treat kidney disease.

Pipette adding fluid to one of several test tubes

Source: motorolka / Shutterstock.com

In a news release, Calliditas Therapeutics said that the FDA has accelerated the approval of its Tarpeyo (budesonide) medication. However, the company notes that continued approval of the drug may be contingent on a few things. For instance, Tarpeyo may need to undergo clinical trials to verify and describe its clinical benefit.

Although there is some uncertainty, the news today is enough to vault shares of CALT stock higher. At one point in the pre-market session, shares notched gains of 57%.

What Happened With CALT Stock

Based in Stockholm, Sweden, Calliditas Therapeutics is focused on developing treatments for renal (kidney) disease. Tarpeyo is its most advanced drug candidate, and the company is pushing to get it commercialized in the U.S. market. To date, the company has not brought any medications to market.

“TARPEYO represents an FDA approved product to help these patients who are at risk of rapid (kidney) disease progression,” said Calliditas CEO Renée Aguiar-Lucander in the company news release.

Why It Matters

Today’s big move higher is a positive development for CALT stock. At yesterday’s market close, shares were down 43% year to date. The stock was at a 52-week high of $34.75 in July of this year, but has slid 39% in the past six months.

News that the FDA has put Calliditas Therapeutics kidney disease treatment on the fast track to approval is a big indication that the medication has some merit. If all goes well, the drug will be commercially available in the U.S.

What’s Next for Calliditas

CALT stock is going to get a big boost when markets open today, which is good for shareholders who have had to fret as the share price has dropped in recent months. If today’s gains hold, they will wipe out the losses and give the stock a positive return on the year. While this is all great news, investors should remember that Calliditas Therapeutics still has some hurdles to jump through to get its kidney medication into U.S. pharmacies.

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On the date of publication, Joel Baglole did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.

Article printed from InvestorPlace Media, https://investorplace.com/2021/12/calt-stock-pops-on-major-fda-news-what-to-know/.

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