Caladrius Biosciences Inc (CLBS) stock price is increasing significantly in the pre-market session on Wednesday 10th March 2021. The stock price has been increased by 23.50% as of this writing.
The reason behind the positive trend
The stock analysts at Brookline Capital Management increased their estimated price from $7.00 to $10.00. Brookline Capital Management’s price target suggests a potential upside of 446.45% from the company’s current price. Caladrius Biosciences currently has a consensus rating of “Buy” and a consensus target price of $8.06.
Orphan Drug status for CLBS12 from FDA
On March 8, 2021, the Caladrius Biosciences announced that their CD34+ cell therapy, CLBS12, the product has received orphan drug designation from the U.S. Food and Drug Administration (“FDA”). The above-mentioned drug is used to treat Buerger’s disease, a condition which is related to critical limb ischemia (CLI) and it has no approved treatments to date in the U.S.
President and Chief Executive Officer of Caladrius. David J. Mazzo, PhD expresses his pleasure in the approval of CLBS12 as an orphan drug designation. He further said that their drug has shown strong results in Japan for the treatment of Buerger’s Disease. The company is now looking to discuss the next step with the FDA, which is the registration of CLBS12 in the USA.
The company announced its Q4 and full-year 2020 financial results on February 25, 2021.
Fourth Quarter and Full Year 2020 Financial Highlights
The company spent 2.9 million in the fourth quarter on Research and development expenses and $9.3 million for the year ended December 31, 2020. The company reported a net loss of $8.1 million for the year ended December 31, 2020, compared to $19.4 million for the year 2019. The company spent $2.5 million in General and administrative expenses in the fourth quarter and $9.9 million for the year ended December 31, 2020. The company reported earnings of $0.28 per share for the quarter, missing the analyst’s estimates of ($0.27) by ($0.01).