CalciMedica said that it has decided to discontinue the trial evaluating its lead product candidate Auxora in patients with Stage 2 or Stage 3 acute kidney injury following a committee recommendation.
- According to the company, the committee said that the safety concerns warrant reevaluation of the study design, particularly with respect to patient enrollment criteria.
- There were no deaths in the trial related to the study drug or any serious adverse events that warranted expedited reporting to the U.S. Food and Drug Administration, the company added.
- Oppenheimer sees the stock as oversold on today’s news and “significantly undervalued.”
CalciMedica (CALC) shares closed down 76% and edged further 4% lower after-hours on Wednesday after the company said that it has decided to discontinue the trial evaluating its lead product candidate Auxora in patients with Stage 2 or Stage 3 acute kidney injury with associated acute hypoxemic respiratory failure.
Rationale For Discontinuation
The biopharmaceutical company said that the discontinuation decision followed a recommendation from an independent data monitoring committee that identified a safety concern.
According to the company, the committee said that the safety concerns warrant reevaluation of the study design, particularly with respect to patient enrollment criteria.
There were no deaths in the trial related to the study drug or any serious adverse events that warranted expedited reporting to the U.S. Food and Drug Administration, the company added.
CalciMedica will now perform a review of the clinical data, which will inform how evaluation of Auxora will proceed in acute kidney injuries.
“Based on the IDMC’s feedback, we will review the unblinded KOURAGE data and explore modifications to the trial design, particularly patient enrollment criteria, that may support further clinical testing of Auxora in patients with AKI,” said CEO Rachel Leheny.
CalciMedica is also evaluating Auxora in acute pancreatitis and severe COVID-19 pneumonia.
Analyst Take
Oppenheimer on Wednesday said that shares of CALC were oversold after the company announced the discontinuation of the mid-stage trial in patients with kidney injury.
Oppenheimer said that it caught up with management following the news, who said the safety concern identified by the independent committee’s review of unblinded data “appears to stem not from the drug itself, but from aspects of this particular trial.”
The firm sees the stock as oversold on today’s news and “significantly undervalued.” Even if one removes any revenue potential in AKI from projections, Auxora’s derisked $200M opportunity in acute pancreatitis alone supports a favorable outlook, the analyst said.
The firm has an ‘Outperform’ rating on CalciMedica shares.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment around CALC stock jumped from ‘bearish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume rose from ‘low’ to ‘extremely high’ levels.
A Stocktwits user voiced hopes for a rebound in share price to sell.
Another echoed Oppenheimer and said that the stock is oversold for the news. “This should correct itself either fast or slow but it will correct itself,” they said.
CALC stock has dropped 53% over the past 12 months.
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