Ardelyx doesn't know where to go from here. The FDA won't give the biopharma clarity on the prospects for its chronic kidney disease drug, so the company is going to have to say goodbye to 65% of its staff.
The company already cut about 80 jobs in August. Today's news is another 102 jobs, and the latest round of cuts will take effect by December 15, the biopharma said in an SEC filing dated Wednesday.
Shares cratered 19% to $1.06 apiece as of 10:10 a.m. ET.
The FDA rejected tenapor in July with a complete response letter that said the treatment's effect was "small and of unclear clinical significance." That was despite "substantial evidence" that the drug was able to reduce serum phosphorus in patients with chronic kidney disease on dialysis across three phase 3 trials, the agency said.
Ardelyx has now emerged from an Oct. 4 meeting with the FDA without the clarity needed to move forward. The discussions did not provide enough visibility into what the company could submit to support "clinical relevance of the magnitude of treatment effect."
"Given that we have conducted the requisite registration studies, which met all primary and key secondary endpoints with no safety or other identified issues, we continue to be extremely disappointed and surprised by the lack of clarity from the FDA on the next steps to resubmit our NDA," said Mike Raab, CEO and president, in a statement.
But getting across the finish line for CKD has been a different story. Ardelyx is tied up with a number of partners on the therapy, including Kyowa Kirin in Japan, Shanghai Fosun Pharmaceutical in China and Knight Therapeutics in Canada. Knight launched the drug in March.
Ardelyx's annual cash compensation costs will decrease by about $18.1 million and the restructuring will cost about $2.3 million, mainly this quarter, for severance and employee-related costs, the statement said.
The company finished the third quarter, ended Sept. 30, with $141.7 million in cash and cash equivalents. That figure was $171.8 million at the end of the second quarter.