Unicycive Therapeutics (UNCY) said Tuesday it has received a Complete Response Letter from the US Food and Drug Administration over its resubmitted new drug application for oxylanthanum carbonate for treating hyperphosphatemia in patients with chronic kidney disease on dialysis.
The letter relates to deficiencies previously identified at third-party manufacturing vendor, the firm said, adding that the FDA inspection of third-party facility did not occur during the resubmission review.
Shares sank 37% amid a surge in intraday trading volume to over 17.2 million from a daily average of about 907,000 shares.
JPMorgan Chase (JPM), which is running a stock and note offering from Sable Offshore (SOC), has seen limited investor demand for a loan paying 15%, Bloomberg reported Tuesday, citing people familiar with the matter.
Sable shares sank 46% as intraday trading volume catapulted to over 45.0 million from a daily average of about 3.8 million.
Pacira Biosciences (PCRX) has agreed to sell its Iovera cold-therapy pain relief system to Zimmer Biomet (ZBH) for up to $140 million.
Zimmer shares dropped 7.5%, with intraday trading volume of over 2.31 million against a daily average of about 2.34 million.
Price: $4.83, Change: $-2.87, Percent Change: -37.27%