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$UNCY

4 stories mentioning UNCYUpdated 75d ago

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Sectors

Sector Update: Healthcare Stocks Softer Late Afternoon

Healthcare stocks were lower late Tuesday afternoon, with the NYSE Healthcare Index decreasing 0.9% and the State Street Health Care Select Sector SPDR ETF (XLV) shedding 1.1%.The iShares Biotechnology ETF (IBB) rose 0.2%.In corporate news, Pacira Biosciences (PCRX) has agreed to sell its Iovera cold-therapy pain relief system to Zimmer Biomet (ZBH) for up to $140 million. Pacira shares rose 1%, and Zimmer fell past 6%.Unicycive Therapeutics (UNCY) shares tumbled 40% after it 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 people with chronic kidney disease on dialysis.AbbVie (ABBV) and Merck (MRK) are facing investigations by the China Select Committee of the US House over whether clinical trials conducted in China may have contributed to the country's military capabilities, Reuters reported. AbbVie shares were down 1.3%, and Merck shed nearly 1%.Align Technology (ALGN) shares fell 3% after the European Commission said Tuesday it has opened an antitrust probe to determine whether the company has violated EU competition rules by tying its dental clear aligners to its intra-oral scanners in the European Economic Area.

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Wire

Top Midday Decliners

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%

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Wire

Unicycive Therapeutics Gets FDA's Complete Response Letter for Resubmitted Oxylanthanum Carbonate NDA

Unicycive Therapeutics (UNCY) said Tuesday it has received US Food and Drug Administration's Complete Response Letter regarding a resubmitted new drug application for oxylanthanum carbonate for treating hyperphosphatemia in patients with chronic kidney disease on dialysis.The letter is based on previously identified deficiencies at a third-party manufacturing vendor, the company said, adding that FDA has not yet conducted an inspection of that third-party vendor as part of its review process for the resubmitted application.The FDA has not raised any concerns regarding clinical efficacy or safety data, and no additional data has been requested from the company, Unicycive Therapeutics further said.Shares of the company were down 50% in Tuesday premarket activity.Price: $3.90, Change: $-3.80, Percent Change: -50.00%

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Research

B. Riley Initiates Unicycive Therapeutics at Buy With $22 Price Target

Unicycive Therapeutics (UNCY) has an average rating of buy and mean price target of $41.33, according to analysts polled by FactSet.Price: $7.62, Change: $-0.04, Percent Change: -0.59%

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