Health care stocks were mostly lower late in afternoon trading, with the NYSE Health Care Index falling 0.7% while the SPDR Health Care Select Sector ETF (XLV) was down 0.7%.
The Nasdaq Biotechnology index also was sinking 1.2%.
In company news, MannKind (MNKD) shares slumped over 18% after the FDA declined to approve the company's Tyvaso DPI inhaled treatment for pulmonary arterial hypertension, saying the agency cited a single deficiency at a third-party analytical testing center rather than any issue at MannKind's manufacturing and packaging facility in Connecticut.
Revance Therapeutics (RVNC) dropped more than 39% after late Friday, saying the US Food and Drug Administration declined to approve a biologics license for the company's daxibotulinumtoxinA injection for the treatment of frown lines after the agency found deficiencies at the company's manufacturing facility during an onsite inspection. No other deficiencies were identified, Revance said.
To the upside, Valneva (VALN) raced nearly 40% higher after its COVID-19 vaccine candidate met its co-primary endpoints during phase III testing, with VLA2001 demonstrating superiority against AstraZeneca's (AZN) AZD1222 vaccine as well as non-inferiority in terms of seroconversion rates two weeks after a second jab. VLA2001 also was generally well-tolerated, with participants reporting significantly fewer solicited adverse events up to seven days after the vaccination.
Adamis Pharmaceuticals (ADMP) rose nearly 11% after the US Food and Drug Administration approved its Zimhi high-dose naloxone injection for the treatment of opioid overdose. Adamis and commercial partner US WorldMeds are preparing for a full commercial launch of Zimhi in Q1 of next year.