Thursday's Biotech Catalyst Recap - End of Day Recap

by , Benzinga Staff Writer

September 1, 2022 6:36 p.m. | 4 minute read

Important Biotech Catalysts for September 01, 2022 - EoD Summary The United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to Intellia Therapeutics' NTLA lead asset, NTLA-2002, for the treatment of hereditary angioedema (HAE). Intellia shares traded in a range of $56.52 to $60.06 on daily volume of 901,430 shares, regular trading session closed at $59.97. Shares of the company were trading at $60.96, up 1.65% in the after-hours trading session. Vaxart VXRT has announced positive early data from the first part of a planned two-part Phase 2 study of its oral-only COVID-19 vaccine candidate Wuhan S, VXA-CoV2-1.1-S. Vaxart shares traded up 2.26%, in the range of $2.91 to $3.17 on daily volume of 5.23 million shares against a three-month average volume of 2, 57 million shares, regular trading session closed at $3.15. Shares of the company were trading at $3.10, down 1.59% in the after-hours trading session. The U.S. Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) is scheduled to meet on October 28, 2022 to review Y-mAbs Therapeutics' YMAB (BLA) Biologics License Application for its product candidate , OMBLASTYS (omburtamab) for pediatric patients with CNS/leptomeningeal metastases from neuroblastoma. Y-mAbs shares traded in the $15.23-$16.06 range on daily volume of 157,040 shares, regular trading session closed at $16.01. Novavax NVAX has announced that the Nuvaxovid (NVX-CoV2373) COVID-19 vaccine has been recommended for extended conditional marketing authorization (AMC) in the European Union (EU) as a homologous and heterologous booster for the active immunization to prevent COVID-19 caused by SARS-CoV-2 for adults 18 years and older. Shares of Novavax traded in a range of $30.69 to $32.93 on daily volume of 4.73 million shares, closing the regular trading session at $31.95. Pfizer PFE and BioNTech SE BNTX have announced a 30 mcg booster dose of their bivalent COVID-19 vaccine Omicron BA.1 has been recommended for conditional marketing authorization (cMA) by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) (CHMP) for people aged 12 and over. Pfizer shares traded up 3.14%, in the range of $45.14 to $46.65 on daily volume of 19.13 million shares, closing the regular trading session at 46 $.63. Moderna MRNA announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a conditional marketing authorization for Spikevax bivalent Original/Omicron BA.1 (mRNA -1273.214), targeting the Omicron variant of concern (BA.1). Moderna shares traded up 5.09%, in the range of $130.11 to $139 on daily volume of 6.65 million shares versus three-month average volume of 4.92 million shares, regular trading session closed at $138.95. Cue Health HLTH announced that it has made a de novo submission to the United States Food and Drug Administration (FDA) for full clearance of the Cue Molecular Test Flu for home and point-of-care (POC) use. Cue Health shares traded up 5.71%, in the $3.21-$3.52 range on daily volume of 435,380 shares, closing the regular trading session at $3.50 . Pliant Therapeutics PLRX has announced a positive safety review from the ongoing INTEGRIS-IPF Phase 2a trial of PLN-74809 at a dose of 320 mg once daily in patients with idiopathic pulmonary fibrosis (IPF) at a regular meeting of its independent Data Safety Monitoring Board (DSMB). The DSMB recommended the INTEGR...