- The U.S. Food and Drug Administration (FDA) has approved Arcutis Biotherapeutics’ (NASDAQ:ARQT) New Drug Application (NDA) for ZORYVE (roflumilast) cream 0.3% for the treatment of plaque psoriasis in patients 12 years of age or older. The company expects commercial launch of the product in Mid-August. Arcutis shares traded in a range of $23.09 to $24.56 on a day volume of 563.43 thousand shares, closed regular trading session at $24.26.
- The European Commission (EC) has approved AbbVie’s (NYSE:ABBV) lead candidate RINVOQ (upadacitinib 15 mg, once daily) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI). AbbVie shares traded in a range of $139.05 to $146.3 on a day volume of 17.63 million shares, closed regular trading session at $143.51.
- The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Omeros Corporation’s (NASDAQ:OMER) lead asset OMS906 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Omeros shares traded in a range of $4.5 to $5.27 on a day volume of 1.26 million shares, closed regular trading session at $4.98. The company shares are currently trading at $4.89, down 1.81 percent in the after-hours trading session.
- Bristol Myers Squibb (NYSE:BMY) announced that Part A of the Phase 3 CheckMate -914 trial, evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as an adjuvant treatment for patients with localized renal cell carcinoma (RCC) did not meet the primary endpoint of disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR). Bristol Myers shares traded in a range of $73.17 to $74.65 on a day volume of 13.04 million shares, closed regular trading session at $73.78.
- Enanta Pharmaceuticals (NASDAQ:ENTA) reported positive topline data from a Phase 1 study evaluating the safety, tolerability, and pharmacokinetics (PK) of orally administered single and multiple ascending doses of EDP-235 in healthy adult subjects. Enanta shares traded in a range of $50 to $55.32 on a day volume of 335.41 thousand shares, closed regular trading session at $55.15.
- Sarepta Therapeutics (NASDAQ:SRPT) announced its intention to submit Biologics License Application (BLA) seeking accelerated approval for SRP-9001 to treat ambulant individuals with Duchenne muscular dystrophy. Sarepta shares traded in a range of $89.75 to $95.85 on a day volume of 3.64 million shares, closed regular trading session at $92.95.
- Adamis Pharmaceuticals (NASDAQ:ADMP) provided an update on the ongoing U.S. Phase 2/3 clinical trial to evaluate the safety and efficacy of Tempol as a treatment for COVID-19. The next Data Safety Monitoring Board (DSMB) meeting to review interim data results has been scheduled for late September. Adamis shares traded in a range of $0.37 to $0.38 on a day volume of 491.6 thousand shares, closed regular trading session at $0.38. The company shares are currently trading at $0.36, down 4.34 percent in the after-hours trading session.
- GSK’s (NASDAQ:GSK) subsidiary ViiV Healthcare with Pfizer (NASDAQ:PFE) and Shionogi as shareholders, announced week 240 (five-year) results from the phase III BRIGHTE study of fostemsavir in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection who have very few treatment options left available to them due to resistance, intolerance, or other safety concerns. Pfizer shares traded in a range of $49.28 to $50.71 on a day volume of 24.9 million shares, closed regular trading session at $50.51.
- Meridian Bioscience (NASDAQ:VIVO) has received re-authorization of its Emergency Use Authorization (EUA) for the Revogene SARS-COV-2 molecular assay from the U.S. Food and Drug Administration (FDA). The company expects to begin shipping this product before September 30, 2022. Meridian shares traded in a range of $31.65 to $32.01 on a day volume of 567.83 thousand shares, closed regular trading session at $31.66.
