Recap Of Friday's Biotech Catalysts - End of The Day Summary - Sarepta Therapeutics (NASDAQ:SRPT), Enanta Pharma (NASDAQ:ENTA)

The U.S. Food and Drug Administration (FDA) has approved Arcutis Biotherapeutics’ 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 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 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 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 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 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 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 GSK subsidiary ViiV Healthcare with Pfizer 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 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.

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