Ardelyx, Inc. (Nasdaq: ARDX) 73% LOWER; received a letter from the U.S. Food and Drug Administration (the "FDA") on July 13, 2021, stating that, as part of its ongoing review of the company's New Drug Application ("NDA") for the control of serum phosphorus in adult patients with chronic kidney disease ("CKD") on dialysis, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The letter stated that the notification does not reflect a final decision on the information under review. The company immediately requested a meeting to discuss the deficiencies and was notified by the FDA today that the request for a meeting was denied.
Arcus Biosciences (NYSE: RCUS) 7% LOWER; announced that Bill Grossman M.D., Ph.D., will transition out of his role as chief medical officer at Arcus Biosciences and into a role at Gilead Sciences (NASDAQ: GILD) as senior vice president of oncology clinical research to oversee Gilead’s clinical-stage oncology portfolio. This will include leading Gilead’s efforts in the company’s alliance with Arcus to co-develop and co-commercialize Arcus’s portfolio of investigational cancer medicines. Kartik Krishnan, M.D., Ph.D., senior vice president, clinical development at Arcus, will assume full leadership of the Arcus clinical development program and continue to work closely with Grossman at Gilead. The transition will be effective July 26, 2021.
PPG Industries (NYSE: PPG) 5.9% LOWER; reported Q2 EPS of $1.94, $0.26 worse than the analyst estimate of $2.20. Revenue for the quarter came in at $4.4 billion versus the consensus estimate of $4.33 billion.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) 5.8% HIGHER; announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for the generic version of TobraDex®, which adds another complex ophthalmic product to the generics portfolio.
Crown Holdings (NYSE: CCK) 4.6% HIGHER; reported Q2 EPS of $2.14, $0.37 better than the analyst estimate of $1.77. Revenue for the quarter came in at $2.86 billion versus the consensus estimate of $2.97 billion. Crown Holdings sees Q3 2021 EPS of $1.90-$2.00, versus the consensus of $1.69. Crown Holdings sees FY2021 EPS of $7.30-$7.40, versus the consensus of $6.86.
IBM (NYSE: IBM) 3% HIGHER; reported Q2 EPS of $2.33, $0.04 better than the analyst estimate of $2.29. Revenue for the quarter came in at $18.7 billion versus the consensus estimate of $18.29 billion. The company expects to grow revenue for the full year 2021 based on mid-July 2021 foreign exchange rates. The company continues to expect adjusted free cash flow of $11 billion to $12 billion in 2021. Adjusted free cash flow expectations exclude approximately $3 billion of cash impacts from the company’s structural actions initiated in the fourth quarter of 2020 and the transaction costs associated with the separation of Kyndryl.