Pre-Open Stock Movers 07/20: (IMNM) (NURO) (PTON) Higher; (ARDX) (PPG) (RKT) Lower (more...)
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Pre-Open Stock Movers
Ardelyx, Inc. (Nasdaq: ARDX) 73.3% 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.
Immunome, Inc. (Nasdaq: IMNM) 35.5% HIGHER; announced today that its three-antibody cocktail (IMM-BCP-01) has demonstrated potent neutralizing activity against the SARS-CoV-2 Delta variant in pre-clinical pseudovirus testing. Furthermore, IMM-BCP-01 showed in-vitro activity via non-neutralizing mechanisms, such as complement fixation, which Immunome expects will enable viral clearance.
NeuroMetrix, Inc. (Nasdaq: NURO) 14.7% HIGHER; announced that its Quell® device has received Breakthrough Designation from the U.S. Food and Drug Administration (FDA) for treating the symptoms of fibromyalgia in adults.
MediWound Ltd. (Nasdaq: MDWD) 11.4% HIGHER; announced positive topline results from its pivotal phase 3 pediatric clinical study (CIDS - Children Innovation Debridement Study) with NexoBrid® to treat children with severe thermal burns, evaluating the efficacy and safety compared with standard-of-care (SOC).
PLx Pharma Inc. (NASDAQ: PLXP) 10.3% HIGHER; announced that three stock-keeping units (“SKUs”) of VAZALORE, the first and only U.S. Food and Drug Administration (“FDA”) approved liquid-filled aspirin capsules, will be available in over 8,000 Walgreens stores nationwide later in August. Walgreens is a global leader in retail pharmacy.
Peloton (Nasdaq: PTON) 6.7% HIGHER; UnitedHealthcare, part of UnitedHealth Group (NYSE: UNH), and Peloton (Nasdaq: PTON) are working together to provide millions of Americans with access at no additional cost to classes that can help improve their overall fitness and well-being, the first such relationship between Peloton and a health plan.
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.
Rocket Cos Inc. (NYSE: RKT) 3.3% LOWER; Wedbush downgraded from Neutral to Underperform with a price target of $12.00 (from $14.00).
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.
Ally Financial (NYSE: ALLY) 1.3% HIGHER; reported Q2 EPS of $2.33, $0.87 better than the analyst estimate of $1.46. Revenue for the quarter came in at $2.09 billion versus the consensus estimate of $1.87 billion.
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