Eli Lilly, Incyte Announce FDA Approval Of OLUMIANT For Hospitalized Patients With COVID-19

Eli Lilly and Co. (LLY) and Incyte (INCY) announced Wednesday that the U.S. Food and Drug Administration (FDA) has approved OLUMIANT (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The recommended dosage is 4-mg once daily for 14 days or until hospital discharge, whichever comes first.

OLUMIANT is the first and only JAK inhibitor FDA-approved for the treatment of COVID-19 in certain hospitalized adults requiring various degrees of oxygen support.

The FDA’s approval is supported by results from two randomized, double-blind, placebo-controlled Phase 3 studies (ACTT-2 and COV-BARRIER, including the COV-BARRIER OS 7 addendum study), announced previously. No new safety signals potentially related to the use of OLUMIANT were identified in the studies.

Baricitinib has been available in the U.S. under Emergency Use Authorization (EUA) since November 2020.

Lilly has submitted applications for regulatory approval or authorization to multiple regulatory agencies around the world and anticipates further regulatory decisions to follow.

OLUMIANT is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly. It is available in the U.S. as 1-mg and 2-mg tablets through Lilly’s authorized specialty distributors.

Arcus Biosciences Stock Tanks 27%

Shares of Arcus Biosciences, Inc. (RCUS), a clinical-stage biopharmaceutical company that focuses on cancer therapies, tanked 27% on Wednesday morning. The stock seems to be impacted by the failure of Roche’s lung cancer drug trial.

Genentech, a member of the Roche Group (RHHBY), on Wednesday said that phase III SKYSCRAPER-01 study in PD-L1-High Metastatic Non-Small Cell Lung Cancer did not meet its co-primary endpoint of progression-free survival.

Roche is testing the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone as an initial treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancer.

The company noted that the other co-primary endpoint of overall survival was immature, and the study will continue until the next planned analysis.

RCUS is currently trading at $17.48, down $6.53 or 27.22%, on the NYSE.

Ondas Holdings Stock Slips 3% On Quarterly Results

Shares of Ondas Holdings Inc. (ONDS) slipped over 3% on Wednesday morning after the company reported a wider loss for the first quarter.

ONDS is currently trading at $5.59, down $0.19 or 3.29%, on the Nasdaq. The stock opened its trading at $4.05 after closing Tuesday’s trading at $5.78. The stock has traded between $3.92 and $11.74 in the past 52-week period.

Net loss for the first quarter was $9.9 million or $0.24 per share, as compared to a net loss of $3.1 million or $0.12 per share last year. Revenues were $0.4 million for the quarter, down from $1.2 million last year.

Electronic Arts Climbs On Surge In Q4 Profit

Electronic Arts Inc. (EA) shares are gaining more than 10 percent on Wednesday morning trade after the company reported a surge in fourth-quarter net profit on revenue growth.
The company reported a quarterly net profit of $225 million or $0.80 compared to net profit of $76 million or $0.26 per share last year.

Revenue for the quarter increased to $1.825 billion from $1.346 billion last year.

Currently, shares are at $122.39, up 9.66 percent from the previous close of $111.60 on a volume of 2,074,027. The shares have traded in a range of $109.24-$148.93 on average volume of 2,032,656 for the last 52 weeks.

Ryerson Holding Down 11%; Announces Pricing Of 3.5 Mln Shares Secondary Offering

Shares of metal suppliers and distributor Ryerson Holding Corp. (RYI) are trading down 11 percent on Wednesday after the company announced the pricing of an earlier declared secondary public offering of 3.5 million shares of its common stock, following a shelf registration statement filed with the Securities and Exchange Commission by its principal shareholder, an affiliate of Platinum Equity LLC.

Ryerson Holding added that the affiliate would receive all of the net proceeds from the offering.

Currently at $29.10, the stock has traded between $13.39 and $44.09 during the past 52 weeks.

AbbVie Announces Positive Topline Results From U-ENDURE Phase 3 Study Evaluating Upadacitinib

Biopharmaceutical company AbbVie Inc. (ABBV) announced on Wednesday positive topline results from U-ENDURE, its Phase 3 maintenance study evaluating upadacitinib in adult patients with moderate to severe Crohn’s disease who had an inadequate response or were intolerant to a conventional or biologic therapy.

The results showed that more patients treated with either dose of upadacitinib (15 mg or 30 mg once daily) achieved the co-primary endpoints of endoscopic response and clinical remission, as well as the secondary endpoint of endoscopic remission, at one year (week 52) compared to placebo.

Use of upadacitinib in Crohn’s disease has not been evaluated by health authorities. Results from the U-ENDURE maintenance study, in addition to results from the U-EXCEED and U-EXCEL induction studies, will be included in future regulatory submissions.

In the U-ENDURE maintenance study, patients from U-EXCEED and U-EXCEL who responded to 12 weeks of upadacitinib 45 mg oral induction treatment were re-randomized to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo.

The safety results of upadacitinib (15 mg or 30 mg) were generally consistent with the safety profile observed in the Phase 3 induction studies in Crohn’s disease.