Astellas Pharma announced that it submitted on March 23, 2018, a new drug application for marketing approval of gilteritinib in Japan for the treatment of adult patients with FLT3 mutation-positive relapsed or refractory acute myeloid leukemia. Astellas also submitted a NDA for approval of gilteritinib in the same patient population to the U.S. Food and Drug Administration on March 29, 2018 following the submission in Japan. The applications for marketing approval for gilteritinib are based on data from the ongoing pivotal Phase 3 ADMIRAL study investigating gilteritinib in adult patients with FLT3mut+ relapsed or refractory AML.

Eli Lilly (LLY) and Incyte (INCY) announced that the U.S. Food and Drug Administration's Arthritis Advisory Committee recommended approval of the 2-mg dose of baricitinib, a once-daily oral medication for the treatment of moderately-to-severely active rheumatoid arthritis for adult patients who have had an inadequate response or intolerance to methotrexate. While the Advisory Committee unanimously supported the efficacy of the 4-mg dose of baricitinib, it did not recommend approval of the 4-mg dose of baricitinib for the proposed indication based on the adequacy of the safety and benefit-risk profiles. Baricitinib 2-mg and 4-mg doses are approved in more than 40 countries, including the member states of the European Union and Japan. For both doses, the Advisory Committee voted to support the assessment that baricitinib's data provide substantial evidence of efficacy. For the 2-mg dose, the Advisory Committee voted in favor of the assessment that baricitinib's safety data adequately support its approval. For the 4-mg dose, the Advisory Committee voted against the assessment that baricitinib's safety data was adequate to support its approval based on the proposed indication.

Fortescue Metal reports Q3 iron ore production 41.6M tons vs. 47.5M last year

According to a regulatory filing, United Continental chairman Robert Milton and board director Laurence Simmons will not stand for reelection to the board at the Annual Meeting and will retire retire from the board at the end of their current terms as director. Following the Annual Meeting, the board will elect a new, independent chairman and the size of the board will be reduced from 16 directors to 14 directors.

Comments from the Infosys Analyst Day investor slides earlier today. In constant currency, revenue growth trending at 5.8% vs. 8.3% in FY17. Sees FY18 number of clients with over $100M deal value rising to 20 from 14 in FY16. Sees FY18 free cash flow at $1.95B vs. 1.69B in FY17. Sees FY18 Operating Margin 24.3% vs. 24.7% in FY17. Sees FY18 ROE rising to 23.9% from 22.0% in FY17.

Says Assured Guartany's (AGO) self-grading could result in bias. Says Puerto Rican debt is troubled as population is shrinking and default is not traditional. Says Puerto Rico can only support so much debt. Says it doesn't appear company took hurricane into account. David Einhorn, president, Greenlight Capital (GLRE) is presenting at the 2018 Sohn Investment Conference.

Shares of Tivity Health are down 18.9% in after-hours trading to $32 per share.

Says Assured Guaranty (AGO) survived financial crisis "relatively unscathed." Says business is shrinking. Says tax bill eliminated benefits of advanced refundings.Says David Einhorn, president, Greenlight Capital (GLRE) is presenting at the 2018 Sohn Investment Conference.

Webster Financial, the holding company for Webster Bank and its HSA Bank division, announced that its Board of Directors declared a quarterly cash dividend of 33c per share on its common stock, an increase of 7c from the previous 26c per share. The dividend on the common shares will be payable May 21 to shareholders of record on May 7.

The chairman of brokerage Charles Schwab, Charles Schwab, disclosed in a filing that he had sold 250,000 shares of company stock at an average price of $54.99 per share on April 23. The value of the transaction was $13,747,475.

David Einhorn, president, Greenlight Capital (GLRE) is presenting at the 2018 Sohn Investment Conference.

Safeguard Scientifics announced that it has entered into an agreement with Sierra Capital Investments, L.P. and its affiliates, which currently own approximately 5.1% of the company's outstanding common stock. Under the terms of the agreement, the Safeguard Board of Directors has appointed two new independent directors, Russell D. Glass and Ira M. Lubert, to the Safeguard Board, effective immediately, and will support their re-election at the 2018 Annual Meeting of Shareholders as part of a five-person slate of nominees recommended by the Safeguard Board. Under the terms of the cooperation agreement, Sierra will vote its shares in favor of all of Safeguard's director nominees, including the new independent directors, at the Company's 2018 Annual Meeting of Shareholders. Sierra will also abide by certain customary standstill provisions until the date that is the earlier of 10 calendar days prior to the expiration of the advance notice period for the submission of shareholder nominations to be considered at Safeguard's 2019 Annual Meeting of Shareholders pursuant to Safeguard's Bylaws and 100 days prior to the first anniversary of Safeguard's 2018 Annual Meeting of Shareholders.