On October 24, 2019 OPKO Health, Inc. ("OPKO Health" or the "Company") (NASDAQ:OPK) reported the pricing of an underwritten public offering of 50 million shares of its common stock (the "Shares") at a price of $1.50 per Share, resulting in gross proceeds to the Company, before deducting underwriting discounts and commissions and estimated offering expenses, of $75,000,000 (Press release, Opko Health, OCT 24, 2019, View Source [SID1234542529]). The Company has also granted the underwriters an option for a period of 30 days to purchase up to an additional 7.5 million Shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about October 29, 2019, subject to customary closing conditions.

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The Company intends to use the net proceeds received from the offering of the Shares to fund research and development to further develop and commercialize its portfolio of proprietary pharmaceutical and diagnostic products and for working capital, capital expenditures, acquisitions and other general corporate purposes.

Jefferies LLC, Piper Jaffray & Co. and Guggenheim Securities, LLC are acting as joint book-running managers for the offering.

The offering of the Shares is being made by means of a prospectus supplement to the prospectus forming a part of the Company’s effective shelf registration statement on Form S-3 (Registration No. 333-229400) filed with the Securities and Exchange Commission (the "SEC") on January 28, 2019 and other related documents. You may obtain these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the final prospectus supplement may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY, 10022, by email at [email protected] or by phone at +1 877 821 7388; Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by email at [email protected] or by phone: 1-800-747-3924; and Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by email at [email protected] or by phone at +1 212 518 5548. Before you invest, you should read the prospectus supplement and the accompanying base prospectus along with other documents that the Company has filed with the SEC for more complete information about the Company and these offerings.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, the Shares or any other securities, nor will there be any sale of the Shares or any other securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On October 24, 2019 Gilead Sciences, Inc. (Nasdaq: GILD) reported that the company’s Board of Directors has declared a cash dividend of $0.63 per share of common stock for the fourth quarter of 2019 (Press release, Gilead Sciences, OCT 24, 2019, View Source [SID1234542528]). The dividend is payable on December 30, 2019, to stockholders of record at the close of business on December 13, 2019. Future dividends will be subject to Board approval.

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On October 24, 2019 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with a primary focus in hematology and oncology, reported that the company submitted an updated Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ROLONTIS (eflapegrastim) (Press release, Spectrum Pharmaceuticals, OCT 24, 2019, View Source [SID1234542527]).

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The BLA for ROLONTIS is supported by data from two identically designed Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLONTIS in 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLONTIS demonstrated the pre-specified hypothesis of non-inferiority (NI) in Duration of Severe Neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLONTIS also demonstrated non-inferiority to pegfilgrastim in the DSN across all 4 cycles (all NI p<0.0001) in both studies.

"We have submitted a robust package to the FDA that incorporates strong clinical data and addresses previously communicated FDA requests relating to manufacturing processes," said Joe Turgeon, President and CEO of Spectrum. "ROLONTIS could be the first novel G-CSF available to healthcare providers in over 15 years and, if approved, we are looking forward to competing in this multibillion-dollar market."

In March 2019, Spectrum voluntarily withdrew the ROLONTIS BLA that it filed with the FDA in 2018. The updated BLA filed today includes additional information in the Chemistry, Manufacturing and Controls (CMC) section.

About ADVANCE

The ADVANCE trial was a Phase 3, multicenter, randomized, active-controlled, open label trial that enrolled 406 early-stage breast cancer patients, who received docetaxel and cyclophosphamide chemotherapy every 21 days for four cycles. Patients were randomized in a 1:1 ratio to receive ROLONTIS or pegfilgrastim (eflapegrastim n=196; pegfilgrastim n=210). The primary trial endpoint was the DSN (absolute neutrophil counts [ANC] <0.5×109/L) in Cycle 1, based on central laboratory assessment of ANC over the 21-day cycle. Secondary endpoints included the DSN in Cycles 2, 3, and 4, time to ANC recovery, depth of ANC nadir and incidence of febrile neutropenia at Cycle 1. Patients with stage I to stage IIIA breast cancer were treated with four cycles of adjuvant/neo-adjuvant docetaxel and cyclophosphamide. On Day 2 of each cycle, patients received a single dose of either eflapegrastim 13.2 mg/0.6 mL (3.6 mg G-CSF) or pegfilgrastim (6 mg) subcutaneously. ADVANCE was conducted under a special protocol assessment (SPA) with the FDA.

About RECOVER

The RECOVER trial was a Phase 3, multicenter, randomized, active-controlled, open label trial that enrolled 237 breast cancer patients who received docetaxel and cyclophosphamide chemotherapy every 21 days. Patients were randomized in a 1:1 ratio to receive ROLONTIS (n=118) or pegfilgrastim (n=119). The primary trial endpoint was the DSN in Cycle 1 of chemotherapy (absolute neutrophil count [ANC] <0.5×10^9/L), based on central laboratory assessment of ANC over a 21-day cycle. Secondary endpoints included the DSN in Cycles 2, 3, and 4, time to ANC recovery, depth of ANC nadir and incidence of febrile neutropenia at Cycle 1. Patients with stage I to stage IIIA breast cancer were treated on Day 1 of each of the four cycles with adjuvant/neo-adjuvant docetaxel and cyclophosphamide. On Day 2 of each cycle, patients received a single dose of either eflapegrastim 13.2 mg/0.6 mL (3.6 mg G-CSF) or pegfilgrastim (6 mg) subcutaneously.

On October 24, 2019 Cytokinetics, Incorporated (Nasdaq:CYTK) reported that it is scheduled to report third quarter results on October 31, 2019 at 4:00 PM Eastern Time (Press release, Cytokinetics, OCT 24, 2019, View Source [SID1234542526]). Following the announcement, Cytokinetics’ senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company’s outlook for the future.

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The conference call will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 9440838.

An archived replay of the webcast will be available via Cytokinetics’ website until November 7, 2019. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 9440838 from October 31, 2019 at 7:30 PM Eastern Time until November 7, 2019.

On October 24, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a biopharmaceutical company focused on commercializing novel vaccines, reported that it will report third quarter 2019 financial results on Wednesday, November 6, 2019, after the U.S. financial markets close (Press release, Dynavax Technologies, OCT 24, 2019, View Source [SID1234542489]).

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Dynavax will host a conference call and live audio webcast on Wednesday, November 6, 2019 at 4:30 p.m. (ET)/1:30 p.m. (PT).

The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the company’s website at www.dynavax.com. Alternatively, participants may dial 800-479-1004 (domestic) or 720-543-0206 (international) and refer to conference ID 5687867.

The archived conference call will be available on Dynavax’s website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.