Entry into a Material Definitive Agreement

On October 24, 2019, OPKO Health, Inc., a Delaware corporation (the "Company"), reported that it has entered into an underwriting agreement (the "Underwriting Agreement") with Jefferies LLC, Piper Jaffray & Co. and Guggenheim Securities, LLC, as representatives of the several underwriters identified therein (the "Underwriters"), pursuant to which the Company agreed to issue and sell to the Underwriters, and the Underwriters agreed to purchase from the Company, 50,000,000 shares (the "Firm Shares") of the Company’s common stock, par value $0.01 per share ( "Common Stock"), in a registered public offering under the Securities Act of 1933, as amended (the "Securities Act"), pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-229400) and a related prospectus, together with the related prospectus supplements for the underwritten public offering of the Common Stock, filed with the Securities and Exchange Commission (Filing, 8-K, Opko Health, OCT 29, 2019, View Source [SID1234550012]).

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In addition, the Company granted the Underwriters a 30-day option to purchase up to an additional 7,500,000 shares of Common Stock.

The Company intends to use the net proceeds received from the offering of the Common Stock 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.

The Underwriting Agreement includes customary representations, warranties and covenants by the Company and customary closing conditions. Under the terms of the Underwriting Agreement, the Company has agreed to indemnify the Underwriters against certain liabilities.

The closing of the issuance of the Firm Shares occurred on October 29, 2019.

The foregoing description of the Underwriting Agreement is qualified in its entirety by reference to the complete text of the Underwriting Agreement attached as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated by reference herein. A copy of the opinion of Greenberg Traurig, LLP regarding the validity of the Common Stock issued in this offering is filed as Exhibit 5.1 to this Current Report on Form 8-K.

RhoVac Receives Approval in Finland to Start Clinical Phase IIb Study in Prostate Cancer

On October 29, 2019 RhoVac AB ("RhoVac") reported, on 29th October, 2019, that the company has received approval from FIMEA (Finnish Medicines Agency) for starting the clinical phase IIb study in prostate cancer, a multicenter study entitled RhoVac-002 ("BRaVac") (Press release, RhoVac, OCT 29, 2019, View Source [SID1234550006]). The phase IIb study is an international, multicenter study, which is expected to recruit more than 175 patients in six European countries (Denmark, Finland, Sweden, the UK, Belgium and Germany), as well as in the United States.

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BRaVac is a randomized, placebo-controlled and double-blind study, with the primary objective of evaluating if and to what extent treatment with the drug candidate RV001 can prevent or limit the development of cancer measured as a limited development of PSA (Prostate Specific Antigene) in prostate cancer patients compared to the control group (placebo group). The Phase IIb study is an international multicenter study, which is expected to recruit more than 175 patients in six European countries (Denmark, Finland, Sweden, the United Kingdom, Belgium and Germany), as well as in the United States. The ambition is for all patients to be recruited by end Q3 2020. The results reporting on the primary objective of the study is expected during H2 2021. RhoVac has, after obtaining approval, received it in two countries, Denmark and Finland.

For further information, please contact:

Anders Månsson – CEO, RhoVac AB
Phone number: +46-73-751-72-78
E-mail: [email protected]

This information is such that RhoVac AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on 29th October 2019.

Protalix BioTherapeutics to Release Third Quarter 2019 Financial Results and Business Update on November 7, 2019

On October 29, 2019 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported that it will release its financial results for the third quarter 2019 and business update on Thursday, November 7th, 2019 (Press release, Protalix, OCT 29, 2019, View Source [SID1234550005]). The Company’s management will host a conference call to discuss its financial results and provide a general business update at 8:30 a.m. Eastern Standard Time (EST).

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Conference Call Details
Thursday, November 7th at 8:30 a.m. Eastern Standard Time
Domestic (USA): 888-224-1005
International: 323-994-2093
Conference ID: 1931108
Webcast: http://bit.ly/2BSCaiY

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

Rigel Announces Conference Call and Webcast to Report Third Quarter 2019 Financial Results

On October 29, 2019 Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) reported that it will report its third quarter 2019 financial results after market close on Tuesday, November 5, 2019 (Press release, Rigel, OCT 29, 2019, View Source [SID1234550004]). Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results.

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Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from Rigel’s website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website.

Caprion Biosciences Leads Pre-Conference Workshop on Best Practices for Biomarkers Validation at Upcoming AAPS PharmaSci 360 Conference

On October 29, 2019 Caprion is reported its leadership role in a Pre-Conference Workshop at the upcoming AAPS PharmaSci 360 conference, San Antonio, Texas (Press release, Caprion, OCT 29, 2019, View Source [SID1234550002]).

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The workshop initiated by Caprion’s team and led by Dr. Virginia Litwin, Vice-President of Flow Cytometry, will include pharmaceutical, biotech and regulatory leaders in biomarker research.

The workshop entitled "Best Practices for the Development and Fit-for-Purpose Validation of Biomarker Methods" will consist of presentations and break-out sessions, leading to consensus on the best practice for biomarker assay development and minimum validation requirements based on intended use. As a result of the workshop, a white paper will propose recommendations for the industry and regulatory agencies.

"Caprion’s involvement in this pre-conference workshop reflects its commitment to be an active player and a leader in defining the industry standards when it comes to the development of robust assay validation strategies", stated Dr. Lorella Di Donato, Senior Vice-President and Chief Operating Officer. "

Dr. Litwin is a frequent speaker, moderator, and panelist at pharmaceutical industry, scientific, and clinical conferences, and was recently recognized at the 2019 WRIB meeting for her outstanding contribution. She is the chair of the Document Development Committee for the new CLSI guidance document H62: The Validation of Assay Performed by Flow Cytometry, which will be open for public comment until November 18.