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Y-mAbs Announces Proposed Public Offering of Common Stock

On October 29, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported the commencement of a registered underwritten public offering of up to $125 million in shares of its common stock (Press release, Y-mAbs Therapeutics, OCT 29, 2019, View Source [SID1234550051]). All shares in the offering are expected to be offered by the Company. In addition, the Company intends to grant the underwriters a 30-day option to purchase up to $18.75 million in shares of its common stock.

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Morgan Stanley, J.P. Morgan and BofA Securities, are acting as the joint book-running managers for the proposed offering. The offering is subject to market and other customary closing conditions, and there can be no assurance as to whether or when the offering may be completed.

A shelf registration statement relating to the shares of common stock being offered in the public offering described above was filed on Form S-3 (Reg. No. 333-234034) which was declared effective by the Securities and Exchange Commission (SEC) on October 15, 2019. The securities may be offered only by means of a written prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, Second Floor, New York, New York 10014; J.P. Morgan, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, or by telephone at (866) 803-9204; or BofA Securities, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by emailing [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or 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 jurisdiction.

TRACON To Report Third Quarter 2019 Company Highlights And Financial Results On November 5, 2019

On October 29, 2019 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and wet age-related macular degeneration through our license to Santen Pharmaceutical Co. Ltd., and utilizing our product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that it will report its third quarter 2019 financial and operating results after the close of U.S. financial markets on Tuesday, November 5, 2019 (Press release, Tracon Pharmaceuticals, OCT 29, 2019, View Source [SID1234550050]). In addition, management will host a conference call to provide an update on corporate activities and discuss the quarterly financial results.

Conference call and webcast:
Date: November 5, 2019
Time: 4:30 pm Eastern Time (1:30 pm Pacific Time)
Dial-in: (855) 779-9066 (Domestic) or (631) 485-4859 (International)
Passcode: 3896667
Via web: www.traconpharma.com; "Events and Presentations" section within the "Investors" section
A replay of the webcast will be available for 60 days on the website.

MorphoSys AG: Ad hoc: Primary Endpoint met in Real-World Data Study Demonstrating Clinical Superiority of the Combination of Tafasitamab and Lenalidomide compared to Lenalidomide alone

On October 29, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; Nasdaq: MOR) reported topline results from the primary analysis of the retrospective observational matched control cohort (Re-MIND) (Press release, MorphoSys, OCT 29, 2019, View Source [SID1234550048]). This study was designed to compare the effectiveness of lenalidomide monotherapy based on real-world patient data with the efficacy outcomes of the tafasitamab/lenalidomide combination, as investigated in MorphoSys’s L-MIND trial (primary analysis results announced on June 22, 2019).

Re-MIND collected outcome data from 490 non-transplant eligible patients with relapsed/ refractory diffuse large B cell lymphoma (r/r DLBCL) who had received lenalidomide monotherapy in the U.S. and the EU in a real-world setting. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible Re-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective response rates (ORR) were validated based on this subset of 76 patients in Re-MIND and L-MIND, respectively.

The primary endpoint of Re-MIND has been met and shows a statistically significant superior best ORR of the tafasitamab/lenalidomide combination compared to lenalidomide monotherapy. ORR was 67.1% (95% confidence interval (CI): 55.4-77.5) for the tafasitamab/ lenalidomide combination, compared to 34.2% (CI: 23.7-46.0) for the lenalidomide monotherapy (p<0.0001). Superiority was consistently observed across all secondary endpoints, including complete response (CR) rate (tafasitamab/lenalidomide combination 39.5%; CI: 28.4-51.4 versus lenalidomide monotherapy 11.8%; CI: 5.6-21.3; p<0.0001), as well as in pre-specified statistical sensitivity analyses. In addition, there was a significant difference observed in overall survival, which was not reached in the tafasitamab/lenalidomide combination as compared to 9.3 months in the lenalidomide monotherapy (hazard ratio 0.47; CI: 0.30-0.73; p<0.0008).

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]).

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.

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.