Quest Diagnostics Declares Quarterly Cash Dividend

On August 18, 2020 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that its Board of Directors declared a quarterly cash dividend of $0.56 per share, payable on October 21, 2020 to shareholders of record of Quest Diagnostics common stock on October 6, 2020 (Press release, Quest Diagnostics, AUG 18, 2020, View Source [SID1234563778]).

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Results of BioNTech Rights Offering

On August 18, 2020 BioNTech SE (Nasdaq: BNTX) ("BioNTech" or the "Company") a clinical-stage biotechnology company focused on patient-specific immunotherapies for the treatment of cancer and infectious diseases, reported an offering of rights to subscribe for new ordinary shares and new American Depositary Shares ("ADSs") representing new ordinary shares (Press release, BioNTech, AUG 18, 2020, View Source [SID1234563777]). The respective subscription periods expired on August 14, 2020 (the "expiration date"). Pursuant to the rights offering, subscribers will purchase an aggregate of 16,124 ordinary shares, represented by 16,124 ADSs, at the subscription price of $93.00 per ADS. Delivery of the ADSs in the rights offering is expected to be made on or about August 27, 2020.

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BioNTech expects to use the net proceeds that it receives from the exercise of the subscription rights issued in the rights offering for general corporate purposes.

If a holder of ordinary shares or ADSs did not exercise its ordinary share or ADS subscription rights prior to the expiration date, such rights have expired and are void and have no value, and such rights will not affect the number of ordinary shares (including those represented by ADSs) held by such holder.

A registration statement on Form F-1, as amended, relating to the rights and ordinary shares was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on July 24, 2020. A prospectus relating to the rights offering was filed with the SEC on July 23, 2020 and is available on the SEC’s website.

Entry into a Material Definitive Agreement

On August 17, 2020, Aduro Biotech, Inc. ("Aduro" or the "Company"), Aspire Merger Sub, Inc. ("Merger Sub") and Chinook Therapeutics U.S., Inc. ("Chinook") reported that it entered into Amendment No. 1 (the "Amendment") to the Agreement and Plan of Merger and Reorganization (the "Merger Agreement"), dated June 1, 2020, by and among the Company, Merger Sub and Chinook (Filing, 8-K, Aduro Biotech, AUG 18, 2020, View Source [SID1234563776]). The Amendment revises the Merger Agreement to, among other things, reflect Chinook’s contemplated private placement financing, which is expected to occur immediately prior to the closing of the merger of Merger Sub with and into Chinook (the "Merger"). The Amendment revises the Exchange Ratio to be used for purposes of determining the number of shares of Aduro common stock to be received by Chinook stockholders in the Merger to exclude the shares of common stock issued by Chinook in its proposed private placement financing from the shares of Chinook capital stock treated as outstanding for purposes of the Exchange Ratio.

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Other than as expressly modified pursuant to the Amendment, the Merger Agreement remains in full force and effect as originally executed on June 1, 2020. The foregoing summary of the terms of the Amendment is subject to, and qualified in its entirety by, the copy of the Amendment filed as Exhibit 2.1 to this Current Report on Form 8-K, which is incorporated herein by reference.

Aeglea BioTherapeutics to Present at World Orphan Drug Congress USA 2020

On August 18, 2020 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare and other high-burden diseases, reported it will participate in two presentations at the World Orphan Drug Congress USA 2020 being held virtually August 24-27, 2020 (Press release, Aeglea BioTherapeutics, AUG 18, 2020, View Source [SID1234563775]).

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Presentation Details

Panel Title: Stronger Together: Continuing industry and patient partnerships to ensure inclusion of patient voice along the full continuum of development, from pre-clinical through commercialization
Date/Time: August 24 at 9:10 a.m. EDT
Moderator: Michael C. Hanley, Aeglea’s chief commercial officer

Presentation Title: Next generation human enzymes: Innovative solutions for patients with rare diseases
Date/Time: August 25 at 12:50 p.m. EDT
Presenter: Anthony G. Quinn, M.B. Ch.B., Ph.D., Aeglea’s president and chief executive officer

The company presentation will be available for download on the Presentations & Events section of the Company’s website.

National Comprehensive Cancer Network® Adds Monjuvi® (tafasitamab-cxix) to its Clinical Practice Guidelines in Oncology for B-cell Lymphomas

On August 18, 2020 MorphoSys AG (FSE:MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (Nasdaq:INCY) reported that Monjuvi (tafasitamab-cxix), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, has been included in the latest National Comprehensive Cancer Network Clinical Practice Guidelines (NCCN Guidelines) in Oncology for B-cell Lymphomas (Press release, Incyte, AUG 18, 2020, View Source [SID1234563774]). Specifically, the NCCN Guidelines in the United States now include Monjuvi in combination with lenalidomide with a Category 2A designation as an option for the treatment of previously-treated adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma who are ineligible for autologous stem cell transplant (ASCT).

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This press release features multimedia. View the full release here: View Source

"We are very gratified the NCCN acted quickly to include Monjuvi in combination with lenalidomide with a Category 2A designation in its Clinical Practice Guidelines in Oncology as a treatment for patients with relapsed or refractory DLBCL who are not candidates for transplant. This targeted therapeutic option helps address an immediate medical need for patients who previously had limited treatment options," said Dr. Malte Peters, Chief Research & Development Officer, MorphoSys. "There is no other FDA-approved second line treatment for these patients with a 2A designation within the NCCN guidelines."

The U.S. Food and Drug Administration (FDA) approved Monjuvi in combination with lenalidomide under accelerated approval on July 31, 2020, for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DBLCL arising from low grade lymphoma, and who are not eligible for ASCT. The approval was based on data from the MorphoSys-sponsored Phase 2 L-MIND study, an open label, multicenter single arm trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1

The NCCN is a not-for-profit alliance of 30 leading cancer centers devoted to patient care, research and education. The intent of the NCCN Guidelines is to assist in the decision-making process of individuals involved in cancer care – including physicians, nurses, pharmacists, payers, patients and their families – with the ultimate goal of improving patient care and outcomes.

"The inclusion of Monjuvi in the NCCN Guidelines will help further inform healthcare providers of this advancement for patients," said Peg Squier, M.D., Group Vice President, U.S. Medical Affairs, Incyte. "We believe Monjuvi has the potential to address an urgent medical need for patients with relapsed or refractory DLBCL and are pleased that the NCCN has acknowledged the clinical benefit of this targeted therapeutic option."

DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide,2 characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafter.3 In the United States each year, approximately 10,000 patients are diagnosed with relapsed or refractory DLBCL who are not eligible for ASCT.4,5,6

The updated NCCN Guidelines are available at www.nccn.org.

NCCN and the NCCN Guidelines are registered trademarks of National Comprehensive Cancer Network.

About Monjuvi (tafasitamab-cxix)
Monjuvi is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize Monjuvi globally. Monjuvi will be co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

Tafasitamab-cxix is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi is a registered trademark of MorphoSys AG.
XmAb is a registered trademark of Xencor, Inc.

Important Safety Information
What are the possible side effects of MONJUVI?
MONJUVI may cause serious side effects, including:

Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.
Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding.
Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs and symptoms of an infection.
The most common side effects of MONJUVI include:

Feeling tired or weak
Diarrhea
Cough
Fever
Swelling of lower legs or hands
Respiratory tract infection
Decreased appetite
These are not all the possible side effects of MONJUVI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you:

Have an active infection or have had one recently.
Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.
You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.