On January 8, 2020 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report fourth quarter and full year 2019 results on Thursday, January 30, 2020, before the market opens (Press release, Quest Diagnostics, JAN 8, 2020, View Source [SID1234552854]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "Investor." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-357-4210 for domestic callers or 203-369-0125 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on January 30, 2020 until midnight Eastern Time on February 13, 2020.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On January 8, 2020 Centene Corporation (NYSE:CNC) ("Centene") reported the extension of the expiration date of the offers to exchange (the "Exchange Offers") notes (the "WellCare Notes") issued by WellCare Health Plans, Inc. (NYSE:WCG) ("WellCare") for up to $1,950,000,000 aggregate principal amount of new notes to be issued by Centene (the "Centene Notes") and cash and the related consent solicitations (the "Consent Solicitations") being made by Centene on behalf of WellCare to adopt certain proposed amendments (the "Amendments") to the indentures governing the WellCare Notes (Press release, Centene , JAN 8, 2020, View Source [SID1234552871]). Centene hereby extends such expiration date from 5:00 p.m., New York City time, on January 8, 2020, to 5:00 p.m., New York City time, on January 14, 2020 (as the same may be further extended, the "Expiration Date").

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On November 14, 2019, requisite consents were received and supplemental indentures were executed, eliminating substantially all restrictive covenants and certain events of default and other provisions in each of the indentures governing the WellCare Notes. Such supplemental indentures will only become operative upon the settlement date of the Exchange Offers.

The Exchange Offers and Consent Solicitations are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement dated November 1, 2019, as amended on November 12, 2019 and the related letter of transmittal and consent hereby, each as amended by the press releases dated December 2, 2019 and December 18, 2019 and as amended hereby, and are conditioned upon the closing of Centene’s acquisition of WellCare (the "Merger"), which condition may not be waived by Centene, and certain other conditions that may be waived by Centene.

The settlement date for the Exchange Offers is expected to occur promptly after the Expiration Date and immediately prior to the closing of the Merger, which is expected to occur by the first half of 2020. As a result, the Expiration Date may be further extended one or more times. Centene will provide notice of any such extension in advance of the Expiration Date.

Except as described in this press release, all other terms of the Exchange Offers and Consent Solicitations remain unchanged.

As of 5:00 p.m., New York City time, on January 8, 2020, the principal amounts of WellCare Notes set forth in the table below had been validly tendered and not validly withdrawn:

Documents relating to the Exchange Offers and Consent Solicitations will only be distributed to eligible holders of WellCare Notes who complete and return an eligibility form confirming that they are either a "qualified institutional buyer" under Rule 144A or not a "U.S. person" and outside the United States under Regulation S for purposes of applicable securities laws. Except as amended by the press releases dated December 2, 2019 and December 18, 2019 and as amended hereby, the complete terms and conditions of the Exchange Offers and Consent Solicitations are described in the confidential offering memorandum and consent solicitation statement dated November 1, 2019 as amended on November 12, 2019 and the related letter of transmittal and consent, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent and information agent in connection with the Exchange Offers and Consent Solicitations, at (866) 470-4200 (U.S. toll-free) or (212) 430-3774 (banks and brokers). The eligibility form is available electronically at: View Source

This press release does not constitute an offer to sell or purchase, or a solicitation of an offer to sell or purchase, or the solicitation of tenders or consents with respect to, any security. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such an offer, solicitation or sale would be unlawful. The Exchange Offers and Consent Solicitations are being made solely pursuant to the offering memorandum and consent solicitation statement dated November 1, 2019, as amended on November 12, 2019 and as amended by the press releases dated December 2, 2019 and December 18, 2019 and as amended hereby and the related letter of transmittal and consent, and only to such persons and in such jurisdictions as are permitted under applicable law.

The Centene Notes offered in the Exchange Offers have not been registered under the Securities Act of 1933, as amended, or any state securities laws. Therefore, the Centene Notes may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act of 1933, as amended, and any applicable state securities laws.

On January 8, 2020 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that management will present at the 38th Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2020 at 9:30 AM PT at the Westin St. Francis Hotel in San Francisco, CA (Press release, Stemline Therapeutics, JAN 8, 2020, View Source [SID1234552935]). A live webcast of the presentation can be viewed on the company’s website at www.stemline.com.

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About ELZONRIS
ELZONRIS (tagraxofusp), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.

On January 8, 2020 Adagene, Inc., a clinical-stage, leading-edge oncology immunotherapy company driven by a powerful antibody discovery and engineering platform, reported the completion of a $69 million Series D financing, including $50 million from lead investor General Atlantic (Press release, Adagene, JAN 8, 2020, View Source [SID1234553209]). Adagene has raised more than $150 million from private financings since 2014.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Strong support from our new and existing investors endorses Adagene’s technology platform and strategy to develop differentiated immunotherapies in areas where others have failed," said Peter Luo, Ph.D., Co-founder and Chief Executive Officer of Adagene. "This financial commitment enables us to continue developing our lead clinical programs, ADG106 and ADG116, while extending the frontiers of our novel technology. We look forward to advancing our clinical pipeline and exploring strategic and synergistic opportunities to facilitate long-term sustainable growth."

"We believe China is a rising, vibrant hub for global life sciences innovation. Adagene represents a new-generation biotechnology company that is driving global innovation. Its cutting-edge Dynamic Precision Library platform, combined with its dedicated founders and management team, allows Adagene to advance assets of true novelty to the value inflection point," said Lefei Sun, Managing Director and Head of Healthcare for China at General Atlantic. "We are proud to partner with Adagene as we increase our commitment to the life sciences industry in China."

"Adagene demonstrates that some of the world’s most exciting life sciences developments are now happening in China. We look forward to working closely with Dr. Luo and the entire Adagene team to support the company’s vision to bring innovative therapeutics to patients around the world," said David Hodgson, Vice Chairman of General Atlantic.

About Adagene’s Lead Clinical Programs

ADG106
Adagene’s lead agonist program, ADG106, is a fully human agonistic anti-CD137 monoclonal IgG4 antibody that targets a unique conserved epitope of CD137 and is cross-reactive across human, monkey and mouse. ADG106 has a novel mechanism of action for CD137 agonism (which activates CD137 in a native ligand-like fashion), CD137 ligand antagonism (which blocks reverse signaling of CD137 ligand), and potent cross-linking via Fc receptor. ADG106 is being evaluated in an ongoing Phase 1 clinical trial in the U.S. and China in patients with advanced or metastatic solid and liquid tumors. ADG106 has demonstrated a superior safety profile and no dose-dependent liver toxicity has been observed to date. Early efficacy signals and significant biomarker response demonstrating T-cell proliferation have also been observed.

ADG116
Adagene’s lead antagonist program, ADG116, is a fully human and cross-reactive antagonistic anti-CTLA-4 monoclonal IgG1 antibody that binds to a unique conserved epitope on CTLA-4. ADG116 has a novel mechanism of action including dynamic modulation of CTLA-4 by soft ligand blocking and highly effective depletion of regulatory T cells. ADG116 has demonstrated a superior safety profile and efficacy in pre-clinical studies. The U.S. Food and Drug Administration has approved Adagene’s IND application for ADG116

On January 8, 2020 Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses diagnostic technologies through its MolDX program, has expanded coverage of the clonoSEQ Assay to include monitoring minimal residual disease (MRD) in Medicare patients with chronic lymphocytic leukemia (CLL) (Press release, Adaptive Biotechnologies, JAN 8, 2020, View Source [SID1234552838]). This adds to existing Medicare coverage in B-cell acute lymphoblastic leukemia (ALL) and multiple myeloma, which was established in January 2019. Medicare coverage for clonoSEQ is aligned with clinical practice guidelines in covered disease states which support assessing MRD at multiple time points throughout therapy to monitor treatment response and help predict patient outcomes. This expanded coverage policy is effective immediately and continues the positive momentum for clonoSEQ with over 175M lives covered to date.

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"Patients with CLL who achieve undetectable MRD have better outcomes than those with detectable MRD," said Javier Pinilla-Ibarz, M.D., Ph.D., Senior Member and Head of the Lymphoma program in the Department of Malignant Hematology at Moffit Cancer Center. "As newer therapies emerge for CLL that can help patients achieve very deep remissions, assessment of MRD can help guide clinical care by determining a patient’s response to therapy and informing that patient’s prognosis."

MRD refers to the remaining number of cancer cells that may be present in a patient’s body during and after treatment and that may eventually lead to recurrence of the disease. MRD testing is performed as a series of tests throughout a patient’s cancer journey to monitor for remission, detect relapse, determine response to treatment and inform care. Controlled trials have shown that even the smallest amounts of residual disease significantly predict a patient’s long-term clinical outcomes.

"Data are mounting to support the clinical benefits of MRD measurement in lymphomas and leukemias, including CLL, to help assess a patient’s prognosis, measure response to therapy and inform treatment decisions," said Lance Baldo, chief medical officer, Adaptive Biotechnologies. "The Medicare coverage expansion validates this growing body of evidence and provides patients living with CLL greater access to highly sensitive, standardized MRD testing."

clonoSEQ is the only test authorized by the U.S. Food and Drug Administration (FDA) to detect and monitor minimal residual disease in any lymphoid cancer. At the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, an unprecedented amount of data was presented demonstrating the clinical significance of MRD in blood cancers and further validating it as one of the strongest predictors of patient outcomes.

About the clonoSEQ Assay

The clonoSEQ Assay was granted de novo designation and marketing authorization by FDA for the detection and monitoring of minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from bone marrow samples. clonoSEQ is the first and only FDA-authorized in vitro diagnostic assay for MRD testing. It is also the first clinical diagnostic powered by immunosequencing to receive FDA clearance. clonoSEQ leverages Adaptive’s proprietary immunosequencing platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The assay provides standardized, accurate and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to therapy over time, monitor patients during remission and detect potential relapse. Clinical practice guidelines in hematological malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes are strongly associated with MRD levels measured by the clonoSEQ Assay in patients diagnosed with ALL and MM. More than 175 million people in the US now have access to clonoSEQ through Medicare and private payor coverage.

clonoSEQ is a single-site assay performed at Adaptive Biotechnologies. It is also available as a CLIA-regulated laboratory developed test (LDT) service for use in other lymphoid cancers. For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit www.clonoSEQ.com/technical-summary.