MannKind Corporation to Hold 2019 Third Quarter Financial Results Conference Call on November 6, 2019

On October 30, 2019 MannKind Corporation (NASDAQ:MNKD) reported that it will release its 2019 third quarter and year-to-date financial results and its management will host a conference call to discuss the financial results and corporate updates at 9:00 AM (Eastern Time) on Wednesday, November 6, 2019 (Press release, Mannkind, OCT 30, 2019, View Source [SID1234550042]).

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Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven Binder.

To participate in the live call by telephone, please dial (866) 548-4713 or (323) 794-2093 and use the participant passcode: 8987532. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at View Source under News & Events.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 8987532. A replay will also be available on MannKind’s website for 14 days.

Asuragen to Present at 2019 Association for Molecular Pathology (AMP) Annual Meeting

On October 30, 2019 Asuragen, Inc., a molecular diagnostics company delivering easy-to-use products for complex testing in genetics and oncology, reported that it will host three corporate workshops and present multiple scientific posters highlighting their rapidly expanding product portfolio and industry collaborations at the upcoming 2019 Association for Molecular Pathology (AMP) Annual Meeting & Expo November 7-9 in Baltimore (Press release, Asuragen, OCT 30, 2019, View Source [SID1234550058]).

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Asuragen’s sessions at the Corporate Workshop Day on November 6 will highlight user experiences with the new AmplideX PCR/CE SMN1/2 Plus Kit** and multiple assays within the company’s QuantideX oncology product portfolio.

Asuragen will present four posters during the Scientific Poster Sessions, demonstrating its continuing innovation in translating molecular biology to impactful diagnostic products. Of note, a recent collaboration with ProteinSimple, a Bio-Techne brand, combines the quantification of nucleic acid and protein markers relevant to targeted therapies and immune checkpoint inhibitors into a single, multiplexed workflow for Simple Western systems. "Diseases like non-small cell lung cancer require a multi-omics approach to better manage patients and this trend is likely to expand to other conditions as our knowledge of disease drivers grows," said Robert Gavin, senior vice president, Analytical Systems Division at Bio-Techne. "Our collaboration with Asuragen represents a forward-looking approach for streamlining the analysis of clinically relevant targets across analyte types with a goal of transforming how these patients are diagnosed, treated, and managed."

Asuragen’s Corporate Workshops will occur in Room 338 of the Baltimore Convention Center at 10am, 12pm, and 2pm, on Wednesday, respectively.

Simple, Sensitive, and Scalable Patient Monitoring with the QuantideX qPCR BCR-ABL IS Kit
Presenter: Emily Adams, BS(ASCP)CM, clinical laboratory specialist and lead technologist at Johns Hopkins University, will review her analytical and clinical validation of the QuantideX qPCR BCR-ABL IS Kit and how the assay provides a highly-sensitive, rapid, and scalable solution for their molecular diagnostics laboratory.
From Two Days to Four Hours: How the AmplideX PCR/CE SMN1/2 Plus Kit** Provides SMN1 and SMN2 Copy Number Information and More…
Presenter: Vivianna van Deerlin, MD, PhD, professor of pathology and laboratory medicine at the University of Pennsylvania Perelman School of Medicine, will share her experience with the new AmplideX PCR/CE SMN1/2 Plus Kit**, which automates the reporting of copy number, gene duplication, and disease modifier information on the SMN1 and SMN2 genes in less than four hours from a single PCR reaction.
Next-Generation Sequencing Within Your Reach: Complete, NGS-in-a-Box Testing Solutions for DNA and RNA Variants in Cancer
Presenters: Nimesh Patel, MD, director of molecular pathology at Lifespan Academic Medical Center, and Stephen Hyter, PhD, senior scientist in pathology and laboratory medicine at the University of Kansas Medical Center, will review why their institutions adopted the QuantideX NGS DNA Hotspot 21* and RNA Lung Cancer* Kits, respectively, and how these panels have empowered them to collect clinically relevant biomarker information via comparatively simple and streamlined NGS testing workflows.
The following will be presented during Friday’s poster session from 2:30 – 3:30 p.m.

G022: A Multiplex PCR/CE CFTR Assay Resolves Zygosity of the 23 ACMG/ACOG-recommended CFTR variants and Sizes poly-T and TG Repeats in a Single Tube. (Pranesh Rao)
G044: A Rapid Diagnostic and Screening System for Spinal Muscular Atrophy that Reports Copy Number Changes, Single Nucleotide Variants and Small Indels (Huiping Zhu, PhD)
I024: A Deep Learning Method for High-Throughput FMR1 Triplet Repeat Screening (Lando Ringel)
The following will be presented during Saturday’s poster session from 9:45-10:45 a.m.

TT049: A Single-Platform Technology for Proteogenetic Biomarker Analysis in Oncology: Complementary Protein and RNA Quantification Relevant to Targeted and Immuno-therapies in Non-Small Cell Lung Cancer (Gary Latham, PhD)
"AMP affords us the unique opportunity to showcase our rapidly growing genetics and oncology product portfolios to a diverse audience spanning disease areas and practice types," said Matthew McManus, MD, PhD, president and CEO of Asuragen. "As demonstrated through our numerous workshops, scientific posters, and collaborations, our best-in-class products for challenging genomic targets continue to provide simple, robust and reliable solutions for a highly dynamic customer base."

The company will also have a presence at booth #2525 during the conference.

* For Research Use Only. Not for use in diagnostic procedures.
** Product in development. Specifications not finalized.

European Commission Approves Astellas’ XOSPATA ™ for Patients with Relapsed or Refractory Acute Myelogenous Leukemia, Identifying Mutations Using Invivoscribe’s LeukoStrat® CDx FLT3 Mutation Assay

On October 30, 2019 Invivoscribe Inc. reported that the European Commission (EC) has granted regulatory approval for the Astellas drug XOSPATA (gilteritinib) (Press release, Invivoscribe Technologies, OCT 30, 2019, View Source;825237203.html [SID1234550074]). This is a monotherapy for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations ( FLT3 mut +), which discovers from the Invivo leukostrat CDx FLT3 mutation assay can be.

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The LeukoStrat test is available as a test menu service through the subsidiaries of Invivoscribe LabPMM LLC ( San Diego , California, USA ), LabPMM GmbH (Martinsried, Germany), and LabPMM GK ( Kawasaki, Japan ). Test kits of the LeukoStrat CDx FLT3 mutation assay are currently distributed in Europe, Japan , Switzerland and Australia and are expected to be available in the United States and China in the future .

Invivoscribe has developed the LeukoStrat CDx FLT3 Mutation Assay in collaboration with Astellas as a companion diagnostic to predict patient response to Astellas Pharma’s AOS drug XOSPATA (gilteritinib fumarate). The current approval is based on the results of the Phase 3 ADMIRAL study in which gilteritinib is compared to second-line chemotherapy in patients with relapsed or refractory FLT3mut + -AML was investigated. There was a significantly higher Overall Survival (OS) in patients treated with gilteritinib than those who received second-line chemotherapy. The mean OS for patients receiving gilteritinib was 9.3 months, compared to 5.6 months for patients treated with second-line chemotherapy alone.

With this milestone, the LeukoStrat CDx FLT3 Mutation Assay can continue to establish itself as an international gold standard for comprehensive FLT3 assessment of critically ill AML patients. This is especially true because this CDx can identify both ITD and TKD FLT3 mutations (including large internal tandem duplications) and is globally available.

This approval completes the series of regulatory approvals previously received by Invivoscribe for the LeukoStrat CDx FLT3 mutation assay as an adjunctive diagnostic for Astellas XOSPATA (gilteritinib fumarate), Novartis RYDAPT (midostaurine) and Daichi Sankyo quizartineib hydrochloride.

"The approval by the European Commission is a significant forest step for patients with relapsed or refractory FLT3 mutation-positive acute myeloid leukemia. Invivoscribe looks forward to additional treatment options that can extend the lives of patients, and the company looks forward to partnering with other pharmaceutical companies interested in using our Streamlined CDx program, whether its therapies for hematologic disease or cancer targeting solid tumors to accelerate drug approvals worldwide, "said Jeffrey Miller , CSO and CEO of Invivoscribe .

About the Invivoscribe LeukoStrat CDx FLT3 Mutation Assay
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test that incorporates internal tandem duplication (ITD) mutations and the D835 and I836 mutations in the Tyrosine kinase domain (TKD) can be detected in the FLT3 gene. The gene is derived from genomic DNA extracted from mononuclear cells derived from peripheral blood or bone marrow aspirate from patients diagnosed with acute myeloid leukemia.

The LeukoStrat CDx FLT3 Mutation Assay is used as a tool to evaluate patients with AML who are considering treatment with Midostaurin (United States, Europe, Switzerland and Australia).

The LeukoStrat CDx FLT3 Mutation Assay is used as a tool to evaluate patients with AML who are considering treatment with gilteritinib fumarate (United States, Europe and Japan ).

The LeukoStrat CDx FLT3 mutation assay is used as a tool to evaluate patients with AML who are considering treatment with quizartineib hydrochloride ( Japan ).

The globally standardized test includes software that interprets data and determines the respective mutant / wild-type signal quotient for ITD and TKD mutations. This extensively tested assay helps standardize the discovery of genetic mutations in the FLT3 gene, which is one of the major causes of mutations in acute myeloid leukemia (AML).

Ultragenyx to Host Conference Call for Third Quarter 2019 Financial Results and Corporate Update

On October 30, 2019 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported that it will host a conference call on Tuesday, November 5, 2019 at 5pm ET to discuss third quarter 2019 financial results and provide a corporate update (Press release, Ultragenyx Pharmaceutical, OCT 30, 2019, http://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-host-conference-call-third-quarter-2019-financial [SID1234550020]).

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The live and replayed webcast of the call will be available through the company’s website at View Source To participate in the live call by phone, dial (855) 797-6910 (USA) or (262) 912-6260 (International) and enter the passcode 9946526. The replay of the call will be available for one year.

NewLink Genetics to Host Its Third Quarter 2019 Conference Call on November 6, 2019

On October 30, 2019 NewLink Genetics Corporation (NASDAQ:NLNK) reported it will host its third quarter 2019 conference call and webcast at 8:30 AM ET on Wednesday, November 6, 2019, to discuss its third quarter financial results and provide an update on corporate activities (Press release, NewLink Genetics, OCT 30, 2019, View Source [SID1234550043]). There will also be a question and answer session following the prepared remarks.

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Investors and the general public are invited to listen to a live audio webcast of the conference call, which can be accessed five minutes prior to the start of the call by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international). The conference call will be webcast live and a link can be accessed through the NewLink Genetics website at View Source A replay of the call will be available for two weeks from the date of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode: 3794399.