Puma Biotechnology to Present at the BofA Securities Health Care Conference 2020

On May 6, 2020 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that it will provide an overview of the Company at 3:40 p.m. EDT on Wednesday, May 13, at the BofA Securities Health Care Conference 2020 (Press release, Puma Biotechnology, MAY 6, 2020, View Source [SID1234557165]). The conference will be held in a virtual meeting format.

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A live webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com. The presentation will be archived on the website and available for 30 days.

GRAIL Announces $390 Million Series D Financing

On May 6, 2020 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, when it can be cured, reported a $390 million Series D financing round (Press release, Grail, MAY 6, 2020, View Source [SID1234557164]). New investors including Public Sector Pension Investment Board (PSP Investments) and Canada Pension Plan Investment Board (CPP Investments), as well as two undisclosed investors, joined existing backers including Illumina, Inc. in this round of funding.

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"GRAIL is making significant progress with our blood-based, multi-cancer early detection test," said Hans Bishop, Chief Executive Officer at GRAIL. "Nearly 80 percent of cancer deaths result from cancers for which there is no screening test today, and GRAIL’s mission is to change that through the early detection and localization of more than 50 cancers. Enabling this through a single blood draw could improve patient access and adherence to cancer screening and address disparities in cancer care by improving access for rural, vulnerable, and under-served populations. We are delighted that such a high-quality group of investors share our vision and recognize the public health benefits of our technology."

The Series D funding adds to the company’s balance sheet and will support continued development and commercialization of GRAIL’s multi-cancer early detection blood test. Since early 2016, GRAIL has raised more than $1.9 billion in four rounds of equity financing to pursue reducing cancer mortality worldwide through multi-cancer early detection.

About GRAIL’s Multi-Cancer Early Detection Test

GRAIL’s multi-cancer early detection test is designed to detect cancers in early stages, when the chance of survival is higher than if cancer is detected after symptoms appear. Clinical data have shown the ability of this technology to detect more than 50 cancer types with a very low false positive rate of less than one percent. GRAIL’s test was designed to minimize false positives in order to limit associated harms, including patient anxiety and unnecessary diagnostic workups. When a cancer signal is detected, the test has been able to identify where in the body the cancer is located with high accuracy, an important step to guiding diagnostic next steps and care.

GRAIL’s methylation-based technology preferentially targets the most informative regions of the genome and is designed to use its proprietary database and machine-learning algorithms to both detect the presence of cancer and identify the tumor’s tissue of origin. GRAIL believes its sequencing database of cancer and non-cancer methylation signatures is the largest of its kind.

Exelixis to Webcast Fireside Chats as Part of Virtual Investor Conferences in May

On May 6, 2020 Exelixis, Inc. (Nasdaq: EXEL) reported that members of Exelixis’ management team will participate in fireside chats at the following virtual investor conferences in May (Press release, Exelixis, MAY 6, 2020, View Source [SID1234557163]):

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BofA Securities 2020 Health Care Conference: Exelixis is scheduled to present at 2:20 PM EDT / 11:20 AM PDT on Tuesday, May 12, 2020.
RBC 2020 Global Healthcare Conference: Exelixis is scheduled to present at 2:30 PM EDT/ 11:30 AM PDT on Tuesday, May 19, 2020.
UBS Virtual Global Healthcare Conference: Exelixis is scheduled to present at 4:40 PM EDT / 1:40 PM PDT on Tuesday, May 19, 2020.
To access the webcast links, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentations to ensure adequate time for any software download that may be required to listen to the webcasts. Replays will also be available at the same location for 14 days.

Foundation Medicine Receives FDA Approval for FoundationOne®CDx as the Companion Diagnostic for Tabrecta™ (capmatinib), the Only FDA-Approved MET Inhibitor for Patients With Metastatic Non-Small Cell Lung Cancer With METex14

On May 6, 2020 Foundation Medicine, Inc. reported that FoundationOneCDx has been approved by the U.S. Food and Drug Administration (FDA) for use as the companion diagnostic (CDx) to aid in identifying patients with non-small cell lung cancer (NSCLC) for whom treatment with Tabrecta (capmatinib) may be appropriate (Press release, Foundation Medicine, MAY 6, 2020, View Source [SID1234557162]). Tabrecta is the first and only therapy approved by the FDA for adult patients with metastatic non-small cell lung cancer whose tumors have a mutation that leads to MET exon 14 skipping (METex14). This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). FoundationOne CDx is the only FDA-approved broad comprehensive genomic profiling (CGP) test for all solid tumors that incorporates multiple companion diagnostic claims. It is currently approved as the companion diagnostic test for 21 unique therapies.

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NSCLC accounts for approximately 85% of lung cancer diagnoses,1 3 to 4% of which have MET exon 14 skipping.2 This milestone marks an important advancement for patients with METex14 mutated metastatic NSCLC, as there have previously been no treatment options available specifically for this diagnosis.

"Because non-small cell lung cancer is a particularly aggressive and difficult to treat form of cancer, taking a comprehensive and validated approach to genomic testing is critical to help guide physicians’ treatment decisions," stated Foundation Medicine’s Chief Medical Officer Brian Alexander, M.D., M.P.H. "FoundationOne CDx is a powerful tool for identifying patients with mutations that lead to MET exon 14 skipping who may be eligible for treatment with Tabrecta. This simultaneous therapy and companion diagnostic approval marks an important step forward in the treatment of rare cancer and demonstrates how deep collaboration across industry partners can advance patient care."

As part of the strategic collaboration with Novartis, which now includes two companion diagnostics for the Novartis portfolio of targeted oncology and immuno-oncology therapeutics, a companion diagnostic for Tabrecta is also in development for Foundation Medicine’s liquid biopsy assay.

About FoundationOne CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit View Source

NOXXON Announces Issuance of a Tranche of Convertible Bonds Under Financing Agreement With Atlas

On May 6, 2020 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that it has issued a second tranche of Convertible Bonds under the financing agreement published on April 23, 2020 (Press release, NOXXON, MAY 6, 2020, View Source [SID1234557161]).

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The investor, Atlas Special Opportunities, LLC, has received 483 Notes (including 8 Convertible Bonds issued in relation to the transaction fee) with a nominal value of €1,000 each.

NOXXON maintains an updated summary table of issued convertible bonds in the Investors’ section of its website.

The characteristics, terms, conditions and dilutive potential of the financing may be found in the Annex to the press release published on April 23, 2020 available on the company’s website.