On April 21, 2020 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported that the Company will release its financial results for the first quarter ended March 31, 2020 after the market closes on May 5, 2020 (Press release, Nevro, APR 21, 2020, View Source [SID1234556480]).

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Investors interested in listening to the conference call may do so by dialing (833) 968-2321 in the U.S. or (778) 560-2840 internationally, using Conference ID: 8129245. In addition, a live webcast, as well as an archived recording, will be available on the "Investors" section of the Company’s website at: www.nevro.com.

On April 21, 2020 ArcherDX, Inc. and Premier Inc., a leading healthcare improvement company, reported that they have signed a two-part agreement, kicking off a multi-year program. Premier Applied Sciences will identify eight to 10 member institutions that will implement STRATAFIDE – in a research use only (RUO) capacity – to participate in a retrospective study to evaluate its sequencing performance in comparison to other diagnostic tests (Press release, ArcherDX, APR 21, 2020, View Source [SID1234556481]). ArcherDX plans to seek approval from the U.S. Food and Drug Administration (FDA) for STRATAFIDE as a genomic sequencing in vitro diagnostic (IVD) cancer assay capable of analyzing both tissue and blood samples. The ultimate goal of the partnership is to help solve for the underutilization of targeted therapies in late-stage cancer patients.

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"Genomic testing has resulted in clear benefit at multiple stages in the fight against cancer. However, there remains a stark need for a kitted IVD solution designed for broader use in any hospital’s molecular diagnostic laboratory," said Jason Myers, Chief Executive Officer and co-founder, ArcherDX. "Premier shares our commitment to providing actionable, accurate information to patients and healthcare providers in a community setting, where clinicians are empowered to control the sample, data and economics. This agreement provides for both a clinical and commercial collaboration, and we are pleased to partner with such a forward-thinking healthcare enterprise dedicated to serving more than 4,000 U.S. hospitals and health systems and approximately 175,000 other providers."

ArcherDX and Premier’s research team will identify retrospective samples from patients with lung, thyroid and colorectal cancer to be analyzed by Archer Clinical Services. The study aims first to evaluate STRATAFIDE as a composite test to identify genomic alterations associated with cancer. The expanded collaboration intends to further understand best practices to implement and utilize a distributed IVD in community hospital settings, which may currently lack advanced molecular genomics tools.

"Our partnership with ArcherDX demonstrates the expanse of Premier’s research portfolio so that it is now engaged in next-generation sequencing for multiple forms of cancer in various provider settings," said Stella A. Safo, M.D., MPH, Chief Clinical Transformation Officer and Vice President for Premier Applied Sciences. "We hope this research will help accelerate appropriate cancer care for hard to reach populations and are thrilled to be working with an innovative team that has the potential to bring accurate and actionable genomic data to patients and their caregivers everywhere. This represents a critical unmet need since so many cancer patients lack access to genomic testing and therapy selection tools in their communities."

On April 21, 2020 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for 67Cu-SARTATE, a therapy for the clinical management of neuroblastoma (Press release, Clarity Pharmaceuticals, APR 21, 2020, View Source [SID1234556447]).

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Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour grows and causes symptoms. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of paediatric cancer mortality. High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.1

FDA grants ODDs to facilitate the development of investigational therapies intended to treat, diagnose or prevent rare diseases affecting fewer than 200,000 people in the United States. The designation allows Clarity Pharmaceuticals to qualify for a number of incentives, including: seven years of market exclusivity upon regulatory approval, if received; potential tax credits on US clinical costs; exemptions from certain administrative FDA fees; and eligibility for grants to fund future clinical work.

Dr Alan Taylor, Clarity’s Executive Chairman, commented, "At Clarity, we are especially passionate about the development of SARTATE in neuroblastoma. At present, prognosis of high-risk neuroblastoma patients remains unfavourable, despite intensive, multimodal therapy. Also, the effectiveness of current neuroblastoma treatment strategies, such as chemotherapy, radiation, and surgery, is limited in late-stage disease due to patients’ numerous metastases. It is clear that improvements in current treatment approaches are needed to overcome poor outcomes for the patients."

"ODD status will potentially provide a number of advantages for the development of SARTATE for the treatment of neuroblastoma and allow us to progress more swiftly to our ultimate goal of better treatment of children and adults with cancer."

On April 21, 2020 Gilead Sciences, Inc. (Nasdaq: GILD), Kite, a Gilead Company, and oNKo-innate reported the companies have entered into a three-year cancer immunotherapy research collaboration to support discovery and development of next-generation drug and engineered cell therapies focused on natural killer (NK) cells (Press release, Gilead Sciences, APR 21, 2020, View Source [SID1234556484]).

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Current cancer immunotherapy approaches primarily focus on T cell mediated anti-tumor immunity, including checkpoint inhibition and chimeric antigen receptor (CAR) T cell therapy. Like T cells, NK cells are a class of lymphocytes (white blood cells) that play a critical surveillance and effector role in the immune system. NK cells and T cells each have the potential to attack cancer cells, but have different mechanisms for tumor cell killing. Thus, appropriately activated and targeted NK cells may represent a differentiated approach that would be potentially complementary and synergistic with T cell mediated anti-tumor strategies.

"Gilead is pleased to partner with oNKo-innate as a leader in this new and highly promising area of cancer immunotherapy," said William A. Lee, PhD, Executive Vice President, Research, Gilead Sciences. "We have a strategic focus of growing both our expertise and pipeline in immuno-oncology and we believe this exciting collaboration will support each of these objectives as we work to discover and develop novel cancer therapies for patients."

"Kite is committed to building upon our leadership in cell therapy as we seek to meet the needs of patients with cancer," said Peter Emtage, PhD, Senior Vice President of Research at Kite. "Early clinical data utilizing adoptively transferred NK cells has been encouraging and we are excited by the opportunity to scientifically expand our capabilities in this area and to identify novel NK cell therapies to advance toward clinical development."

"With more than 20 years of collective academic expertise in NK cell biology, we have long believed in the potential for NK cells to play a role in cancer immunotherapy," said Jai Rautela, PhD, Co-founder and Chief Executive Officer of oNKo-innate. "We look forward to bringing this NK cell expertise and our unique screening techniques into a collaboration with Gilead and Kite to serve a common goal of discovering new treatments for patients."

Through this research collaboration, oNKo-innate will use genome-wide screening techniques and its proprietary technology platform to discover novel immune cell targets that enhance NK cell anti-tumor immunity and to create NK cell therapies. For Gilead, oNKo-innate will execute screens to identify and validate targets to seed internal Gilead immuno-oncology discovery programs. For Kite, oNKo-innate will create and evaluate NK constructs for Kite’s development of next-generation cell therapies.

Under the terms of the agreement, oNKo-innate will receive an upfront payment and will be eligible to receive additional payments based on achievement of certain clinical, regulatory and commercial milestones, as well as sales royalties across the immuno-oncology and cell therapy programs.

On April 21, 2020 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or "the Company") reported that it intends to offer and sell shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) in an underwritten public offering (Press release, Actinium Pharmaceuticals, APR 21, 2020, View Source [SID1234556502]). The Company expects to grant the underwriter a 30-day option to purchase up to an additional 15% of the number of the securities to be sold in the offering at the public offering price, less underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

Actinium intends to use the net proceeds from the offering to complete its ongoing pivotal, Phase 3 SIERRA trial for its lead product candidate, Iomab-B, and progress Phase 1 trials from its refocused CD33 program to the proof of concept stage. Net proceeds from this offering will also be used to support its AWE Technology Platform, Iomab-ACT program, research and development and general working capital needs.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on October 24, 2017. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement describing the terms of the offering will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and the accompanying base prospectus relating to the offering may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source

This press release shall 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.