Palm Beach, FL – March 4, 2020 – Despite decades of research costing billions of dollars, a cure for cancer still remains elusive. This fact when juxtaposed with the epidemic spread of cancer will result in the disease emerging into the single most difficult to tackle public healthcare burden in the coming years. The pressure is therefore intensifying to research and develop newer and more effective therapies and treatment options, so says a recent report from Report Linker. The report projects that the global market for cancer therapies is projected to reach US$220. 5 billion by 2025, driven by the rise in cancer prevalence to epidemic proportions and the still ongoing search to find effective treatments for the disease. It added that the reason why cancer is complex is due to its ability to continuously evolve and undergo molecular, genetic changes that affect behavior and response of tumor cells. Cancer cells evolve myriad ways to sabotage, stymie and trick the immune system preventing it from recognizing cancer cells, making the disease more resilient, aggressive and deadly… Active companies in the markets this week include: Spherix Incorporated (NASDAQ: SPEX), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Stealth BioTherapeutics Corp (NASDAQ: MITO), Pfizer Inc. (NYSE: PFE), Omeros Corporation (NASDAQ: OMER).
Also, there are over 100 types of known cancer types. In addition the genetic diversity of tumors especially intra-tumor genetic heterogeneity makes finding a cure a challenge which the medical community continues to grapple with. Although the Cancer Genome Atlas (TCGA) has increased understanding of the diversity of cancer types, the disease continues to elude a cure while continuing to stretch the boundaries of medical science and understanding. Significant research is still required to understand the vast diversity of tumor gene expression, mutations and drug sensitivities. It continues: “There is an urgent need for developing newer ways to target cancer’s diversity and evolution. While a cure for cancer is unlikely, targeted therapies will witness huge gains for their better prognosis.”
Spherix Incorporated (NASDAQ: SPEX) BREAKING NEWS: Spherix Moves Dividend Record Date to Friday, March 6, 2020 – Spherix Incorporated announced that, in light of the expected closing of its public offering tomorrow, March 5, 2020, the Hoth dividend date has been moved to Friday, March 6, 2020, so that its new shareholders may participate in the Hoth dividend.
As a result, each Spherix stockholder as of 5 p.m. Eastern Time on Friday, March 6, 2020, will be entitled to receive shares of Hoth common stock for shares of Spherix common stock held at such time by such stockholders. We expect the number of shares of Hoth Common Stock distributed per share of Spherix Common Stock to be one share of Hoth common stock for every one-hundred seventy shares of Spherix common stock held at such time. The ex-dividend date for the distribution will be announced by Nasdaq once the effectiveness of the registration statement registering the Hoth shares is determined. In the event that warrants issued in our recently announced offering are exercised between the record date and the ex-dividend date, the ratio of Spherix shares to Hoth shares may increase. We will not distribute fractional shares of Hoth common stock, and any fractional shares will be rounded down to the nearest whole share.
Spherix stockholders do not need to take any action to receive the shares of Hoth common stock, other than be a shareholder of record on March 6, 2020. Spherix stockholders do not need to pay any consideration for, surrender or exchange shares of Spherix common stock.
Mr. Anthony Hayes, CEO of Spherix stated, “This is a transformative time for Spherix. We are excited to move forward with developing our new assets. Returning capital to shareholders is an important part of our strategy, and the distribution of a portion of our holdings is another step in this endeavor. We continue to work towards becoming a diversified biopharmaceutical company with a compelling portfolio of potential compounds to develop and commercialize.” Read this and more news for Spherix at: https://financialnewsmedia.com/news-spex/
Recent developments in the healthcare, biotech industries:
Inovio Pharmaceuticals, Inc. (NASDAQ: INO) recently announced an accelerated timeline for developing its DNA vaccine INO-4800 to address COVID-19, the respiratory infection the World Health Organization (WHO) has designated a Public Health Emergency of International Concern of the highest level. According to WHO, approximately 89,000 cases have been reported globally with more than 3,000 deaths.
Dr. J. Joseph Kim, Inovio’s President & CEO, shared this accelerated timeline at the U.S. Coronavirus Task Force meeting at the White House on March 2. Dr. Kim said, “Inovio is the leader in coronavirus vaccine development and the only company with a Phase 2 vaccine for a related coronavirus that causes Middle East Respiratory Syndrome (MERS). Using our modern DNA medicines platform, we designed our DNA vaccine INO-4800 in three hours after the publication of the genetic sequence of the novel coronavirus that causes COVID-19.”
Stealth BioTherapeutics Corp (NASDAQ: MITO) recently announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for elamipretide for the treatment of Barth syndrome, an ultra-rare genetic condition.
Under the FDA’s RPD designation program, the FDA may grant a priority review voucher to a sponsor who receives approval for a “rare pediatric disease,” a serious and life-threatening disease that primarily affects individuals aged from birth to 18 years and fewer than 200,000 people in the United States. Upon FDA approval of elamipretide for Barth syndrome, Stealth BioTherapeutics is eligible for a voucher that can be used to obtain priority review for a subsequent human drug application upon meeting relevant statutory requirements associated with the RPD program.
Pfizer Inc. (NYSE: PFE) and Eli Lilly and Company (NYSE:LLY) recently announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for tanezumab 2.5 mg administered subcutaneously (SC), which is being evaluated for patients with chronic pain due to moderate-to-severe osteoarthritis (OA) who have experienced inadequate pain relief with other analgesics. Tanezumab is a monoclonal antibody that is part of an investigational class of non-opioid chronic pain medications known as nerve growth factor (NGF) inhibitors.
More than 27 million Americans are living with OA, 11 million of whom have moderate-to-severe OA. Currently available treatment options for moderate-to-severe OA do not meet the needs of all patients, and many cycle through multiple therapies to find relief from their pain. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA to make a decision on the tanezumab application is in December 2020. In its acceptance letter, the FDA stated that it is currently planning to hold an Advisory Committee meeting to discuss this application.
Omeros Corporation (NASDAQ: OMER) recently reported an update on clinical data from its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), markedly exceeding the FDA-agreed threshold for the primary efficacy endpoint. While an overview of preliminary data submitted to FDA was made public on December 4, 2019 in a press release from the company, all patients have now completed treatment and trial enrollment has been closed. Narsoplimab is Omeros’ human monoclonal antibody targeting mannan-binding lectin-associated serine protease 2 (MASP-2).
In recent meetings with FDA focused on clinical as well as chemistry, manufacturing and controls (CMC) data, FDA confirmed important aspects of Omeros’ rolling Biologics License Application (BLA) for narsoplimab in HSCT-TMA. The BLA continues on its clear path to completion.
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