On Wednesday, Shares of CASI Pharmaceuticals, Inc. (NASDAQ:CASI), skyrocketed 40.20% to $1.43.
CASI Pharmaceuticals, declares that its oncology drug candidate, ENMD-2076, has received Orphan Drug designation from the European Medicines Agency (EMA) for the treatment of hepatocellular carcinoma (HCC), counting fibrolamellar carcinoma (FLC), a rare type of HCC.
The designation provides CASI with 10 years of market exclusivity in EU after ENMD-2076 receives marketing authorization there. The product was also granted Orphan Drug designation for the treatment of HCC by US Food and Drug Administration (FDA) in 2014, which provides CASI with a 7-year market exclusivity in the country after its New Drug Application approval.
Dr. Ken Ren, Chief Executive Officer of CASI, commented, “We are very happy with the Orphan Drug designation in the EU for HCC. This is an important regulatory milestone for us to enhance the commercial value of ENMD-2076 for global market. We are in the process of initiating our phase 2 clinical trials in the US for the treatment of FLC and expecting to start patient recruitment very soon. We will seek regulatory approvals and expand the trial into EU once a signal of clinical benefits is indicated in our US trial. As a part of our global development plan, we also have clinical trial application filed with Chinese FDA pending for approval for FLC. We are quite optimistic and committed to the development of ENMD-2076 as a first line therapy for the treatment of FLC and look forward to advancing its development to the next step.”
CASI Pharmaceuticals, Inc., a biopharmaceutical company, acquires, develops, and commercializes therapeutics addressing cancer and other unmet medical needs in North America and China.
Shares of Amicus Therapeutics, Inc. (NASDAQ:FOLD), declined -1.75% to $6.73, during its last trading session.
Amicus Therapeutics, has booked the year to date performance of -19.11% while its market capitalization stands at $798.25M. The institutional ownership of the company was 51.20% while its debt to equity ratio was 0.00. Return on equity was -60% while return on assets was booked as -38.50%. Shares of the company were below SMA 20 with -43.41% and below SMA 50 with -52.89%.
Amicus Therapeutics, Inc., a biopharmaceutical company, develops and commercializes therapeutic products for rare and orphan diseases. Its product candidate is a small molecule that can be used as a monotherapy and in combination with enzyme replacement therapy (ERT) for Fabry disease.
Finally, Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI), ended its last trade with 2.34% gain, and closed at $6.12.
Spectrum Pharmaceuticals, has market capitalization of $402.52M. Its shares were below its 50 days simple moving average with -8.66%. The company offered earning per share of $-0.65 while its 67.31M shares were outstanding. YTD performance of the company was -9.87%. Stock volatility for the week was 5.38% while for the month it was shown at 6.24%.
Spectrum Pharmaceuticals, Inc., a biotechnology company, develops and commercializes oncology and hematology drug products. The company markets five drug products, counting FUSILEV for the treatment of patients with metastatic colorectal cancer, rescue after high-dose methotrexate therapy in osteosarcoma, and to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists; FOLOTYN, a folate analogue metabolic inhibitor for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL); ZEVALIN injection for patients with follicular non-Hodgkin’s lymphoma; MARQIBO, a sphingomyelin/cholesterol liposome-encapsulated formulation of the anticancer drug vincristine for the treatment of adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia; and BELEODAQ injection for patients with relapsed or refractory PTCL.
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