Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Up another 25% yesterday on 20x the volume. Still haven't seen any SEC 8k or PR. CASI provided a pipeline development update PR a couple of weeks ago showing they are making progress with Evomela et al in China but I don't know how that translates to becoming an actual product in China. Is this rise in SP a delayed reaction to this PR? Who knows right now. If no other news comes out then maybe so. Here's the PR

www.prnewswire.com/news-releases/casi-provides-pipeline-development-update-300515388.html

CASI Provides Pipeline Development Update
ROCKVILLE, Md., Sept. 7, 2017 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs today provided an update to its pipeline.
EVOMELA®:
China's Food and Drug Administration (CFDA) has granted priority review for CASI's import drug registration clinical trial application for EVOMELA (melphalan) for Injection. The CFDA cited the following three reasons for granting the priority review:
1. EVOMELA is indicated for the treatment of multiple myeloma, which is classified as a rare disease in China;
2. There is no melphalan in any formulation available in China to address this unmet medical need;
3. EVOMELA has clear therapeutic advantages to currently available therapeutics.
MARQIBO® and ZEVALIN®
The CFDA review of CASI's MARQIBO import drug clinical trial application (CTA) is in process. The Company anticipates that the CFDA will complete its review of the CTA in the next four to six months, and expects to initiate the confirmatory trial within six months after CTA approval. The confirmatory trial is required as part of the registration process for the import drug registration.
The CFDA filing and review of CASI's ZEVALIN import drug clinical trial application (CTA) is in process. The ZEVALIN antibody kit and the radioactive Yttrium-90 component of the clinical trial application require separate submissions to the CFDA, which the first part is currently under review and the latter part is in the submission process. The Company expects to initiate the confirmatory trial within six months after the CFDA's approval of both the ZEVALIN kit and the Yttrium-90 submissions.
Ken Ren, Ph.D., CASI's Chief Executive Officer, commented, "We are pleased that the CFDA in granting priority review for EVOMELA has recognized the superior therapeutic advantages of EVOMELA to address the urgent unmet medical need in the rare disease of multiple myeloma in China. Melphalan is extensively used worldwide in the treatment of patients with multiple myeloma, however, no formulation of melphalan is currently available in China. We appreciate the CFDA opening this accelerated pathway for this critical medicine to reach patients in China; it also is a positive signal from the CFDA to accelerate the import drug registration process for U.S. FDA approved drugs in order to address the significant unmet medical needs of the Chinese population in an accelerated time frame. We also are pleased with the progress of MARQIBO and ZEVALIN and are looking forward to their continued advancement in the import drug registration process."
ENMD-2076:
• Clear Cell Ovarian Carcinoma (CCOC) and Soft Tissue Sarcoma (STS). The data from the investigator-sponsored Phase 2 study in patients with CCOC was presented at the 2017 Annual Meeting of the American Society of Clinical Oncology. The data from the investigator-sponsored Phase 2 study in patients with STS was presented at the 2015 Annual Meeting of the Connective Tissue Oncology Society. The correlative genomics testing has been completed and a publication is expected to be submitted in 2017. Based on the clinical data, CASI has determined it will not pursue company sponsored development of ENMD-2076 in CCOC and STS.
• Triple Negative Breast Cancer (TNBC). The accrual to the investigator sponsored Phase 2 study in patients with previously treated advanced and metastatic TNBC is complete and the correlative biomarker/genomics analysis is ongoing. The data will be presented at the 2017 San Antonio Breast Cancer Symposium.
• Fibrolamellar Carcinoma (FLC). The accrual to this ongoing Phase 2 study is complete and is in the follow up phase. It is anticipated that the data from this study will be submitted to a medical conference for presentation in 2018.
Dr. Alex Zukiwski, M.D, CASI's Chief Medical Officer, commented, "ENMD-2076 has been investigated in a number of tumor types based on the known mechanism of action and the oncogenic pathways of the specific malignancy. Although anticancer activity was observed in the clear cell ovarian carcinoma and soft tissue sarcoma studies, the level of single agent activity does not support the development of ENMD-2076 in these two tumor types as a monotherapy. We look forward to providing an update on the ENMD-2076 Triple Negative Breast Cancer and Fibrolamellar Carcinoma data in the next few months."

Went to the iHUB CASI board and one thing interesting was a little discussion on insider buys and progress on ENMD-2076. Since I don't follow CASI closely not sure how much hype is in those ihub discussions. But as a 20% owner of CASI via SPPI it's nice to see this happening.