US based but China focused small cap biopharmaceutical stockCASI Pharmaceuticals (NASDAQ: CASI) is up around 78% over the last three trading days on no apparent news on the newswires as the following chart illustrates:
CASI Pharmaceuticals is a U.S. based, late-stage small cap biopharmaceutical company focused on the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a focus on commercialization in China. The Company’s product pipeline features
EVOMELA庐, MARQIBO庐 and ZEVALIN庐, all U.S. Food and Drug Administration (FDA) approved drugs in-licensed from Spectrum Pharmaceuticals, Inc. for China regional rights, and currently in various stages in the regulatory and clinical process for market approval in China Proprietary drug candidate, ENMD-2076, ongoing in one Phase 2 clinical study CASI-001 and CASI-002, proprietary preclinical candidates in immune-oncology.
The Companyis headquartered in Rockville, Maryland and has a wholly owned subsidiary and R&D operations in Beijing, China.
On September 7th, CASI Pharmaceuticals announced that Chinas Food and Drug Administration (CFDA) has granted priority review for the Companys import drug registration clinical trial application for EVOMELA (melphalan) for Injection. The CFDA cited the following three reasons for granting the priority review:
EVOMELA is indicated for the treatment of multiple myeloma, which is classified as a rare disease in China; There is no melphalan in any formulation available in China to address this unmet medical need; EVOMELA has clear therapeutic advantages to currently available therapeutics.
The CEO stated:
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.
The CMO added:
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.
Thus, one could conclude that someone or a few someones know something that the rest of us dont as some traders are speculating about on Yahoo! Finance:
daniel CEO buys 330,000 shares in the open market and then announces CASI has 2 new immunotherapy drugs and wants to be Celgene of China.
He now has close to 2.5 million shares total.
Small float and news from phase 2 trial for hepatic cancer due by 4th quarter 2017.
Insider buying usually precedes excellent news .
Huge volume also speaks well of near term future event.
The news this time is implied not written and is the most desirable type for CASI. Yo 5 days ago someone wants in……volume has steadily increased