NEW YORK, NY / ACCESSWIRE / October 3, 2017 / Shares of Endocyte exploded on Monday and hit a new high after the company announced the completion of an exclusive worldwide license of PSMA-617 from ABX GmbH, a PSMA-targeted radioligand therapy for development in prostate cancer. Shares of INSYS also saw gain after announcing last Friday that it had filed an NDA for a novel formulation of buprenorphine as a sublingual spray.
RDI Initiates Coverage on:
INSYS Therapeutics, Inc.
Endocyte, Inc.’s shares were on fire in Monday trading, closing the day up 157.45%. With nearly 56 million shares traded yesterday, the stock also hit a brand new high of $3.75 during intra-day trading. The company made a big announcement that it has completed an exclusive worldwide license of PSMA-617 from ABX GmbH. 177Lu-PSMA-617 is a radioligand therapeutic (RLT) that targets the prostate-specific membrane antigen (PSMA), present in approximately 80% of patients with metastatic castration-resistant prostate cancer (mCRPC). Traders were encouraged that the company is planning to quickly seek regulatory approval to begin a Phase 3 trial early next year. The company’s CEO Mike Sherman commented, “We intend to seek regulatory approval to initiate a Phase 3 registration trial of 177Lu-PSMA-617 in early 2018. By focusing the company’s resources on the execution of this program, we project trial completion as early as 2020.” He also said, “This transaction is transformational to Endocyte, accelerating our path to commercialization. 177Lu-PSMA-617 has the potential to be the first-in-class RLT to address both bone and soft tissue disease, and it is profoundly important to the many patients suffering from mCRPC.”
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INSYS Therapeutics, Inc.’s shares closed up 12.05% on Monday with about 1.6 million shares traded. Shares of the specialty pharmaceutical company advanced after the company announced this past Friday that it had filed a New Drug Application (NDA) for a novel formulation of buprenorphine as a sublingual spray for the management of moderate-to-severe acute pain with the U.S. Food and Drug Administration (FDA). The company’s senior vice president of Regulatory Affairs, Steve Sherman, commented, “We believe that buprenorphine sublingual spray represents a promising new treatment option that will address an unmet need for physicians and patients who would like an alternative to the traditional opioids used to treat their moderate-to-severe acute pain.”
“As a partial mu-opioid agonist, it is believed that buprenorphine has less abuse potential than other opioids frequently used in this indication and is thought to have a ceiling effect for respiratory depression.”
CEO Saeed Motahari stated, “This submission to the FDA supports our goal of filing one NDA every year for the next five years as we execute on our collective vision and expand our product portfolio.”
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Our Actionable Research on Endocyte, Inc. (NASDAQ:ECYT) and INSYS Therapeutics, Inc. (NASDAQ:INSY) can be downloaded free of charge at Research Driven Investing.
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