In a May 30 research note, Paradigm Capital analyst Rahul Sarugaser reported that Zymeworks Inc.'s (ZYME:NYSE; ZYME:TSX) lead product candidate ZW25 was just granted fast track status by the U.S. Food and Drug Administration (FDA) for firstline treatment in combination with standard of care chemotherapy of patients with gastroesophageal adenocarcinoma. ZW25, a next-generation antibody targeting HER2-expressing tumors, is currently in Phase 2 of clinical development.
"The FDA fast track designation is an additional, emphatic bid of confidence in Zymeworks' technology and in its capacity to execute its very own world-class, clinical development programs," Sarugaser added.
He pointed out the designation's advantages. The categorization could speed up the regulatory approval process of ZW25 by an estimated six to 12 months, Sarugaser indicated, and improve the drug's chances of approval based on its inherent incentives.
Among those, it allows Zymeworks to use surrogate rather than direct endpoints, which offer a shorter data readout period. It affords automatic eligibility for priority review, meaning the company's application goes to the front of the line for review when submitted. The designation leads to more frequent interactions with the FDA for clinical design advice and application submission guidance. It also allows a rolling review process, so that pieces of the application may be submitted when ready rather than simultaneously after all are completed.
Sarugaser reported that in other noteworthy news, Zymeworks earned a $2 million milestone payment from Merck because Merck just finished late-stage preclinical studies. "We see it as a very positive signal that Merck, an $80 billion global pharma, understands the power of Zymeworks' technology to build clinical candidates," the analyst commented.
Paradigm Capital has a Buy recommendation and a $30 per share price target on Zymeworks, whose stock is currently trading at around $18.90 per share. "The company is a drug discovery engine, and it is coming increasingly clear Zymeworks is a clinical development machine," added Sarugaser.[NLINSERT]
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Disclosures from Paradigm Capital, Zymeworks Inc., Research Note, May 30, 2019
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