Shares of Coherus Biosciences (NASDAQ: CHRS) closed up 14% on Monday after the company announced the long-awaited approval of its drug, Loqtorzi, by the U.S. Food and Drug Administration (FDA).
A first-of-its kind FDA approval
In a press release dated late Friday, Coherus and partner Shanghai Junshi Biosciences announced that the U.S. FDA has approved Loqtorzi (toripalimab-tpzi) in all lines of treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC). NPC is a rare tumor of the head and neck which originates in the nasopharynx (near the back of the nose).
The approval was based on results of Coherus' JUPITER-02 Phase 3 study and its POLARIS-02 Phase 2 study, and is irrespective of a patient's PD-L1 status (a test that measures a protein on cancer cells that stops your immune system from attacking cancer). Loqtorzi is a next-generation programmed death receptor-1 (PD-1) monoclonal antibody that blocks PD-1 ligands PD-L1 and PD-L2, enabling a patient's immune system to activate and kill the tumor.
Though this FDA approval arrived five years after toripalimab became the first anti-PD-1 drug to gain approval in China, it makes Loqtorzi the first FDA-approved therapy for NPC to enter the U.S. market.
On Loqtorzi's launch date, pricing, and what's next for Coherus
Coherus CEO Denny Lanfear called the approval a "pivotal event for Coherus as an innovative oncology company," elaborating that the company is now excited to turn its attention to developing Loqtorzi across multiple tumor types.
In an investor call Friday, Lanfear added that Coherus "will not engage in heavily discounted pricing for the treatment" -- a nod to the trend of locally developed drugs in China being priced significantly lower than Western competitors' similar treatments.
Assuming all goes as planned, Coherus expects to officially launch Loqtorzi in the first quarter of 2024 and will provide more details on its exact pricing at that time.
In the meantime, with shares of Coherus still down more than 60% year to date as of this writing, it's no surprise to see it rebounding in response today. For patient investors willing to open or add to a stake as Coherus turns its efforts toward expanding Loqtorzi's applications to multiple tumor types, this leading cancer stock might well prove to be a bargain worth owning now.
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