HRTX - Heron spikes on FDA filing to expand label for pain therapy

Heron Therapeutics ( NASDAQ: HRTX ) added ~10% in the morning hours Thursday after announcing that the company submitted a supplemental New Drug Application ((sNDA) to the FDA seeking label expansion for its pain therapy Zynrelef.

A combination of a non-steroidal anti-inflammatory drug and local anesthetic, Zynrelef, is indicated in the U.S. to produce pain relief following surgical procedures in the foot and ankle, small-to-medium open abdominal, and lower extremities.

With the sNDA, Heron ( HRTX ) seeks the FDA's nod to expand its use for soft tissue and orthopedic surgical procedures.

"Submission of this sNDA is designed to further expand ZYNRELEF's indication for use in soft tissue and orthopedic procedures, which would double the current target surgical procedures to 14 million," Chief Executive of Heron ( HRTX ) Barry Quart said.

Additionally, the company also announced the passage of a congressional bill requiring the Centers for Medicare and Medicaid Services (CMS) to pay for certain non-opioids, including Zynrelef, outside the existing bundled payment for surgeries for nearly three years.

The label expansion "and gaining almost three additional years of separate payments from CMS is anticipated to significantly accelerate uptake of ZYNRELEF in large hospital systems," Quart added.

A few days ago, Seeking Alpha contributor Out of Ignorance issued a Hold rating on the company, arguing that "despite its approved therapies, Heron continues to accumulate excessive ongoing losses making it a high-risk investment."

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