Heron Therapeutics' Non-Opioid, Post-Operative Pain Drug Approved For Use In Additional Orthopedic, Soft Tissue Procedures - FDA Gives Nod
Portfolio Pulse from Vandana Singh
The FDA has approved Heron Therapeutics Inc's (NASDAQ:HRTX) Zynrelef for additional orthopedic and soft tissue procedures, expanding its use beyond the previously approved indications. This approval increases the potential patient base by an estimated 86%, covering 13 million procedures annually. Heron conducted studies in various surgeries to support this expansion, with no new safety issues found. The company expects significant positive impacts from this label expansion, a recent partnership with CrossLink, and the potential approval of the Vial Access Needle later in the year. Zynrelef has shown superiority over bupivacaine, the standard-of-care, in Phase 3 studies. HRTX shares rose 5.91% to $2.33 following the announcement.

January 24, 2024 | 4:48 pm
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POSITIVE IMPACT
Heron Therapeutics' Zynrelef has received FDA approval for expanded use in orthopedic and soft tissue procedures, significantly increasing its market reach and potential revenue.
The FDA approval for expanded use of Zynrelef is a significant positive development for Heron Therapeutics. It increases the addressable market for the drug, which is likely to lead to increased sales and revenue. The positive market reaction is reflected in the stock's price increase. The company's expectation of further positive impacts from a recent partnership and potential future approvals adds to the optimistic outlook for the stock in the short term.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100