HRTX - Upcoming FDA Decision: Heron Therapeutics' ZYNRELEF SNDA

2024-01-22 06:30:00 ET

Company: Heron Therapeutics, Inc. (HRTX)

SA Analyst Rating for HRTX: " Buy " SA Quant rating: " Strong Buy ".

Seeking FDA Approval for greatly expanded use of ZYNRELEF for post-operative pain management in soft tissue and orthopaedic surgical procedures.

Type of Application: Supplemental New Drug Application ((SNDA)).

FDA Decision (PDUFA) Date: January 23, 2024.

Drug Status: ZYNRELEF is now approved in the U.S. in adults to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures.

Drug's Mechanism of Action: ZYNRELEF is the first and only extended-release dual-acting local anesthetic delivering a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam.

Drug's superiority over standard of care: ZYNRELEF is the first and only non-opioid dual-acting local anesthetic for post-operative pain. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery vs. bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control.

Market Potential: If the ZYNRELEF SNDA is approved, it would almost double the opportunity from ~7 million procedures covered by the current label to ~13 million procedures annually.

Revenues: For the nine months ended September 30, 2023, ZYNRELEF generated revenues of ~$12 million (representing ~13% of total revenues) vs. year-ago $6.3 million (representing ~8% of revenues).

Management Guidance in Q3 Call with respect to FDA approval: "First is the sNDA PDUFA Date scheduled for January 23, 2024. We anticipate a positive response from the FDA and are excited to offer ZYNRELEF to additional patients that may benefit from the added indications."

Recent Developments: Heron inked a 5-year distribution deal with CrossLink Life Sciences, LLC to expand the sales network supporting ZYNRELEF.

SA Analyst Opinion:

SA Analyst Biotech Beast says, "I think the potential for the Zynrelef sNDA to be approved, which I expect, serves as a near-term catalyst for the company." HRTX is up > 20% since the analyst's Buy Rating on December 29, 2023.

SA Analyst Edgar Torres H wrote in November, "I think it's key to understand how important Zynrelef can become for HRTX going forward. For context, this drug is the first and only extended-release local anesthetic with Phase 3 studies. This is key because, if successfully developed and commercialized, Zynrelef could quickly become a viable alternative to opioids for pain management post-surgery. This means Zynrelef could gain the narrative as a drug that helps against the opioid epidemic in the US and quickly become an important revenue contributor to HRTX at the same time. Since 2020, Zynrelef has made significant strides toward wider approval and acceptance and is now well on its way to becoming the gold-standard alternative in pain management.". HRTX is up ~60% since the analyst's Buy Rating on November 30, 2023.

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