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Heron's (HRTX) Zynrelef Gets FDA Nod for Label Expansion

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Heron Therapeutics (HRTX - Free Report) announced that the FDA has approved the supplementary new drug application (sNDA) seeking the expanded use of its extended-release solution, Zynrelef, in postoperative pain management.

Per the approval, Zynrelef is indicated for use in adults for soft tissue or periarticular instillation 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.

Heron estimates that Zynrelef will cover 7 million procedures annually, following the expanded approval.

Classified by the FDA as an extended-release product, Zynrelef is a fixed-dose combination of local anesthetic bupivacaine and low-dose nonsteroidal drug meloxicam. Bupivacaine is the current standard-of-care local anesthetic for postoperative pain control.

This sNDA to the FDA seeking label expansion for Zynrelef was filed in October 2021 based on consistent safety, efficacy and pharmacokinetic data from previously completed clinical studies. No new clinical studies were conducted for this sNDA.

Shares of Heron rose 11.4% following the news. Yet, the stock has plunged 56.1% so far this year in comparison with the industry’s 17.6% fall.

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We remind investors that earlier this year in May, the FDA granted approval to Zynrelef for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.

Per the company, the use of Zynrelef can positively impact a patient’s well-being. An estimated 2 million Americans become persistent opioid users after receiving opioids following surgery. A decline in the use of opioids will help limit postoperative discharge opioids.

Heron also plans to submit another sNDA to the FDA in second-half 2022 to support a broad indication of soft tissue and orthopedic surgical procedures. If this second sNDA is approved, management expects to cover 14 million target procedures.

Zacks Rank & Stocks to Consider

Heron presently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech/drug sector include Endo International (ENDP - Free Report) , IVERIC bio (ISEE - Free Report) and Precision BioSciences (DTIL - Free Report) . While Endo International sports a Zacks Rank #1 (Strong Buy), both Precision BioSciences and IVERIC bio currently carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Endo International’s earnings per share estimates for 2021 have increased from $2.29 to $2.84 in the past 60 days. The same for 2022 has increased from $2.24 to $2.47 in the past 60 days.

Earnings of Endo International beat estimates in all the last four quarters, with the average being 57.7%.

IVERIC bio’s loss per share estimates for 2021 have narrowed from $1.18 to $1.09 in the past 60 days. The same for 2022 has narrowed from $1.17 to $1.03 in the past 60 days. Shares of IVERIC bio have gained 111.4% in the year so far.

Earnings of IVERIC bio missed estimates in three of the last four quarters and surpassed expectations once, with the negative surprise being 5.6%, on average.

Precision BioSciences’ loss per share estimates for 2021 have narrowed from $1.17 to $0.65 in the past 60  days. The same for 2022 has narrowed from $2.39 to $1.91 in the past 60 days. Shares of Precision BioSciences have risen 6.6% in the year so far.

Earnings of Precision BioSciences beat estimates in all the last four quarters, delivering a surprise of 76.9%, on average.