Yahoo Finance Pacira's (PCRX) sNDA for Exparel Accepted for FDA Review
Pacira Biosciences PCRX announced that the FDA has accepted for review its supplemental new drug application (sNDA) for Exparel. The sNDA seeks to expand Exparel’s label to include a single-dose sciatic nerve block in the popliteal fossa and a femoral nerve block in the adductor canal.
A decision from the FDA is expected on Nov 13, 2023.
The sNDA filing was based on results from two successful phase III studies of Exparel. The drug achieved statistically significant and clinically meaningful reductions in postsurgical pain and opioid consumption through 96 hours compared with bupivacaine HCl. These observations were made in lower extremity surgical procedures, including bunionectomy and total knee arthroplasty.
Data from both studies also showed that treatment with Exparel demonstrated a well-tolerated safety profile, consistent with previously conducted studies.
In the past year, the shares of Pacira have plunged 46.5% compared with the industry’s 16.6% fall.
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Management strongly believes that Exparel has the potential to include both sciatic and femoral nerve blocks under its label, which would enable a single 10 mL dose of Exparel to manage pain for more than 3 million lower extremity procedures annually. Management also believes that a potential approval of the sNDA would provide clinicians with a safe and effective option to provide four days of postsurgical pain control, reduce opioid requirements and continue to migrate relevant orthopedic procedures to the outpatient setting.
Since its launch, more than 12 million patients have been treated with Exparel in the United States. Exparel generated sales worth $536.9 million in 2022. Rolling into 2023, Parica expects Exparel’s net product sales to be in the range of $570 million to $580 million.
Pacira’s flagship product, Exparel, was launched in 2012. Exparel is a liposome injection of bupivacaine indicated for single-dose administration into the surgical site to produce postsurgical analgesia. In 2012, the company signed a licensing agreement with Aratana to develop and commercialize Exparel for animal health indications.
Pacira BioSciences, Inc. Price and Consensus
Pacira BioSciences, Inc. price-consensus-chart | Pacira BioSciences, Inc. Quote
Zacks Rank and Stocks to Consider
Pacira currently has a Zacks Rank #5 (Strong Sell).
Some better-ranked stocks are Avalo Therapeutics AVTX, Avita Medical RCEL and EQRx EQRX, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the last 90 days, Avalo’s loss estimates for the year 2023 have narrowed from $3.62 to $1.56 per share. In the past year, shares of Avalo have plunged 81.5%.
AVTX beat estimates in two of the last three reported quarters, missing the mark on one occasion and delivering an average earnings surprise of 37.83%.
In the last 90 days, Avita’s loss estimates for the year 2023 have narrowed from $1.26 to 99 cents per share. In the past year, shares of Avita have shot up by 60.1%.
RCEL beat estimates in three of the last four reported quarters, missing the mark on one occasion and delivering an average earnings surprise of 22.16%.
In the last 90 days, EQRx’s loss estimates for the year 2023 have narrowed from 71 cents to 58 cents per share. In the past year, shares of EQRx have fallen 54.2%.
EQRX beat earnings estimates in all the last four reported quarters, clocking an average earnings surprise of 34.99%.
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