Pacira BioSciences licenses AMT-143 for postsurgical pain control, expanding its non-opioid therapy pipeline. Phase 2 starts in 2026.
Quiver AI Summary
Pacira BioSciences, Inc. announced a collaboration with AmacaThera for the development of AMT-143, a new long-acting formulation of the non-opioid analgesic ropivacaine, aimed at improving postsurgical pain control. This initiative aligns with Pacira's 5x30 growth strategy, which emphasizes expanding their pipeline with complementary, clinical-stage products. The Phase 2 program for AMT-143 is expected to commence in 2026, following positive results from a Phase 1 study showing sustained release of the analgesic over 14 days. Under the agreement, Pacira will handle clinical development costs, pay AmacaThera an upfront fee of $5 million, and provide additional milestone payments and royalties on future sales. This move reinforces Pacira's commitment to delivering innovative, opioid-sparing pain management solutions.
Potential Positives
- Expansion of the pipeline with AMT-143 enhances Pacira's position as a leader in non-opioid pain management, addressing a significant unmet need in the market.
- The exclusive collaboration with AmacaThera provides potential for cash flow and earnings growth, aligning with the company's 5x30 growth strategy.
- Initiation of the Phase 2 program for AMT-143 expected in 2026 indicates a commitment to progressing innovative pain management solutions.
- The long-acting formulation of ropivacaine has demonstrated sustained release in Phase 1, showcasing the potential for effective postsurgical pain control and reduced systemic side effects.
Potential Negatives
- The Phase 2 program for AMT-143 is not expected to begin until 2026, indicating a significant delay in the timeline for potential revenue generation from this asset.
- Pacira is responsible for funding the clinical development through to commercial launch, which could strain financial resources and affect cash flow if the investment does not yield expected returns.
- The reliance on a new product in a highly competitive market may introduce risks related to market acceptance and the success of commercialization efforts for both AMT-143 and existing products.
FAQ
What is AMT-143?
AMT-143 is a novel long-acting formulation of the non-opioid analgesic ropivacaine for postsurgical pain control.
When will the Phase 2 program for AMT-143 begin?
The Phase 2 program for AMT-143 is expected to begin in 2026.
What does the agreement with AmacaThera involve?
The agreement includes an exclusive worldwide license for the development and commercialization of AMT-143, with Pacira funding clinical development.
How does AMT-143 improve pain management?
AMT-143 provides a longer-acting pain control option, addressing the significant unmet need for opioid-sparing treatments.
What is Pacira’s growth strategy?
Pacira's growth strategy, called 5x30, focuses on clinical stage opportunities that enhance their portfolio in pain management.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
-- Advances 5x30 strategy by expanding pipeline with a highly complementary asset that has the potential to provide several days of pain control --
-- Phase 2 program for AMT-143 expected to begin in 2026 --
BRISBANE, Calif., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced an exclusive worldwide license and collaboration agreement with AmacaThera for the development and commercialization of AMT-143, a novel long-acting formulation of the non-opioid analgesic ropivacaine for postsurgical pain control.
“Expanding our pipeline with this novel formulation of ropivacaine builds on our leadership in innovative opioid-sparing pain management,” said Frank D. Lee, chief executive officer of Pacira BioSciences. “We believe this franchise-enhancing asset is highly complementary to EXPAREL and underscores our commitment to personalizing and improving the patient journey with a range of options. There remains a significant unmet need for safe and effective opioid-sparing pain control including an easy-to-use longer-acting therapy to serve a broader range of patients and physicians.”
“Importantly, this agreement aligns with our 5x30 growth strategy to prioritize clinical stage, derisked opportunities complementary to our call points in pain management. Given its strong commercial synergies with our existing product offering, this asset has the potential to be meaningfully accretive to cash flow and earnings within our 5x30 timeframe,” continued Mr. Lee.
About the Agreement
Under the terms of the agreement, Pacira will fund clinical development through to commercial launch and the companies will collaborate on Phase 2 clinical development. AmacaThera will receive an upfront payment of $5 million with the potential for future development- and sales-based milestone payments and a tiered royalty on future net sales.
About AMT-143
AMT-143 is a long-acting local analgesic for postsurgical pain control. It is administered via instillation at the time of the surgery. In a Phase 1 study, AMT-143 demonstrated sustained release of ropivacaine through 14 days. Pacira and AmacaThera expect to initiate a Phase 2 program in 2026.
AMT-143 leverages AmacaThera’s innovative hydrogel-based drug delivery platform, a fast-gelling physical hydrogel composed of two well-established polymers enabling slow-release while minimizing systemic side effects. It is delivered via a conventional syringe and rapidly forms a depot as it warms to body temperature.
About Pacira
Pacira delivers innovative, non-opioid pain therapies to transform the lives of patients. Pacira has three commercial-stage non-opioid treatments: EXPAREL® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block, an adductor canal nerve block, and a sciatic nerve block in the popliteal fossa for postsurgical pain management; ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and iovera®º, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. The company is also advancing the development of PCRX-201 (enekinragene inzadenovec), a novel locally administered gene therapy with the potential to treat large prevalent diseases like osteoarthritis. To learn more about Pacira, visit www.pacira.com.
Forward-Looking Statements
Any statements in this press release about Pacira’s future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “should,” “will,” “would,” and similar expressions, constitute forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995, including, without limitation, statements related to: '5x30', our growth and business strategy, our future outlook, our intellectual property and patent terms, our future growth potential and future financial and operating results and trends, our plans, objectives, expectations (financial or otherwise) and intentions, including our plans with respect to the repayment of our indebtedness, anticipated product portfolio and product development programs, strategic alliances, plans with respect to the Non-Opioids Prevent Addiction in the Nation (“NOPAIN”) Act, the expected cost savings and benefits of a July 2025 reduction in force and any other statements that are not historical facts. For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement. We cannot assure you that our estimates, assumptions and expectations will prove to have been correct. Actual results may differ materially from these indicated by such forward-looking statements as a result of various important factors, including risks relating to, among others: the failure to realize the anticipated benefits and synergies from the acquisition of GQ Bio Therapeutics GmbH; risks associated with acquisitions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; our manufacturing and supply chain, global and United States economic conditions (including tariffs, inflation and rising interest rates), and our business, including our revenues, financial condition, cash flows and results of operations; the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL, ZILRETTA and iovera°; the rate and degree of market acceptance of EXPAREL, ZILRETTA and iovera°; the size and growth of the potential markets for EXPAREL, ZILRETTA and iovera° and our ability to serve those markets; our plans to expand the use of EXPAREL, ZILRETTA and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL, ZILRETTA, iovera° and any of our other product candidates, including PCRX-201; the commercial success of EXPAREL, ZILRETTA and iovera°; the related timing and success of United States Food and Drug Administration supplemental New Drug Applications and premarket notification 510(k)s; the related timing and success of European Medicines Agency Marketing Authorization Applications; our plans to evaluate, develop and pursue additional product candidates utilizing our proprietary multivesicular liposome (“pMVL”) drug delivery technology; the approval of the commercialization of our products in other jurisdictions; clinical trials in support of an existing or potential pMVL-based product; our commercialization and marketing capabilities; our ability to successfully complete capital projects; the outcome of any litigation; the recoverability of our deferred tax assets; assumptions associated with contingent consideration payments; assumptions used for estimated future cash flows associated with determining the fair value of the Company and the anticipated funding or benefits of our share repurchase program. and factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. Except as required by applicable law, we undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, and readers should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.