Core Insights - Pacira BioSciences has announced an exclusive worldwide license and collaboration agreement with AmacaThera for the development of AMT-143, a novel long-acting formulation of the non-opioid analgesic ropivacaine aimed at postsurgical pain control [1][2] Company Strategy - The addition of AMT-143 to the pipeline aligns with Pacira's 5x30 growth strategy, focusing on clinical stage, derisked opportunities that complement existing pain management offerings [2] - The company aims to enhance its leadership in opioid-sparing pain management through this new asset, which is expected to improve patient outcomes and expand treatment options [2] Financial Terms of the Agreement - Under the agreement, Pacira will fund the clinical development up to commercial launch, with AmacaThera receiving an upfront payment of $5 million, along with potential future milestone payments and a tiered royalty on net sales [3] Product Details - AMT-143 is designed for postsurgical pain control and demonstrated sustained release of ropivacaine for up to 14 days in a Phase 1 study [4] - The product utilizes AmacaThera's hydrogel-based drug delivery platform, which allows for slow release while minimizing systemic side effects [5] Current Product Portfolio - Pacira currently offers three commercial-stage non-opioid treatments: EXPAREL, ZILRETTA, and iovera, which target various pain management needs [6]

Core Insights - Pacira BioSciences, Inc. will report its third quarter financial results on November 6, 2025, after U.S. market close [1] - A live conference call and webcast will follow the financial results announcement at 4:30 p.m. ET [1] Company Overview - Pacira specializes in innovative, non-opioid pain therapies aimed at transforming patient lives [3] - The company has three commercial-stage non-opioid treatments: - EXPAREL, a long-acting local analgesic for various postsurgical pain management applications [3] - ZILRETTA, an extended-release injection for osteoarthritis knee pain management [3] - ioveraº, a handheld device providing immediate, long-acting, drug-free pain control [3] - Pacira is also developing PCRX-201, a novel gene therapy targeting prevalent diseases like osteoarthritis [3]

Core Viewpoint - Pacira BioSciences, Inc. has received a Paragraph IV Certification Notice Letter from Qilu Pharmaceutical, indicating Qilu's intent to file a generic version of EXPAREL, which may challenge Pacira's patent rights [1][2]. Company Overview - Pacira BioSciences is focused on delivering innovative, non-opioid pain therapies, with three commercial-stage products: EXPAREL, ZILRETTA, and iovera [5]. - EXPAREL is a long-acting local analgesic approved for various postsurgical pain management applications, utilizing a unique multivesicular liposome technology [6]. Patent and Legal Context - Qilu Pharmaceutical claims that 18 patents related to EXPAREL are invalid or unenforceable, which could allow them to market a generic version [2]. - The contested patents belong to two families, with expiration dates in 2041 and 2044 [3]. - Pacira has 45 days to respond to the PIV Notice and may file a lawsuit to protect its intellectual property, which would trigger a 30-month stay on FDA approval for Qilu's ANDA submission [4].

Core Insights - Pacira BioSciences, Inc. is presenting real-world evidence on the clinical effectiveness and economic benefits of EXPAREL at the AMCP Nexus 2025 Annual Meeting [1][3] - The company aims to advance understanding of postsurgical pain management and reduce reliance on opioids through multimodal pain pathways [3] Company Overview - Pacira specializes in innovative, non-opioid pain therapies, with three commercial-stage products: EXPAREL, ZILRETTA, and iovera [5] - EXPAREL is a long-acting local analgesic approved for various postsurgical pain management applications [5][6] - The company is also developing PCRX-201, a novel gene therapy targeting prevalent diseases like osteoarthritis [5] Research Presentations - The AMCP Nexus 2025 will feature presentations on the impact of liposomal bupivacaine on healthcare resource utilization and costs in total knee arthroplasty [4] - Additional presentations will cover outcomes related to intraoperative liposomal bupivacaine and its effects on opioid use and functional outcomes [7] Product Details - EXPAREL utilizes multivesicular liposome technology to deliver bupivacaine over time, achieving significant reductions in cumulative pain scores and opioid consumption [8] - The product is indicated for postsurgical local and regional analgesia in patients aged 6 years and older [6]

Core Viewpoint - Pacira BioSciences, Inc. has received a Paragraph IV Certification Notice Letter from The WhiteOak Group, which has filed an Abbreviated New Drug Application for a generic version of EXPAREL, claiming that the patents are invalid or not infringed [1][2] Patent and Legal Context - WhiteOak alleges that 19 patents related to EXPAREL are invalid, unenforceable, or will not be infringed by their product [2] - The contested patents are from two families, with expiration dates of January 22, 2041, and July 2, 2044 [3] - Pacira has 45 days to file a lawsuit to protect its intellectual property rights, which would trigger a 30-month stay of FDA approval for WhiteOak's ANDA submission [4] Company Overview - Pacira specializes in non-opioid pain therapies, with three commercial-stage products: EXPAREL, ZILRETTA, and iovera° [5] - EXPAREL is a long-acting local analgesic approved for various postsurgical pain management applications, significantly reducing opioid consumption by up to 78% [6]

Core Viewpoint - Semnur Pharmaceuticals has successfully completed its business combination with Denali Capital Acquisition Corp, transitioning to a public company to enhance growth and address non-opioid pain management needs [1][2][3] Company Overview - Semnur Pharmaceuticals, Inc. is a clinical late-stage specialty pharmaceutical company focused on developing and commercializing novel non-opioid pain therapies, particularly targeting moderate to severe chronic radicular pain/sciatica with its product candidate SP-102 (SEMDEXA™) [4][5] - The combined company will operate under the name Semnur Pharmaceuticals, Inc., with shares trading on the OTC Markets under the ticker symbols "SMNR" and "SMNRW" starting September 23, 2025 [2][7] Business Combination Details - The business combination was officially closed on September 22, 2025, allowing Semnur to access public capital markets for business growth [1][3] - Scilex Holding Company owns approximately 87.5% of Semnur's common stock post-business combination, indicating strong backing for the company's future endeavors [7] Leadership Statements - Henry Ji, Executive Chairperson of Semnur, emphasized the importance of public capital markets in enhancing business growth and fulfilling the company's mission [3] - Jaisim Shah, CEO of Semnur, expressed pride in the company's leadership in non-opioid therapeutics and the aim to accelerate access to these treatments through advancing clinical development and payer adoption [3] Product Development Focus - Semnur is advancing its second Phase 3 clinical development for SP-102, which is a novel gel formulation for epidural administration aimed at treating chronic radicular pain/sciatica [3][4] - The company is committed to increasing access to prescription non-opioid therapeutics and expanding its market presence [3]

Core Insights - The FDA has released draft guidance on the development of non-opioid pain therapies, which is expected to benefit Apimeds Pharmaceuticals' lead program, Apitox, aimed at treating chronic osteoarthritis pain [1]. Company Summary - Apimeds Pharmaceuticals US, Inc. (NYSE: APUS) is positioned to accelerate its lead program, Apitox, in response to the FDA's new draft guidance [1]. Industry Summary - The draft guidance titled "Development of Non-Opioid Analgesics for Chronic Pain" is a significant regulatory development that may influence the landscape for non-opioid pain management therapies [1].

Core Insights - Pacira BioSciences reported solid execution in its corporate, clinical, and commercial initiatives, advancing its 5x30 growth strategy aimed at accelerating topline growth and transitioning into an innovative biopharmaceutical organization [4][5] Financial Highlights - Total revenues for Q2 2025 were $181.1 million, an increase from $178.0 million in Q2 2024 [11] - Net product sales included $142.9 million for EXPAREL, $31.3 million for ZILRETTA, and $5.6 million for iovera° [6] - The company reported a net loss of $4.8 million, or $0.11 per share, compared to a net income of $18.9 million, or $0.41 per share in Q2 2024 [11] - Adjusted EBITDA for Q2 2025 was $54.3 million, down from $62.1 million in Q2 2024 [11] Business Developments - The company surpassed 50% enrollment in its Phase 2 ASCEND study of PCRX-201 for knee osteoarthritis, with completion expected by the end of 2025 [7] - A new $300 million revolving credit facility was established to enhance liquidity and financial flexibility [7] - A co-promotion agreement with Johnson & Johnson MedTech aims to expand ZILRETTA's market reach [7] - Manufacturing efficiencies from large-scale EXPAREL production are expected to improve gross margins and inventory management [7] Legal and Patent Developments - A favorable court ruling resulted in a $28.3 million payment from the Research and Development Foundation [8] - The company secured additional patents for EXPAREL, extending exclusivity through 2041 and 2044 [8] Financial Guidance - The company updated its full-year 2025 revenue guidance to a range of $730 million to $750 million, while increasing non-GAAP gross margin guidance to 78-80% [19]

Core Viewpoint - Pacira BioSciences, Inc. is set to report its second quarter financial results on August 5, 2025, and will host a live conference call and webcast following the release [1]. Company Overview - Pacira specializes in innovative, non-opioid pain therapies aimed at transforming patient lives [3]. - The company has three commercial-stage non-opioid treatments: - EXPAREL, a long-acting local analgesic for various postsurgical pain management applications [3]. - ZILRETTA, an extended-release injection for osteoarthritis knee pain management [3]. - ioveraº, a handheld device providing immediate, long-acting, drug-free pain control through cold temperature [3]. - Pacira is also developing PCRX-201, a novel gene therapy targeting prevalent diseases like osteoarthritis [3].

Core Insights - Pacira BioSciences has announced a strategic collaboration with Johnson & Johnson MedTech to enhance the market reach of ZILRETTA, an extended-release treatment for osteoarthritis knee pain, by leveraging Johnson & Johnson's specialized sales force [1][2] - The partnership aims to significantly increase ZILRETTA sales calls and expand patient access, targeting a substantial portion of the seven million intra-articular knee injections administered annually in the U.S. [1][3] Company Overview - Pacira BioSciences specializes in innovative, non-opioid pain therapies, with three commercial-stage products: EXPAREL, ZILRETTA, and iovera° [4] - ZILRETTA is the first and only extended-release intra-articular therapy approved by the FDA for osteoarthritis-related knee pain, utilizing proprietary microsphere technology for prolonged pain relief [5] Strategic Collaboration Details - The collaboration with Johnson & Johnson MedTech will enhance promotional efforts and extend ZILRETTA's reach beyond orthopedic practices into other specialties such as sports medicine, pain management, and rheumatology [3] - This partnership is part of Pacira's "5x30 strategy," which focuses on leveraging targeted collaborations to drive growth and improve patient outcomes with non-opioid treatments [2]