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Semnur Pharmaceuticals, Inc. (“Semnur”), a Majority-Owned Subsidiary of Scilex Holding Company (Nasdaq: SCLX, “Scilex”), and Denali Capital Acquisition Corp. Announced the Closing of Their Previously Announced Business Combination on September 22, 2025
Globenewswire· 2025-09-23 10:00
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]
Apimeds Welcomes FDA Draft Guidance as Catalyst for Advancing Apitox Non-Opioid Pain Program
Businesswire· 2025-09-12 01:54
Core Insights - The FDA has released draft guidance on the development of non-opioid pain therapies, which is expected to benefit Apimeds Pharmaceuticals' lead program, Apitox, aimed at treating chronic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].
Pacira BioSciences Reports Second Quarter 2025 Financial Results
GlobeNewswire News Room· 2025-08-05 20:00
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]
Pacira to Report Second Quarter 2025 Financial Results on Tuesday August 5, 2025
Globenewswire· 2025-07-24 12:00
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].
Pacira BioSciences Announces Strategic Collaboration to Significantly Expand ZILRETTA Promotional Efforts
Globenewswire· 2025-07-22 12:00
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]
Pacira BioSciences Debuts Inspiring New Film Highlighting One Patient’s Journey to Pain Relief and Innovation in Care at BIO 2025
Globenewswire· 2025-06-18 12:00
Core Insights - Pacira BioSciences, Inc. is focusing on non-opioid pain therapies to improve patient outcomes and reduce opioid dependency [1][4] - The film "The Next Frontier: Mark & Leah's Story" showcases the personal journey of Mark Allen, who overcame opioid dependency through non-opioid treatments [2][3] - The opioid crisis remains a significant public health issue, with chronic pain affecting approximately 82 million Americans and costing the U.S. up to $635 billion annually [4] Company Overview - Pacira offers three commercial-stage non-opioid treatments: EXPAREL, ZILRETTA, and iovera°, aimed at managing pain without opioids [5] - EXPAREL is a long-acting local analgesic approved for various pain management applications, while ZILRETTA is for osteoarthritis knee pain, and iovera° provides drug-free pain control [5] - The company is also developing PCRX-201, a gene therapy targeting prevalent diseases like osteoarthritis [5] Industry Context - The U.S. experienced approximately 80,391 drug overdose deaths in 2024, with opioid-related deaths decreasing to 54,743, indicating a need for alternative pain management solutions [4] - Despite the decline in opioid-related deaths, the overall opioid crisis continues to have a severe impact on public health [4] - Investment in novel pain treatments has decreased, highlighting the urgent need for innovative non-opioid therapies [4]
Pacira BioSciences to Participate in Fireside Chat at Two Upcoming Healthcare Conferences
Globenewswire· 2025-05-14 12:00
Core Insights - Pacira BioSciences, Inc. is committed to delivering innovative, non-opioid pain therapies to transform patients' lives [2] - The company will participate in two upcoming healthcare conferences, providing opportunities for analysts to engage with its leadership [1][3] Company Overview - Pacira has three commercial-stage non-opioid treatments: - EXPAREL, a long-acting local analgesic approved for various postsurgical pain management applications [2] - ZILRETTA, an extended-release injection for osteoarthritis knee pain management [2] - ioveraº, a handheld device for drug-free pain control using cold temperature [2] - The company is also developing PCRX-201, a novel gene therapy aimed at treating prevalent diseases like osteoarthritis [2]
Pacira to Report First Quarter 2025 Financial Results on Thursday May 8, 2025
Globenewswire· 2025-04-29 12:00
Core Viewpoint - Pacira BioSciences, Inc. is set to report its first quarter financial results on May 8, 2025, and will host a live conference call 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 [3] - Pacira is also developing PCRX-201, a novel gene therapy targeting prevalent diseases like osteoarthritis [3]