Pacira BioSciences reports developments across a commercial portfolio of non-opioid pain management and regenerative health products. Its recurring updates center on EXPAREL® (bupivacaine liposome injectable suspension) for postsurgical pain, ZILRETTA® extended-release intra-articular corticosteroid injection for osteoarthritis, and the iovera° cold-therapy device for targeted nerve pain control.
Company news also covers earnings and product revenue trends, real-world evidence on opioid use and healthcare costs, pipeline development involving ZILRETTA, iovera° and PCRX-201, share repurchases, equity inducement awards, and stockholder governance matters tied to board composition and proxy materials.
Pacira BioSciences (Nasdaq: PCRX) has received FDA 510(k) clearance for a new Smart Tip designed for the iovera° system to manage chronic low back pain via long-lasting medial branch nerve block. The iovera° system uses cryoneurolysis, applying focused cold therapy to nerves to interrupt pain signals temporarily. The new 25-gauge, 180-mm Smart Tip treats deeper nerves, including the medial branch nerve, and is designed to relieve chronic low back pain associated with facet-mediated pain.
Chronic low back pain is a significant health issue in the U.S., leading to disability and opioid prescriptions. The iovera° system provides an alternative to radiofrequency ablation (RFA), which has limitations like delayed pain relief and potential tissue damage. A single-center randomized pilot study showed that patients treated with iovera° reported pain scores more than 2 points lower at 180 and 360 days compared to RFA-treated patients. Additionally, iovera° patients exhibited significant functional improvements and greater satisfaction with pain management.
The FDA clearance of this new Smart Tip is a step forward in offering drug-free, effective pain relief for millions of Americans with chronic back pain.
Pacira BioSciences (NASDAQ: PCRX) has announced its upcoming presentation at the 43rd Annual J.P. Morgan Healthcare Conference. The presentation is scheduled for Wednesday, January 15, 2025, at 10:30 AM PT (1:30 PM EST).
Interested parties can access the live audio presentation through the 'Events' page on the company's investor website at investor.pacira.com. The company will make a replay of the webcast available for a two-week period following the event.
VectorY Therapeutics announces Jim Scibetta as new CEO, while former CEO Sander van Deventer transitions to President of R&D. The company's lead program, VTx-002, a vectorized antibody targeting TDP-43 for ALS treatment, advances to IND-enabling studies following positive FDA feedback. The company recently completed a $138 million Series A funding round co-led by EQT Life Sciences and Forbion, and expanded its presence with a new office in Boston.
Scibetta brings over 20 years of executive leadership experience, including roles as CEO of Maverick Therapeutics and President of Pacira BioSciences. VTx-002 aims to delay ALS disease progression by targeting TDP-43 pathology and is expected to enter clinical trials by the end of 2025.
DOMA Perpetual Capital Management, owning 4.14% of Pacira BioSciences (NASDAQ: PCRX), announced plans to nominate four independent director candidates for Pacira's 2025 annual stockholder meeting. DOMA has hired Olshan Frome Wolosky LLP as legal counsel for company dealings.
Expressing strong confidence in Pacira's intellectual property value, DOMA believes the company's stock is significantly undervalued. They are urging Pacira to initiate an immediate stock tender offer for 10 million shares using available cash reserves, followed by executing their previously approved $150 million buyback program using the company's healthy and growing free cash flow.
Pacira BioSciences (Nasdaq: PCRX), a leader in non-opioid pain therapies, has granted inducement awards to four new employees on December 3, 2024. The awards include:
- Stock options to purchase 19,800 shares of common stock at $16.68 per share, with a 10-year term and four-year vesting schedule
- 23,600 restricted stock units (RSUs) vesting annually in four equal installments starting December 1, 2024
The awards were approved by the Compensation Committee under Pacira's Amended and Restated 2014 Inducement Plan and comply with Nasdaq Listing Rule 5635(c)(4). Vesting is contingent upon continued employment.
Pacira BioSciences (Nasdaq: PCRX) has been awarded U.S. Patent No. 12,156,940 for EXPAREL's chemical composition, providing protection until July 2044. This patent is the first in a new family related to EXPAREL produced by their enhanced manufacturing process in San Diego, approved by FDA in February 2024. The company plans to list the patent in the FDA Orange Book and file a patent infringement lawsuit against Jiangsu Hengrui Pharmaceuticals and Fresenius Kabi USA. Additionally, two new patents (No. 12,151,024 and 12,144,890) were issued, extending protection until January 2041.
Pacira BioSciences (NASDAQ: PCRX) announced promising 104-week safety and efficacy data for its gene therapy candidate PCRX-201 in treating knee osteoarthritis. The Phase 1 trial involving 72 patients demonstrated sustained improvements in knee pain, stiffness, and function. The pretreated cohort showed 48-65% pain improvement and 53-72% stiffness reduction from baseline. Over 70% of participants achieved >50% pain reduction by week 16. The therapy showed a well-tolerated safety profile with no serious treatment-related adverse events. PCRX-201, which received FDA's RMAT designation in March 2024, is designed to produce IL-1Ra protein to reduce inflammation. A Phase 2 study is planned for 2025.
Pacira BioSciences (NASDAQ: PCRX) announced its participation in two upcoming healthcare conferences. The company will engage in an analyst-led fireside chat at the Jefferies London Healthcare Conference on November 19th at 3:00 PM GMT (10:00 AM ET).
Additionally, Pacira BioSciences will be present at the 36th Annual Piper Sandler Healthcare Conference on December 3rd at 1:00 PM ET. Interested parties can access live audio of these events on the “Events” page of the company’s website at investor.pacira.com. Replays will be available for two weeks following the events.
Pacira BioSciences (PCRX) reported Q3 2024 financial results with total revenues of $168.6 million. Net product sales were $132.0 million for EXPAREL, $28.4 million for ZILRETTA, and $5.7 million for iovera°. The company reported a net loss of $143.5 million, or $3.11 per share, including a $163.2 million goodwill impairment charge. Adjusted EBITDA was $54.7 million. The company maintained its 2024 guidance of total revenue between $680-705 million. CMS confirmed EXPAREL and iovera° qualify for separate Medicare payment under the NOPAIN Act starting January 2025.
Pacira BioSciences (NSDQ: PCRX) announced that CMS has confirmed both EXPAREL and iovera° as qualifying non-opioid pain management products under the NOPAIN Act. Starting January 1, 2025, hospitals and ambulatory surgical centers will receive additional Medicare reimbursement for these products. EXPAREL will be reimbursed at 106% of average sales price using J-code J0666, while iovera° will receive up to $255.85 additional payment using C-code C9809. This implementation is part of the final Medicare Hospital OPPS and ASC Payment System rule for 2025, aimed at providing better access to non-opioid pain management options.