Indivior Pharmaceuticals Inc Stock Price, News & Analysis

Indivior PLC (Nasdaq/LSE: INDV) announced that the FDA has delayed the final review of proposed label changes for SUBLOCADE® (buprenorphine extended-release) Injection. The PDUFA action date was originally scheduled for February 7, 2025. On February 11, 2025, the FDA informed Indivior that while there were no outstanding items to address following acceptance of the proposed label, the final review has been delayed. The proposed changes include rapid initiation protocol and alternative injection sites. The company will provide updates on the approval status as appropriate.

Indivior PLC presented significant findings at CSAM 2024 showing that rapid initiation (RI) with once-monthly SUBLOCADE improves treatment retention for opioid use disorder (OUD) patients compared to standard initiation (SI). The study of 729 participants demonstrated a 12% overall improvement in retention rates, with a 15% increase among fentanyl-positive patients.

The RI protocol involves administering SUBLOCADE within one hour of a single transmucosal buprenorphine dose, followed by a second injection after one week, versus the standard 28-day interval. The FDA has granted Priority Review for label expansion to include rapid initiation and alternative injection sites (thigh, upper arm, and buttocks), with a PDUFA date of February 7, 2025.

Indivior PLC (NASDAQ/LSE: INDV) has acknowledged a letter published by Oaktree Capital Management to its Board of Directors. The Board confirms it has been actively engaging with Oaktree in recent weeks and maintains an open-minded stance regarding proposals for value creation. Indivior, a global pharmaceutical company focused on substance use disorders (SUD) treatment, emphasizes its commitment to acting in the best interests of all shareholders while executing its strategy. The company operates in over 30 countries and employs more than 1,000 people globally.

Indivior PLC (Nasdaq/LSE: INDV) highlights key findings demonstrating the effectiveness and safety of SUBLOCADE in treating opioid use disorder (OUD). A post-hoc analysis showed that SUBLOCADE 300 mg maintenance dose significantly increased opioid abstinence in injecting participants compared to 100 mg dose. The CoLAB Study demonstrated 96-week treatment maintenance with improvements in abstinence, depression, and quality of life. Research identified telemedicine as a common solution during COVID-19 for overcoming access barriers, though challenges persist. Multiple real-world evidence presentations addressed various aspects of OUD treatment, including ER visits, healthcare utilization, and treatment outcomes. Only 18% of the nearly 6 million people with OUD received MOUD treatment in 2023.

Indivior PLC (Nasdaq/LSE: INDV) has announced its financial results for Q3 2024, ending September 30, 2024. The company has made available its earnings release and investor presentation on www.indivior.com. CEO Mark Crossley will host a live webcast presentation at 13:00 BST (8:00 am ET). Participants can join the presentation through a webcast link or register for telephonic access.

Indivior PLC (Nasdaq/LSE: INDV) announced preliminary Q3 2024 financial results and updated FY 2024 guidance. Key points:

• Q3 2024 SUBLOCADE net revenue (NR): $187m to $192m
• Revised FY 2024 SUBLOCADE NR: $725m to $745m (+17% vs. FY 2023)
• Expected peak SUBLOCADE NR of >$1.5 billion unchanged
• No longer expects $1 billion SUBLOCADE NR run rate exiting 2025

Factors impacting performance:

• Faster adoption of competing long-acting injectable
• Variability in Criminal Justice System funding timing
• Lower trade stocking

The company remains confident in SUBLOCADE's differentiated profile for opioid use disorder patients and is evaluating actions to fuel growth and support margins.

Indivior PLC (Nasdaq/LSE: INDV) has provided an update on Aelis Farma's clinical Phase 2B trial results for AEF0117, a potential treatment for Cannabis Use Disorder (CUD). The study, which evaluated the efficacy and safety in treatment-seeking participants with moderate to severe CUD, failed to meet its primary and secondary endpoints. The primary goal was to reduce cannabis use to ≤1 day per week, while secondary endpoints included complete abstinence or use ≤2 days per week.

Despite the disappointing results, the study highlights the need for further research into CUD subpopulations, particularly those with severe cases. As a result of these outcomes, Indivior does not currently plan to exercise its option to license the global rights to AEF0117, which was part of a strategic collaboration with Aelis Farma.

Indivior PLC (LSE/Nasdaq: INDV) announced the first order of OPVEE® (nalmefene) nasal spray from the Biomedical Advanced Research and Development Authority (BARDA). This order, worth $8.7 million, is part of BARDA's national preparedness efforts against synthetic opioid overdose emergencies. OPVEE is the first and only nasal rescue medicine specifically indicated for synthetic opioids like fentanyl.

The order comes as opioid overdose deaths in the U.S. reached 76,922 in the year ending January 2024. BARDA will use OPVEE to supplement local supplies for emergency rooms, ambulances, and other sites in case of medical countermeasure shortages during emergencies. This is the first option exercised under an agreement announced in December 2023, with BARDA having the option to purchase additional OPVEE annually for the next nine years.

Indivior PLC (Nasdaq/LSE: INDV) has announced a new $100 million share repurchase program to be executed over an accelerated six-month timeframe. This follows the expedited completion of their current $100 million program, expected to finish by the end of July 2024. The new program, set to begin immediately after, will be carried out through a non-discretionary agreement with Morgan Stanley.

Key points:

• Repurchases will be made on London Stock Exchange, Aquis Stock Exchange, and CBOE Europe
• Maximum of 13,649,017 ordinary shares may be repurchased
• All repurchased shares will be cancelled to reduce issued share capital
• Program complies with shareholder authorization and regulatory standards