ABBVIE INC. - ABBV STOCK NEWS

Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced FDA approval of BOTOX® Cosmetic for temporary improvement of moderate to severe platysma bands in adults. This marks BOTOX® Cosmetic's fourth aesthetic indication, making it the first product to go beyond the face. The approval offers a nonsurgical, injectable option for treating vertical bands connecting the jaw and neck.

In Phase III clinical studies, BOTOX® Cosmetic demonstrated significant improvement in platysma band appearance compared to placebo. The FDA-approved doses are 26, 31, or 36 units based on severity. A majority of patients reported being satisfied with their neck and jawline definition after treatment.

Patients can learn more and enroll in Allē, Allergan Aesthetics' loyalty rewards program, which offers points on various treatments and flexible payment options.

AbbVie announced that the U.S. FDA has approved VYALEV™ (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for treating motor fluctuations in adults with advanced Parkinson's disease (PD). The approval was based on a 12-week Phase 3 study and a 52-week open-label study. Key findings include:

1. VYALEV demonstrated superior improvement in motor fluctuations compared to oral immediate-release carbidopa/levodopa.
2. Patients reported increased "on" time without troublesome dyskinesia and decreased "off" time.
3. Most adverse reactions were non-serious and mild to moderate in severity.
4. The most frequent adverse reactions were infusion site events, hallucinations, and dyskinesia.

VYALEV allows for personalized dosing based on individual needs. Coverage for Medicare patients is expected in the second half of 2025.

Allergan Aesthetics, an AbbVie company (NYSE: ABBV), will present data at the 2024 American Society for Dermatologic Surgery (ASDS) Annual Meeting, showcasing efficacy, safety, and patient-reported outcomes across its facial injectable portfolio. The company will present 12 abstracts, including four Best of Cosmetic Abstracts, demonstrating its commitment to patient outcomes and understanding key concerns across patient segments.

Highlights include:

• Safety and patient-reported outcomes for BOTOX® Cosmetic in treating platysma bands
• Patient satisfaction with JUVEDERM VOLUMA XC for temple hollowing
• Findings from a 4,000-subject study across ethnic, racial, and gender groups

Allergan Aesthetics will also host a panel discussion on social integrity in the aesthetics industry, focusing on social media trends and ethical practices. The event will take place on October 17-20, 2024, in Orlando, Florida.

Allergan Aesthetics, an AbbVie company, announces its sixth consecutive year of partnership with Girls Inc. to support high school and college girls' interest in STEM and mentorship. The collaboration aims to highlight the importance of mentorship and role models in addressing challenges and supporting women and girls in STEM careers.

The partnership includes programs like "Girls Meet the Workforce" with the Orange County Girls Inc. affiliate, mentoring nearly 100 girls in four years. Allergan Aesthetics is launching an online social campaign from October 4th to November 8th, 2024, encouraging aesthetics professionals and consumers to take a mentorship moment with a girl in their lives.

At the Girls Inc. Be Bold LeadHERS Summit at Houston Community College, participants will engage with successful women physician role models in Houston during the Empower YOU panel. The initiative aims to increase education, improve confidence, and expand networks for girls pursuing STEM careers.

Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announces the nationwide availability of JUVÉDERM® VOLUMA® XC for treating moderate to severe temple hollowing in adults over 21. This follows its FDA approval in March 2024, making it the first and only hyaluronic acid filler approved for this purpose. Key highlights include:

- 90% patient satisfaction with natural look and feel at 3 months post-treatment
- 85% of patients reported overall aesthetic improvement lasting up to 13 months
- 98% of patients would recommend the treatment to a friend
- Acceptable safety profile for all Fitzpatrick skin types over 21

Allergan Aesthetics has implemented a comprehensive training protocol for providers to ensure safe and effective treatment. The JUVÉDERM® Collection of Fillers now offers the largest range of treatment indications for patients' aesthetic goals.

AbbVie (NYSE: ABBV) has announced that it will release its third-quarter 2024 financial results on Wednesday, October 30, 2024, before the market opens. The company will host a live webcast of the earnings conference call at 8 a.m. Central time. Investors and interested parties can access the webcast through AbbVie's Investor Relations website at investors.abbvie.com. For those unable to attend the live event, an archived edition of the session will be made available later on the same day.

AbbVie has submitted a Biologics License Application (BLA) to the FDA for accelerated approval of telisotuzumab vedotin (Teliso-V). This investigational antibody-drug conjugate is intended for adult patients with previously treated, locally advanced or metastatic EGFR wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression.

Key points:

• Teliso-V could be the first-in-class therapy for c-Met overexpressing NSCLC
• c-Met protein is overexpressed in about 25% of advanced EGFR wild type, nonsquamous NSCLC patients
• The BLA is supported by data from the Phase 2 LUMINOSITY trial
• Teliso-V received FDA Breakthrough Therapy Designation in December 2021
• A Phase 3 confirmatory study, TeliMET NSCLC-01, is currently underway

AbbVie (NYSE: ABBV) has announced positive topline results from its Phase 3 TEMPO-1 trial for tavapadon, an investigational D1/D5 dopamine receptor partial agonist, as a monotherapy for early Parkinson's disease. The trial met its primary endpoint, showing statistically significant improvements in the MDS-UPDRS Parts II and III combined score at week 26 for both 5 mg and 15 mg doses compared to placebo. It also met a key secondary endpoint, demonstrating significant improvement in the MDS-UPDRS Part II score. The safety profile was consistent with prior clinical trials, with most adverse events being mild to moderate. Full results will be submitted for presentation at future medical meetings and used for regulatory submissions. Results from the Phase 3 TEMPO-2 trial, studying tavapadon as a flexible-dose monotherapy, are expected by the end of 2024.

AbbVie announced positive results from a new post-hoc analysis of the Measure Up 1 and Measure Up 2 Phase 3 studies, evaluating the efficacy of RINVOQ® (upadacitinib) in patients with moderate-to-severe atopic dermatitis (AD) with varying degrees of head and neck involvement. The analysis showed that a higher proportion of patients treated with upadacitinib (15 mg or 30 mg) achieved optimal treatment targets compared to placebo at week 16, including:

- Near complete skin clearance in the head and neck region (EASI Head & Neck Score <1)
- Minimal or no impact on quality of life (DLQI 0/1)
- Minimal disease activity (EASI 90 + WP-NRS 0/1)

The study highlights the efficacy of RINVOQ in treating AD in the challenging head and neck regions, which can significantly impact patients' quality of life. Additional data presented at EADV 2024 further support RINVOQ's efficacy and safety profile in moderate-to-severe AD.