Comparative Outcomes of Migraine Preventives and Anti-CGRP Therapies for Tinnitus in Patients With Migraine: A Randomized Active-Comparator Controlled Trial (COMPACT-PM)

Many people with migraine also experience tinnitus - a persistent ringing, buzzing, or hissing in the ears - and research suggests these conditions share underlying biological mechanisms, including a protein called calcitonin gene-related peptide (CGRP) that is active in both the brain and the inner ear. COMPACT-PM is a randomized trial comparing two classes of migraine preventive medications in adults with bothersome tinnitus and a history of migraine: anti-CGRP therapies (newer injectable or oral agents that block CGRP or its receptor) versus conventional migraine preventives (antidepressants including amitriptyline, nortriptyline, and venlafaxine; antihypertensives including propranolol, verapamil, and candesartan; and the anticonvulsant topiramate). Participants are randomly assigned - like a coin flip - to one of the two treatment groups; neither group receives a placebo, as both receive active migraine treatment. The study's primary outcome is change in the Tinnitus Functional Index (TFI) over 24 weeks, with additional measures including hearing tests, balance assessments, auditory brainstem response testing, and a comprehensive symptom diary. The study is conducted at the Stanford Ear Institute and is funded by a philanthropic gift to the Department of Otolaryngology - Head & Neck Surgery at Stanford University.

Start Date01 Jul 2026

Sponsor / Collaborator

Stanford University

IRCT20200105046010N167

/ SuspendedNot Applicable

In-vivo Bioequivalence Study of Atogepant 60 mg Tablets of The Test Drug (Abidi Pharma, Iran) in Compared with The Reference Drug (QUILIPTA® 60 mg Tabs, AbbVie, UK) In Iranian Healthy Volunteers

Start Date20 Feb 2026

Sponsor / Collaborator

Arena Pharmaceuticals, Inc.

NCT06972056

/ RecruitingPhase 4IIT

A Comparative Effectiveness Study of Oral Medications Used for Migraine Prevention: The APT Comparison Study

This goal of this study is to compare three medications used for migraine preventive treatment.
This study will compare atogepant, a newer migraine preventive medication, with two older preventive medications, topiramate and propranolol. It will be determined if one works better and is more tolerable than the others.
Research participants will:
* Be randomly assigned to one of the three medications.
* Provide information about their migraine pattern using a daily headache diary and during research visits.

Start Date09 Jul 2025

Sponsor / Collaborator

Mayo Clinic

[+3]

100 Clinical Results associated with Atogepant

100 Translational Medicine associated with Atogepant

100 Patents (Medical) associated with Atogepant

196

Literatures (Medical) associated with Atogepant

01 Sep 2026·LANCET NEUROLOGY

Tolerability, safety, and efficacy of atogepant versus topiramate in adults with migraine (TEMPLE): a randomised, head-to-head, phase 3b trial

Article

Author: Dabruzzo, Brett ; Luo, Lei ; Guo, Hua ; Farkas, Mark Kristof ; Holle-Lee, Dagny ; Cohen, Eric ; Reuter, Uwe ; Tepper, Stewart J ; Gandhi, Pranav ; Forero, Giovanna ; Versijpt, Jan ; Nagy, Krisztian ; Dycke, Annelies Van

BACKGROUND:

Oral calcitonin gene-related peptide (CGRP) receptor antagonists such as atogepant have been approved for preventive treatment of migraine but have not been compared directly with conventional oral non-specific preventive treatments. Topiramate is a widely used conventional oral non-migraine-specific preventive treatment for migraine but its use is often limited by poor tolerability. We aimed to evaluate the tolerability, safety, and efficacy of atogepant versus topiramate in adults with migraine, to provide direct comparative evidence to help inform treatment selection.

METHODS:

TEMPLE was a phase 3b, randomised, double-dummy, active-controlled trial with a 24-week double-blind treatment period and a 52-week open-label treatment period, done in sites with experience in diagnosing and treating migraine across 12 countries (Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Portugal, and the UK). Participants had a history of migraine and at least 4 migraine days per month on average across the 3 months before screening and during the combined screening and baseline period. Participants were randomly assigned 1:1 to atogepant (60 mg once daily) or topiramate (highest tolerated dose of 50 mg/day, 75 mg/day, or 100 mg/day) using interactive response technology. The primary endpoint assessed tolerability by measuring treatment discontinuation owing to treatment-emergent adverse events during the double-blind period in the safety population (all participants who received ≥1 dose of the study treatment during the double-blind period). Secondary efficacy endpoints related to clinical efficacy were at least 50% reduction from baseline in mean monthly migraine days and change from baseline in mean monthly migraine days during months 4-6 in the modified intention-to-treat population (all randomised participants who received ≥1 dose of study treatment, had an evaluable baseline period of eDiary data, and had ≥1 evaluable postbaseline 4-week [1 month] period of eDiary data within 24 weeks after first dose of study medication [month 1 to month 6], regardless of whether on study treatment or off study treatment). TEMPLE is registered with ClinicalTrials.gov (NCT05748483) and EU Clinical Trials Register (2022-501172-25-00); the double-blind period is completed and the open-label period is ongoing.

FINDINGS:

Between Oct 7, 2023, and April 28, 2025, 730 participants were screened, 545 were randomly assigned, and 540 (479 [89%] female and 61 [11%] male, 517 [96%] White) were included in the safety population (atogepant n=273; topiramate n=267). Discontinuation due to treatment-emergent adverse events across the 24-week double-blind period was lower in the atogepant group (33 [12%] of 273) compared with the topiramate group (79 [30%] of 267; relative risk [RR] 0·4, 95% CI 0·3 to 0·6; p<0·0001). Treatment-related adverse events were reported by 153 (56%) of 273 participants in the atogepant group and 208 (78%) of 267 in the topiramate group. Serious treatment-emergent adverse events occurred in six participants on atogepant and in three participants on topiramate. One serious treatment-emergent adverse event (anaphylactic reaction in the atogepant group) was considered related to study drug. No deaths occurred. More participants experienced at least 50% reduction in mean monthly migraine days in the atogepant group (64% [173 of 270]) compared with the topiramate group (39% [101 of 257], RR 1·6, 95% CI 1·4 to 2·0, p<0·0001) and reduction from baseline in mean monthly migraine days was greater in the atogepant group (least squares mean -6·3 [SE 0·3]) than the topiramate group (-4·5 [0·3]; treatment difference -1·8 [-2·5 to -1·0]; p<0·0001).

INTERPRETATION:

Atogepant 60 mg once daily showed better tolerability and efficacy across 24 weeks compared with topiramate. Although both topiramate and atogepant are established as effective oral migraine preventive treatments, their usefulness in clinical practice hinges on patients' ability to tolerate treatment. Our findings provide direct comparative evidence that might guide clinicians in selecting the most appropriate preventive therapy for their patients.

FUNDING:

AbbVie.

01 Aug 2026·Neurology and Therapy

Efficacy, Safety, and Tolerability of Atogepant in Migraine Patients from the UAE

Article

Author: Hamoulila, Khaled ; Alsabbagh, Ghaith ; Suliman, Reem ; Saidam, Mohammad ; Aljaafari, Mariam Nasser ; Khandoker, Ahsan H ; Alsaadi, Taoufik

INTRODUCTION:

Atogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for migraine prevention; however, real-world data from the Middle East and North Africa (MENA) region remain limited. This study evaluated the efficacy and safety of atogepant in patients with chronic and episodic migraine in the United Arab Emirates.

METHODS:

This retrospective study included adult patients (≥ 18 years) diagnosed with chronic or episodic migraine who received atogepant for at least 6 months. Clinical data were extracted from electronic medical records at the American Center for Psychiatry and Neurology, Abu Dhabi. Monthly migraine days (MMD) at baseline were compared with follow-up MMD documented at visits occurring at least every 2 months. Safety outcomes were assessed through descriptive analysis of reported adverse events (AEs) in the all-exposed population. Sensitivity analyses (non-responder imputation, baseline observation carried forward, multiple imputation under MAR, and tipping point analysis) were conducted to evaluate the robustness of efficacy results in the presence of missing data.

RESULTS:

Of 86 patients identified, 59 met the inclusion criteria and their data were analyzed. Among these, 39% had chronic migraine and 61% had episodic migraine. The majority were female patients (86.4%) and Emirati nationals (69%). The mean baseline MMD was 12 (SD 8.1), which decreased to 4 (SD 5.2) at the most recent follow-up. Overall, 71% achieved ≥ 50% reduction in MMD, 20% achieved < 50% reduction, and 9% experienced no change. Paired-sample t test demonstrated a significant reduction in MMD t(58) = 9.44, p < 0.001. Adverse events were reported in 10.5% (9/86) of patients, most commonly constipation and nausea. Most patients experiencing AEs (78%) continued treatment, while two discontinued.

CONCLUSION:

In this real-world cohort from the UAE, atogepant was associated with significant reductions in monthly migraine days in both patients with chronic and episodic migraine and demonstrated a favorable safety and tolerability profile.

01 Jul 2026·Neurologia

Real-life effectiveness, tolerability, and safety of atogepant: a prospective, observational, multicentre study by the Headache Study Group in Castile-La Mancha

Article

Author: Ávila Fernández, Ana ; Payá Montes, María ; Calvo Alzola, Marcos ; Ibáñez Alonso, Ramón Ernesto ; Garrido Robres, José Antonio ; Andrés López, Alberto ; Cano Vargas-Machuca, Enrique Francisco ; Navarro Muñoz, Santiago ; Castellano Vicente, Alberto José ; Flores Barragán, José Manuel ; Sánchez Cano, Noelia

INTRODUCTION:

Migraine is the most frequent reason for neurology consultation and has a significant impact on patients at the professional, social, and financial level. In the past year, atogepant, an oral drug targeting the calcitonin gene-related peptide (CGRP) receptor, has been approved in Spain, and clinical trials have shown that it is a promising option for the treatment of both episodic and chronic migraine.

METHODS:

We present a prospective, multicentre, observational study of 136 patients with drug-resistant migraine, recruited from seven hospitals in Castile-La Mancha. Our aim was to compare the efficacy of atogepant 60 mg reported in clinical trials with our real-world experience. Data on demographic characteristics, diagnosis, number of monthly migraine days, impact scale scores, adverse reactions, and patient outcomes after 3 months of treatment were gathered and analysed.

RESULTS:

Forty percent of patients experienced a ≥ 50% reduction in monthly migraine days compared to baseline. An overall net reduction of -5.7 monthly migraine days was observed. Adverse reactions were reported by 41.9% of patients; and treatment was discontinued due to intolerance before the end of the treatment period in 11.7% of patients.

CONCLUSION:

Our findings confirm the effectiveness and safety of atogepant reported in clinical trials, although tolerability is poorer, which could compromise treatment adherence in clinical practice.

134

News (Medical) associated with Atogepant

31 Jul 2026

·www.prnewswire.com

AbbVie Reports Second-Quarter 2026 Financial Results

Reports Second-Quarter Diluted EPS of $2.03 on a GAAP Basis, an Increase of 290.4 Percent; Adjusted Diluted EPS of $3.65, an Increase of 22.9 Percent; These Results Include an Unfavorable Impact of $0.17 Per Share Related to Acquired IPR&D and Milestones Expense Delivers Second-Quarter Net Revenues of $16.990 Billion, an Increase of 10.2 Percent on a Reported Basis or 9.5 Percent on an Operational Basis Second-Quarter Global Net Revenues from the Immunology Portfolio Were $8.786 Billion, an Increase of 15.1 Percent on a Reported Basis, or 14.6 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $5.505 Billion; Global Rinvoq Net Revenues Were $2.525 Billion; Global Humira Net Revenues Were $756 Million Second-Quarter Global Net Revenues from the Neuroscience Portfolio Were $3.228 Billion, an Increase of 20.3 Percent on a Reported Basis, or 19.8 Percent on an Operational Basis; Global Vraylar Net Revenues Were $1.071 Billion; Global Botox Therapeutic Net Revenues Were $1.042 Billion; Combined Global Ubrelvy and Qulipta Net Revenues Were $742 Million; Global Vyalev Net Revenues Were $256 Million Second-Quarter Global Net Revenues from the Oncology Portfolio Were $1.650 Billion, a Decrease of 1.5 Percent on a Reported Basis, or 2.4 Percent on an Operational Basis; Global Venclexta Net Revenues Were $771 Million; Global Imbruvica Net Revenues Were $532 Million; Global Elahere Net Revenues Were $211 Million Second-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.282 Billion, an Increase of 0.3 Percent on a Reported Basis, or a Decrease of 0.9 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $728 Million; Global Juvederm Net Revenues Were $245 Million Announced Definitive Agreement to Acquire Apogee Therapeutics, Deepening AbbVie's Immunology Portfolio Updates 2026 Adjusted Diluted EPS Guidance Range from $13.91 - $14.11 to $13.87 - $14.07; Now Includes a $0.14 per Share Dilutive Impact Related to the Proposed Acquisition of Apogee Therapeutics, Which is Anticipated to Close in the Third Quarter of 2026; Includes an Unfavorable Impact of $0.58 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the Second Quarter 2026 NORTH CHICAGO, Ill., July 31, 2026 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the second quarter ended June 30, 2026. "AbbVie delivered another excellent quarter, marked by outstanding execution and pipeline advancement. We also announced the proposed acquisition of Apogee Therapeutics, which strengthens our ability to deliver innovative medicines to patients, bolsters our immunology leadership and creates significant shareholder value," said Robert A. Michael, chairman and chief executive officer, AbbVie. "Based on our substantial momentum, AbbVie's long-term outlook remains very strong." Second-Quarter Results Worldwide net revenues were $16.990 billion, an increase of 10.2 percent on a reported basis, or 9.5 percent on an operational basis. Global net revenues from the immunology portfolio were $8.786 billion, an increase of 15.1 percent on a reported basis, or 14.6 percent on an operational basis. Global Skyrizi net revenues were $5.505 billion, an increase of 24.4 percent on a reported basis, or 24.0 percent on an operational basis. Global Rinvoq net revenues were $2.525 billion, an increase of 24.5 percent on a reported basis, or 23.7 percent on an operational basis. Global Humira net revenues were $756 million, a decrease of 35.9 percent on a reported basis, or 36.1 percent on an operational basis. Global net revenues from the neuroscience portfolio were $3.228 billion, an increase of 20.3 percent on a reported basis, or 19.8 percent on an operational basis. Global Vraylar net revenues were $1.071 billion, an increase of 18.9 percent. Global Botox Therapeutic net revenues were $1.042 billion, an increase of 12.2 percent on a reported basis, or 11.6 percent on an operational basis. Global Ubrelvy net revenues were $392 million, an increase of 16.0 percent on a reported basis, or 15.9 percent on an operational basis. Global Qulipta net revenues were $350 million, an increase of 30.9 percent on a reported basis, or 30.3 percent on an operational basis. Global Vyalev net revenues were $256 million. Global net revenues from the oncology portfolio were $1.650 billion, a decrease of 1.5 percent on a reported basis, or 2.4 percent on an operational basis. Global Venclexta net revenues were $771 million, an increase of 11.6 percent on a reported basis, or 9.6 percent on an operational basis. Global Imbruvica net revenues were $532 million, a decrease of 29.4 percent. Global Elahere net revenues were $211 million, an increase of 33.1 percent on a reported basis, or 31.8 percent on an operational basis. Global net revenues from the aesthetics portfolio were $1.282 billion, an increase of 0.3 percent on a reported basis, or a decrease of 0.9 percent on an operational basis. Global Botox Cosmetic net revenues were $728 million, an increase of 5.2 percent on a reported basis, or 3.4 percent on an operational basis. Global Juvederm net revenues were $245 million, a decrease of 6.0 percent on a reported basis, or 6.6 percent on an operational basis. On a GAAP basis, the gross margin ratio in the second quarter was 74.7 percent. The adjusted gross margin ratio was 84.7 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 21.4 percent of net revenues. The adjusted SG&A expense was 21.0 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 13.8 percent of net revenues. The adjusted R&D expense was 13.6 percent of net revenues. Acquired IPR&D and milestones expense was 1.7 percent of net revenues. On a GAAP basis, the operating margin ratio in the second quarter was 37.9 percent. The adjusted operating margin ratio was 48.3 percent. Net interest expense was $679 million. On a GAAP basis, the tax rate in the quarter was 15.5 percent. The adjusted tax rate was 14.7 percent. Diluted earnings per share (EPS) in the second quarter was $2.03 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.65. These results include an unfavorable impact of $0.17 per share related to acquired IPR&D and milestones expense. Recent Events AbbVie and Apogee Therapeutics announced a definitive agreement under which AbbVie will acquire Apogee and its diverse pipeline of clinical-stage candidates in development across inflammatory and immunological diseases. The proposed acquisition includes zumilokibart (APG777), a late-stage, half-life extended monoclonal antibody targeting IL-13 for atopic dermatitis (AD), as well as APG273, a potential best-in-category long-acting combination targeting IL-13 and thymic stromal lymphopoietin (TSLP) in asthma. The acquisition holds potential for substantial shareholder value creation, with mega-blockbuster peak sales potential across Apogee's pipeline of assets, and is expected to close in the third quarter of 2026. The transaction values Apogee at a total equity value of approximately $10.9 billion. Additional information on the transaction can be found at investors.abbvie.com. AbbVie announced the U.S. Food and Drug Administration (FDA) and the European Commission (EC) approved Skyrizi (risankizumab) for the treatment of children six years of age and older with moderate to severe plaque psoriasis. The FDA also approved Skyrizi for pediatric use in psoriatic arthritis. These approvals were supported by data from Phase 3 OptIMMize clinical trial program. AbbVie announced the EC approved Rinvoq (upadacitinib) for the treatment of adult and adolescent patients with non-segmental vitiligo. With this approval, Rinvoq is the first systemic medication approved in the European Union (EU) for patients with non-segmental vitiligo. This approval is supported by data from the Phase 3 Viti-Up clinical program, in which Rinvoq met both co-primary endpoints, with statistically significant and clinically meaningful improvements in total body and facial repigmentation at week 48, as well as key ranked secondary endpoints. AbbVie announced the EC approved Rinvoq for the treatment of adult and adolescent patients with severe alopecia areata. This approval is supported by data from the Phase 3 UP-AA clinical program, in which Rinvoq met the primary endpoint of severity of alopecia tool score ≤ 20 as well as key secondary endpoints, including improvements in eyebrows and eyelashes, at week 24. At the 2026 Digestive Disease Week (DDW) Annual Meeting, AbbVie presented new data across its gastroenterology portfolio, including 18 abstracts in Crohn's disease (CD) and ulcerative colitis (UC). Presentations included real-world evidence and long-term findings that reinforced the efficacy, safety profile and durability of Skyrizi and Rinvoq in inflammatory bowel diseases (IBD). AbbVie announced the EC approved Aquipta (atogepant) for the acute treatment of migraine in adults with or without aura. This approval marks the second indication for Aquipta in the EU, where it is now approved as both an acute treatment option for migraine attacks and as a preventive treatment option for adults with chronic or episodic migraine who experience at least four migraine days per month. The approval is supported by data from the Phase 3 ECLIPSE trial, which showed that Aquipta resulted in statistically significant pain freedom at two hours versus placebo during the first migraine attack, with sustained pain freedom from 2 to 48 hours and a clinically meaningful and consistent effect across multiple migraine attacks. AbbVie announced the FDA approved Decnupaz (pivekimab sunirine) for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an ultra-rare and aggressive hematologic malignancy. Decnupaz is the first antibody-drug conjugate (ADC) approved for BPDCN that is initiated in an outpatient setting and marks AbbVie's first ADC approved for blood cancer. The approval is supported by data from the Phase 1/2 CADENZA trial, in which newly diagnosed patients with BPDCN treated with Decnupaz demonstrated clinically meaningful and durable responses. AbbVie announced the EC authorized an expanded label for Venclyxto (venetoclax) to include use in combination with acalabrutinib and use in combination with Imbruvica (ibrutinib) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). The authorization provides an all-oral, fixed-duration, chemotherapy-free treatment option for patients with CLL and supports the potential for time off treatment. The expanded label is supported by data from the Phase 3 AMPLIFY trial, Phase 3 GLOW trial and Phase 2 CAPTIVATE trial. AbbVie announced the EC granted marketing authorization for Tepkinly (epcoritamab) in combination with lenalidomide and rituximab (R2) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the pivotal Phase 3 EPCORE FL-1 trial, in which fixed-duration Tepkinly plus R2 achieved statistically significant improvement of progression-free survival (PFS) and overall response rates (ORR) compared to R2, with approximately three out of four patients achieving a complete response (CR). This approval marks the first bispecific-based therapy approved in Europe for the treatment of R/R FL in the second-line setting, offering patients a chemotherapy-free option. Tepkinly/Epkinly is being co-developed by AbbVie and Genmab. AbbVie announced topline results from the Phase 3 EPCORE DLBCL-4 trial evaluating the combination of Epkinly (epcoritamab) and lenalidomide, compared to rituximab plus gemcitabine plus oxaliplatin in adult patients with R/R diffuse large B-cell lymphoma (DLBCL) who received at least one prior line of therapy. In the trial, the chemotherapy-free combination of Epkinly plus lenalidomide demonstrated statistically significant and clinically meaningful improvement in PFS. The safety profile of Epkinly when administered in combination with lenalidomide was consistent with the known safety profiles of the individual agents. At the American Society of Clinical Oncology (ASCO) Annual Meeting, AbbVie announced new data demonstrating the breadth and momentum of its next-generation oncology pipeline. Presentations highlighted the potential of AbbVie's novel topoisomerase 1 inhibitor–based ADC and T‑cell engager platforms within solid tumors and blood cancers, including oral presentations in prostate cancer, small cell lung cancer (SCLC), platinum-resistant ovarian cancer (PROC) and multiple myeloma (MM). At the European Hematology Association (EHA) 2026 Congress, AbbVie presented data that reinforced its leadership and commitment to ongoing research to improve outcomes for people living with blood cancers. Featured data from AbbVie's blood cancer portfolio and pipeline included 21 oral and poster presentations, which highlighted etentamig (ABBV-383), Epkinly and Decnupaz. The presentations also showcased Venclexta (venetoclax) data, including a final analysis of the Phase 3 CLL14 trial which demonstrated that after a median follow-up of 9.2 years, treatment with Venclexta plus obinutuzumab resulted in superior PFS compared to treatment with obinutuzumab plus chlorambucil in previously untreated CLL. Allergan Aesthetics announced the FDA approved Skinvive by Juvederm as the first hyaluronic acid injectable indicated to reduce neck lines for the improvement of neck appearance in adults over the age of 21. This approval is supported by a randomized, multicenter, evaluator-blinded, controlled pivotal clinical study in which participants treated with Skinvive by Juvederm saw a clinically significant improvement in neck lines at one month. This approval represents the second FDA-approved indication for Skinvive by Juvederm, which is also approved to improve skin smoothness of the cheeks in adults. Allergan Aesthetics announced the EC and Health Canada approved Boey (trenibotulinumtoxinE) as the first rapid-onset, short-duration neurotoxin for the temporary improvement of moderate to severe glabellar lines in adults. These approvals are supported by data from two Phase 3 clinical trials, in which Boey demonstrated rapid onset of action as early as eight hours after administration and observed efficacy duration of two to three weeks, with treatment-emergent adverse events similar to placebo. AbbVie announced the EC approved Maviret (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus (HCV) infection in adults and children aged 3 years and older. This approval gives clinicians an option to initiate treatment as soon as acute infection is confirmed and makes Maviret the only treatment approved in the EU for both acute and chronic HCV infection. Full-Year 2026 Outlook AbbVie is updating its adjusted diluted EPS guidance to include the impact of the proposed Apogee Therapeutics acquisition, which is expected to be $0.14 dilutive in 2026, based upon an anticipated close in the third quarter of this year. This dilution is partially offset by $0.10 of overperformance. As a result, AbbVie is updating its adjusted diluted EPS guidance range for the full year 2026 from $13.91 - $14.11 to $13.87 - $14.07, reflecting a change of $0.04 at the midpoint. The company's 2026 adjusted diluted EPS guidance includes an unfavorable impact of $0.58 per share related to acquired IPR&D and milestones expense incurred year-to-date through the second quarter 2026. This guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the second quarter of 2026, as both cannot be reliably forecasted. About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Conference Call AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our second-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central Time. Non-GAAP Financial Results Financial results for 2026 and 2025 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with generally accepted accounting principles in the United States (GAAP) and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks related to the proposed acquisition of Apogee Therapeutics, Inc. ("Apogee"), including the possibility that such acquisition may not be consummated on the anticipated timeframe or at all, risks related to the ability to realize the anticipated benefits of the proposed acquisition on the anticipated timeframe or at all, risks that the costs to consummate the acquisition or to obtain the anticipated benefits of the proposed acquisition could be greater than expected, the failure to obtain applicable regulatory or Apogee stockholder approval in a timely manner or otherwise, the risk that an event occurs that could give rise to the right of AbbVie or Apogee to terminate the merger agreement, risks related to the ability of AbbVie and Apogee to successfully integrate the businesses and the possibility that such integration may be more difficult, time consuming or costly than expected, risks that the proposed acquisition disrupts Apogee's or AbbVie's current plans and operations and makes it more difficult to maintain business and operational relationships, the diversion of management's attention from ongoing business operations and opportunities due to the proposed transaction, negative effects of the consummation of the proposed acquisition on business or employee relationships or the market price of AbbVie's common stock and/or operating results, significant transaction costs, the assumption of unknown liabilities, the risk of litigation and/or regulatory actions related to the proposed acquisition, the risk that zumilokibart (APG777) or other Apogee pipeline assets may not demonstrate the anticipated success, safety, or efficacy in ongoing or future clinical trials, the risk that positive interim clinical trial results for zumilokibart (APG777) may not be predictive of results in later-stage or larger clinical trials, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to AbbVie's industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes, tariffs and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's and Apogee's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information; and Item 1A, "Risk Factors," of Apogee's most recently filed Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q and in other documents that Apogee subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 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31 Jul 2026

·firstwordpharma.com

AbbVie hikes revenue forecast as Skyrizi, Rinvoq keep growing

AbbVie has bumped up its total 2026 revenue guidance up to about $67.6 billion, an increase of $300 million, riding on the combined strength of blockbuster immunology duo Skyrizi and Rinvoq, as well as a resurgent neuroscience lineup.The new outlook assumes Skyrizi will haul in roughly $21.7 billion this year, a $100-million bump from earlier projections, based on momentum across its psoriatic and inflammatory bowel disease indications, said Chief Financial Officer Scott Reents.Beyond that, the neuroscience portfolio now stands at $12.7 billion in projected revenue, another $100-million upgrade, driven largely by Vraylar sales nearing $4.1 billion and therapeutic Botox approaching $4.2 billion. The remaining increase reflects continued momentum from Rinvoq and Venclexta.The stronger sales guidance followed better-than-expected second-quarter results. Overall revenue rose 10.2% year-over-year to $17 billion, ahead of analyst expectations of $16.8 billion.However, expenses related to its planned $10.9-billion acquisition of Apogee Therapeutics, which is expected to close in the third quarter, forced a trim to full-year earnings guidance. Earnings are now forecast to be between $13.87 and $14.07 per share, down from a previous range of $13.91 to $14.11.'Narrative swings'Ahead of the financial results presentation, Goldman Sachs analyst Asad Haider remarked that AbbVie was experiencing "narrative swings," noting the company headed into earnings "from a relatively stronger foundational base, with the investment narrative becoming increasingly anchored to the emergence of new revenue drivers."He highlighted the Apogee acquisition and its immunology pipeline, with several candidates that boast higher efficacy than Skyrizi and Rinvoq.Immunology, neuro momentumMeanwhile, AbbVie reported that immunology portfolio sales climbed 15.1% during the second quarter to $8.8 billion. Skyrizi and Rinvoq generated $5.5 billion and $2.5 billion, respectively, both up roughly 24% over the same time last year. Those gains continued to offset the decline of Humira, whose sales fell nearly 36% to $756 million amid biosimilar competition.The neuroscience franchise also delivered a strong quarterly performance, with revenues rising 20.3% to $3.2 billion boosted by atypical antipsychotic Vraylar (+18.9%, $1.1 billion), migraine drugs Ubrelvy (+16%, $392 million) and Qulipta: (+30.9%, $350 million), and Parkinson's therapy Vyalev (>100%, $256 million).By contrast, oncology revenues were down 1.5% to almost $1.7 billion as weakness in Imbruvica (-29.4%, $532 million) offset growth elsewhere in the portfolio, including Venclexta (+11.6%, $771 million), Elahere (+33.1%, $211 million) and Epkinly (+46.8%, $103 million).

AcquisitionFinancial StatementIPO

08 Jun 2026

·www.prnewswire.com

AbbVie Announces European Commission Approval of AQUIPTA® (atogepant) for the Acute Treatment of Migraine in Adults

AQUIPTA® (atogepant) is now approved in the European Union for the acute treatment of migraine in adults, with or without aura, and for the prophylaxis of migraine in adults who have at least four migraine days per month. Approval was based on the pivotal Phase 3 ECLIPSE trial, which showed that AQUIPTA resulted in statistically significant pain freedom at two hours versus placebo during the first migraine attack, with sustained pain freedom from 2 to 48 hours and a clinically meaningful and consistent effect across multiple migraine attacks.1 The approval expands AbbVie's portfolio of migraine therapies for adult patients in the European Union, broadening treatment choices for those living with migraine. June 2, 2026 -- AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has approved AQUIPTA® (atogepant) for the acute treatment of migraine in adults with or without aura, to be taken as needed (PRN). This approval is the second indication in the European Union for AQUIPTA, an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), which is now approved as both an acute treatment option for migraine attacks in adults and as a once-daily preventive treatment option for adults with chronic or episodic migraine who experience four or more migraine days per month. "The European Commission's approval of AQUIPTA is an important milestone for individuals requiring acute treatment for migraine. Clinical data have shown that AQUIPTA delivers fast and lasting relief for migraine attacks, including sustained pain freedom up to 48 hours," said Roopal Thakkar, M.D., executive vice president, research and development, and chief scientific officer, AbbVie. "With this approval, AbbVie is able to address unmet needs for those living with migraine in Europe, offering a broad portfolio of acute and preventive treatments for chronic and episodic migraine." Migraine is a prevalent and debilitating neurological disease, affecting roughly 14% of the global population,2 with a higher incidence in women than men.3 Especially common among individuals aged 25 to 55,4 migraine attacks can be characterized by severe, throbbing headaches, cognitive impairment , sensitivity to light and sound, and nausea, resulting in significant limitations on daily activities.5,6 Migraine is a leading cause of years lived with disability and profoundly affects quality of life.7 This debilitating disease also imposes both a social and financial burden for people living with migraine and on health care systems.8 According to recent analysis of six European countries, migraine contributes an estimated economic burden of 1.2% to 2.0% of GDP, corresponding to €35 billion to €557 billion in lost productivity from both paid and unpaid work.*9 "Migraine is an invisible disease that disrupts daily life, including meaningful time with friends and family, while also imposing significant mental, physical, and socioeconomic burdens," said Uwe Reuter, M.D., Ph.D., MBA, professor of neurology at Charité University Hospital, Berlin, Germany, and president of the European Headache Federation. "The pivotal Phase 3 study showed that AQUIPTA is an effective acute treatment option for migraine, and getting the right treatment can help clinicians better address the burden of this disease in people living with migraine." The approval of AQUIPTA is supported by data from the Phase 3 ECLIPSE study, which evaluated the efficacy, safety, and tolerability of AQUIPTA (60 mg) versus placebo for the acute treatment of migraine for a single attack and the consistency of effect across multiple attacks in adults with a history of migraine, with or without aura.1 The study met its primary endpoint, demonstrating that AQUIPTA was superior to placebo in achieving pain freedom at two hours after treatment of the first migraine attack (p<0.0001).1 Additionally, the study demonstrated statistical significance versus placebo across several ranked secondary endpoints, including freedom from the most bothersome migraine symptom at two hours post-treatment, pain relief at two hours, reduced use of rescue medication within 24 hours, and sustained pain freedom from 2 to 48 hours (p1 AQUIPTA also demonstrated clinically meaningful and consistent effect across multiple migraine attacks. During the 16-week, placebo-controlled, double-blind treatment period, AQUIPTA's safety profile was generally consistent with that observed in its approved indication for the preventive treatment of migraine. The most common adverse events were nasopharyngitis and upper respiratory tract infection. AQUIPTA is also approved in the European Union as a once-daily CGRP receptor antagonist (gepant) for the prophylaxis (prevention) of migraine in adults with at least four migraine days per month. ECLIPSE is a 24-week, Phase 3, multicenter, randomized, double-blind, placebo-controlled multiple-attack study with an open-label extension that enrolled 1,328 adults aged 18 to 75 years with migraine, with or without aura, who had two to eight moderate to severe migraine attacks per month in each of the three months before screening. The study was conducted across 149 sites in Europe, the United Kingdom, Japan, China, South Korea, and Taiwan. The primary endpoint was pain freedom at two hours after the first attack, while key secondary endpoints included absence of the most bothersome migraine symptom at two hours post-dose, pain relief at two hours, reduced rescue-medication use within 24 hours, and sustained pain freedom from 2 to 48 hours. Participants in the ECLIPSE study were randomized to four double-blind treatment sequences to treat four qualifying migraine attacks with moderate or severe headache intensity with single-dose atogepant (60 mg) or placebo during the 16-week double-blind period. The first attack (1:1 placebo-to-atogepant allocation) was the single attack used to evaluate the primary and 16 secondary efficacy endpoints. After treating four qualifying migraine attacks during the double-blind period, participants entered an open-label treatment period through the end of the study (until week 24) and treated migraine attacks with a single dose of atogepant (60 mg). AQUIPTA® (atogepant) is an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist, approved in the European Union for both acute and preventive treatment of migraine in adults. For preventive treatment, AQUIPTA is taken once daily; for acute treatment, it is taken as needed (PRN). Atogepant is approved for migraine prophylaxis in more than 60 countries and is marketed as AQUIPTA in the EU and QULIPTA® in the U.S., Canada, Israel, and Puerto Rico. At AbbVie, we are committed to empowering people living with migraine disease. We advance science that enables healthcare providers to care for people impacted across the spectrum of migraine. Through education and partnerships with the migraine community, we strive to help those with migraine navigate barriers to care, access effective treatments, and reduce the impact of migraine on their lives. AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience – and products and services in our Allergan Aesthetics portfolio. References 1 AQUIPTA. Summary of Product Characteristics. AbbVie; 2026 2 Stovner, L.J., Hagen, K., Linde, M. et al. The global prevalence of headache: an update, with analysis of the influences of methodological factors on prevalence estimates. J Headache Pain 23, 34 (2022). https://doi-org.libproxy1.nus.edu.sg/10.1186/s10194-022-01402-2 3 Al-Hassany L, Haas J, Piccininni M, et al. Sex and Gender Differences in Migraine. Front Neurol. 2020;11:549038. 4 What is Migraine. The Migraine Trust. Available at: https://migrainetrust.org/understand-migraine/what-is-migraine. Accessed January 1, 2026. 5 Migraine headaches. Cleveland Clinic. Available at: https://my.clevelandclinic.org/health/diseases/5005-migraine-headaches. Accessed January 1, 2026. 6 Fernandes C, Dapkute A, Watson E, et al. Migraine and cognitive dysfunction: a narrative review. J Headache Pain. 2024;25(1):221. doi:10.1186/s10194-024-01923-y 7 Steiner TJ, Stovner LJ, Jensen R, et al. Lifting The Burden: the Global Campaign against Headache. Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020;21(1):1375 8 Messali A, Sanderson JC, Blumenfeld AM, et al. Direct and indirect costs of chronic and episodic migraine in the United States: a web-based survey. Headache. 2016;56:306-322. 9 The socioeconomic burden of migraine: The case of 6 European Countries. Wif0r Institute. Available at: https://www.wifor.com/de/download/the-socioeconomic-burden-of-migraine-the-case-of-6-european-countries/?wpdmdl=358248&refresh=685c5ea88c24c1750884008. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultDrug Approval

100 Deals associated with Atogepant

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KEGG	Wiki	ATC	Drug Bank
D11313	Atogepant	-	DB16098

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Migraine Disorders	United States	AbbVie, Inc.	28 Sep 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute migraine	Phase 3	Belgium	AbbVie, Inc.	25 Mar 2024
Migraine Without Aura	Phase 3	Australia	Allergan UC	05 Mar 2021
Migraine Without Aura	Phase 3	France	Allergan UC	05 Mar 2021
Migraine Without Aura	Phase 3	Russia	Allergan UC	05 Mar 2021
Migraine Without Aura	Phase 3	Sweden	Allergan UC	05 Mar 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05748483 (TEMPLE, Pubmed \| Lancet Neurol)	Phase 3	Migraine Disorders	540	Atogepant 60 mg once daily	opgcmuwcgg(jngtftrvmv) = xnfcxnquhg sftzuiuohj (jslmavxdyo ) View more	Positive	01 Sep 2026
NCT05748483 (TEMPLE, Pubmed \| Lancet Neurol)	Phase 3	Migraine Disorders	540	Topiramate (highest tolerated dose of 50 mg/day, 75 mg/day, or 100 mg/day)	opgcmuwcgg(jngtftrvmv) = atlfkzxctl sftzuiuohj (jslmavxdyo ) View more	Positive	01 Sep 2026
NCT05748483 (TEMPLE \| ATO-TOPIRAMATE, CTgov)	Phase 3	Migraine Disorders	545	Placebo for Atogepant+Topiramate+Atogepant (Topiramate)	idljxsmnws = jvoajhgrgb gvekfadxqu (sfehsdoobb, rgnqrongqq - xhzggofewh) View more	-	02 Jul 2026
NCT05748483 (TEMPLE \| ATO-TOPIRAMATE, CTgov)	Phase 3	Migraine Disorders	545	Placebo for Topiramate+Atogepant (Atogepant)	idljxsmnws = wdkntmqecj gvekfadxqu (sfehsdoobb, jrxjtxbfxz - tudypchefc) View more	-	02 Jul 2026
ATOMUR (EAN2026)	Not Applicable	Migraine Disorders	101	Atogepant (Chronic or Episodic Migraine)	bmjnmetebx(chesefttup) = Discontinuations were mainly due to lack of effectiveness or mild adverse events (nausea) yuncganvnw (lsbagiyqqh ) View more	Positive	26 Jun 2026
NCT05216263 (ATO-BOTOX, CTgov)	Phase 3	Migraine Disorders	75	BOTOX+atogepant	hefizwjthr = gdxwvzmxoc xalucjjwno (njzegtsiyk, fhdohvqapi - sywinsllxd) View more	-	16 Jun 2026
NCT05861427 (JPN PIVOTAL \| RELEASE, CTgov)	Phase 3	Migraine Disorders	524	Placebo for Atogepant+Atogepant	zkqeazvxox(aefumczhrh) = gefkzxkcyx jatjfffxia (peibooljcn, hbtqczyclw - vkmcymxrjk) View more	-	11 Jun 2026
NCT04437433 (PROGRESS, Pubmed \| Neurol Ther)	Phase 3	Migraine Disorders	186	Atogepant 60 mg once daily	mdrdzwqmoj(dmuatoohhh) = gmmuzfclgu ybbtqihklf (fbfkycdifw ) View more	Positive	01 Jun 2026
NCT05216263 (Pubmed \| Cephalalgia)	Phase 3	Migraine Disorders	75	Atogepant 60 mginA + Atogepant 60 mg	yrftrtzahd(zdolocyyqp) = jcyquntoxe rtxontvkhd (hywyhriurf ) View more	Positive	01 Apr 2026
NCT06241313 (GEMA project, Pubmed \| Cephalalgia)	Phase 3	Migraine Disorders	513	Atogepant	npmvytvhpp(lxtbjsield) = mostly mild, mainly constipation (30%) and nausea (18%) pajsbdqyjy (uauhgqtnxr )	Positive	01 Apr 2026
NCT06414044 (STAR, Pubmed \| Cephalalgia)	Phase 2	Migraine Disorders	81	Atogepant 60 mg	beqrgpyesk(ciluacrgxz) = llpmtgjsau nowocaweqh (vwgdmipggd )	Positive	01 Mar 2026
NCT05861427 (RELEASE, Pubmed \| Cephalalgia)	Phase 2/3	Migraine Disorders	523	Atogepant 10 mg QD	qpvgmvxhvk(ytarkhcpdh) = TEAEs occurring ≥5% were constipation and nasopharyngitis vutlhyigxo (bsluiiwwqt )	Positive	01 Sep 2025
NCT05861427 (RELEASE, Pubmed \| Cephalalgia)	Phase 2/3	Migraine Disorders	523	Atogepant 30 mg QD		Positive	01 Sep 2025

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