On July 30, 2025 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported its half year 2025 results and provided a second quarter business update (Press release, argenx, JUL 31, 2025, View Source [SID1234654645]).

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"We continue to make meaningful progress towards our Vision 2030, advancing bold innovation that has already reached more than 15,000 patients globally" said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "VYVGART is delivering strong growth across all indications, formulations and regions. We are still in the early stages of capturing the full market opportunity in MG and CIDP, with the recent launch of the VYVGART SC prefilled syringe driving demand from new patients and prescribers. In MG, we are shaping the market as the fastest growing biologic, moving earlier in the patient treatment paradigm, and working toward the broadest possible label. In CIDP, we continue to see consistent patient growth, with ample runway to reach the 12,000 patients in the U.S. who remain inadequately controlled on standard of care. This is just the beginning of the larger growth opportunity ahead. With six registrational and six proof-of-concept readouts expected by the end of 2026, we are executing on our proven innovation playbook that is delivering pipeline-in-a-product opportunities aimed at transforming care for patients with high unmet need."

Advancing Towards Vision 2030

argenx has established its strategic priorities to advance Vision 2030, aiming to treat 50,000 patients globally with its medicines, secure 10 labeled indications across all approved medicines, and advance five pipeline candidates into Phase 3 development by 2030.

Expand global VYVGART opportunity and launch VYVGART SC as prefilled syringe

VYVGART (IV: efgartigimod alfa-fcab and SC: efgartigimod alfa and hyaluronidase-qvfc) is a first-and-only IgG Fc-antibody fragment that targets the neonatal Fc receptor (FcRn). It is approved in three indications, including generalized myasthenia gravis (gMG) globally, primary immune thrombocytopenia (ITP) in Japan, and chronic inflammatory demyelinating polyneuropathy (CIDP) in the U.S., Japan, China, and the EU. The VYVGART-SC prefilled syringe (PFS) is now approved for use in the U.S. and EU.

Generated global product net sales (inclusive of both VYVGART and VYVGART SC) of $949 million in the second quarter of 2025
Strong underlying fundamentals across key patient and prescriber metrics with 97% operational growth in product net sales year-over-year from second quarter 2024, and 19% from the first quarter of 2025
First patient dosed in Germany following European Commission (EC) approval for VYVGART-SC (vial and PFS) for CIDP
PFS decision on approval for gMG and CIDP expected in Japan and Canada by end of year
Evidence generation through label-enabling studies:

Topline results expected in second half of 2025 for seronegative gMG (ADAPT-SERON) and first half of 2026 for ocular MG (ADAPT OCULUS)

Topline results expected in second half of 2026 to support FDA submission of VYVGART IV for primary ITP (ADVANCE-NEXT)
Execute 10 registrational and 10 proof-of-concept studies across efgartigimod, empasiprubart and ARGX-119 to advance the next wave of launches

argenx continues to demonstrate breadth and depth within its immunology pipeline, advancing multiple first-in-class product candidates with potential across high-need indications.

Efgartigimod Development

Efgartigimod is being studied across 15 severe autoimmune diseases, highlighting the broad potential of FcRn biology in neurology, rheumatology, and beyond.

Registrational studies are currently ongoing in idiopathic inflammatory myopathies (IIM or myositis), thyroid eye disease (TED), and Sjögren’s disease
Topline results from ALKIVIA study evaluating three myositis subsets (immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS) and dermatomyositis (DM)) expected in second half of 2026
Topline results from two registrational UplighTED studies (TED) expected in second half of 2026
Topline results from registrational UNITY study (Sjögren’s disease) expected in 2027
Proof-of-concept studies ongoing in lupus nephritis (LN), systemic sclerosis (SSc) and antibody mediated rejection (AMR); topline results expected for LN in fourth quarter of 2025, SSc in second half of 2026, and AMR in 2027

Empasiprubart Development

Empasiprubart, a first-in-class, humanized, monoclonal antibody that specifically binds to C2, is currently being evaluated in four indications. These include registrational studies in multifocal motor neuropathy (MMN) and CIDP, and proof-of-concept studies in delayed graft function (DGF) and DM.

Topline results from registrational EMPASSION study (MMN) evaluating empasiprubart head-to-head versus IVIg expected in second half of 2026
Registrational EMVIGORATE study ongoing in CIDP evaluating empasiprubart head-to-head versus IVIg
Topline results expected for DGF in the second half of 2025 and for DM in first half of 2026

ARGX-119 Development

ARGX-119, a first-in-class agonist antibody that targets muscle-specific kinase (MuSK), is being evaluated in congenital myasthenic syndromes (CMS), amyotrophic lateral sclerosis (ALS), and spinal muscular atrophy (SMA).

Registrational study to start in CMS in 2026 following positive Phase 1b proof-of-concept data
Phase 2a proof-of-concept study ongoing in ALS; topline results expected in first half of 2026
SMA proof-of-concept study on track to start by end of year
ARGX-119 R&D webinar to be hosted on September 16, 2025
Advance four new pipeline molecules and generate sustainable value through continued investment in Immunology Innovation Program

argenx continues to invest in its Immunology Innovation Program (IIP) to drive long-term sustainable pipeline growth. Through the IIP, four new pipeline candidates have been nominated, including: ARGX-213, targeting FcRn and further solidifying argenx’s leadership in this biology; ARGX-121, a first-in-class molecule targeting IgA; ARGX-109, targeting IL-6, which plays an important role in inflammation, and a fourth pipeline candidate, a first-in-class sweeping antibody for which the target has not yet been disclosed.

Phase 1 results from ongoing ARGX-109 study expected in second half of 2025, and from ongoing ARGX-213 and ARGX-121 studies expected in first half of 2026
Entered strategic collaboration with Unnatural Products (UNP) to expand argenx discovery capabilities into the oral peptide space. This partnership reinforces argenx’s commitment to enhance the patient experience and advance its pipeline of precision therapies.

SECOND QUARTER 2025 FINANCIAL RESULTS
argenx SE
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS

Three Months Ended Six Months Ended
30 June, 30 June,
(in thousands of $ except per share data) 2025 2024 2025 2024
Product net sales $ 948,594 $ 477,635 $ 1,738,644 $ 875,918
Other operating income* 18,593 11,793 35,913 26,023
Total operating income $ 967,187 $ 489,428 $ 1,774,557 $ 901,941

Cost of sales $ (110,747) $ (52,383) $ (191,552) $ (95,561)
Research and development expenses (327,697) (225,286) (636,767) (450,255)
Selling, general and administrative expenses (324,902) (255,699) (601,150) (491,694)
Loss from investment in a joint venture (2,780) (1,521) (5,087) (3,313)
Total operating expenses $ (766,126) $ (534,889) $ (1,434,556) $ (1,040,823)

Operating profit/(loss) $ 201,061 $ (45,461) $ 340,001 $ (138,882)

Financial income $ 38,399 $ 38,933 $ 75,517 $ 77,828
Financial expense (1,126) (572) (2,261) (1,084)
Exchange gains/(losses) 48,565 (7,903) 76,003 (27,215)

Profit/(Loss) for the period before taxes $ 286,899 $ (15,003) $ 489,260 $ (89,353)
Income tax (expense)/benefit $ (41,541) $ 44,069 $ (74,433) $ 56,822
Profit/(Loss) for the period $ 245,358 $ 29,066 $ 414,827 $ (32,531)
Profit/(Loss) for the period attributable to:
Owners of the parent $ 245,358 $ 29,066 $ 414,827 $ (32,531)
Weighted average number of shares used for basic profit/(loss) per share 61,084,250 59,490,437 61,034,202 59,400,217
Basic profit/(loss) per share (in $) 4.02 0.49 6.80 (0.55)
Weighted average number of shares used for diluted profit/(loss) per share 65,639,446 63,893,007 65,653,007 59,400,217
Diluted profit/(loss) per share (in $) 3.74 0.45 6.32 (0.55)
*Comparative figures have been presented to be consistent with the one adopted in the current period with respect to the combination of collaboration revenue and other operating income.

DETAILS OF THE FINANCIAL RESULTS

Total operating income for the three and six months ended June 30, 2025, was $967 million and $1,775 million, respectively, compared to $489 million and $902 million, respectively, for the same periods in 2024, and mainly consists of:

Product net sales of VYVGART and VYVGART SC for the three and six months ended June 30, 2025, were $949 million and $1,739 million, respectively, compared to $478 million and $876 million, respectively, for the same periods in 2024.

Other operating income for the three and six months ended June 30, 2025, was $19 million and $36 million, respectively, compared to $12 million and $26 million, respectively, for the same periods in 2024. The other operating income for the three and six months ended June 30, 2025 and 2024, primarily relates to research and development tax incentives and payroll tax rebates.

Total operating expenses for the three and six months ended June 30, 2025 were $766 million and $1,435 million, respectively, compared to $535 million and $1,041 million, respectively, for the same periods in 2024, and mainly consist of:

Cost of sales for the three and six months ended June 30, 2025, was $111 million and $192 million, respectively, compared to $52 million and $96 million for the same periods in 2024, respectively. The cost of sales was related to the sale of VYVGART and VYVGART SC.
Research and development expenses for the three and six months ended June 30, 2025, were $328 million and $637 million, respectively, compared to $225 million and $450 million, respectively, for the same periods in 2024. The research and development expenses mainly relate to:
the clinical development and expansion of efgartigimod in 15 severe autoimmune diseases;
the ramp-up of studies for the development of empasiprubart into MMN, DGF, DM and CIDP;
the investments for ARGX-119 in proof-of-concept studies ongoing in ALS, CMS and SMA; and
other discovery and preclinical pipeline candidates.
Selling, general and administrative expenses for the three and six months ended June 30, 2025, were $325 million and $601 million, respectively, compared to $256 million and $492 million, respectively, for the same periods in 2024. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the global commercialization of VYVGART franchise, and personnel expenses.

Financial income for the three and six months ended June 30, 2025, was $38 million and $76 million, respectively, compared to $39 million and $78 million, respectively, for the same periods in 2024.

Exchange gains for the three and six months ended June 30, 2025, were $49 million and $76 million, respectively, compared to $8 million and $27 million, respectively, of exchange losses for the same periods in 2024. Exchange gains/losses are mainly attributable to unrealized exchange rate gains or losses on the cash, cash equivalents and current financial assets denominated in Euro.

Income tax for the three and six months ended June 30, 2025 and 2024 is detailed below:

Three Months Ended Six Months Ended
30 June, 30 June,
(in millions of $) 2025 2024 2025 2024
Current tax (expense)/benefit $ (41) $ (9) $ (70) $ (16)
Deferred tax (expense)/benefit (1) 53 (4) 72
Income tax (expense)/benefit $ (42) $ 44 $ (74) $ 57
Profit for the three- and six-month periods ended June 30, 2025, was $245 million and $415 million, respectively, compared to a profit of $29 million and a loss of $33 million, respectively, for the same periods in 2024. The basic profit per share was $4.02 for the three months ended June 30, 2025, compared to a basic profit per share of $0.49 for the same period in 2024. The basic profit per share was $6.80 for the six months ended June 30, 2025, compared to a basic loss per share of $0.55 for the same period in 2024.

Cash flow from operating activities for the six months ended June 30, 2025 was $362 million compared to a cash flow used in operating activities for the same period in 2024 of $126 million.

FINANCIAL GUIDANCE

The financial guidance on the combined research and development and selling, general and administrative remains unchanged at approximately $2.5 billion.

EXPECTED 2025 FINANCIAL CALENDAR

October 30, 2025: Third Quarter 2025 Financial Results and Business Update
February 26, 2025: Full-year 2025 Financial Results and Fourth Quarter 2025 Business Update

CONFERENCE CALL DETAILS

The half-year 2025 financial results and second quarter business update will be discussed during a conference call and webcast presentation today at 2:30 pm CET/8:30 am ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website.

On July 31, 2025 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) ("Supernus") reported that it has successfully completed its previously announced acquisition of Sage Therapeutics, Inc. (Nasdaq: SAGE) ("Sage") (Press release, Supernus, JUL 31, 2025, View Source [SID1234654689]).

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"Sage is an ideal fit in our corporate development strategy, adding a significant fourth growth product to our portfolio and further diversifying our sources of future revenue," said Jack Khattar, President and CEO of Supernus Pharmaceuticals. "With our proven track record of strong commercial execution along with the expected cost synergies, the acquisition is expected to be accretive in 2026."

Compelling Strategic Rationale

Strengthens psychiatry portfolio with ZURZUVAE (zuranolone) capsules CIV, the first and only FDA-approved oral medicine indicated for the treatment of postpartum depression in adults.
Diversifies and increases revenue base and cash flow:
Addition of collaboration revenue from net sales of ZURZUVAE (50% of total net revenue Biogen, Inc. records for ZURZUVAE in the U.S. pursuant to a collaboration agreement), and
Combined with its three other growth products (Qelbree, ONAPGO, and GOCOVRI), Supernus believes it is poised for significant future growth.
Augments Supernus central nervous system discovery platforms and expertise.
Strong fit with existing Supernus infrastructure is expected to result in cost synergies of up to $200 million on an annual basis.
The acquisition is expected to be accretive in 2026.
The Offer and the Merger

The Offer and withdrawal rights for all outstanding shares of common stock, par value $0.0001 per share (the "Shares"), of Sage in exchange for (i) $8.50 per Share, net to the seller in cash, subject to any withholding of taxes and without interest (the "Closing Amount"), plus (ii) one non-transferable and non-tradable contingent value right per Share (a "CVR"), which represents the right to receive up to $3.50 per Share upon the satisfaction of specified milestones (as described further in the Offer to Purchase), net to the seller in cash, without interest and subject to any withholding of taxes, pursuant to the CVR Agreement (the Closing Amount plus one CVR collectively, the "Offer Price"), expired as scheduled at one minute following 11:59 p.m., New York time, on July 30, 2025 (the "Expiration Time").

Each CVR paid to Sage stockholders represents a non-transferable and non-tradable contractual contingent right to receive a cash payment of up to $3.50, net to the seller in cash, subject to any withholding of taxes and without interest, upon the achievement of certain milestones in accordance with the terms of the Contingent Value Rights Agreement entered into between Supernus and Equiniti Trust Company, LLC as rights agent, (the "CVR Agreement").

One milestone payment of $0.50 per CVR, net to the seller in cash, subject to any withholding of taxes and without interest, is payable (subject to certain terms and conditions) upon the first commercial sale after Regulatory Approval (as defined in the CVR Agreement) in Japan to a third-party customer of the pharmaceutical product that is marketed in the United States under the name ZURZUVAE and is the subject of the current regulatory filing (including any amended filings based thereon) by Shionogi & Co., Ltd., inclusive of its affiliates, in Japan for Major Depressive Disorder by June 30, 2026.

A second milestone payment of $1.00 per CVR, net to the seller in cash, subject to any withholding of taxes and without interest, is payable (subject to certain terms and conditions) if Net Sales (as defined in the CVR Agreement) of ZURZUVAE are equal to or exceed $250 million in the United States during a calendar year on or prior to December 31, 2027.

A third milestone payment of $1.00 per CVR, net to the seller in cash, subject to any withholding of taxes and without interest, is payable (subject to certain terms and conditions) if Net Sales (as defined in the CVR Agreement) of ZURZUVAE are equal to or exceed $300 million in the U.S. during a calendar year on or prior to December 31, 2028.

A fourth milestone payment of $1.00 per CVR, net to the seller in cash, subject to any withholding of taxes and without interest, is payable (subject to certain terms and conditions) if Net Sales (as defined in the CVR Agreement) of ZURZUVAE are equal to or exceed $375 million in the U.S. during a calendar year on or prior to December 31, 2030.

Each milestone may only be achieved once. The maximum amount payable with respect to the CVR issued in respect to each Share is $3.50 in the aggregate. There can be no assurance any payments will be made with respect to any CVR. It is possible that no milestone is achieved and no payment is made with respect to the CVRs.

Equiniti Trust Company, LLC, the depositary for the Offer, has advised Supernus that a total of 36,313,509 Shares were validly tendered and not validly withdrawn in the Offer, representing approximately 58 percent of the Shares outstanding.

All of the conditions of the Offer have been satisfied, and effective as of the Expiration Time, Supernus and its wholly owned subsidiary, Saphire, Inc. ("Purchaser"), accepted for payment all Shares that were validly tendered and not validly withdrawn in the Offer, and will as promptly as practicable thereafter pay for all such validly tendered Shares. Following the completion of the Offer, Supernus completed the acquisition of Sage through the merger of Purchaser with and into Sage, without a vote of Sage stockholders in accordance with Section 251(h) of the General Corporation Law of the State of Delaware ("DGCL"), with Sage surviving the merger as a wholly owned subsidiary of Supernus. In connection with the merger, each Share not previously purchased in the Offer (other than (i) Shares held by Sage (or held in Sage’s treasury) immediately prior to the effective time of the merger, (ii) any Shares held by Supernus or Purchaser or any direct or indirect wholly owned subsidiary of Supernus or Purchaser immediately prior to the effective time of the merger, or (iii) Shares held by any stockholder who was entitled to appraisal rights under Section 262 of the DGCL and properly exercised and perfected their respective demands for appraisal of such Shares pursuant to Section 262 of the DGCL and, as of the effective time of the merger, has neither effectively withdrawn nor lost their rights to such appraisal and payment under the DGCL with respect to such Shares) was converted into the right to receive the Offer Price, less any applicable withholding taxes and without interest. The Shares will be delisted from the Nasdaq Global Market.

Advisors

Moelis & Company LLC acted as the exclusive financial advisor to Supernus. Goldman Sachs & Co. LLC acted as the exclusive financial advisor to Sage. Saul Ewing LLP served as legal counsel to Supernus. Kirkland & Ellis LLP served as legal counsel to Sage.

On July 31, 2025 Ipsen reported first half 2025 financial results (Presentation, Ipsen, JUL 31, 2025, View Source [SID1234654821]).

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On July 31, 2025 AbbVie (NYSE:ABBV) reported financial results for the second quarter ended June 30, 2025 (Press release, AbbVie, JUL 31, 2025, View Source [SID1234654664]).

"AbbVie delivered another outstanding quarter with strong performance from our diversified growth platform. We also made meaningful pipeline progress with several regulatory approvals, encouraging clinical data and strategic investments in promising external innovation," said Robert A. Michael, chairman and chief executive officer, AbbVie. "We’re entering the second half of the year with substantial momentum and are once again raising our full-year outlook."

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Second-Quarter Results

•Worldwide net revenues were $15.423 billion, an increase of 6.6 percent on a reported basis, or 6.5 percent on an operational basis.

•Global net revenues from the immunology portfolio were $7.631 billion, an increase of 9.5 percent on a reported basis, or 9.2 percent on an operational basis.
◦Global Skyrizi net revenues were $4.423 billion, an increase of 62.2 percent on a reported basis, or 61.8 percent on an operational basis.
◦Global Rinvoq net revenues were $2.028 billion, an increase of 41.8 percent on a reported basis, or 41.2 percent on an operational basis.
◦Global Humira net revenues were $1.180 billion, a decrease of 58.1 percent on a reported basis, or 58.2 percent on an operational basis.

•Global net revenues from the neuroscience portfolio were $2.683 billion, an increase of 24.2 percent on a reported basis, or 24.0 percent on an operational basis.
◦Global Vraylar net revenues were $900 million, an increase of 16.3 percent.
◦Global Botox Therapeutic net revenues were $928 million, an increase of 14.1 percent on a reported basis, or 14.2 percent on an operational basis.
◦Global Ubrelvy net revenues were $338 million, an increase of 47.1 percent on a reported basis, or 47.2 percent on an operational basis.
◦Global Qulipta net revenues were $267 million, an increase of 77.5 percent on a reported basis, or 76.9 percent on an operational basis.

•Global net revenues from the oncology portfolio were $1.676 billion, an increase of 2.6 percent on a reported basis, or 2.4 percent on an operational basis.
◦Global Imbruvica net revenues were $754 million, a decrease of 9.5 percent.
◦Global Venclexta net revenues were $691 million, an increase of 8.5 percent on a reported basis, or 8.3 percent on an operational basis.
◦Global Elahere net revenues were $159 million, an increase of 24.2 percent on a reported basis, or 23.7 percent on an operational basis.

•Global net revenues from the aesthetics portfolio were $1.279 billion, a decrease of 8.1 percent on a reported basis, or 8.0 percent on an operational basis.
◦Global Botox Cosmetic net revenues were $692 million, a decrease of 5.0 percent on a reported basis, or 4.9 percent on an operational basis.
◦Global Juvederm net revenues were $260 million, a decrease of 24.0 percent.

•On a GAAP basis, gross margin in the second quarter was 71.8 percent. The adjusted gross margin was 84.4 percent.

•On a GAAP basis, selling, general and administrative (SG&A) expense was 21.1 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 13.7 percent of net revenues.

•Acquired IPR&D and milestones expense was 5.3 percent of net revenues.

•On a GAAP basis, operating margin in the second quarter was 31.7 percent. The adjusted operating margin was 44.3 percent.

•Net interest expense was $678 million.

•On a GAAP basis, the tax rate in the quarter was 39.4 percent. The adjusted tax rate was 16.2 percent.

•Diluted EPS in the second quarter was $0.52 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.97. These results include an unfavorable impact of $0.42 per share related to acquired IPR&D and milestones expense.

Recent Events

•AbbVie announced the U.S. Food and Drug Administration (FDA) approved Rinvoq (upadacitinib) as the first oral Janus Kinase (JAK) inhibitor approved for the treatment of adults with giant cell arteritis (GCA). The approval was supported by data from the pivotal Phase 3 SELECT-GCA trial, which met the primary endpoint of sustained remission and key secondary endpoints. This marks the ninth approved indication for Rinvoq in the U.S., across rheumatology, gastroenterology and dermatology.

•AbbVie announced positive topline results from the first of two pivotal studies in the Phase 3 UP-AA clinical program evaluating the safety and efficacy of Rinvoq in adult and adolescent patients with severe alopecia areata (AA). In the study, Rinvoq achieved the primary endpoint, demonstrating that 44.6% and 54.3% of patients with severe AA treated with Rinvoq 15mg and 30mg, respectively, reached 80% or more scalp hair coverage at week 24 as defined by the severity of alopecia tool (SALT) score ≤20. Key secondary endpoints, including improvements in eyebrows and eyelashes, as well as the percentage of subjects with 90% or more scalp coverage (SALT ≤10) and complete scalp hair coverage (SALT=0) at Week 24, were also met. Rinvoq’s safety profile in AA was generally consistent with that in approved indications, and no new safety signals were identified in this study.

•AbbVie and Capstan Therapeutics, a clinical-stage biotechnology company dedicated to advancing in vivo engineering of cells through RNA delivery using targeted lipid nanoparticles (tLNPs), announced a definitive agreement under which AbbVie will acquire Capstan. The transaction includes CPTX2309, a potential first-in-class in vivo tLNP anti-CD19 CAR-T therapy candidate, currently in Phase 1 development for the treatment of B cell-mediated autoimmune diseases. Additionally, AbbVie will acquire Capstan’s proprietary tLNP platform technology designed to deliver RNA payloads, such as mRNA, capable of engineering specific cell types in vivo.

•AbbVie announced new data from its Phase 3 TEMPLE head-to-head study evaluating the tolerability, safety and efficacy of Qulipta (atogepant) compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month. In the study, Qulipta met the primary endpoint of fewer treatment discontinuations attributed to adverse events versus topiramate, and all six secondary endpoints achieved statistical significance for superiority versus topiramate, demonstrating clinical efficacy. Full results from the TEMPLE study will be presented at an upcoming medical meeting.

•AbbVie announced that Emrelis (telisotuzumab vedotin-tllv) was granted accelerated approval by the FDA for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression who have received a prior systemic therapy. Emrelis is the first treatment approved for previously treated advanced NSCLC patients with high c-Met protein overexpression, a population that often faces poor prognosis and has limited treatment options.

•AbbVie announced the submission of a supplemental New Drug Application (sNDA) to the FDA for Venclexta (venetoclax) and acalabrutinib combination therapy for the treatment of chronic lymphocytic leukemia (CLL). This combination therapy has potential to be the first all oral, fixed-duration regimen for previously untreated patients with CLL. The submission is supported by data from the Phase 3 AMPLIFY trial which demonstrated that the combination regimen of Venclexta and acalabrutinib improved progression-free survival (PFS) compared to standard chemoimmunotherapy in previously untreated patients with CLL.

•At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, AbbVie presented key data that showcased significant progress across AbbVie’s robust oncology pipeline, in a range of difficult-to-treat solid tumors and blood cancers. Highlights included new data from AbbVie’s novel investigational antibody-drug conjugates (ADCs) telisotuzumab adizutecan (ABBV-400, Temab-A) in advanced NSCLC, ABBV-706 in high-grade neuroendocrine neoplasms (NENs) and pivekimab sunirine (PVEK) in blastic plasmacytoid dendritic cell neoplasm (BPDCN).

•AbbVie announced the global Phase 3 VERONA trial evaluating Venclexta (venetoclax) in combination with azacitidine in the treatment of newly diagnosed higher-risk myelodysplastic syndrome (MDS) did not meet the primary endpoint of overall survival. No new safety signals were observed and results from the trial will be available in a future medical congress and/or publication.

•AbbVie and Ichnos Glenmark Innovation (IGI) announced an exclusive licensing agreement for IGI’s lead investigational asset, ISB 2001, which is being investigated for the treatment of oncology and autoimmune diseases. ISB 2001 is a first-in-class trispecific T-cell engager currently in Phase 1 development for relapsed/refractory (r/r) multiple myeloma (MM).

•AbbVie announced the FDA approved a label expansion for Mavyret (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. Mavyret is the first oral eight-week pangenotypic treatment option approved for people with acute or chronic hepatitis C virus (HCV). With this approval, providers can now treat HCV patients immediately at the time of diagnosis.

•AbbVie and ADARx Pharmaceuticals, a late clinical-stage biotechnology company developing next-generation RNA therapeutics, announced a collaboration and license option agreement to develop small interfering RNA (siRNA) therapeutics across multiple disease areas. The collaboration will leverage AbbVie’s expertise in biotherapeutic drug development and commercialization with ADARx’s proprietary RNA technology to advance next-generation siRNA therapies across neuroscience, immunology and oncology.

Full-Year 2025 Outlook

AbbVie is raising its adjusted diluted EPS guidance for the full year 2025 from $11.67 – $11.87 to $11.88 – $12.08, which includes an unfavorable impact of $0.55 per share related to acquired IPR&D and milestones expense incurred year-to-date through the second quarter 2025. The company’s 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the second quarter of 2025, as both cannot be reliably forecasted.