This study aims to provide real-world information about the duration, safety, and overall benefit of DaxibotulinumtoxinA (also called DAXI) treatment for adults living with blepharospasm (BSP), a condition that causes uncontrolled blinking or muscle spasms around the eyes, which can interfere with vision and daily activities. Specifically, it is being done to learn more about how well and how long DAXI works for treating adults with blepharospasm.
This is a single-center, open-label, single-arm study, meaning everyone in the study will receive DAXI, and both participants and researchers will know what treatment is being given. The study will include 20 adult participants.
Participants may receive two to three treatment cycles of DAXI injections over about 12 months. The timing between treatments will depend on how long each injection works for each person. Injections will be given at least every 90 days (3 months) but no later than every 180 days (6 months). Participants and their doctors will decide when another injection is needed based on symptom control using a tool called the Blepharospasm Severity Tracker Form (BSTF). To make the injections more comfortable, participants may use topical lidocaine cream, cooling spray, or another local anesthetic before injection.
DAXI will be prepared by the injecting clinician or trained staff right before use. The medication is made by mixing a measured amount of DAXI powder with a small amount of sterile saline solution (salt water) to reach the correct concentration. The exact injection technique (including the dose, location, and number of injection sites) will be chosen by the injector based on each participant's needs, but treatment will only be given in specific facial muscles (corrugator, procerus, orbicularis oculi, and nasalis). The use of imaging tools such as electromyography (EMG) or ultrasound is optional and typically not required for injections around the eyes.
The starting DAXI dose will be based on each participant's current or previous botulinum toxin treatment:
* If the participant was previously treated with onabotulinumtoxinA (Botox®), the same number of "units" will be used for DAXI (a 1:1 conversion).
* If the participant was previously treated with incobotulinumtoxinA (Xeomin®), the DAXI dose will be adjusted to about two-thirds of the previous incobotulinumtoxinA dose (a 1.5:1 conversion).
If a participant experienced side effects such as droopy eyelids (ptosis), double vision (diplopia), or dry eyes with prior treatments, that information will help guide dosing decisions. For later injection cycles, the injector may adjust the dose or injection pattern based on how well the participant responds. Whenever possible, the same injector will perform all of a participant's treatments to keep results consistent.
Participants will come to the clinic for in-person visits for most study assessments. After each DAXI injection, the peak effect (best response) will be evaluated about one month later, guided by the BSTF. These visits may be done remotely (via phone or video) when appropriate. The same schedule will be followed for future cycles. For the final treatment, this one-month check will occur unless the participant reports that the treatment's full effect happened sooner.
The main goal (primary endpoint) of the study is to measure how long DAXI's effects last, specifically by tracking the median time until the next injection is needed.
Other key goals (secondary endpoints) include:
* How long participants feel the treatment works
* How severe their blepharospasm symptoms are over time
* What side effects or safety concerns occur (adverse events)

Start Date01 Jul 2026

Sponsor / Collaborator

University of Pennsylvania

[+1]

NCT06195241

/ RecruitingPhase 4IIT

The Safety and Efficacy of DaxibotulinumtoxinA-Lanm for Benign Essential Blepharospasm and Hemifacial Spasm

The goal of this clinical trial is to test the effects of DaxibotulinumtoxinA-Lanm (Daxxify) in patients with benign essential blepharospasms (BEB) and hemifacial spasms (HFS). The main questions to answer:
1. Is there clinically significant difference (measured by Jankovic Rating Scale (JRS) score from base to peak efficacy) for patients with BEB and HFS treated with Daxxify?
2. What percentage of patients achieve a clinical response?
Participants historically treated with Botox for either BEB or HFS will be crossed over to Daxxify treatment in order to serve as their own control and examine the efficacy of Daxxify.

Start Date11 Feb 2025

Sponsor / Collaborator

Montefiore Medical Center

[+1]

NCT06411002

/ CompletedPhase 2

A Phase 2a Study to Evaluate the Effects of DaxibotulinumtoxinA for Injection on the Treatment of Dynamic Forehead Lines and Glabellar Lines

This is a Phase 2a open-label, single-arm study to evaluate the effects of DaxibotulinumtoxinA-lanm (DAXI) for Injection on the treatment of dynamic forehead lines (FHL) and glabellar lines (GL).
Approximately 40 subjects (18 years of age and above) with moderate to severe GL and FHL (all assessed at maximum contraction) will be screened for eligibility with the goal of enrolling and treating 30 subjects to receive DAXI for injection after providing informed consent.
The primary objective of this study is to determine the efficacy and safety of the combined treatment of two upper facial regions with DAXI for injection.

Start Date08 Apr 2024

Sponsor / Collaborator

Revance Therapeutics, Inc.

100 Clinical Results associated with Daxibotulinumtoixn A-LANM

100 Translational Medicine associated with Daxibotulinumtoixn A-LANM

100 Patents (Medical) associated with Daxibotulinumtoixn A-LANM

Literatures (Medical) associated with Daxibotulinumtoixn A-LANM

01 Apr 2026·LARYNGOSCOPE

Comparing DaxibotulinumtoxinA to OnabotulinumtoxinA for Adductor Laryngeal Dystonia: A Pilot Study

Article

Author: Gutierrez, Desi ; Marshall, Camryn R. ; Shuman, Elizabeth A. ; Schneider, Sarah L. ; Rawat, Tanvi ; Rosen, Clark A. ; Perrin, Claire E. ; D'Oto, Alexandra D. ; Young, VyVy N.

ABSTRACT:

Objectives:

Botulinum toxin A (BtxA) injection for AdLD is typically performed approxiamately every 3 months. DaxibotulinumtoxinA‐lanm (Daxi) is a peptide‐formulated neuromodulator with reported longer therapeutic duration. This study compared the safety and efficacy of Daxi to historical BtxA results in AdLD patients.

Methods:

In this open‐label, prospective clinical trial, 22 stable‐dose, BtxA‐responsive AdLD patients underwent Daxi injection. To optimize safety, the first 10 patients' doses were given in a staged fashion (3–6 days between half doses). Safety and duration of voice benefit (DVB) were the primary outcomes. PROMs and voice analyses were obtained pre‐ and monthly post‐injection.

Results:

Of 22 patients, 20 (75% female, mean age = 58.3) were analyzed, with two excluded for injection “misses.” No adverse reactions were reported. EAT‐10 showed no difference pre‐ and post‐Daxi injection ( p = 0.068). VHI‐10 significantly improved ( p = 0.004) pre‐ to post‐injection. Procedural LEMG quantitative data for Daxi and BtxA were comparable ( p = 0.279). DVB of Daxi was longer than BtxA in 8/20 (40%), equal to BtxA in 7/20 (35%), and shorter than BtxA in 5/19 (25%). Those with Daxi benefit had on average 43.9% (39.5 days) longer therapeutic duration than previous BtxA treatments. Seven patients (35%) returned to BtxA at subsequent injection whereas 13 patients (65%) desired repeat Daxi injection.

Conclusion:

This study represents the first implementation of Daxi for AdLD. Daxi was notably safe and effective. Although no overall significant difference was noted for the entire study cohort, 40% of patients reported substantially longer duration of voice benefit with Daxi than with BtxA, with 43.9% longer duration than their previous BtxA treatments.

Level of Evidence:

01 Mar 2026·LARYNGOSCOPE

Repeat Administration and Dose Escalation of DaxibotulinumtoxinA in Adductor Type Laryngeal Dystonia

Article

Author: Marshall, Camryn R. ; Rawat, Tanvi ; Rosen, Clark A. ; D'Oto, Alexandra D. ; Schneider, Sarah L. ; Young, VyVy N.

ABSTRACT:

Objectives:

During initial comparison of DaxibotulinumtoxinA‐lanm (Daxi) to botulinum toxin A (BtxA) in adductor laryngeal dystonia (AdLD) (Phase 1), Daxi administration was found to be safe and efficacious. This study sought to determine the reproducibility of Daxi results (Phase 2) and safety/results for Daxi dose escalation (Phase 3) in patients who previously had been successfully treated with Daxi.

Methods:

Thirteen AdLD patients with consistent benefit from BtxA were enrolled in an open‐label prospective clinical trial involving repeat administration and/or up‐titration of Daxi dose. Duration of voice benefit (DVB) and safety of dose escalation were primary outcomes. PROMs and voice recordings were obtained pre‐ and post‐injection.

Results:

Twenty‐nine total injections (21 repeat dose, 8 dose escalation) were performed in 13 patients (85% female, mean age = 60.4). No adverse events occurred, and there was no difference in EAT‐10 pre‐ to post‐injection (repeated dose p = 0.08, dose escalation p = 0.12). In patients who experienced greater benefit with Daxi, average DVB was 112.75 days, 33.5% longer than their average BtxA duration (mean = 84.2 days, p = 0.003). 54% (7/13) had longer DVB with Daxi, and 46% (6/13) had equivocal DVB compared to BtxA DVB by the end of the study. Daxi DVB was comparable to an earlier study, demonstrating reproducibility of Daxi injection results ( p = 0.332, SD = 13.6 days).

Conclusions:

Our results were variable but showed reproducible results with Daxi, with overall longer DVB with Daxi in 42.8% of total injections, with an average of 33.5% longer DVB than BtxA in a cohort of known Daxi‐responsive patients. Daxi dose escalation did not result in significant dysphagia or adverse events. Further studies are needed to determine the clinical utility of Daxi in the treatment of AdLD.

Level of Evidence:

01 Feb 2026·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Corrigendum to “A novel peptide excipient stabilizes DaxibotulinumtoxinA” [Int. J. Pharm. 685 (2025) 126238]

Author: Zhou, Shaoqiu ; Gallagher, Conor J ; Reza Malmirchegini, G

103

News (Medical) associated with Daxibotulinumtoixn A-LANM

23 Jun 2026

·www.prnewswire.com

Allergan Aesthetics receives approval for Boey® (trenibotulinumtoxinE) in Canada, the first and only rapid-onset, short-duration neurotoxin for the temporary improvement of frown lines in adult patients

Canada is the first country to approve a new botulinum neurotoxin serotype for aesthetic use Boey® is the first and only rapid-onset and short-duration botulinum neurotoxin serotype E approved for the temporary improvement in the appearance of glabellar lines Boey® offers a differentiated treatment option for many people who are curious about facial injectables Results may be seen as early as eight hours after treatment and typically wear off within approximately two to three weeks BOTOX Cosmetic® (onabotulinumtoxinA) is the only neurotoxin clinically tested for use following treatment with Boey® IRVINE, Calif., June 23, 2026 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced Health Canada has approved Boey® (trenibotulinumtoxinE) for the temporary improvement in the appearance of moderate to severe lines between the eyebrows (glabellar lines) in adult patients. Boey® is the first and only rapid-onset and short-duration botulinum neurotoxin serotype E approved for the temporary improvement in the appearance of glabellar lines. "Health Canada's approval of Boey® marks an important scientific and regulatory milestone in advancing toxin science. As the world's first approval of a botulinum neurotoxin based on serotype E in aesthetics, Boey® represents a meaningful advancement in aesthetic medicine — a fast-acting neurotoxin with a differentiated profile that expands the treatment options for clinicians and patients," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. A new Allergan Aesthetics survey found that 80% of people are open to learning about new treatments to get the results they want and 79% wish they could temporarily preview the outcome of an aesthetic treatment. 1 Despite growing interest in facial injectables, many patients are hesitant to take the next step due to uncertainty around treatment outcomes and committing to long-lasting results. Boey® was developed for these patients, offering a new way to experience neurotoxin treatment. "Boey® represents an important new advancement for patients and healthcare professionals, addressing a key need in aesthetic neurotoxins. With its truly differentiated profile, Boey® is redefining aesthetics and expanding what's possible by giving practitioners another option to tailor treatment to individual needs and goals, specifically, the ability to try a toxin without the long-term commitment," said Nicole Mowad-Nassar, senior vice president, AbbVie and president, global Allergan Aesthetics. "Allergan Aesthetics is proud to bring this innovation to Canada first and to continue advancing options that help shape the future of aesthetic medicine." Developed by the makers of BOTOX Cosmetic®, Boey® offers a new option for suitable patients considering facial injectables. BOTOX Cosmetic® is the only neurotoxin clinically tested for use following treatment with Boey®. Allergan Aesthetics plans to begin training healthcare professionals on the appropriate use of Boey® and is preparing for a commercial launch in the upcoming months as trenibotulinumtoxinE is under review for approval in multiple other countries. Allergan Aesthetics develops, manufactures and markets a portfolio of leading aesthetics brands and products. Allergan Aesthetics is well positioned to lead the future of injectable aesthetics, with dedicated research and development focused on driving innovation to meet the evolving needs of patients and healthcare professionals worldwide. -ENDS- About the Boey® clinical studies The approval of Boey® is supported by data from two randomised, multi-centre, double-blind, placebo-controlled studies Phase 3 clinical trials evaluating the efficacy and safety of Boey® in adults with moderate to severe glabellar lines (M21-500 and M21-508) associated with corrugator and/or procerus muscle activity. The studies enrolled 947 patients treated with Boey® 700 U total dose or placebo. The primary efficacy measure was defined as the percentage of subjects achieving None or Mild and ≥ 2-Grade Improvement from baseline in glabellar line severity at maximum frown based on both investigator and subject assessments using the Facial Wrinkle Scale (FWS) at Day 7. Efficacy was assessed in the ITT population. The composite responder rates at Day 7 were 60.0% and 65.7% (M2-500: n=289/482; M21-508: n=149/227; p<0.0001). Secondary efficacy endpoints were measured by Facial Line Satisfaction Questionnaire (FLSQ), a validated scale developed by Allergan Aesthetics, and included satisfaction with achieving a natural look and overall satisfaction with treatment effect. The onset of effect for patients treated with Boey® appeared as early as 8 hours after injection in both pivotal studies. Glabellar lines returned to baseline severity in approximately 14-21 days after administration. The most frequently reported treatment-related adverse events were headache (3.4% in the Boey-treated group and 4.2% in the placebo-treated group), injection site pain (1.7% in the Boey-treated group and 2.9% in the placebo-treated group), and injection site erythema (0.6% in the Boey-treated group and 1.3% in the placebo-treated group).2 BOEY ® CANADA APPROVED USES AND IMPORTANT SAFETY INFORMATION Boey® is used in adults to temporarily improve the appearance of moderate to severe frown lines between the eyebrows (glabellar/frown lines). IMPORTANT SAFETY INFORMATION Boey ® may cause serious side effects, including: Distant spread of toxin effects. It is possible that the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. Trouble breathing and trouble swallowing can be life threatening. One unit (amount) of Boey® is NOT the same as one unit of other botulinum products. Boey® should only be given by a trained healthcare professional. They should have experience using Boey®. Follow the dose and schedule of injection recommended by your healthcare provider. Do not use Boey® if you are allergic to botulinum toxin or any of the other ingredients or you have a skin infection where you plan to get the injection To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Boey®. Talk about any health conditions or problems you may have, including if you have allergies to any botulinum toxin product, had a side effect from any botulinum toxin product in the past, have had facial surgery or injured your face, are planning to have facial surgery soon, have any redness or swelling (inflammation) where you plan to get an injection, muscles where the injection will be given are weak, have drooping of one or both eyelids (ptosis), have any other change in the way your face normally looks, have certain diseases that affect your nervous system (such as amyotrophic lateral sclerosis or motor neuropathy) Other warnings you should know about include: Injection site reactions: Like with any injection procedure, injection site reactions may happen after receiving Boey®. Symptoms at the injection site(s) may include pain/discomfort, swelling/inflammation, redness, bruising, bleeding, itching, warmth, hardness at the site where the needle entered your skin Muscle weakness in areas next to or near the injection sites such as eyelid drooping and double vision (seeing two objects when there is only one). Driving and using machines: If you have drooping eyelids or problems with your vision after using Boey®, do not drive or use machinery until those symptoms go away. After you get Boey®, talk to your healthcare professional if you have the following: Allergic reaction: An allergic reaction is a reaction your body has to a medicine. This can cause symptoms such as hives, rash, or fever. Contact your healthcare professional right away if you have any of the symptoms listed as they can be signs of a severe allergic reaction: trouble breathing, swallowing, or speaking, swelling, including swelling of the face or throat, wheezing (a whistling sound while breathing), feeling dizzy or light-headed, shortness of breath Distant spread of toxin effect: Sometimes, the effects of botulinum toxin may spread from the injection area to other parts of the body. Contact your healthcare provider right away if you have any of the symptoms listed: muscle weakness, trouble swallowing, unwanted food or liquid going into the airways Reduced blinking or experience dryness in one or both eyes. Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines. The following may interact with Boey®: a different medicine that has botulinum toxin, muscle relaxants (medicines that reduce muscle tension), antibiotics (medicines used to treat infections) , anticholinergics (medicines that reduce muscle strength). Ask your healthcare provider for advice before you take any new medicines. Boey® can have side effects, although not everybody gets them, including drooping eyelid (uncommon), drooping eyebrow (uncommon), or raising of the outer eyebrow (rare). These are not all the possible side effects you may have when taking Boey®. If you experience any side effects not listed here, tell your healthcare professional. Please consult the Boey® product monograph for more information. BOTOX® COSMETIC US APPROVED USES AND IMPORTANT SAFETY INFORMATION BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet lines, frown lines between the eyebrows, and vertical bands connecting the jaw and neck (platysma bands) in adults. IMPORTANT SAFETY INFORMATION BOTOX® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic: Problems swallowing, speaking, or breathing, due to weakening of associated muscles, which can be severe and result in loss of life. You are at the highest risk if these problems are preexisting before injection. Swallowing problems may last for several months. Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms, including loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing. BOTOX® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product. There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow's feet lines, forehead lines, and/or platysma bands. BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of receiving BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities. Serious and/or immediate allergic reactions have been reported, including itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint. Do not receive BOTOX® Cosmetic if you are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc (rimabotulinumtoxinB), Dysport (abobotulinumtoxinA), Xeomin (incobotulinumtoxinA), Jeuveau (prabotulinumtoxinA-xvfs), Daxxify (daxibotulinumtoxinA-lanm), or Letybo (letibotulinumtoxinA-wlbg); or have a skin infection at the planned injection site. This list may not include all available botulinum toxin products. Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects, including difficulty swallowing and difficulty breathing, from standard doses of BOTOX® Cosmetic. Tell your doctor about all your medical conditions , including surgery or plans to have surgery on your face, trouble raising your eyebrows, drooping eyelids, any other abnormal facial change, are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby), or are breastfeeding or plan to (it is not known if BOTOX® Cosmetic passes into breast milk). Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past. Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc, Dysport, Xeomin, Jeuveau, Daxxify, or Letybo in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; or take aspirin-like products or blood thinners. Other side effects of BOTOX® Cosmetic include dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems, including double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of eyelids, and dry eyes. For more information, refer to the Medication Guide or talk with your doctor. To report a side effect, please call Allergan Aesthetics at 1-800-678-1605. Please see BOTOX® Cosmetic full US Product Information , including Boxed Warning and Medication Guide . © 2026 AbbVie. All rights reserved. All trademarks are the property of their respective owners. About Boey® Boey® is a facial injectable neurotoxin serotype E indicated in adult patients for the temporary improvement in the appearance of of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity. It blocks neuromuscular transmission as the neurotoxin cleaves SNAP-25. It has a rapid uptake and translocation into neuronal cells, with a short half-life of the type E light chain, giving it a rapid onset of action and a short duration of effect when treating glabellar lines.2 About Glabellar lines Glabellar lines are the vertical lines that appear between the eyebrows and are commonly referred to as "frown lines". These lines develop over time due to repeated muscle contractions from facial expressions such as frowning, concentrating or squinting. About Allergan Aesthetics At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit 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. 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, 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 our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and 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 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. 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. FOOTNOTES * A global survey (28th November 2025 – 15th December 2025) of N=12,286 adults aged 18+ who have paid for at least 2 beauty or aesthetics related services in the past year (Brazil n=1318, Canada n=1304, China n=1318, France n=1302, Germany n=1301, KSA n=1311, Thailand n=1321, USA n=1802, UK n=1309).1 References Allergan Aesthetics Holistic Beauty Global Research. REF-148616. January 2026 Boey® Product Monograph. AbbVie 2026. -ENDS- Contacts: Allergan Aesthetics Media: Michael Salzillo +1 (908) 269-1688 [email protected] AbbVie Investors: Liz Shea +1 (847) 935-2211 [email protected] © 2026 AbbVie. All rights reserved. All trademarks are the property of their respective owners. SOURCE AbbVie 21% more press release views with Request a Demo

Clinical ResultDrug ApprovalPhase 3

24 Mar 2026

·www.prnewswire.com

Fosun Pharma Announces 2025 Annual Results

Innovation and Globalization Propel Fosun Pharma's High-Quality Growth SHANGHAI, March 24, 2026 /PRNewswire/ -- On 24 March, 2026, Fosun Pharma ("the company", stock code: 600196.SH; 02196.HK), an innovation-driven global pharmaceutical and healthcare group, announced its 2025 annual operating results (the reporting period). Powered by the dual engines of innovation and globalization, Fosun Pharma achieved total operating revenue of RMB 41.662 billion, up 1.45% year-on-year. Of this, revenue from innovative drugs reached RMB 9.893 billion, rising 29.59% year-on-year; overseas revenue amounted to RMB 12.977 billion, growing 14.87% year-on-year. Net profit attributable to shareholders of the parent company was RMB 3.371 billion, up 21.69% year-on-year; recurring net profit attributable to shareholders of the parent company amounted to RMB 2.34 billion, increasing 1.12% year-on-year; and net cash flow generated from operating activities reached RMB 5.213 billion, up 16.45% year-on-year, further consolidating the foundation for high-quality development. Innovative Drugs Emerge as Core Growth Engine Revenue from innovative drugs hit RMB 9.893 billion, accounting for 33.16% of pharmaceutical business revenue, becoming the core engine of performance growth. Total R&D investment for the year amounted to RMB 5.913 billion, up 6.46% year-on-year, of which R&D investment related to innovative pharmaceuticals reached RMB 4.303 billion, a year-on-year increase of 15.98%, accounting for 80.26% of pharmaceutical business R&D investment. High-intensity R&D investment has been translated into fruitful results. During the reporting period, 16 indications of 7 innovative drugs were approved for marketing in China and overseas markets; marketing applications for 6 innovative drug candidates were accepted, and nearly 40 innovative drug clinical trials received approval from China and overseas regulatory authorities; and multiple core products entered key clinical phases, laying a solid pipeline foundation for subsequent commercial growth. Additionally, 5 new innovative drugs were included in the 2025 National Reimbursement Drug List (NRDL), and the CAR-T therapy Yikaida (axicabtagene ciloleucel injection) was successfully listed in the first edition of the Commercial Insurance Innovative Drug Catalog. This not only improves patient access to innovative drugs but also further unlocks the volume potential of commercialization. Building Differentiated Clinical Pipeline Advantages Fosun Pharma focuses on innovative drugs as its development priority. Centering on the three core therapeutic areas of oncology (solid tumors, hematologic tumors), immune inflammation and neurodegenerative diseases, the Company continuously strengthens its pipeline construction through in-house R&D, collaborative development and licensing-in. Oncology: In 2025, Fosun Pharma further strengthened the layout of its innovative pipeline around key indications such as breast cancer and lung cancer. The company's self-developed small-molecule innovative drug Fumaining® (luvometinib Tablet) received approval for two indications, filling the gap in the treatment of rare tumors in China; the innovative small-molecule CDK4/6 inhibitor Futuoning® (fovinaciclib citrate capsules) was launched for two indications in China, bringing a brand-new treatment option for breast cancer patients; the anti-PD-1 monoclonal antibody Serplulimab Injection was approved in Europe and multiple emerging markets for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), becoming the first anti-PD-1 monoclonal antibody to receive such approval in the EU and accelerating the company's globalization pace; antibody and ADC drugs such as HLX43 and HLX22 entered key clinical phases, continuously improving the echelon of the oncology pipeline. The marketing application for the second CAR-T product Brexucabtagene Autoleucel was accepted. Immune Inflammation and Chronic Diseases: The licensed-in first-in-class innovative drug Wantile (Tenapanor Hydrochloride Tablets) was successfully approved, providing a new treatment option for chronic kidney disease patients on dialysis in China. Steady clinical progress was made for core products such as FXS7553. Neurodegenerative diseases: Opicapone Capsules, a treatment for Parkinson's disease, was launched in the Boao Pilot Zone for innovative drugs. Fosun Insightech accelerated product upgrading and indication expansion for its Magnetic Resonance-guided Focused Ultrasound (MRgFUS) system. Sodium Oligomannate Capsule was incorporated into the Company's Alzheimer's disease innovative drug pipeline, with post-marketing confirmatory clinical trials underway. AR1001, an in-licensed asset, has advanced into global multi-center Phase 3 clinical trials. These initiatives further enriched the Company's product pipeline in the neurodegenerative disease sector. Breakthroughs in Cutting-Edge Technologies and Two-way Licensing On the basis of consolidating core technology platforms including antibodies, ADCs, small molecules, and cell therapy, Fosun Pharma is strategically investing in advanced fields such as radiopharmaceuticals and small interfering RNA (siRNA). The radiopharmaceutical project SRT-007 successfully initiated Phase I clinical trials, establishing a preliminary "imaging diagnosis - targeted therapy" integrated R&D pathway; in cell therapy, the autologous dual-target CAR-T product FKC289 had its clinical trial application accepted by the NMPA, continuously empowering the reserve of follow-on innovative products. In 2025, Fosun Pharma's global resource integration capability has been significantly enhanced. The total upfront payment from out-licensing reached over US$260 million in the whole year, with potential milestone payments exceeding US$ 3.8 billion. Among them, the global licensing project of the GLP-1 target YP05002 garnered an upfront payment of US$150 million and potential total payments of US$2.085 billion, fully confirming the global competitiveness of the company's innovative R&D. In terms of collaborative development, Fosun Pharma entered into a joint development agreement with Teva for FXB0871 and established original innovation cooperation with a fund under Aditum Bio. Meanwhile, Fosun Pharma introduced multiple overseas original drugs, including Akynzeo (netupitant and palonosetron hydrochloride capsules), Pu Rui Ni (pretomanid tablets) , and Daxxify (botulinum toxin type A for injection), through licensing-in, achieving marketing approval for them in China. Globalization Moves Towards "System-centric Globalization" In 2025, Fosun Pharma's international development achieved a strategic upgrade from "product-centric going global" to "system-centric globalization", making comprehensive breakthroughs in innovative R&D, production quality, registration and access, commercialization and academic influence, and building a global operation network covering markets such as China, the United States, Europe, Africa, India and Southeast Asia. In 2025, the company's overseas revenue reached RMB 12.977 billion, accounting for 31.15% of the total revenue, increased by 3.64 percentage points year-on-year. Fosun Pharma has built a global R&D and production synergy registration capability featuring "leading breakthroughs in Europe and the US, and in-depth cultivation in emerging markets". The core innovative drug Serplulimab Injection has been approved for marketing in more than 40 countries and regions worldwide. In the United States, the bridging study for first-line ES-SCLC has completed enrolment, with a Biologics License Application (BLA) submission planned for 2026. Biosimilars such as Denosumab have successively obtained approvals from the FDA and the EU, marking that the quality system and registration capability of the biologic drug platform have been certified to international standards; the small-molecule innovative drug Fumaining® received Priority Review status from the Saudi Food and Drug Authority (SFDA) in Saudi Arabia, becoming an important fulcrum to leverage the Middle East and global markets. Seventeen of Fosun Pharma's workshops/production lines in China have passed GMP certifications of mainstream regulatory markets such as the US, the EU and the WHO. The relevant biologic drug production lines have realized regular supply to the global market, covering China, Europe, Latin America, Southeast Asia, India and other markets. Multiple injection production lines of India's Gland Pharma have passed certifications in Europe, the US, Japan and Australia, providing a solid guarantee for the stability and quality controllability of the global supply chain. Fosun Pharma has formed a mature overseas go-global model of "independent operation + licensing authorization" running in parallel, with over 6,000 commercial personnel worldwide and established a marketing network covering over 40 countries and regions in Africa; the controlling subsidiary Sisram's marketing network covers over 110 countries and regions, while Breas covers over 50 countries and regions. ESG Governance Recognized by Global Authorities While achieving high-quality development of its core business, in 2025, Fosun Pharma's MSCI ESG rates were upgraded to "AA", retained its Hang Seng ESG rating of "A-" and was selected into the 2025 Fortune China ESG Influence List, being the only Chinese pharmaceutical enterprise on the list. "In 2025, Fosun Pharma firmly implemented its corporate strategy of Innovation Driven, Deep Globalization and AI Embracement, achieving high-quality growth powered by innovative drugs and globalization." Chen Yuqing, Chairman of Fosun Pharma said, "Looking ahead, Fosun Pharma will always focus on unmet clinical needs, continue to innovate, and further deepen its layout in core therapeutic areas such as oncology, immune inflammation and neurodegenerative diseases. It will integrate innovative resources from a global perspective, drive operational upgrading with digital intelligence, and strive to become a world-leading integrator of medical innovation, creating long-term value for shareholders and providing more high-quality and accessible medicines and healthcare solutions for patients." About Fosun Pharma Founded in 1994, Fosun Pharma (stock code: 600196.SH; 02196.HK) is an innovation-driven global pharmaceutical and healthcare group. With the mission of Better Health for Families Worldwide, we focus on developing innovative medicines, medical technologies and diagnostics as well as delivering healthcare services. Through our business partner Sinopharm Group, we have also established pharmaceutical distribution network, built a comprehensive pharmaceutical and healthcare ecosystem. Fosun Pharma is dedicated to innovation and globalization. The company has established a global R&D innovation system targeting at unmet medical needs. Our strategic focus is on key therapeutic areas including oncology, immunology and inflammation, neurodegenerative diseases, and selected cardiometabolic diseases and rare diseases. This approach enables the development of high valued competitive pipelines and comprehensive healthcare solutions. Meanwhile, Fosun Pharma has consolidated its core technical platforms including but not limited to antibodies and antibody-drug conjugates (ADC), small molecules and cell therapy. Additionally, we also actively advance cutting-edge therapeutic modalities such as radiopharmaceuticals and small nucleic acids. These efforts have strengthened our early-stage innovative portfolios and accelerated the transformation of scientific discoveries to drug development. Our innovative products are now available in more than 90 countries and regions worldwide, including major markets across China, the United States, Europe, Africa, India and Southeast Asia. Looking ahead, guided by the strategy of "Innovation Driven, Deep Globalization, and AI Embracement", Fosun Pharma remains committed to its core values: Care for life, Continuous innovation, Pursuit of excellence and Sustainable partnership. We strive to become a leading global healthcare innovation integrator, ensuring that the benefits of medical innovation reach more patients worldwide, and contribute to safeguarding human health. For more information, please visit the company website: SOURCE Fosun Pharma 21% more press release views with Request a Demo

Phase 1Drug ApprovalLicense out/in

23 Mar 2026

·www.prnewswire.com

Sisram Medical Reports Solid Growth in 2025

Solid growth driven by strong performance in international markets, with the injectables business accelerating rapidly DAXXIFY shows promising results from initial commercialization in China, with expansion plans underway HONG KONG, March 23, 2026 /PRNewswire/ -- Sisram Medical Ltd (the " Company" or "Sisram", 1696.HK; together with its subsidiaries collectively referred to as the "Group"), a global wellness group offering Energy-Based Devices (EBD), injectables, and other complementary solutions, today announced that its audited consolidated annual results for the year ended December 31, 2025 (the "Reporting Period"). During the Reporting Period, the Group's clear strategic focus and disciplined execution drove steady revenue and profit growth, supported by strong injectables momentum and robust expansion across international markets. FINANCIAL HIGHLIGHTS Revenue was US$365.3 million, representing an increase of 4.7% year on year ("YoY"). Revenue from injectables was US$28.0 million, representing an increase of 185.6% YoY. International markets[1] (excluding North America) grew 20.1% YoY. Revenue in APAC increased by 26.9% YoY to US$147.4 million, accounting for 40.4% of total revenue and making it the Company's largest revenue-contributing region. Revenues in Europe, and Middle East and Africa were US$56.4 million and US$36.4 million, representing increases of 11.7% YoY and 5.3% YoY respectively. Revenue in North America was US$111.0 million, representing a decrease of 19.2% YoY. Gross profit margin was 58.9%, compared with 62.1% in 2024, mainly due to changes in geographic and product mix, as well as newly established import tariffs. Net profit decreased by 13.1% YoY to US$25.0 million from US$28.8 million in 2024. Net profit margin was 6.8%, compared with 8.2% in 2024. Adjusted net profit increased by 7.9% YoY to US$31.0 million from US$28.7 million in 2024. Adjusted net profit margin was 8.5%, compared with 8.2% in 2024. FINAL DIVIDEND The Board has resolved to declare a final dividend of HK$0.095 per share (inclusive of tax) for the year ended December 31, 2025. KEY ACHIEVEMENTS EBD Reinforcing Core Strengths and Industry Leadership Sisram's energy-based device portfolio continued to reinforce the Company's leadership in the global aesthetics market. Alma Harmony maintained strong international traction, with its Harmony Bio-Boost treatment receiving multiple prestigious recognitions, including the ELLE Awards, positioning the platform among leading patient choices. Alma Hybrid also delivered its fifth consecutive year of growth, highlighting the durability of the Company's core EBD platforms. In China, the launch of "钛提升" further strengthened Sisram's presence in the premium medical aesthetics segment. Injectables Expanding Market Presence with Strong Growth Sisram continued to expand its injectables portfolio across key global markets. In Mainland China, DAXXIFY achieved important milestones, including regulatory approval and its first clinical applications. Since then, the product has been rolled out across multiple provinces and cities, with shipments surpassing ten thousand units and usage demonstrating a steady upward trend. At the same time, Profhilo maintained strong momentum in Thailand and Revanesse delivered solid performance in the United Kingdom, reflecting growing practitioner adoption. The Company also advanced the rollout of Hallura, a next-generation hyaluronic acid filler, following a successful launch in Israel. Building an Intelligent Aesthetics Ecosystem As part of its strategy to build an intelligent aesthetics ecosystem, Sisram introduced several key innovations during the year. Universkin by Alma, an AI-powered personalized skincare platform, enables physicians to generate customized formulations based on advanced skin analysis. The system was launched in the United States and Hong Kong, extending personalized care from clinical treatments to daily skincare routines. Complementing this platform, Alma IQ™, developed with Sylton, provides advanced skin imaging and diagnostics that support more precise treatment planning. OUTLOOK Sisram is entering a strategic phase aimed at creating a fully integrated medical‑aesthetics ecosystem, building on its operational resilience. The Company will strengthen its local footprint worldwide, most notably by establishing a manufacturing facility in China to support regional R&D and production of core EBD technologies, and will increase R&D investment across EBD, injectables, diagnostics, and personalized skincare to deliver distinctive aesthetic solutions. In 2026, Sisram will prioritize commercializing DAXXIFY in mainland China while advancing regulatory approvals for additional injectables. Simultaneously, the Company will drive broader adoption of Alma Harmony, Universkin by Alma, and Alma IQ™, and expand AI integration across diagnostics, personalized treatment planning, and ongoing patient care. In addition, Sisram will explore strategic M&A opportunities to strengthen its ecosystem and innovation capabilities. Execution will focus on APAC and North America. In APAC, Sisram will deepen market penetration with ecosystem-driven, locally tailored solutions. In North America, amid challenging market conditions, Sisram will concentrate on operational discipline and strategic capacity building, supported by deeper market analytics and optimized regional resource allocation to position the business for long-term growth. MANAGEMENT COMMENTARY Mr. Lior Moshe Dayan, Chairman of Sisram Medical, commented: "The medical aesthetics industry continues to demonstrate strong long-term fundamentals, driven by rising patient awareness and broader treatment adoption. Anticipating this shift early, Sisram has been building an integrated ecosystem spanning devices, diagnostics, injectables, and AI-driven skincare. Supported by our global footprint and strong physician partnerships, these foundations drove Sisram's performance in 2025 and position the Company well for the years ahead." Mr. Eyal Ben David, CEO of Sisram Medical, added: "2025 marked an important step in strengthening the foundations for Sisram's next phase of growth. Strong demand for our EBD portfolio and the continued expansion of our injectables business reflect growing practitioner confidence in Sisram's integrated approach to aesthetic care. During the year, we also made significant progress in advancing our ecosystem strategy—enhancing consultations with Alma IQ and introducing AI-driven skincare with Universkin by Alma—bringing greater value to our partners and clinics while positioning Sisram to capture long-term opportunities across the global aesthetics market." Mr. Jiahong Li, Co-CEO and CFO of Sisram Medical, said: "In 2025, Sisram proactively addressed external challenges, advanced its strategic agenda in an orderly manner and delivered solid financial performance. Revenue grew 4.7% year-on-year, with double-digit growth in both year-on-year and sequential terms in the second half, reflecting a stable growth trajectory. Driven by disciplined cost management and operational efficiency, profitability further improved, with adjusted net profit rising 7.9% year-on-year. Looking ahead, we will continue investing in core businesses and new growth engines, pursue ecosystem‑aligned M&A opportunities to broaden our product portfolio and boost innovation, and expand localized R&D and manufacturing to lay a solid foundation for long-term growth and shareholder value creation." About Sisram Medical Ltd Sisram Medical Ltd (1696.HK) is a global leader in medical aesthetic solutions with over 25 years of expertise in Energy-Based Devices (EBD). Built on a legacy of innovation and clinical excellence, the Company's synergistic ecosystem spans EBD technologies, injectables, diagnostics, and complementary solutions. Serving customers in over 110 countries and regions, Sisram delivers award-winning products that set new standards in safety, efficacy, and personalized aesthetic care for millions of patients worldwide. Majority-owned by Fosun Pharma, Sisram has been listed on the Main Board of the Hong Kong Stock Exchange since September 2017. For more information, please visit: . Forward-Looking Statement The information communicated in this press release contains certain statements that are or may be forward-looking. These statements typically contain words such as "will," "expects," "believes," "plans" and "anticipates," and words of similar import. By their nature, forward-looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There may be additional material risks that are currently not considered to be material or of which the Company is unaware. These forward-looking statements are not a guarantee of future performance. Against the background of these uncertainties, readers should not rely on these forward-looking statements. The Company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments. SOURCE Sisram Medical Ltd 21% more press release views with Request a Demo

Financial Statement

100 Deals associated with Daxibotulinumtoixn A-LANM

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dystonic Disorders	China	Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.	22 Nov 2024
cervical dystonia	United States	Revance Therapeutics, Inc.	11 Aug 2023
Glabellar frown lines	United States	Revance Therapeutics, Inc.	07 Sep 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Torticollis	NDA/BLA	United States	Revance Therapeutics, Inc.	20 Oct 2022
Isolated cervical dystonia	Phase 3	United States	Revance Therapeutics, Inc.	20 Jun 2018
Isolated cervical dystonia	Phase 3	Austria	Revance Therapeutics, Inc.	20 Jun 2018
Isolated cervical dystonia	Phase 3	Canada	Revance Therapeutics, Inc.	20 Jun 2018
Isolated cervical dystonia	Phase 3	Czechia	Revance Therapeutics, Inc.	20 Jun 2018
Isolated cervical dystonia	Phase 3	France	Revance Therapeutics, Inc.	20 Jun 2018
Isolated cervical dystonia	Phase 3	Germany	Revance Therapeutics, Inc.	20 Jun 2018
Isolated cervical dystonia	Phase 3	Poland	Revance Therapeutics, Inc.	20 Jun 2018
Isolated cervical dystonia	Phase 3	Spain	Revance Therapeutics, Inc.	20 Jun 2018
Isolated cervical dystonia	Phase 3	United Kingdom	Revance Therapeutics, Inc.	20 Jun 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05158166 (CTgov)	Phase 1/2	Spastic Dysphonia	22	DaxibotulinumtoxinA	hyuzsxncwg(omfougdhwm) = cniuwbzngz omcqgvefqc (sfbvdrfxll, 8.18) View more	-	27 Mar 2026
CTR20202553 (Pubmed)	-	Facial wrinkles	307	Daxxify	ybpztqypkg(gjauythbsr) = mbdeshwqtw cgrhjqhdqk (dxmowrlqcp ) View more	Positive	01 Dec 2024
				安慰剂	ybpztqypkg(gjauythbsr) = ajteftnqgc cgrhjqhdqk (dxmowrlqcp )
ASPEN-1 (MDS2024)	Phase 3	cervical dystonia	321	DaxibotulinumtoxinA	qwarjrgtqj(yhqqidrkzi) = shdpvarsce matkjxohlr (ftavlzbrbx ) View more	Positive	27 Sep 2024
AAN2024	Not Applicable	cervical dystonia	-	DaxibotulinumtoxinA	pumfggrmas(lilrkumezf) = jeryhxvkkf wurhdwhlym (qpejiwmbwt ) View more	-	09 Apr 2024
NCT02973269 (CTgov)	Phase 2	Fasciitis, Plantar	7	daxibotulinumtoxin type A (DAXI 240 U)	dqnzmsjdjt(wmfmfvvzmo) = ctbixqzroz gujgnwflfi (vflyfdrepf, 11.0) View more	-	03 Apr 2024
				Placebo (Placebo)	dqnzmsjdjt(wmfmfvvzmo) = noeqxheyzq gujgnwflfi (vflyfdrepf, 12.1) View more
NCT03608397 \| EUCTR2018-000446-19-AT (ASPEN-1, Pubmed \| Neurology) Manual	Phase 3	cervical dystonia	301	DAXI125U	adoidujsnz(gonzotdbnn) = tsikmwxfsv xbwsztjabg (hzpeqyuqxo, 1.30) View more	Positive	31 Jan 2024
				DAXI250U	adoidujsnz(gonzotdbnn) = cbcctogeem xbwsztjabg (hzpeqyuqxo, 1.25) View more
NCT03825315 (CTgov)	Phase 2	Fasciitis, Plantar	155	DAXI 80 U (DAXI 80 U)	vocxfxaagk(sdfjaaegdo) = fdvgtlrpnd extpsixagx (ilgnmyuipr, 0.329) View more	-	21 Sep 2023
				DAXI 120 U (DAXI 120 U)	vocxfxaagk(sdfjaaegdo) = xqstnfloao extpsixagx (ilgnmyuipr, 0.298) View more
NCT03821402 (JUNIPER, CTgov)	Phase 2	Stroke \| Limb spasticity \| Brain Injuries, Traumatic ... View more	83	DAXI (DAXI 250 U)	msusdlvikp(hlxpirdzmj) = lltorsnciw woeubtlctx (pojeqkouot, 0.25) View more	-	21 Sep 2023
				DAXI (DAXI 375 U)	msusdlvikp(hlxpirdzmj) = ishpwlgetc woeubtlctx (pojeqkouot, 0.26) View more
GL-2 (FDA) Manual	Not Applicable	Glabellar frown lines	609	DAXXIFY (STUDY GL-1)	cdxiqkxjxu(uayxbassnb) = caydzuxikk cxgejzxard (oawxnnuccq ) View more	Positive	11 Aug 2023
				Placebo (STUDY GL-1)	cdxiqkxjxu(uayxbassnb) = tyikyvfpnq cxgejzxard (oawxnnuccq ) View more
NCT03608397 (FDA) Manual	Phase 3	cervical dystonia	301	Placebo	ylbgcyvigb(ksuxkukyww) = pfoprkdkft fvxatqvpwq (ttmjzaduza )	Positive	11 Aug 2023
				DAXI 125 U	ylbgcyvigb(ksuxkukyww) = iiggbuxdmi fvxatqvpwq (ttmjzaduza )

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