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.

开始日期2025-02-11

申办/合作机构

Montefiore Medical Center

[+1]

NCT06411002

/ Completed临床2期

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.

开始日期2024-04-08

申办/合作机构

Revance Therapeutics, Inc.

NCT06225492

/ Completed临床4期IIT

Use of DaxibotulinimtoxinA Injection for Platysma Bands of the Neck

This study seeks to evaluate the effectiveness and duration of action of DaxibotulinumtoxinA for neck rejuvenation through treatment of platysmal bands. This study will consist of one treatment visit with subjects being randomized to receiving 15 or 20 units of DaxibotulinumtoxinA per platysmal band. Subjects will return for 5 follow-up visits at 8, 12, 16, 20, and 24 weeks for evaluation.

开始日期2024-01-01

申办/合作机构

Main Line Center for Laser Surgery

100 项与 Daxibotulinumtoixn A-LANM 相关的临床结果

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100 项与 Daxibotulinumtoixn A-LANM 相关的专利（医药）

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项与 Daxibotulinumtoixn A-LANM 相关的文献（医药）

2025-03-01·OPHTHALMIC PLASTIC AND RECONSTRUCTIVE SURGERY

Successful Treatment of Severe, Poorly Controlled Benign Essential Blepharospasm with DaxibotulinumtoxinA

Article

作者: Kikkawa, Don O. ; Sargsyan, Suzan ; Dib El Jalbout, Nahia ; Korn, Bobby S. ; Liu, Catherine Y. ; Al-Sharif, Eman ; Shoji, Marissa K.

Benign essential blepharospasm is a focal dystonia characterized by involuntary contractions of the orbicularis oculi. Botulinum toxin type A injections are often first-line treatment, but patients may experience refractory symptoms or decreased response over time. DaxibotulinumtoxinA, a novel botulinum toxin type A product, has shown promise in cervical dystonia and facial rhytids but has not been previously reported for benign essential blepharospasm treatment. This case highlights a 57-year-old male with severe, poorly controlled benign essential blepharospasm despite high-dose injections of onabotulinumtoxinA and incobotulinumtoxinA. He subsequently received 100 units of daxibotulinumtoxinA in the same periorbital injection pattern with subjective faster onset, extended duration of effect, and improved symptom management compared to previous treatments. Notably, the patient experienced 50% to 75% efficacy retention at 3 months postinjection, significantly better than his response to other botulinum toxin type A products. This case suggests that daxibotulinumtoxinA may be an effective treatment for benign essential blepharospasm including patients experiencing poor symptom control with other botulinum toxin type A products.

2025-02-01·PM&R

A randomized, double‐blind, placebo‐controlled trial of DaxibotulinumtoxinA for Injection for the treatment of upper limb spasticity in adults after stroke or traumatic brain injury

Article

作者: Ayyoub, Ziyad ; Kazerooni, Rashid ; Munin, Michael C. ; Gross, Todd M. ; Francisco, Gerard E. ; Patel, Atul T.

Abstract:

Background:

Intramuscular injection of botulinum toxin type A is a first‐line pharmacotherapy for adults with upper limb spasticity (ULS). However, reemergence of symptoms within 12 weeks of treatment is common and longer‐lasting treatments are needed.

Objective:

To evaluate the efficacy and safety of three doses of DaxibotulinumtoxinA for Injection (DAXI) for treatment of ULS in adults with stroke or traumatic brain injury.

Intervention:

Intramuscular injections of placebo (N = 24), DAXI 250 U (N = 22), DAXI 375 U (N = 19), or DAXI 500 U (N = 18) to the suprahypertonic muscle (SMG) and other muscle groups.

Design:

Randomized, double‐blind, placebo‐controlled study.

Setting:

Twenty‐six study centers across the United States.

Participants:

Eighty‐three adult patients with ULS were randomly assigned to each treatment group and followed for up to 36 weeks.

Outcome Measures:

Co‐primary endpoints were the Modified Ashworth Scale (MAS) score change from baseline in the designated SMG and Physician Global Impression of Change (PGIC) at Week 6.

Results:

The mean changes from baseline in MAS score for the designated SMG for placebo and the DAXI 250 U, 375 U, and 500 U groups were −0.6, −0.9, −0.9, and −1.8, respectively, at Week 4 and −0.8, −0.9, −1.0, and −1.5, respectively, at Week 6. Statistically significant improvement in MAS score compared with placebo was reported only for the 500 U dose (Week 4: p < .001; Week 6: p = .049). Significant improvements in PGIC ratings compared with placebo were reported for DAXI 375 U (p = .015) and DAXI 500 U (p = .009) at Week 4 but not for any DAXI doses at Week 6. All DAXI doses were well tolerated with no trend toward more adverse events with increased dose.

Conclusion:

Results from this Phase 2 study indicate that DAXI 500 U is effective and well tolerated for treatment of adults with ULS.

2025-01-01·JOURNAL OF VOICE

DaxibotulinumtoxinA Treatment for Laryngeal Respiratory Dystonia

Article

作者: Rosen, Clark A ; Marshall, Camryn

BACKGROUND:

Laryngeal respiratory dystonia (LRD) is diagnosed based on clinical presentation, patient history, and physical examination. Key indicators include dyspnea, desynchronized breathing patterns, and laryngoscopic findings that reveal vocal fold adduction during inspiration. Treatment for LRD remains controversial and often yields limited effectiveness. While botulinum toxin type A (BtxA) is commonly injected into the thyroarytenoid-lateral cricothyroid (TA-LCA) muscle complex, there are cases where injections into the interarytenoid (IA) muscle have also proven beneficial. DaxibotulinumtoxinA (DAXI) is an emerging therapy that has shown promising effectiveness and safety across various conditions, including cervical dystonia. In this report, we present the first documented use of DAXI specifically for LRD, highlighting the significant benefits experienced by the patient compared to previous treatments with BtxA.

CASE:

A 77-year-old man presented with a 1-year history of significant shortness of breath. Laryngeal endoscopy demonstrated inappropriate adduction of the patient's vocal folds during respiration, suggestive of LRD. The patient received their first Botox (BtxA) injection in May 2018 and has since undergone a total of 40 injections. The patient had a variable response to BtxA injection into his TA-LCA muscle complex, experiencing general improvement in breathing but frequent negative impact on voice and swallowing function. In November of 2021, electromyography-guided BtxA injection into the patient's IA muscle was performed with significant improvement in results. The patient described near-complete resolution of his LRD breathing symptoms with minimal voice changes and a duration of benefit of ~50 days. In November of 2023, DAXI injection into the patient's IA muscle was performed. The patient self-reported a complete resolution of his symptoms for a total duration of benefit of 91 days. Subsequent injections with DAXI in February and May of 2024 had near identical responses.

CONCLUSION:

DAXI appears to provide ~80% better duration than the patient's average BtxA injection and a 57% improvement than his best BtxA injection. DAXI is a safe and realistic alternative to BtxA injection in patients with LRD.

151

项与 Daxibotulinumtoixn A-LANM 相关的新闻（医药）

2025-05-14

·investors.aeonbiopharma.com

AEON Biopharma Reports First Quarter 2025 Financial Results and Provides Corporate Update

– Continue to conduct analytical studies to prepare for a potential Biosimilar Biological Product Development (“BPD”) Type 2a meeting with the FDA in the second half of 2025 – – Pursuing a 351(k) regulatory pathway for ABP-450, which offers potential access to the U.S. market under a single approval for all of BOTOX’s currently approved and future therapeutic indications – – Appointed Rob Bancroft as the Company’s President and Chief Executive Officer; Mr. Bancroft also joined AEON’s Board of Directors – IRVINE, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, announced its financial results for the first quarter ended March 31, 2025, and provided a business update. “I am excited to report that our team is quickly advancing the biosimilar development program for ABP-450 under the 351(k) regulatory pathway utilizing BOTOX as the reference product. By utilizing this pathway, we plan to bring ABP-450 to the U.S. market under a single FDA approval that could cover all of BOTOX’s currently approved and future therapeutic indications,” commented Rob Bancroft, AEON’s President and Chief Executive Officer. “We are making progress in conducting the primary analytical studies. Once the initial analytical studies are completed, we will be able to conduct the primary comparative analytical assessment, which the FDA will evaluate at our Biosimilar BPD Type 2a meeting and determine the next steps for the program.” “Once we successfully complete the FDA's rigorous approval process for ABP-450 as a biosimilar to Botox, we believe our therapeutic neurotoxin has the potential to offer a more economically viable solution that would enhance patient access and optimize cost-efficiency for payers and healthcare providers. These changes would likely be widely welcomed by these stakeholders, given the current dynamics of the therapeutic toxin market, which is estimated to be at least $3.3 billion worldwide and predominantly controlled by a single toxin,” concluded Mr. Bancroft. Recent Clinical and Corporate Highlights Advancing its development plan for ABP-450 utilizing 351(k) regulatory pathway for biosimilars – The Company is pursuing a 351(k) biosimilar regulatory pathway for ABP-450 (prabotulinumtoxinA) injection, using BOTOX® (onabotulinumtoxinA) as a proposed reference product for all of the therapeutic indications for which BOTOX is approved. The Company believes it is aligned with the FDA on the initial key requirements to proceed with the 351(k) regulatory pathway. The Company continues to conduct the primary analytical studies to fulfill the standard regulatory requirements for a comparative analytical assessment (CAA). Extensive preclinical toxicology and other data have been previously generated by the Company’s licensing partner. The Company plans to hold a Biosimilar Biological Product Development (BPD) Type 2a meeting with FDA in the second half of 2025 to discuss the outcome from these studies and determine the next steps in development. Management Changes – The Company appointed Rob Bancroft as President and Chief Executive Officer, effective April 29, 2025. He was also appointed to the Company’s Board of Directors. Mr. Bancroft has over 25 years of leadership experience in the life sciences industry, spanning biopharmaceuticals, medical devices, and healthcare technology. Prior to joining AEON, he served as General Manager of the Therapeutics business at Revance Therapeutics, where he led the launch of Daxxify® in cervical dystonia with a novel strategy that prioritized expert endorsement, payer coverage, and reimbursement infrastructure ahead of broader investment - driving strong early adoption and differentiated positioning in the $3.3 billion botulinum toxin therapeutics market. Former CEO, Marc Forth, to remain as a member of the Company’s Board of Directors, through which he will continue to advise the Company’s management team and provide strategic guidance. Liquidity and Capital Resources – The Company reported cash and cash equivalents of $10.4 million as of March 31, 2025, which is expected to be sufficient to fund the Company’s operating plan through the fourth quarter of 2025 and its planned BPD Type 2a meeting with the FDA targeted in the second half of 2025. NYSE American Listing – AEON recently announced the NYSE American LLC (“NYSE American”) accepted the Company's previously submitted plan to regain compliance with continued listing standards relating to minimum market capitalization and stockholders' equity. The NYSE American granted the Company until August 3, 2026 to regain compliance with the continued listing standards, subject to the Company’s continued monitoring by NYSE American in the interim. The Company continues to conduct the primary analytical studies to fulfill the standard regulatory requirements for a comparative analytical assessment (CAA). Extensive preclinical toxicology and other data have been previously generated by the Company’s licensing partner. The Company plans to hold a Biosimilar Biological Product Development (BPD) Type 2a meeting with FDA in the second half of 2025 to discuss the outcome from these studies and determine the next steps in development. Former CEO, Marc Forth, to remain as a member of the Company’s Board of Directors, through which he will continue to advise the Company’s management team and provide strategic guidance. About AEON Biopharma AEON is a clinical stage biopharmaceutical company focused on developing its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection, or ABP-450, for debilitating medical conditions. ABP-450 is the same botulinum toxin complex that is currently approved and marketed for cosmetic indications by Evolus under the name Jeuveau. ABP-450 is manufactured by Daewoong in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, Health Canada and European Medicines Agency. The product is approved as a biosimilar in Mexico and India. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. The Company has built a highly experienced management team with specific experience in biopharmaceutical and botulinum toxin development and commercialization. To learn more about AEON, visit www.aeonbiopharma.com. Forward-Looking Statements Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or AEON’s future financial or operating performance. For example, statements regarding meetings with the FDA, the timing of primary comparative analytical studies, and potential determination that ABP-450 is highly similar to the reference product for currently approved and future therapeutic indications are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "plan", "possible", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by AEON and its management, are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the outcome of any legal proceedings that may be instituted against AEON or others; (ii) AEON’s future capital requirements; (iii) AEON’s ability to raise financing in the future; (iv) AEON’s ability to continue to meet continued stock exchange listing standards; (v) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; (vi) the outcomes from any meetings or discussions with regulatory authorities; and (vii) other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s filings with the Securities and Exchange Commission (the "SEC"), which are available on the SEC’s website at www.sec.gov. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. AEON does not undertake any duty to update these forward-looking statements. Contacts Investor Contact: Corey Davis, Ph.D. LifeSci Advisors +1 212 915 2577 cdavis@lifesciadvisors.com Source: AEON Biopharma The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and include the accounts of the Company and its controlled subsidiaries.

高管变更上市批准财报多肽偶联药物

2025-05-14

·ir.dermatarx.com

Dermata Therapeutics Provides Corporate Update and Reports First Quarter 2025 Financial Results

- Dermata announced positive topline results from its XYNGARI™ Phase 3 Spongilla Treatment of Acne Research (STAR-1) clinical trial, achieving all co-primary endpoints - - Dermata entered into a Clinical Trial Collaboration Agreement with Revance Therapeutics to study DMT410 with DAXXIFY® for the treatment of axillary hyperhidrosis - - Raised $8.8 million in gross proceeds from private placement and warrant inducement financings during the first quarter of 2025 - SAN DIEGO, CA / ACCESS Newswire / May 14, 2025 / Dermata Therapeutics, Inc. (NASDAQ:DRMA)(NASDAQ:DRMAW) ("Dermata," or the "Company"), a late-stage biotechnology company focused on the treatment of medical skin diseases and aesthetic applications, today highlighted recent corporate progress and reported financial results for the first quarter ended March 31, 2025. "It was an exciting quarter for our team to announce positive topline results of the XYNGARI™ Phase 3 STAR-1 trial for the treatment of acne, which achieved statistically significant results of its three co-primary endpoints at all time points," commented Gerry Proehl, Dermata's Chairman, President, and Chief Executive Officer. "Our team has spent many years working with this product and knew it had strong potential as a treatment for acne and we are happy to see that hard work has paid off with such positive results. We believe the consistent results from our previous clinical studies and this Phase 3 trial derisks the planned second Phase 3 trial and well positions XYNGARI™ to potentially be the first once-weekly, natural, topical treatment for moderate-to-severe acne, if approved. We are also excited to have partnered with Revance to study DMT410 with DAXXIFY® for the topical treatment of axillary hyperhidrosis," continued Mr. Proehl. "We see a lot of potential uses for our DMT410 program and studying it in a Phase 2 study with a long-lasting botulinum toxin, like DAXXIFY®, could provide us with the data needed to show the clinical efficacy of DMT410 aiding in the topical delivery of a botulinum toxin," concluded Mr. Proehl. Corporate Highlights Announced positive topline data from its XYNGARI™ Phase 3 STAR-1 clinical trial in moderate-to-severe acne. In March 2025, Dermata announced that its STAR-1 study met all primary endpoints by producing highly statistically significant results versus placebo at the end of study. In April 2025, Dermata also announced that XYNGARI™ achieved statistically significant separation from placebo after just 4 weeks, or only four treatments, further demonstrating its rapid onset of action. STAR-1 is the first of two Phase 3 clinical trials, the second of which will include a 9-month extension study, which the Company will need to complete prior to filing a new drug application with the U.S. Food and Drug Administration. Announced positive topline data from its XYNGARI™ Phase 3 STAR-1 clinical trial in moderate-to-severe acne. In March 2025, Dermata announced that its STAR-1 study met all primary endpoints by producing highly statistically significant results versus placebo at the end of study. In April 2025, Dermata also announced that XYNGARI™ achieved statistically significant separation from placebo after just 4 weeks, or only four treatments, further demonstrating its rapid onset of action. STAR-1 is the first of two Phase 3 clinical trials, the second of which will include a 9-month extension study, which the Company will need to complete prior to filing a new drug application with the U.S. Food and Drug Administration. Signed Clinical Trial Collaboration Agreement for DMT410 with Revance. In January 2025, Dermata entered into a Clinical Trial Collaboration Agreement with Revance, where Dermata and Revance intend to conduct a Phase 2a trial to evaluate XYNGARI™, Dermata's topical Spongilla product candidate, with DAXXIFY®, Revance's botulinum toxin product, for the topical treatment of axillary hyperhidrosis. If successful, the companies may agree to further clinical development in hyperhidrosis and potentially other indications, like acne, rosacea, and facial aesthetics. Signed Clinical Trial Collaboration Agreement for DMT410 with Revance. In January 2025, Dermata entered into a Clinical Trial Collaboration Agreement with Revance, where Dermata and Revance intend to conduct a Phase 2a trial to evaluate XYNGARI™, Dermata's topical Spongilla product candidate, with DAXXIFY®, Revance's botulinum toxin product, for the topical treatment of axillary hyperhidrosis. If successful, the companies may agree to further clinical development in hyperhidrosis and potentially other indications, like acne, rosacea, and facial aesthetics. Raised $8.8 million in gross proceeds during the first quarter 2025. The funds raised during the first quarter 2025 are expected to fund Dermata's operations into the first quarter of 2026. Raised $8.8 million in gross proceeds during the first quarter 2025. The funds raised during the first quarter 2025 are expected to fund Dermata's operations into the first quarter of 2026. Anticipated Upcoming Milestones Initiate the second XYNGARI™ Phase 3 STAR-2 clinical trial in moderate-to-severe acne. With positive results from the STAR-1 trial, Dermata has begun the manufacturing campaign for the STAR-2 trial and plans to initiate the second Phase 3 trial of XYNGARI™ for the treatment of moderate-to-severe acne by the end of 2025. The STAR-2 trial will be followed by a 9-month extension study. Dermata has commenced discussions regarding potential partnerships for the STAR-2 trial and/or commercial rights to XYNGARI™. Initiate the second XYNGARI™ Phase 3 STAR-2 clinical trial in moderate-to-severe acne. With positive results from the STAR-1 trial, Dermata has begun the manufacturing campaign for the STAR-2 trial and plans to initiate the second Phase 3 trial of XYNGARI™ for the treatment of moderate-to-severe acne by the end of 2025. The STAR-2 trial will be followed by a 9-month extension study. Dermata has commenced discussions regarding potential partnerships for the STAR-2 trial and/or commercial rights to XYNGARI™. Continue preparation of DMT410 Phase 2a clinical study with Revance. Dermata and Revance continue to collaborate on the final study design and start-up procedures to prepare for the Phase 2a clinical study of XYNGARI™ with DAXXIFY® for the topical treatment of axillary hyperhidrosis. Continue preparation of DMT410 Phase 2a clinical study with Revance. Dermata and Revance continue to collaborate on the final study design and start-up procedures to prepare for the Phase 2a clinical study of XYNGARI™ with DAXXIFY® for the topical treatment of axillary hyperhidrosis. First Quarter 2025 Financial Results As of March 31, 2025, the Company had $9.7 million in cash and cash equivalents, compared to $3.2 million as of December 31, 2024. The $6.6 million increase in cash and cash equivalents for the quarter ended March 31, 2025, resulted from approximately $8.5 million of financing proceeds offset by $1.9 million of cash used in operations. The Company expects its current cash resources to be sufficient to fund operations into the first quarter of 2026. Research and development expenses were $1.3 million for the quarter ended March 31, 2025, compared to $1.6 million for the quarter ended March 31, 2024. The decrease in research and development expenses was the result of $0.1 million of decreased clinical trial expenses from the XYNGARI™ STAR-1 acne study, which completed enrollment during the fourth quarter of 2024, and $0.2 million of decreased stock-based compensation resulting from the cancellation of out-of-the-money stock options during the first quarter of 2024. General and administrative expenses were $1.1 million for the quarter ended March 31, 2025, compared to $1.6 million for the same period in 2024. The decrease in general and administrative expenses resulted from $0.3 million of decreased stock-based compensation expenses and $0.2 million of decreased audit fees. Stock-based compensation attributable to general and administrative totaled $30K for the quarter ended March 31, 2025, compared to $0.4 million for the quarter ended March 31, 2024, which included a one-time charge for the cancellation of out-of-the-money stock options. Audit fees decreased from $0.4 million for the quarter ended March 31, 2024, to $0.2 million for the quarter ended March 31, 2025. The decrease in audit fees resulted from the Company's use of one audit firm for 2025, whereas it had used two firms in 2024 after Meyer Hoffman McCann (CBIZ) (the Company's former audit firm) stopped auditing public companies. About Dermata Therapeutics Dermata Therapeutics is a late-stage biotechnology company focusing on the treatment of medical skin diseases and aesthetic applications. The Company's lead product candidate, XYNGARI™, recently achieved positive data in its first Phase 3 clinical trial and is the Company's first product candidate being developed from its Spongilla technology platform. XYNGARI™ is a once-weekly, topical product candidate derived from a naturally sourced freshwater sponge with multiple unique mechanisms of action. In addition to acne, XYNGARI™ has been studied for the treatment of psoriasis and rosacea. The Company's second product candidate, DMT410, uses its XYNGARI™ product candidate as a new method for needle-free intradermal delivery of botulinum toxin for the treatment of multiple aesthetic applications and medical skin diseases like hyperhidrosis, acne, and rosacea. Dermata is headquartered in San Diego, California. For more information, please visit http://www.dermatarx.com/. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are based on the Company's current beliefs and expectations and new risks may emerge from time to time. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions, and other factors including, but are not limited to, statements related to: expectations with regard to the timing of meetings and/or responses from submissions with regulatory bodies; expectations with regard to the timing of submission of an NDA; the uncertainties inherent in clinical trials including enrolling an adequate number of patients on time or to be completed on schedule, if at all; timing and ability to generate clinical data; expectations with regard to the nature of any clinical data; expectations with regard to any potential partnership opportunities for any of the Company's product candidates; the Company's expectations with regard to current cash and cash equivalents and the amount of time they will fund operations; the success, cost, and timing of its product candidates XYNGARI™ and DMT410 development activities and ongoing and planned clinical trials; and whether the results of any ongoing or planned clinical trials of XYNGARI™ or DMT410 will lead to future product development. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval, and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to Dermata's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Dermata undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law. DERMATA THERAPEUTICS, INC. Balance Sheets March 31, 2025 December 31, 2024 (unaudited) $ 9,719 $ 3,162 286 372 10,005 3,534 1,395 808 1,308 1,165 2,703 1,973 7,302 1,561 $ 10,005 $ 3,534 DERMATA THERAPEUTICS, INC. Statements of Operations (unaudited) Quarter Ended March 31, 2025 2024 $ 1,281 $ 1,600 1,058 1,603 2,339 3,203 (2,339 ) (3,203 ) 36 69 $ (2,303 ) $ (3,134 ) $ (0.45 ) $ (7.06 ) 5,154,698 443,998 $ 8 $ 237 $ 29 $ 350 Investors: Cliff Mastricola Investor Relations cmastricola@dermatarx.com SOURCE: Dermata Therapeutics Released May 14, 2025

临床3期临床2期财报临床结果

2025-04-20

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头部药企研发投入公布！百济、恒瑞、复星、百利天恒…

编者按：本文来自药智网，作者白夜行；赛柏蓝授权转载，编辑yuki同花顺财经数据显示，2024年A股上市药企研发投入TOP10总计投入达387.73亿元，相比2023年的356.64亿元，同比增长9%。从榜单来看，TOP3企业的研发投入均超过50亿元，第一名高达143亿元。值得一提的是，2024年A股上市药企研发投入TOP10中，有5家企业实现研发投入同比正增长（4家增长超10%），其中百利天恒增长率最高（93%），从2023年约7亿元增长至2024年14亿元。表1 2024年A股上市药企研发投入TOP1001百济神州遥遥领先百济神州以19.53亿美元（约合人民币143亿元）的研发投入，成为2024年A股上市药企研发投入第一名，再次彰显了其在创新药研发领域的雄心与实力。2024年，百济神州共完成了将13个新分子实体推进临床开发阶段。预计在2025年，将于2025年上半年对BGB-43395（CDK4抑制剂）、BG-68501（CDK2抑制剂）和BG-C9074（B7H4 ADC）进行数据读出；预计将于2025年下半年取得多个项目的内部概念验证数据，包括：BG-60366（EGFR CDAC）、BGB-53038（泛KRAS抑制剂）等。图1 百济神州全球自主研发和合作管线在重点瘤种的深度布局上，百济神州展现了其在血液瘤和实体瘤领域的强大竞争力。泽布替尼2024年销售额达到26亿美元，同比大增105%，并获得多个新适应症批准；替雷利珠单抗2024全年销售额为6.21亿美元，同比增长16%。百济神州的国际化优势是其研发管线得以快速推进的重要保障，2024年，其海外收入占比超过60%。通过与诺华等国际药企的合作，百济神州不仅共享了资源和技术，还进一步拓展了市场渠道。这种全球化布局不仅提升了其研发效率，也为其产品进入欧美等高价值市场提供了保障。值得一提的是，2024年百济神州实现营收38亿美元，同比增长55%，净亏损持续收窄。尽管短期内仍面临盈利压力，但随着研发管线的逐步推进和明星产品的持续放量，百济神州有望在2025年实现经营利润为正。02恒瑞医药再创新高2024年，恒瑞医药以82.28亿元的研发投入，创下其历史新高。图2 恒瑞医药2015年—2024年研发投入（点击查看大图）这一年，恒瑞医药的研发管线布局呈现出多点开花、全面发力的态势，从肿瘤到代谢疾病，从免疫到呼吸系统疾病，恒瑞医药在多个领域都取得了显著的进展。2024年至今，恒瑞医药共获得了9项创新药的上市批准，其中包括4款1类创新药，如富马酸泰吉利定、夫那奇珠单抗等。在持续加大自主创新力度的同时，恒瑞医药也积极开展国际合作，通过BD授权交易等方式，将自主研发的创新药推向国际市场。2024年，恒瑞医药实现了多笔创新药海外授权合作，其中包括将GLP-1类创新药许可给美国Kailera公司，首付款加里程碑付款累计可高达60亿美元。在研管线方面，恒瑞医药涵盖了肿瘤、代谢及心血管疾病、免疫和呼吸系统疾病等多个治疗领域。截至2024年底，恒瑞医药共有18项上市申请获NMPA受理，90多个自主创新产品正在临床开发，约400项临床试验在国内外开展。未来三年，恒瑞医药预计有47项创新成果获批上市，其中包括HER2 ADC、GLP-1药物等重磅产品。临床试验方面也取得了显著的进展。2024年，恒瑞共取得创新药临床批件112个，24项临床推进至Ⅲ期，27项进入Ⅱ期，26项启动Ⅰ期临床试验。此外，恒瑞医药的多项临床试验获得了国家药监局的突破性治疗品种认定，以及美国FDA快速通道资格和EMA孤儿药认证。03复星医药重金押注2024年，复星医药以55.54亿元的研发投入，成为2024年A股上市药企研发投入第三名。其中，制药业务研发投入49.1亿元，占制药业务收入的16.98%。2024年，复星医药自主研发及许可引进的7个创新药/生物类似药共16项适应症获批上市，8个创新药/生物类似药进入上市前审批/关键临床阶段，共有18项创新药/生物类似药项目（按适应症计算）获批开展临床试验。图3 2024年复星医药研发投入情况在乳腺癌、胃癌等高发癌症领域，复星医药自主研发的单抗生物类似药汉曲优（注射用曲妥珠单抗）已成功在中国、欧盟、美国等50个国家和地区获批上市，并进入中国、英国等多个国家的医保目录。在非肿瘤领域，复星医药自主研发的冻干人用狂犬病疫苗（Vero细胞）、汉达远（阿达木单抗注射液）4项新增适应症以及许可引进普瑞尼（普托马尼片）、苏可欣（马来酸阿伐曲泊帕片）第二项适应症于中国境内获批。持续加大自主创新力度的同时，复星医药积极开展国际合作，通过BD授权交易等方式，将自主研发的创新药推向国际市场。2024年，复星医药实现了多笔创新药海外授权合作，其中包括将DAXXIFY（达希斐）引入中国市场，填补管线空白等。END内容沟通：郑瑶（13810174402）

抗体药物偶联物医药出海财报上市批准引进/卖出

100 项与 Daxibotulinumtoixn A-LANM 相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
肌张力障碍	中国	上海复星医药产业发展有限公司	2024-11-22
颈肌张力障碍	美国	Revance Therapeutics, Inc.	2023-08-11
眉间纹	美国	Revance Therapeutics, Inc.	2022-09-07

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
斜颈	申请上市	美国	Revance Therapeutics, Inc.	2022-10-20
孤立性颈部肌张力障碍	临床3期	美国	Revance Therapeutics, Inc.	2018-06-20
孤立性颈部肌张力障碍	临床3期	奥地利	Revance Therapeutics, Inc.	2018-06-20
孤立性颈部肌张力障碍	临床3期	加拿大	Revance Therapeutics, Inc.	2018-06-20
孤立性颈部肌张力障碍	临床3期	捷克	Revance Therapeutics, Inc.	2018-06-20
孤立性颈部肌张力障碍	临床3期	法国	Revance Therapeutics, Inc.	2018-06-20
孤立性颈部肌张力障碍	临床3期	德国	Revance Therapeutics, Inc.	2018-06-20
孤立性颈部肌张力障碍	临床3期	波兰	Revance Therapeutics, Inc.	2018-06-20
孤立性颈部肌张力障碍	临床3期	西班牙	Revance Therapeutics, Inc.	2018-06-20
孤立性颈部肌张力障碍	临床3期	英国	Revance Therapeutics, Inc.	2018-06-20

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


AAN2024	N/A	颈肌张力障碍	-	DaxibotulinumtoxinA for injection (DAXI) 250U	鏇鬱醖廠夢遞獵壓鑰鏇(齋製範積艱鹽蓋鹽醖願) = 艱襯築願顧廠憲積繭艱範鑰觸艱繭衊衊鑰膚遞 (憲繭淵網製衊網製築積 )	-	2024-04-09
AAN2024	N/A	颈肌张力障碍	-	DaxibotulinumtoxinA	範簾積餘艱鹽餘艱鏇鑰(鏇構鑰餘願廠範襯鹽觸) = 鏇範夢齋遞觸鏇衊構鬱鹹壓鏇積齋簾願鹹醖網 (襯範願範鹽膚構範窪淵 ) 更多	-	2024-04-09
NCT02973269 (CTgov)	临床2期	足底筋膜炎	7	daxibotulinumtoxin type A (DAXI 240 U)	廠願齋簾繭夢築夢淵鹹(繭鹽鏇鬱鑰構醖顧膚蓋) = 願襯鬱簾壓夢網鑰願繭壓選製襯簾鏇鏇鑰齋鏇 (窪餘顧窪鹹願淵蓋獵衊, 11.0) 更多	-	2024-04-03
				Placebo (Placebo)	廠願齋簾繭夢築夢淵鹹(繭鹽鏇鬱鑰構醖顧膚蓋) = 壓醖觸襯觸鏇蓋艱選顧壓選製襯簾鏇鏇鑰齋鏇 (窪餘顧窪鹹願淵蓋獵衊, 12.1) 更多
NCT03608397 \| EUCTR2018-000446-19-AT (ASPEN-1, Pubmed \| Neurology) 人工标引	临床3期	颈肌张力障碍	301	DAXI125U	鹹壓鏇繭鹽獵廠鬱鏇窪(願淵鬱構網鹽獵選鬱憲) = 願鏇顧蓋齋鏇築齋壓壓夢膚觸構製衊蓋襯膚範 (廠願餘餘餘顧壓範壓遞, 1.30) 更多	积极	2024-01-31
				DAXI250U	鹹壓鏇繭鹽獵廠鬱鏇窪(願淵鬱構網鹽獵選鬱憲) = 鹹願鹹選鹹鬱獵繭餘選夢膚觸構製衊蓋襯膚範 (廠願餘餘餘顧壓範壓遞, 1.25) 更多
NCT03825315 (CTgov)	临床2期	足底筋膜炎	155	DAXI 80 U (DAXI 80 U)	簾願壓膚膚鑰構築衊窪(觸繭獵襯鏇蓋夢窪積醖) = 蓋築鏇製壓窪膚願憲選鏇窪選繭積網簾憲選鑰 (鹹遞窪積繭選窪襯醖膚, 0.329) 更多	-	2023-09-21
				DAXI 120 U (DAXI 120 U)	簾願壓膚膚鑰構築衊窪(觸繭獵襯鏇蓋夢窪積醖) = 艱窪糧淵獵製齋餘獵選鏇窪選繭積網簾憲選鑰 (鹹遞窪積繭選窪襯醖膚, 0.298) 更多
GL-2 (FDA) 人工标引	N/A	眉间纹	609	DAXXIFY (STUDY GL-1)	觸糧獵淵網鹹範鹹鬱蓋(廠餘鬱衊窪簾膚衊鹽艱) = 衊淵鹹醖選繭製艱憲選構製窪選鹽艱範壓鑰構 (壓繭憲顧鹽築餘廠窪遞 ) 更多	积极	2023-08-11
				Placebo (STUDY GL-1)	觸糧獵淵網鹹範鹹鬱蓋(廠餘鬱衊窪簾膚衊鹽艱) = 醖餘範觸齋鏇糧遞壓鹹構製窪選鹽艱範壓鑰構 (壓繭憲顧鹽築餘廠窪遞 ) 更多
NCT03608397 (FDA) 人工标引	临床3期	颈肌张力障碍	301	Placebo	鹽膚夢鹹鹹廠簾遞窪醖(製鏇選襯願構鏇繭壓願) = 窪鏇構壓觸壓構鏇鏇蓋廠糧繭顧餘窪鹹衊壓範 (襯膚醖醖憲齋遞醖淵淵 )	积极	2023-08-11
				DAXI 125 U	鹽膚夢鹹鹹廠簾遞窪醖(製鏇選襯願構鏇繭壓願) = 網醖鏇範鑰鑰淵齋選積廠糧繭顧餘窪鹹衊壓範 (襯膚醖醖憲齋遞醖淵淵 )
NCT04259086 (CTgov)	临床2期	眉间纹	48	DaxibotulinumtoxinA for injection	繭糧遞餘願獵鏇鏇積醖 = 願製構製壓鑰繭醖鏇積衊糧齋繭築獵構糧淵構 (鏇製鑰鹽窪積醖選鏇襯, 襯艱繭餘網網遞簾壓齋 ~ 鑰繭鬱壓窪艱築膚積鹽) 更多	-	2023-06-27
NCT03911102 (CTgov)	临床2期	外眦皱纹	63	DaxibotulinumtoxinA for injection (Cohort 1: DAXI 12 U)	構顧簾膚觸窪壓蓋鏇築 = 窪選簾夢選餘窪願窪壓膚繭簾鏇觸範鹹襯窪鹹 (襯鑰廠艱餘憲淵憲鑰蓋, 積顧衊獵壓鬱鑰選壓鹹 ~ 醖選獵構鑰願鏇衊蓋夢) 更多	-	2023-06-27
				DaxibotulinumtoxinA for injection (Cohort 2: DAXI 24 U)	構顧簾膚觸窪壓蓋鏇築 = 鏇鏇艱鏇鏇窪願襯網積膚繭簾鏇觸範鹹襯窪鹹 (襯鑰廠艱餘憲淵憲鑰蓋, 壓醖遞鑰選製餘選壓壓 ~ 構網鹹齋窪蓋襯艱鬱選) 更多
ASPEN-1 and ASPEN-OLS (AAN2023)	临床3期	颈肌张力障碍	-	Placebo	餘鹽襯願夢艱繭艱襯製(遞蓋膚衊鬱鑰獵壓築觸) = 餘齋構繭遞衊鑰觸構淵鑰醖憲齋糧繭選簾夢醖 (製鑰憲網齋壓願艱蓋鏇 )	积极	2023-04-25
				DAXI 125U	餘鹽襯願夢艱繭艱襯製(遞蓋膚衊鬱鑰獵壓築觸) = 夢窪網襯壓憲鹽繭蓋襯鑰醖憲齋糧繭選簾夢醖 (製鑰憲網齋壓願艱蓋鏇 )