Vertex Provides Updates on Multiple Kidney Programs at the American Society of Nephrology (ASN) Annual Kidney Week Congress

Vertex Provides Updates on Multiple Kidney Programs at the American Society of Nephrology (ASN) Annual Kidney Week Congress




Vertex Provides Updates on Multiple Kidney Programs at the American Society of Nephrology (ASN) Annual Kidney Week Congress

New data on povetacicept 80 mg SC Q4 weeks in IgA nephropathy shows mean UPCR reduction from baseline of 66% observed at 48 weeks, associated with stable renal function (eGFR) and 63% achieving clinical remission —

– First proteinuria data on povetacicept in primary membranous nephropathy shows mean UPCR reduction from baseline of 62% at 24 weeks –

– Global Phase 3 RAINIER trial of povetacicept in IgA nephropathy now underway –

– Enrollment and dosing ongoing in Phase 3 portion of the global Phase 2/3 pivotal clinical trial of inaxaplin for the treatment of APOL1-mediated kidney disease –

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today provided updates on multiple kidney diseases in its pipeline including IgA nephropathy (IgAN), primary membranous nephropathy (pMN), and APOL1-mediated kidney disease (AMKD). These updates demonstrate the transformative potential of Vertex’s investigational therapies in multiple serious kidney diseases, and include positive new data on povetacicept, a dual inhibitor of the BAFF and APRIL pathways, in IgAN and pMN, presented at the American Society of Nephrology’s (ASN) Kidney Week Congress on October 23-27 in San Diego, California.


“We are very pleased with the broadening of our innovative pipeline in renal medicine which now spans programs in AMKD, IgAN, pMN and polycystic kidney disease,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. “The new data in IgAN and pMN we shared at this year’s ASN congress continue to reinforce povetacicept as a potential best-in-class therapy and demonstrate its potential as a pipeline-in-a-product. We also continue to make progress in AMKD and autosomal dominant polycystic kidney disease (ADPKD) where we are advancing the first potential treatments to address the underlying cause of these diseases.”

Povetacicept in IgAN

Vertex presented data on 54 patients with IgAN who received povetacicept 80 mg or 240 mg subcutaneously every 4 weeks (SC Q4W). Treatment with povetacicept 80 mg SC Q4W demonstrated a clinically meaningful decrease in proteinuria, with a mean 66% reduction from baseline in urine protein to creatinine ratio at 48 weeks (UPCR; n=8) associated with stable renal function over 48 weeks as assessed by estimated glomerular filtration rate (eGFR). By 48 weeks, 63% (5 out of 8) of study participants achieved clinical remission, defined as UPCR <0.5 g/g, negative hematuria and stable renal function (<25% reduction in eGFR from baseline).

Treatment with povetacicept 240 mg SC Q4W was associated with similar improvements in proteinuria along with stable renal function.

Both doses have been well tolerated in patients with IgAN. The majority of adverse events (AEs) were mild or moderate in severity, and there were no serious adverse events (SAEs) related to povetacicept.

Vertex has now initiated RAINIER, a global Phase 3 clinical trial of povetacicept 80 mg in IgAN.

A poster presentation #FR-PO854 entitled “Results from Longer Follow-Up with Povetacicept, an Enhanced Dual BAFF/APRIL Antagonist, in IgA Nephropathy (RUBY-3 Study)” was presented during the poster session on October 25 from 10:00 a.m. to 12:00 p.m. PDT.

Povetacicept in pMN

Vertex also presented emerging data in patients with pMN who received povetacicept 80 mg SC Q4W, with three patients having completed at least 24 weeks of treatment. Treatment with povetacicept demonstrated a mean 62% reduction from baseline in UPCR at 24 weeks, associated with stable renal function. By week 24, 67% (2 out of 3) study participants had achieved partial clinical remission, defined as UPCR <3.5 g/g and >50% reduction in UPCR from baseline. Anti-PLA2R1 autoantibodies, which are a marker of disease activity and associated with clinical outcomes, decreased from baseline by a mean of 87% at week 20.

Povetacicept was well tolerated in patients with pMN, with AEs that were mild or moderate in severity. There were no SAEs related to povetacicept.

A poster presentation #TH-PO589 entitled “Updated Results with Povetacicept, an Enhanced Dual BAFF/APRIL Antagonist, in Primary Membranous Nephropathy (RUBY-3 Study)” was presented during the poster session on October 24 from 10:00 a.m. to 12:00 p.m. PDT.

AMKD

Vertex is developing inaxaplin, a potential first-in-class, investigational, oral small molecule inhibitor of APOL1, with the goal of targeting the underlying cause of AMKD. Enrollment and dosing are ongoing in the Phase 3 portion of the global Phase 2/3 pivotal AMPLITUDE clinical trial of inaxaplin.

Vertex has the following AMKD poster presentations at ASN:

  • Poster presentation #TH-P01203 entitled “AMPLITUDE: A Phase 2/3 Adaptive Trial of Inaxaplin in APOL1-mediated Kidney Disease” was presented during the poster session on October 24 from 10:00 a.m. to 12:00 p.m. PDT.
  • Poster presentation #SA-PO701 entitled “Small Molecule APOL1 Channel Inhibitor Reduces Proteinuria, Rescues Podocyte Injury, and Reverses eGFR Decline in an APOL1-Mediated Kidney Disease Mouse Model” will be presented during the poster session on October 26 from 10:00 a.m. to 12:00 p.m. PDT.
  • Poster presentation #SA-PO700 entitled “Small Molecule Inhibition of APOL1 Channel Activity Protects Podocytes from Mitochondrial Dysfunction, Cell Death and Barrier Disruption Induced by APOL1 Risk Variants” will be presented during the poster session on October 26 from 10:00 a.m. to 12:00 p.m. PDT.

All accepted abstracts are available online on the ASN website.

About IgA Nephropathy (IgAN)

IgAN is a serious, progressive, life-threatening, B cell-mediated chronic kidney disease that is the most common cause of primary (idiopathic) glomerulonephritis, affecting people worldwide including approximately 130,000 people in the U.S. IgAN results from deposition of circulating immune complexes consisting of immunoglobulins and galactose-deficient immunoglobulin A (Gd-IgA1) in the renal glomerular mesangium, triggering kidney injury and fibrosis. A high percentage of people with IgAN progress to end-stage renal disease. There are no approved therapies that specifically target the underlying cause of IgAN.

About RAINIER

RAINIER is a global Phase 3 pivotal trial of povetacicept 80 mg vs. placebo on top of standard of care in approximately 480 people with IgAN. The study is designed to have a pre-planned interim analysis evaluating UPCR for the povetacicept arm versus placebo after a certain number of patients reach 36 weeks of treatment. If positive, the interim analysis may serve as the basis for Vertex to seek accelerated approval in the U.S. Final analysis will occur at two years of treatment, with a primary endpoint of total eGFR slope through Week 104.

About Primary Membranous Nephropathy (pMN)

Primary membranous nephropathy is a serious, progressive, life-threatening B cell-mediated chronic kidney disease affecting people worldwide, with approximately 60,000 people diagnosed in the U.S. pMN causes a patient’s immune system to damage the glomeruli and may cause progressive loss of kidney function. There are no approved therapies that specifically target the underlying cause of pMN.

About RUBY-3

RUBY-3 is an ongoing, multiple ascending dose, multi-cohort, open label, Phase 1/2 basket study of povetacicept in autoimmune glomerulonephritis, including IgAN, pMN, lupus nephritis and ANCA-associated vasculitis with glomerulonephritis where povetacicept is being administered subcutaneously for up to 104 weeks.

About Povetacicept

Povetacicept is a dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, which play key roles in pathogenesis of multiple autoimmune diseases via their roles in the activation, differentiation and/or survival of B cells, T cells and innate immune cells. Based upon an engineered TACI (transmembrane activator and CAML interactor) domain, povetacicept has higher binding affinity and greater potency in preclinical studies versus other inhibitors of BAFF and/or APRIL alone and has demonstrated potential best-in-class efficacy in a clinical trial in patients with IgA nephropathy and primary membranous nephropathy. Povetacicept is also in development for multiple serious diseases including other autoimmune kidney diseases and autoimmune cytopenias.

About APOL1-Mediated Kidney Disease (AMKD)

AMKD is a genetic kidney disease affecting approximately 100,000 people in the U.S. and Europe. AMKD is caused by two variants of the APOL1 gene, which exert a toxic effect on kidney cells, leading to cell injury, cell death and damage to glomeruli (which filter blood to the kidney). Even after treatment with currently available therapies, people with AMKD often progress to kidney failure. Kidney failure is treated with frequent, long-term dialysis or a kidney transplant. Both require lifelong treatment and follow-up and carry a high mortality risk. There are currently no approved treatments that address the underlying cause of AMKD.

About Inaxaplin

Inaxaplin is a potential first-in-class, investigational small molecule inhibitor of APOL1, and the first investigational therapy aimed at treating the underlying cause of AMKD.

About AMPLITUDE

AMPLITUDE is a global Phase 2/3 pivotal trial of inaxaplin for the treatment of AMKD, in which a 45 mg once daily oral dose is compared to placebo, on top of standard of care. The study is designed to have a pre-planned interim analysis at Week 48 evaluating estimated glomerular filtration rate (eGFR) slope, a measure of kidney function, supported by a percent change from baseline in proteinuria, in the inaxaplin arm versus placebo. If positive, the interim analysis may serve as the basis for Vertex to seek accelerated approval in the U.S. Enrollment and dosing are ongoing in the Phase 3 portion of the study.

About Autosomal Dominant Polycystic Kidney Disease (ADPKD)

ADPKD is the most common inherited kidney disease and one of the most common severe Mendelian genetic diseases, affecting approximately 250,000 diagnosed people in the U.S. and Europe. As an autosomal dominant disease, one affected parent can pass on the disease to their children.

In most cases, ADPKD is caused by variants in the PKD1 and PKD2 genes, which express proteins known as polycystins. The majority of ADPKD patients (~80%) have a variant in the PKD1 gene, resulting in a loss of function of polycystin 1 (PC1). This leads to the proliferation of kidney epithelial cells, increased fluid secretion and the formation and expansion of numerous fluid-filled cysts. The progressive cyst formation causes an increase in kidney size and decline in kidney function. Around half of patients with ADPKD experience kidney failure by the age of 60. Kidney cysts can also lead to severe abdominal pain, cyst infection, blood in the urine and kidney stones, all of which significantly impair quality of life.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1.

Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry’s top places to work, including 15 consecutive years on Science magazine’s Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex’s history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube and X.

Vertex Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, the statements by Carmen Bozic, M.D., in this press release, and statements regarding Vertex’s expectations and plans for the global Phase 3 RAINIER study of povetacicept, including the potential for an interim analysis to serve as the basis to seek accelerated approval in the U.S., and expectations and plans for the Phase 3 portion of the clinical trial of inaxaplin, including the potential for an interim analysis to serve as the basis to seek accelerated approval in the U.S. While we believe the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company’s beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company’s development programs may not support registration or further development of its compounds due to safety, efficacy, and other reasons, and other risks listed under the heading “Risk Factors” in Vertex’s most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission at www.sec.gov and available through the company’s website at www.vrtx.com. You should not place undue reliance on these statements, or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

Contacts

Vertex Pharmaceuticals Incorporated
Investors:
InvestorInfo@vrtx.com

Media:
mediainfo@vrtx.com

or

International: +44 20 3204 5275

or

U.S.: 617-341-6992

or

Heather Nichols: +1 617-839-3607

3D Bioprinting Market Industry Trends and Global Forecasts, 2019, 2024 and 2035 Featuring Key Players – 3D Systems, Cellink, CollPlant, Organovo, Rokit Healthcare, Stratasys, UPM Biomedicals – ResearchAndMarkets.com

3D Bioprinting Market Industry Trends and Global Forecasts, 2019, 2024 and 2035 Featuring Key Players – 3D Systems, Cellink, CollPlant, Organovo, Rokit Healthcare, Stratasys, UPM Biomedicals – ResearchAndMarkets.com




3D Bioprinting Market Industry Trends and Global Forecasts, 2019, 2024 and 2035 Featuring Key Players – 3D Systems, Cellink, CollPlant, Organovo, Rokit Healthcare, Stratasys, UPM Biomedicals – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “3D Bioprinting Market Industry Trends and Global Forecasts to 2035: Distribution by Type of Component, Type of Consumable, Type of Technology, Type of Material Used, Application Area, End User, Geographical Regions and Key Players” report has been added to ResearchAndMarkets.com’s offering.


The 3D Bioprinting Market is valued at USD 4 billion in 2024 growing at a CAGR of 17.2% during the forecast period 2024-2035.

3D bioprinting is the process of combining living cells, growth factors, bioinks and biomaterials using 3D printing techniques to develop three-dimensional functional biological structures that closely mimic natural tissues.

This report offers a comprehensive overview of the 3D bioprinting industry, highlighting key technologies, historical milestones, and potential future trends. It explores the advantages and various application areas of 3D bioprinting, while discussing factors influencing market growth, including key drivers, restraints, emerging opportunities, and challenges.

The report provides a detailed market forecast, estimating the current market size and projecting future opportunities within the 3D bioprinting sector through 2035. This forecast is based on adoption trends and primary data validation. It also assesses the distribution of current and forecasted opportunities in the industry from 2024 to 2035.

It is worth noting that 103,223 individuals are currently waiting for compatible organs in the US, alone. Moreover, close to 20 deaths per day are caused due to the unavailability of compatible organs. Nevertheless, 3D bioprinting technology has the potential to address the increasing organ demand and revolutionize various application areas like tissue engineering, regenerative medicine, drug testing and personalized medicine.

Presently, in the realm of conventional 2D bioprinting approaches, there are several challenges that are faced by researchers and scientists; notably, some of the significant challenges encountered are achieving high-resolution printing to accurately recreate intricate biological structures, slow printing speed, poor surface quality, real-time monitoring of the printing processes and maintenance of cell viability. These challenges have further contributed to the intricacy of the 2D bioprinting processes and have necessitated the need for advanced printing technologies, such as 3D bioprinting to augment various treatment approaches.

Additionally, the report features detailed profiles of key companies involved in 3D bioprinting, including information on their establishment, headquarters, employee size, leadership team, financial data, product portfolios, and recent developments. An in-depth examination of the 3D bioprinting value chain is provided, covering stages such as facility setup, raw material sourcing, R&D, design, bioprinting, post-processing, quality control, and applications. This analysis highlights areas for potential improvement in industry operations.

3D bioprinting actively explores avenues that enable researchers and scientists to overcome existing challenges in the 2D bioprinting domain by providing a solution for organ shortages and enabling the development of organs and tissues, which are patient-specific and derived from patient’s own stem cells, thereby reducing the risk of rejection.

Additionally, 3D bioprinting helps in the development of viable complex structures and tissues that are difficult to produce using traditional methods. 3D bioprinting has the potential to transform healthcare by offering personalized treatments, accelerating drug development, and advancing regenerative medicine. Such developments and advancements, further supported by the increasing investment activity in this domain are likely to drive the 3D bioprinting market growth over the forecast period.

Lastly, the report explores strategies shaping the 3D bioprinting industry, including the integration of personalized medicine, AI, digitization, and innovations in biomaterials. It also discusses the influence of partnerships, collaborations, social media strategies, and evolving regulatory frameworks on the industry’s development.

Megatrends in the 3D Bioprinting Market

  • Adoption of 3D Bioprinting Technologies
  • Personalized Medicine with Artificial Intelligence
  • Digitization and E-commerce
  • Innovation in Biomaterials and Cell Research
  • Inclusion of Innovative Bioprinting Solutions
  • Remarkable Partnerships and Collaborations
  • Promoting Brands on Social Media
  • The Evolving Regulatory Guidelines

Leading Market Companies in the 3D Bioprinting Industry are

  • Advanced Solutions Life Sciences
  • Allevi
  • Aspect Biosystems
  • Cellink
  • CollPlant Biotechnologies
  • Cyfuse Biomedical K.K.
  • Foldink
  • Formlabs
  • Inventia Life Science
  • it3d Group
  • Medprin Biotech
  • Organovo
  • Pandorum Technologies
  • Precise Bio
  • Regemat 3D
  • REGENHU
  • Rokit Healthcare
  • Stratasys
  • Vivax Bio

Key Topics Covered:

1. BACKGROUND

1.1. Context

1.2. Project Objectives

2. RESEARCH METHODOLOGY

3. MARKET DYNAMICS

4. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS

5. EXECUTIVE SUMMARY

6. INTRODUCTION

6.1. Overview of 3D Bioprinting

6.2. Key Bioprinting Technologies

6.3. Historical Milestones in 3D Bioprinting

6.4. Overview of 3D Bioprinting Process

6.5. Advantages of 3D Bioprinting

6.6. Application Areas of 3D Bioprinting

6.7. Future Perspectives

7. MARKET IMPACT ANALYSIS: DRIVERS, RESTRAINTS, OPPORTUNITIES AND CHALLENGES

7.1. Market Drivers

7.2. Market Restraints

7.3. Market Opportunities

7.4. Market Challenges

8. GLOBAL 3D BIOPRINTING MARKET

8.1. Key Assumptions and Methodology

8.2. Global 3D Bioprinting Market, till 2035

8.3. Key Market Segmentations

9. 3D BIOPRINTING MARKET, BY TYPE OF COMPONENT

9.1. Key Assumptions and Methodology

9.2. 3D Bioprinting Market: Distribution by Type of Component, 2019, 2024 and 2035

9.3. Data Triangulation and Validation

10. 3D BIOPRINTING CONSUMABLES MARKET, BY TYPE OF CONSUMABLE

10.1. Key Assumptions and Methodology

10.2. 3D Bioprinting Consumables Market: Distribution by Type of Consumable, 2019, 2024 and 2035

10.3. Data Triangulation and Validation

11. 3D BIOPRINTING BIOPRINTERS MARKET, BY TYPE OF TECHNOLOGY

11.1. Key Assumptions and Methodology

11.2. 3D Bioprinting Bioprinters Market: Distribution by Type of Technology, 2019, 2024 and 2035

11.3. Data Triangulation and Validation

12. 3D BIOPRINTING MARKET, BY TYPE OF MATERIAL USED

12.1. Key Assumptions and Methodology

12.2. 3D Bioprinting Market: Distribution by Type of Material Used, 2019, 2024 and 2035

12.3. Data Triangulation and Validation

13. 3D BIOPRINTING MARKET, BY APPLICATION AREA

13.1. Key Assumptions and Methodology

13.2. 3D Bioprinting Market: Distribution by Application Area, 2019, 2024 and 2035

13.3. Data Triangulation and Validation

14. 3D BIOPRINTING MARKET, BY END-USER

14.1. Key Assumptions and Methodology

14.2. 3D Bioprinting Market: Distribution by End-user, 2019, 2024 and 2035

14.3. Data Triangulation and Validation

15. 3D BIOPRINTING MARKET, BY GEOGRAPHICAL REGIONS

15.1. Key Assumptions and Methodology

15.2. 3D Bioprinting Market: Distribution by Geographical Regions, 2019, 2024 and 2035

16. 3D BIOPRINTING MARKET, BY KEY PLAYERS

16.1. 3D Systems

16.2. Cellink

16.3. CollPlant Biotechnologies

16.4. Organovo

16.5. Rokit Healthcare

16.6. Stratasys

16.7. UPM Biomedicals

17. MARKET LANDSCAPE: 3D BIOPRINTING SOLUTION PROVIDERS

17.1 Chapter Overview

17.2. 3D Bioprinting Solution Providers: Developer Landscape

17.3. Leading 3D Bioprinting Solution Providers: Market Landscape

18. COMPANY PROFILES: LEADING 3D BIOPRINTING SOLUTION PROVIDERS IN NORTH AMERICA

18.1. Chapter Overview

18.2. Leading 3D Bioprinting Solution Providers in North America

18.2.1. Advanced Solutions Life Sciences

18.2.2. Allevi

18.2.3. Aspect Biosystems

18.2.4. Formlabs

18.2.5. Organovo

18.2.6. Stratasys

18.3. Other Leading 3D Bioprinting Solution Providers Headquartered in North America

18.3.1. Foldink

18.3.2. Precise Bio

18.3.3. Vivax Bio

19. LEADING 3D BIOPRINTING SOLUTION PROVIDERS IN EUROPE

19.1. Chapter Overview

19.2. Leading 3D Bioprinting Solution Providers in Europe

19.2.1. CELLINK

19.2.2. Regemat 3D

19.3. Other Leading 3D Bioprinting Solution Providers Headquartered in Europe

19.3.1. IT3D

19.3.2. Medprin Biotech

19.3.3. REGENHU

20. LEADING 3D BIOPRINTING SOLUTION PROVIDERS IN ASIA-PACIFIC AND REST OF THE WORLD

20.1. Chapter Overview

20.2. Leading 3D Bioprinting Solution Providers in Asia-Pacific and Rest of the World

20.2.1. CollPlant Biotechnologies

20.2.2. Pandora Technologies

20.3. Other Leading 3D Bioprinting Solution Providers Headquartered in Asia-Pacific and Rest of the World

20.3.1. Cyfuse Biomedical

20.3.2. Inventia Life Science

20.3.3. Rokit Healthcare

21. WHITE SPACE ANALYSIS: 3D BIOPRINTING MARKET

21.1. Chapter Overview and Methodology

21.2. White Spaces

22. VALUE CHAIN ANALYSIS: 3D BIOPRINTING MARKET

22.1. Brief Overview on 3D Bioprinting Process and Stakeholders Involved

22.2. Schematic Representation of 3D Bioprinting from Design to Large Scale Production

For more information about this report visit https://www.researchandmarkets.com/r/su1onc

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enGene Announces $60 Million Private Placement Financing

enGene Announces $60 Million Private Placement Financing




enGene Announces $60 Million Private Placement Financing

BOSTON & MONTREAL–(BUSINESS WIRE)–enGene Holdings Inc. (Nasdaq: ENGN or “enGene” or the “Company”), a clinical-stage genetic medicines company whose non-viral lead investigational product detalimogene voraplasmid (also known as detalimogene, and previously EG-70) is in an ongoing pivotal study in patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis), today announced that it has agreed to sell 6,758,311 of its common shares at a price per share of $8.90. The financing is expected to close on October 29, 2024, subject to customary closing conditions. enGene anticipates the gross proceeds from the private placement to be approximately $60 million, before deducting any offering-related expenses.


The financing included participation from new and existing investors, including Deep Track Capital, Cormorant Asset Management, Forbion, OrbiMed, Sphera Healthcare, Vestal Point Capital and Venrock Healthcare Capital Partners.

enGene intends to use the net proceeds from this financing to fund the continued development of detalimogene, pre-commercial activities, the potential expansion of the DDX platform, and for working capital and general corporate purposes. The proceeds from this financing, combined with current cash and cash equivalents, are expected to be sufficient to fund the current operating plan into 2027.

Leerink Partners, Piper Sandler & Co., Guggenheim Securities and Wells Fargo Securities are acting as placement agents to the Company in connection with the private placement.

The securities described above have not been registered under the Securities Act of 1933, as amended. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. enGene has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the “SEC”) registering the resale of the common shares issued in this private placement. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

About enGene

enGene is a clinical-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, with the goal of creating new ways to address diseases with high clinical needs. enGene’s lead program is detalimogene voraplasmid, (also known as detalimogene, and previously EG-70) for patients with Non-Muscle Invasive Bladder Cancer (NMIBC) – a disease with a high clinical burden. Detalimogene is being evaluated in the ongoing multi-cohort LEGEND Phase 2 study, which includes a pivotal cohort studying detalimogene in Bacillus Calmette Guérin (BCG)-unresponsive patients with carcinoma in situ (Cis). Detalimogene was developed using enGene’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA.

Forward-Looking Statements

Some of the statements contained in this press release may constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and “forward-looking information” within the meaning of Canadian securities laws (collectively, “forward-looking statements”). enGene’s forward-looking statements include, but are not limited to, statements regarding enGene’s expectations, hopes, beliefs, intentions, goals, strategies, forecasts and projections. The words “anticipate”, “appear”, “approximate”, “believe”, “continue”, “could”, “estimate”, “expect”, “foresee”, “intend”, “may”, “might”, “plan”, “possible”, “potential”, “predict”, “project”, “seek”, “should”, “would”, and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements may include, for example, statements about: the timing and expectation of the closing of the private placement; the satisfaction of customary closing conditions related to the private placement and the anticipated use of proceeds therefrom; and the period over which enGene estimates the proceeds from the private placement, combined with its existing cash and cash equivalents, will be sufficient to fund its current operating plan.

Many factors, risks, uncertainties and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, that preliminary clinical data may not accurately reflect the complete results of a particular study and remain subject to audit and verification, and final data may differ materially from preliminary data; the Company’s ability to recruit and retain qualified scientific and management personnel; establish clinical trial sites and enroll patients in its clinical trials; execute on the Company’s clinical development plans and ability to secure regulatory approval on anticipated timelines; and other risks and uncertainties detailed in filings with Canadian securities regulators on SEDAR+ and with the U.S. Securities and Exchange Commission (“SEC”) on EDGAR, including those described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended October 31, 2023 and most recent Quarterly Report on Form 10-Q for the fiscal quarter ended July 31, 2024 (copies of which may be obtained at www.sedarplus.ca or www.sec.gov).

You should not place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. enGene anticipates that subsequent events and developments will cause enGene’s assessments to change. While enGene may elect to update these forward-looking statements at some point in the future, enGene specifically disclaims any obligation to do so, unless required by applicable law. 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.

Contacts

For media contact: media@engene.com
For investor contact: investors@engene.com

Dr. Reddy’s Named by Science Magazine in Top 20 Global Pharma Employers List for Third Consecutive Year

Dr. Reddy’s Named by Science Magazine in Top 20 Global Pharma Employers List for Third Consecutive Year




Dr. Reddy’s Named by Science Magazine in Top 20 Global Pharma Employers List for Third Consecutive Year

HYDERABAD, India–(BUSINESS WIRE)–$RDY #AmericanAssociationfortheAdvancementofScience–Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy’s”) has been ranked among the top employers according to the 2024 Top Biotech and Pharma Employers Survey conducted by Science.


This marks the third consecutive appearance of Dr. Reddy’s in the list. In 2022, Dr. Reddy’s entered the prestigious list at rank 18. In 2023, the company was placed at number 16. In the latest 2024 rankings, Dr. Reddy’s is placed at number 15 with high scores in ‘Employee Respect’, ‘Employee Loyalty’ and ‘Social Responsibility’. The full list is available here: https://www.science.org/content/article/top-20-2024-who-did-science-readers-select-best-biopharma

The prestigious Science magazine is a U.S.-based peer-reviewed academic journal of the American Association for the Advancement of Science (AAAS) and one of the world’s top academic journals. Since 2002, Science magazine has evaluated top organizations in biotech, pharma, and biopharma through its Top Employers Survey. The Science and Science Careers’ 2024 Top Employers Survey polled employees in biotechnology, biopharmaceutical, pharmaceutical, and related industries to determine the 20 best employers as well as their driving characteristics. Respondents to the web-based survey were asked to rate companies based on 24 characteristics, including innovative leadership, respect for employees, and social responsibility. The findings are based on approximately 6,400 completed surveys from readers of Science, and other survey invitees.

Commenting on the recognition, G.V. Prasad, Co-Chairman and Managing Director of Dr. Reddy’s said, “We stand for developing affordable and innovative pharmaceuticals by investing in cutting-edge science and technology, developing great scientists and creating an environment that nurtures innovation in all aspects of product development. Our colleagues have the freedom to pursue multiple career tracks within the organization and we expose them to the best ideas and knowledge in whatever field they choose to work in. Our culture and identity have revolved around being bold, entrepreneurial, responsible, humble, empathetic. Our purpose of ‘Good Health Can’t Wait’ is a movement and call to action for all of us, and good health encompasses patients, people and planet. The opportunity is available to each colleague to do their life’s work at our company and make the world a better place. Our people are our pride, and nothing gives us more joy than to see our people realize their full potential in the company.”

A recent report by the Foundation for Advancing Science and Technology (FAST India) in collaboration with IIFL Securities on ‘State of Industry R&D in India’ ranked Dr. Reddy’s first among Indian pharma companies in both R&D intensity and the proportion of PhD employees1.

Note on methodology:

Science Careers, a part of the American Association for the Advancement of Science (AAAS), commissioned Cell Associates and The Brighton Consulting Group to conduct a web-based survey aimed at determining the companies in the biotechnology and pharmaceutical industries with the best reputations as employers. This web-based study was conducted from March 1 through April 7, 2024.

For this year’s survey, a mixed methodology was used. The first part of this methodology included emailed invitations to Science and Science Careers website visitors registered with AAAS as well as several social media posts. The second part of the methodology included email blasts to Human Resource contacts from the Science Careers database, asking them to promote the survey within their organizations.

This report is based on a total sample of approximately 6,400 surveys. A vast majority of the survey participants came from North America (65%), Europe (19%), and Asia/Pacific Rim (11%).

Survey respondents were asked to select the companies they considered best, average, and worst employers. They then rated these companies on 24 different attributes. Attribute categories included Corporate Image, Financial Prowess, Leadership and Direction, Work Culture and Environment, and Academic and Intellectual Challenge.

A mathematical process was used to determine the attributes with the greatest impact on company/employer reputation. Unique ranking scores were then derived from the ratings given to each company on these attributes. The 20 companies with the best reputations as employers were then determined from the list of companies that were each mentioned at least 35 times. The ranking for each company was independent of company size or number of votes.

About AAAS: The American Association for the Advancement of Science (AAAS) is the world’s largest general scientific society and publisher of the journal Science, as well as Science Translational Medicine; Science Signaling; a digital, open-access journal, Science Advances; Science Immunology; and Science Robotics. AAAS was founded in 1848, and includes more than 250 affiliated societies and academies of science, serving 10 million individuals. The nonprofit AAAS is open to all and fulfills its mission to “advance science and serve society” through initiatives in science policy, international programs, science education, public engagement, and more. For additional information about AAAS, see www.aaas.org.

About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.

__________________________________

1 https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/indian-pharma-firms-trail-global-peers-in-rd-innovation-and-talent-metrics-fast-india-iifl-securities/articleshow/114395822.cms?from=mdr

Contacts

MEDIA RELATIONS
USHA IYER

USHAIYER@DRREDDYS.COM

Elucid Announces Fifth Medicare Administrative Contractor to Cover AI Coronary Plaque Analysis

Elucid Announces Fifth Medicare Administrative Contractor to Cover AI Coronary Plaque Analysis




Elucid Announces Fifth Medicare Administrative Contractor to Cover AI Coronary Plaque Analysis

Noridian latest MAC to make Elucid PlaqueIQ™ image analysis software available for eligible patients

BOSTON–(BUSINESS WIRE)–#AIElucid has announced that Noridian will extend coverage for AI-enabled quantitative coronary plaque analysis, including its FDA-cleared PlaqueIQ™ image analysis software, beginning December 8, 2024. With this decision, five of the seven Medicare Administrative Contractors (MACs) will soon provide coverage for AI-enabled quantitative coronary plaque analysis, expanding accessibility to over 70 percent of eligible Medicare patients across the United States.


The updated policy will allow for Medicare patients whose claims are administered within the five MACs who present with acute or stable chest pain and no known history of cardiovascular disease to be assessed with AI-enabled plaque imaging software. Elucid’s PlaqueIQ was designed to help physicians accurately diagnose and potentially personalize treatment for cardiovascular disease.

“AI-enabled plaque software allows, for the first time, accurate quantitation of atherosclerosis, allowing clinicians to scale their treatments based upon plaque burden and types of plaque, moving firmly into the realm of personalized medicine,” said Matthew Jay Budoff, MD, FACC, FAHA, professor of medicine at UCLA’s David Geffen School of Medicine, and the Endowed Chair of Preventive Cardiology at Harbor-UCLA Medical Center. “This has great implications for patient care and improved outcomes, being able to match intensity of treatment with level of risk.”

Cardiovascular disease (CVD) is the most common cause of death and disability globally, largely driven by myocardial infarction (MI) and ischemic stroke caused by atherosclerosis (plaque build-up and rupture in the arteries).1 The cost of CVD in the U.S. alone is approximately $219 billion per year, which includes the cost of healthcare services, medications and premature death.2 Moreover, the total cost of CVD is estimated to more than triple for people over 80 and more than double for people ages 65 to 79 by 2035.3

Elucid’s PlaqueIQ is the first FDA-cleared non-invasive software that can objectively quantify and classify plaque morphology based on ground-truth histology, the gold standard for characterization of plaques. PlaqueIQ is designed to give physicians new, clinically validated information to help stratify patients and inform patient-specific treatment pathways.

“This latest expansion of coverage by Noridian means that even more patients could be positively impacted by PlaqueIQ, which offers the only non-invasive measurement of lipid-rich necrotic core, a vulnerable, high-risk component of plaque that can lead to heart attack and stroke,”4 said Kelly Huang, CEO of Elucid. “These recent decisions from five of the seven MACs recognize the importance of new technologies like ours that can help quantify and classify coronary artery plaque to help physicians reduce the clinical and economic burden of cardiovascular disease.”

PlaqueIQ utilizes first-line diagnostic CCTA and develops comprehensive, interactive reports to help physicians virtually “see” and quantify plaque. With its basis in histology, the software is uniquely able to non-invasively quantify and characterize plaque and its components such as lipid-rich necrotic core (LRNC), giving potential insights into high-risk plaques that are key drivers of risk of heart attack and stroke. In addition, use of the software has the potential to enable earlier identification of higher-risk plaque before presence of symptoms or major adverse events.

About Elucid

Elucid is a Boston-based AI medical technology company dedicated to developing technology designed to provide physicians with a more precise view of atherosclerosis (coronary plaque buildup), the root cause of cardiovascular disease. The company’s PlaqueIQ™ product is designed to help physicians prioritize and personalize treatment based on actual disease, rather than population-based risk of disease. PlaqueIQ is the only FDA-cleared computed tomography angiography (CTA) algorithm that objectively quantifies plaque morphology validated against ground truth histology, the gold standard for characterization of plaque, as indicated by renowned pathologists. PlaqueIQ equips physicians with critical information regarding the type and amount of plaque in arteries that can lead to heart attack and stroke. Elucid is also pursuing an indication for FFRCT, derived from its plaque algorithm, to help identify coronary blockages and the extent of ischemia non-invasively. For more information, visit elucid.com.

References:

1 World Health Organization (WHO), Cardiovascular diseases (CVDs). 2017 23, April 2020. Available from: https://www.who.int/en/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds).

2 Centers for Disease Control and Prevention, Office of Policy, Performance, and Evaluation, Health Topics – Heart Disease and Heart Attacks. August 17, 2021. Available from: https://www.cdc.gov/policy/polaris/healthtopics/heartdisease/index.html.

3 American Heart Association. Cardiovascular Disease: A Costly Burden for America – Projections Through 2035. 2017. Available from: https://www.heart.org/-/media/Files/About-Us/Policy-Research/Fact-Sheets/Public-Health-Advocacy-and-Research/CVD-A-Costly-Burden-for-America-Projections-Through-2035.pdf.

4 Martinet, W., Coornaert, I., et. al. Regulated Necrosis in Atherosclerosis. Arteriosclerosis, Thrombosis, and Vascular Biology. 2022;42(10):1283-1306.

Contacts

Media Contact:
Sam Choinski

Pazanga Health Communications

(860) 301-5058

schoinski@pazangahealth.com

Egle Therapeutics to Share Preclinical Efficacy Data for EGL-001, a CTLA-4/CD25 Antagonist Fusion Protein at the Society for Immunotherapy of Cancer Meeting

Egle Therapeutics to Share Preclinical Efficacy Data for EGL-001, a CTLA-4/CD25 Antagonist Fusion Protein at the Society for Immunotherapy of Cancer Meeting




Egle Therapeutics to Share Preclinical Efficacy Data for EGL-001, a CTLA-4/CD25 Antagonist Fusion Protein at the Society for Immunotherapy of Cancer Meeting

PARIS–(BUSINESS WIRE)–Egle Therapeutics, a biotechnology company focused on advancing the next generation of regulatory T cell-focused therapies for oncology and auto-immunity, will present at the Society for Immunotherapy of Cancer Meeting taking place in Houston, Texas from November 6th to 10th, 2024.

The presentation, entitled “Preferential tumor retention of EGL-001, a CTLA-4/CD25 antagonist fusion protein, to selectively deplete tumor Tregs and minimize peripheral toxicities: towards a first-in-human clinical study”, will highlight the development and promising preclinical results of EGL-001, a humanized antibody designed to selectively target regulatory T cells (Tregs) within the tumor microenvironment. The data showcases EGL-001’s potential as single-agent and to enhance the effectiveness of immune checkpoint blockade therapies by depleting tumor-associated Tregs, leading to increased CD8+ T cell activation and anti-tumor responses in preclinical models.

The SITC presentation will include key findings from studies in mouse models and cynomolgus monkeys, demonstrating the safety, tolerability, and efficacy of EGL-001, as well as its preferential tumor accumulation and rapid clearance from peripheral organs. These promising results leading Egle Therapeutics to conduct a first-in-human open-label, phase I/II trial evaluating the safety, tolerability, PK and preliminary activity of EGL-001 in patients with selected solid tumors, with the goal to address the critical need for more effective immunotherapies in cancer treatment.

Session Date Saturday, Nov. 9 ; Location: George R. Brown Convention Center – Level 1 – Exhibit Halls AB ; Poster Board Number: 674

About Egle Therapeutics SAS (Egle)

Egle Therapeutics is a clinical-stage biotechnology company focused on developing immunotherapies targeting suppressive regulatory T cells. Egle is leveraging a proprietary discovery platform to unveil novel Treg specific targets and to develop innovative Treg-focused drug candidates for oncology and autoimmune diseases. Egle is evaluating its most advanced drug candidate in oncology, EGL-001 (a Treg-selective anti-CTLA4-IL-2m), in a Phase I/II clinical trial. In auto-immunity, Egle aspires to advance toward the clinic its most advanced drug candidate, EGL-003 (non-targeted IL-2 Treg engager), currently in IND-enabling studies.

Find out more at www.egle-tx.com.

Contacts

contact@egle-tx.com / 0033 (0)1 86 64 08 57

investor.relations@egle-tx.com / 0033 (0)1 86 64 08 57

Alterome Therapeutics to Present Preclinical Data for its KRAS Selective Inhibitor ALTA3263 at the 2024 ENA Symposium

Alterome Therapeutics to Present Preclinical Data for its KRAS Selective Inhibitor ALTA3263 at the 2024 ENA Symposium




Alterome Therapeutics to Present Preclinical Data for its KRAS Selective Inhibitor ALTA3263 at the 2024 ENA Symposium

ALTA3263 demonstrates preclinical antitumor activity in the most common KRAS mutant cancers

IND-enabling studies are ongoing to support clinical trial initiation in early 2025

SAN DIEGO–(BUSINESS WIRE)–Alterome Therapeutics, Inc., a biopharmaceutical company pioneering the development of next generation, small molecule targeted therapies for the treatment of cancer, today announced that data from preclinical studies of ALTA3263, the Company’s potential best-in-class KRAS selective inhibitor, will be presented in a plenary oral session at the EORTC-NCI-AACR (ENA) Symposium, taking place on October 23-25 in Barcelona, Spain.


ALTA3263 induces deep and durable tumor regressions in preclinical models addicted to the most common KRAS mutations, G12D, G12V, and G12C,” said Eric Murphy, Ph.D., co-founder and CEO of Alterome Therapeutics. “Mutant KRAS is a driver in approximately 1 out of every 5 cancers and ALTA3263 has the potential to be a robust treatment option for a wide range of KRAS mutant cancers based on its compelling preclinical profile.”

Key Findings:

  • ALTA3263 is an oral, KRAS selective inhibitor designed to enable complete target coverage of the most common mutations including G12V and G12D.
  • ALTA3263 demonstrates potent KRAS ON-state inhibition, picomolar to low single digit nanomolar potency against cells harboring a diverse array of KRAS driver mutations, and is highly selective for KRAS versus the NRAS and HRAS isoforms.
  • ALTA3263 induced complete and sustained tumor regressions in 8 KRAS G12V/D/C/A mutant xenograft models, including complete responses in 2 patient-derived xenograft non-small cell lung cancer models, while being well-tolerated during prolonged daily oral dosing in mice.

Oral Presentation Details:

Title: ALTA3263: an oral, KRAS isoform-selective, dual ON/OFF state, non-covalent inhibitor induces regressions across KRAS G12V, G12D, and G12C cancer models

Session Title: Proffered Papers: New drugs on the Horizon

Session Type: Plenary Session 6

Date and Time: Friday, October 25 at 12:36-12:48 p.m. CEST

Speaker/Lead Author: Tim Sen Wang, Ph.D., Alterome Therapeutics

About Alterome Therapeutics, Inc.

Alterome Therapeutics, Inc. is a precision oncology biotech developing alteration-specific therapeutics to address high-value and validated oncogenic drivers. The company is led by an expert team of precision oncology R&D leaders with a history of developing marketed oncology small molecule drugs.

For more information, visit www.alterome.com.

Follow us on LinkedIn and Twitter.

Contacts

Investors:


Scott Moorefield

Alterome Therapeutics

Scott@alterome.com

Media:


Sarah Sutton/Valerie Schoeck

Argot Partners

212-600-1902

alterome@argotpartners.com

Modalis Therapeutics has received an Orphan Drug Designation from the U.S. Food and Drug Administration for MDL-101, a treatment for congenital muscular dystrophy type 1A (LAMA2-CMD).

Modalis Therapeutics has received an Orphan Drug Designation from the U.S. Food and Drug Administration for MDL-101, a treatment for congenital muscular dystrophy type 1A (LAMA2-CMD).




Modalis Therapeutics has received an Orphan Drug Designation from the U.S. Food and Drug Administration for MDL-101, a treatment for congenital muscular dystrophy type 1A (LAMA2-CMD).

TOKYO & WALTHAM, Mass.–(BUSINESS WIRE)–Modalis Therapeutics Corporation (Tokyo Stock Exchange: 4883, CEO: Haru Morita), a leading company pioneering treatments for rare genetic diseases using its proprietary CRISPR-based epigenome editing technology, CRISPR-GNDM®, today announced that the U.S. Food and Drug Administration (FDA) has granted an Orphan Drug Designation (ODD) to MDL-101, a novel precision medicine being developed for the treatment of congenital muscular dystrophy type 1a (LAMA2-CMD).


The ODD we have just received is based on the Orphan Disease Act of 1983 and is a system for designating drugs that meet certain conditions, such as having fewer than 200,000 patients in the United States and being particularly in need of medical treatment. This system supports and promotes the development of orphan drugs intending to provide safe, high-quality drugs to the medical community as soon as possible, in light of the situation where research and development of orphan drugs is not progressing sufficiently due to the small number of patients despite the high medical need for such drugs.

Haru Morita, CEO and President of Modalis, said, “LAMA2-CMD is a serious, life-threatening rare disease that causes muscle weakness and reduced survival in patients. Currently, there is no approved treatment for LAMA2-CMD in the United States. We are hopeful that MDL-101, which has the potential to activate LAMA1, the sister gene of LAMA2, the causative gene of this disease, and achieve a fundamental cure, will become the first treatment that improves the prognosis of these patients.”

LAMA2-CMD is a severe, early-onset congenital muscular dystrophy caused by the absence of the LAMA2 protein, which is made up of more than 3,000 amino acids. Because it cannot be loaded onto an AAV vector, it is thought that the conventional approach to gene therapy development is difficult. For this reason, there is currently no treatment, including gene therapy, that addresses the underlying cause of LAMA2-CMD.

Modalis’ proprietary CRISPR-GNDM® technology allows for precise modulation of gene expression without altering patient DNA sequence. MDL-101, Modalis’ lead candidate for LAMA2-CMD, represents a first-in-class therapeutic that aims to address the unmet need by inducing expression of the sister gene LAMA1 in muscle tissues, thereby compensating for the deficient function of LAMA2.

Guided by its mission, “Every Life Deserves Attention,” Modalis is dedicated to bringing life-changing treatments to patients suffering from diseases for which no cure currently exists.

About MDL-101

MDL-101 is an experimental, epigenetic editing therapy that is being developed for the treatment of LAMA2-Congenital Muscular Dystrophy (LAMA2-CMD). MDL-101 is comprised of a guide nucleotide targeting LAMA1 gene, a highly homologous sister gene of the disease-causing gene LAMA2, enzyme-null Cas9 (dCas9) fused with trans-activating domain driven by a muscle-specific promoter and coded in a muscle-specific AAV vector. MDL-101 upregulates LAMA1 gene products in patients’ muscle tissue to compensate for loss-of-function caused by mutation of LAMA2, and therefore has the potential to provide a one-time, durable treatment to benefit people living with LAMA2-CMD.

About Modalis:

Modalis Therapeutics develops precision genetic medicines using epigenome editing technology. Modalis is pursuing therapies for orphan genetic diseases using its proprietary CRISPR-GNDM® technology which enables the gene/locus-specific modulation of gene expression or epigenome editing without the need for DNA cleavage or altering DNA sequence. Headquartered in Tokyo with all research and development operations in Waltham Massachusetts, the company is listed on the Tokyo Stock Exchange’s Growth market. For additional information, visit https://www.modalistx.com/en/.

Contacts

For further information, please contact:

Modalis Therapeutics Corporation

Corporate Communications

Sawako Nakamura

media@modalistx.com

Galderma Brings Together Over 650 Healthcare Professionals from Asia-Pacific to Elevate Knowledge of Future Aesthetic Trends

Galderma Brings Together Over 650 Healthcare Professionals from Asia-Pacific to Elevate Knowledge of Future Aesthetic Trends




Galderma Brings Together Over 650 Healthcare Professionals from Asia-Pacific to Elevate Knowledge of Future Aesthetic Trends

  • Galderma convenes a new edition of the Galderma Aesthetic Injector Network (GAIN) event in the Asia-Pacific region (JPAC), which will be the largest to date, bringing together more than 650 healthcare professionals (HCPs) across 14 countries and regions
  • Titled ‘Embarking on the NEXT Aesthetic Journeys’, GAIN JPAC will explore the six trends identified in the ‘NEXT by Galderma’ report to help HCPs stay on top of evolving aesthetic trends1
  • With one of the highest demands for aesthetics,2,3 Asia-Pacific houses some of Galderma’s fastest growing markets, where sales have fueled the company’s strong performance across product categories
  • GAIN is a unique community of highly trained, clinically proficient aesthetic practitioners, committed to delivering a premium experience to their clients

SINGAPORE–(BUSINESS WIRE)–Galderma (SWX:GALD), the pure-play dermatology category leader, today announced a new edition of the Galderma Aesthetic Injector Network (GAIN) event in the Asia-Pacific region, which houses some of the company’s fastest growing markets. This is the largest regional event to date and will deliver a premium and engaging experience for more than 650 delegates. Taking place October 26-27 in Incheon, South Korea, the extensive, two-day agenda will take a deep dive into the six trends identified in the ‘NEXT by Galderma’ report and explore how they will shape the future of aesthetics.1


Aesthetics is increasingly becoming part of beauty and wellness routines worldwide, which, in turn, are driving much of the growth seen in this category. By 2028, the aesthetics market is expected to nearly double in value, reaching $25.9 billion.4 GAIN is Galderma’s long-established training platform designed to educate, inspire, and empower through the creation of a unique community of highly trained, clinically proficient aesthetic practitioners. Created by aesthetic practitioners for aesthetic practitioners, GAIN’s primary purpose is to encourage and facilitate the sharing of knowledge and improve the treatment experience for both patients and aesthetic practitioners themselves.

 

“We’re delighted to bring the GAIN aesthetic community together in the Asia-Pacific region, which houses some of our fastest growing markets and is a key driver of the continued strong commercial performance of our broad and unique portfolio. Built around the six key trends from our groundbreaking ‘NEXT by Galderma’ report, that are expected to drive demand and shape the future, this event is designed to bring the latest in science and skills to the medical aesthetics field and drive the entire segment forward.”

 

HON KEONG CHOO

HEAD OF JPAC

GALDERMA

 

With one of the highest demands for aesthetics,2,3 Asia-Pacific houses some of Galderma’s fastest growing markets, where sales have fueled the company’s strong performance across product categories. There have been multiple successes in the region already this year, with launches in many key aesthetic products including Restylane® VOLYME in China,5 Restylane® EYELIGHT in Korea6 and Alastin Skincare® in Australia.7 More recently, RelfydessTM (RelabotulinumtoxinA) was approved in Australia8 and Sculptra® – which celebrates its 25th launch anniversary this year – was approved in China.9 With its premiumization strategy and broad channel exposure, Galderma is well positioned to capitalize on growing consumer demand across Asia-Pacific, where the compelling dermatology market has remained on a consistent growth trajectory, with robust demand for premium, science-based products.

 

“The field of aesthetics is evolving at pace, and this is having a real impact on our practice in the Asia-Pacific region. Events like GAIN JPAC, where practicing physicians have the opportunity to deep-dive into the future trends, techniques and products in aesthetics, are invaluable in helping us tailor our approaches to every skin story, stay on top of the ever-changing demands we face, and, ultimately, continue to deliver the excellence that our patients expect.”

 

VAN PARK, BSC(MED), MBBS

COSMETIC PHYSICIAN AND FOUNDER, DVP, SYDNEY

 

The event program is built around the six global aesthetic trends identified by ‘NEXT by Galderma’, a groundbreaking report based on a year’s worth of comprehensive trend-forecasting research conducted in collaboration with a network of renowned experts:1

  • Proactive Beauty: An increased shift toward early intervention on ageing.
  • Mindful Aesthetics: The prioritization of products with minimal environmental impact that align with patients’ ethical values and provide natural-looking results.
  • Fast Aesthetics: More and more people now want to use aesthetics to mimic the latest fast-moving trends.
  • Beauty Fandom: A reflection of patients’ fascination with niche idolization—from cultural icons to digital filters, anime, and beyond—which is leading to a desire for metamorphosis.
  • Expressionality: A celebration of the empowerment that comes from creating and enhancing one’s identity with aesthetics.
  • Cancelling Age: We are cancelling expectations of what certain ages “should look like”, as consumers employ aesthetics to express their ageless attitude.

In addition, there will be an exploration of the potential for aesthetics to assist the increasing number of patients experiencing rapid weight loss, and how this could impact the aesthetics landscape in this region in the future.

The event’s agenda features a faculty of 10 renowned global and Asia-Pacific experts. Expert presentations, live demonstrations, case sharing, and panel discussions will bring Galderma’s Integrated Dermatology Strategy to life with sessions aiming to advance skin science, skin education and skin innovation, while further strengthening its GAIN community. Additional ‘GAIN Talks’ on subjects such as reverse ageing and ethics in aesthetics, as well as several Meet The Expert sessions throughout the two-day event will further reinforce Galderma’s thought leadership in dermatology and the cumulative knowledge of the GAIN community, setting the company apart as a true leader and preferred partner in the industry.

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References:

  1. NEXT by Galderma. Emerging aesthetics trend report. 2023. Available online. Last accessed October 2024
  2. Kwon SH, et al. Experiences and attitudes toward aesthetic procedures in East Asia: a cross-sectional survey of five geographical regions. Arch Plast Surg. 2021 Nov;48(6):660-669. doi: 10.5999/aps.2020.02565. Epub 2021 Nov 15. PMID: 34818714; PMCID: PMC8627936.
  3. Asia Pacific Medical Aesthetics Market Size, Share & Industry Trends Analysis Report By End User (Clinics, Hospitals, & Medicals Spas, Beauty Centres, & Home Care Settings), By Procedure, By Product, By Country and Growth Forecast, 2023 – 2030. Available online. Last accessed October 2024
  4. Markets and Markets (2023) Medical aesthetics market by product (botox, filler, peel, implant, liposuction, microneedling, hair removal, laser resurfacing, RF, phototherapy), procedure (surgical, nonsurgical), end user (hospital, beauty clinic, spa), region – global forecast to 2028. Available online. Last accessed October 2024
  5. Galderma. Galderma launches Restylane® Volyme™ in China – one of the world’s fastest growing aesthetics markets. Available online. Last accessed October 2024
  6. Korea BioMed. Galderma Korea to launch ‘Restylane Eyelight’ in June. Available online. Last accessed October 2024
  7. Galderma. Alastin.com.au. Alastin Skincare now available in Australia. Available online. Last accessed October 2024
  8. Galderma. Galderma’s Relfydess™ (RelabotulinumtoxinA) receives positive decision for use in Europe. Available online. Last accessed October 2024
  9. Galderma. Galderma delivers record net sales of 3.259 B USD in the first nine months of 2024, demonstrates significant innovation progress, confirms and narrows its full year net sales guidance. Available online. Last accessed October 2024

Contacts

For further information:

Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com
+41 76 315 26 50

Sébastien Cros

Corporate Communications Director

sebastien.cros@galderma.com
+41 79 529 59 85

Sensient Declares Dividend

Sensient Declares Dividend




Sensient Declares Dividend

MILWAUKEE–(BUSINESS WIRE)–The Board of Directors of Sensient Technologies Corporation (NYSE: SXT) has declared a regular quarterly cash dividend on its common stock of $0.41 per share. The cash dividend will be paid on December 2, 2024, to shareholders of record on November 4, 2024.


About Sensient Technologies

Sensient Technologies Corporation is a leading global manufacturer and marketer of colors, flavors, and other specialty ingredients. Sensient uses advanced technologies and robust global supply chain capabilities to develop specialized solutions for food and beverages, as well as products that serve the pharmaceutical, nutraceutical, and personal care industries. Sensient’s customers range in size from small entrepreneurial businesses to major international manufacturers representing some of the world’s best-known brands. Sensient is headquartered in Milwaukee, Wisconsin.

www.sensient.com

Category: Dividends

Source: Sensient Technologies Corporation

Contacts

Amy Agallar

(414) 347-3706