SonderCare Launches Impulse Essential 39” Residential Comfort Bed, Expanding Affordable Luxury Homecare Options in the United States




SonderCare Launches Impulse Essential 39” Residential Comfort Bed, Expanding Affordable Luxury Homecare Options in the United States

Introducing a new standard in entry-level homecare beds — SonderCare’s Impulse Essential delivers premium comfort, safety, and design at an accessible price, now available exclusively in the United States.

O’Fallon, MO , Oct. 28, 2025 (GLOBE NEWSWIRE) — SonderCare, North America’s leading provider of premium home hospital beds, today announced the launch of its newest model — the Impulse Essential 39” Residential Comfort Bed, available exclusively in the United States. Designed to deliver SonderCare’s signature blend of safety, comfort, and residential aesthetics at a more accessible price point, the Impulse Essential redefines what an entry-level homecare bed can offer.

SonderCare Launches Impulse™ Essential 39” Residential Comfort Bed

“The Impulse Essential represents a new standard for homecare equipment in the U.S. — combining full-electric operation, elegant design, and medical-grade certification, all at a price that makes quality care more attainable,” said Ben Martin, President of SonderCare. “We’re proud to make premium comfort available to more families who wish to age safely and gracefully at home.”

A New Benchmark in Entry-Level Home Hospital Beds

The Impulse Essential 39” model combines fully-electric adjustability with SonderCare’s warm residential woodgrain finish, blending clinical functionality with home-friendly design. It provides users with effortless positioning through a simple hand control, achieving an ergonmic and comfortable backrest angle and smooth elevation for optimal comfort and safety.

This model includes two height-adjustable assist rails for secure transfers, a 400 lb. weight capacity, a motor system engineered for reliability and whisper-quiet operation. The Impulse Essential delivers clinical performance without the institutional appearance of traditional hospital beds.

Key Features

• Model: Impulse Essential 39” Residential Comfort Bed
• Price: $2,999
• Bed Width (Mattress): 39”
• Operation: Fully-Electric with Hand Control
• Design Style: Residential Woodgrain Finish
• Side Rails: Two Fully Height-Adjustable Assist Rails Included
• Weight Capacity: 400 lbs
• Installation: Professional Set-Up Across the United States

Available Now in the United States

The Impulse Essential is available exclusively to U.S. customers through SonderCare’s website and authorized partners. Professional installation and nationwide delivery options ensure a smooth and stress-free setup experience.

For more information, visit: https://www.sondercare.com/product/impulse-essential-hospital-bed/

SonderCare Expanding Affordable Luxury Homecare Options in the United States with Impulse™ Essential 39”

About SonderCare

SonderCare is a leading manufacturer, assembler, and distributor of premium hospital beds designed specifically for home care. With a mission to revolutionize the home care industry, SonderCare combines state-of-the-art engineering with elegant design to offer products that enhance safety, comfort, and dignity. For more information about SonderCare’s innovative solutions and to access educational resources on aging care, please visit www.sondercare.com. 

Press inquiries

SonderCare
https://www.sondercare.com/
Kyle Sobko
kyle.sobko@sondercare.com
1-833-649-7772
2995 Page St, London, ON N5V 4P6

GENFIT Announces Advances Across its ACLF Pipeline at AASLD The Liver Meeting® 2025




GENFIT Announces Advances Across its ACLF Pipeline at AASLD The Liver Meeting® 2025

• Several posters and presentations featuring new data on three ACLF programs, including G1090N (NTZ reformulation) disease model data, new real-world data and biomarker insights in cirrhosis
• New Iqirvo® PBC and PSC data to be presented by partner Ipsen, underscoring its potential in rare cholestatic liver diseases

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), October 28, 2025 – GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced its participation at the upcoming American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2025 in Washington, D.C., November 7-11, 2025.

GENFIT will present new data highlighting the potential of its pipeline in Acute on-Chronic Liver Failure (ACLF):

G1090N (reformulation of nitazoxanide) – Poster #4165: Efficacy of nitazoxanide (NTZ) on systemic inflammation and organ function in disease models of Acute-on-Chronic Liver Failure (ACLF) when administered post-ACLF trigger

Authors: Bobowski-Gerard, M. et al

Session: Acute-on-Chronic Liver Failure

Date & Time: November 10, 2025 (8.00 am – 5.00 pm)

G1090N is the lead program in GENFIT’s ACLF pipeline. Clinical safety data and markers of early efficacy are expected at the end of the year.

SRT-015 – Poster #4171: ASK1 inhibitor SRT-015 reduces systemic inflammation while promoting immune host defense mechanisms in preclinical in vitro and in vivo models related to ACLF
Authors: Legry, V. et al

Session: Acute-on-Chronic Liver Failure

Date & Time: November 10, 2025 (8.00 am – 5.00 pm)

CLM-022 – Poster #4565: Efficacy of CLM-022, an inhibitor of the NLRP3 inflammasome, in vivo and in vitro Pathogen-Associated Molecular Patterns (PAMPs)-induced disease models

Authors: Vidal, G. et al

Session: Inflammation and Immunobiology

Date & Time: November 10, 2025 (8.00 am – 5.00 pm)

A poster on the Effect of VS-01 on systemic inflammation and liver injury in a rat model of endotoxemia will also be presented by GENFIT. While VS-01 has been discontinued in ACLF, pre-clinical studies continue in Urea Cycle Disorder (UCD).

Other posters and oral presentations covering ACLF management and diagnostic and prognostic biomarkers in cirrhosis will be presented:

• Real-World Evidence

Oral presentation #0086: A RWE-based characterization of patients admitted in US hospital for an event of acute decompensation highlights differences in the management of inpatients
Presenters: Trebicka, J. et al

Session: Emerging Determinants and Outcomes in Liver Disease: From Population Trends to Patient-Centered Insights

Date & Time: November 10, 2025 (9.15 am – 9.30 am)

Poster #2325: Impact of bacterial infection on clinical outcomes in patients with acute decompensation: real-world evidence insights
Authors: Fernández, J. et al

Session: Portal Hypertension and Other Complications of Cirrhosis

Date & Time: November 8, 2025 (8.00 am – 5.00 pm)

• Patient journey

Poster (distinction) & Oral presentation #4127: Systemic challenges in managing Acute-on-Chronic Liver Failure (ACLF) in the U.S.: diagnostic delays, referral barriers, and fragmented post-discharge care
Authors: Karvellas, J. C. et al
Session: Acute on-Chronic Liver Failure Special Interest Group
Date & Time: November 7, 2025 (3.45 pm – 4.15 pm)

• Diagnostic and prognostic biomarkers in cirrhosis

Poster (distinction) #2022: Single circulating biomarkers sVCAM-1 and TSP2 achieved effective prognostic performances for the detection of fibrosis progression to cirrhosis
Authors: Ratziu, V.  et al

Date: November 8, 2025 (8.00 am – 5.00 pm)

Poster #2050: Combining sVCAM-1 or TSP2 with FIB-4 for an improved detection of patients with cirrhosis
Authors: Francque, S. et al
Date & Time: November 8, 2025 (8.00 am – 5.00 pm)

New data presented by Ipsen in PBC and PSC

The set of data to be presented underscores Iqirvo®’s potential to address both disease progression and symptom burden across rare cholestatic liver diseases.

• Ipsen will be presenting six abstracts¹ from the ongoing Iqirvo® (elafibranor) ELATIVE® study in Primary Biliary Cholangitis (PBC), including two late-breaking presentations and one abstract in Primary Sclerosing Cholangitis (PSC).
• Data in PBC continue to support Iqirvo®’s efficacy and safety profile towards modifying disease progression while improving multiple key symptoms including fatigue and pruritus (itch), in patients living with PBC.
• Data in Primary Sclerosing Cholangitis (PSC) from the elafibranor ELMWOOD Phase 2 study provide insights into the sustained efficacy and tolerability profile of elafibranor 120mg in patients with PSC.

GENFIT will also organize two events focusing on ACLF: 

• ACLF Insights (November 7, 2025)
• ACLF Patient Advocacy Council (November 9, 2025)

END

ABOUT GENFIT

GENFIT is a biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades.  
Today, GENFIT focuses on Acute on-chronic Liver Failure (ACLF) and associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE). It develops therapeutic assets which have complementary mechanisms of action, selected to address key pathophysiological pathways. GENFIT also targets other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemia (OA). Its R&D portfolio, covering several stages of development, ensures a constant news flow.

GENFIT’s expertise in developing high-potential molecules – from early to advanced pre-commercialization stages – culminated in 2024 with the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for the treatment of Primary Biliary Cholangitis (PBC). Iqirvo® is now marketed in several countries.²   

Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® for the detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis). 

GENFIT is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Nasdaq Global Select Market and on the Euronext regulated market in Paris, Compartment B (Nasdaq and Euronext: GNFT). In 2021, Ipsen became one of GENFIT’s largest shareholders, acquiring an 8% stake in the Company’s capital. www.genfit.com 

ABOUT AMERICAN ASSOCIATION FOR THE STUDY OF LIVER DISEASES (AASLD)

AASLD is the leading organization of scientists and health care professionals committed to preventing and curing liver disease. They foster research that leads to improved treatment options for millions of liver disease patients, and advance the science and practice of hepatology through educational conferences, training programs, professional publications, and partnerships with government agencies and sister societies. Every year AASLD organizes The Liver Meeting® where the global hepatology community comes together. With access to the latest breakthroughs in liver disease research, practical tools for patient care, and a powerful network of experts shaping the future of hepatology, the program offers something for everyone committed to improving liver health. 

FORWARD LOOKING STATEMENTS

This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, such as “believe”, “potential”, “expect”, “target”, “may”, “will”, “should”, “could”, “if” and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to non-clinical and pre-clinical programs, reproducibility of preclinical results, the translation of animal model data to human biology, safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, patient recruitment, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, pricing, approval and commercial success of elafibranor in the relevant jurisdictions, exchange rate fluctuations, and our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 “Risk Factors and Internal Control” of the Company’s 2024 Universal Registration Document filed on April 29, 2025 (no. 25-0331) with the Autorité des marchés financiers (“AMF”), which is available on GENFIT’s website (www.genfit.fr) and the AMF’s website (www.amf.org), and those discussed in the public documents and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s 2024 Annual Report on Form 20-F filed with the SEC on April 29, 2025 and subsequent filings and reports filed with the AMF or SEC or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this press release. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.

CONTACTS

GENFIT | Investors

Tel: +33 3 2016 4000 | investors@genfit.com

GENFIT | Media

Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com

GENFIT | 885 Avenue Eugène Avinée, 59120 Loos – FRANCE | +333 2016 4000 | www.genfit.com      

1 https://www.ipsen.com/statement/ipsen-to-present-data-across-five-rare-liver-diseases-at-aasld-2025-3163092/
2 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo® .

Attachment

• GENFIT Announces Advances Across its ACLF Pipeline at AASLD The Liver Meeting® 2025

Rapid Micro Biosystems to Announce Third Quarter 2025 Financial Results on November 7, 2025




Rapid Micro Biosystems to Announce Third Quarter 2025 Financial Results on November 7, 2025

LEXINGTON, Mass., Oct. 28, 2025 (GLOBE NEWSWIRE) — Rapid Micro Biosystems, Inc. (Nasdaq: RPID) (the “Company”), an innovative life sciences technology company providing mission-critical automation solutions to facilitate the efficient manufacturing and fast, safe release of healthcare products, will release third quarter 2025 financial results prior to the market open on Friday, November 7, 2025.

In conjunction with the release, the Company’s management team will host a webcast conference call at 8:30 a.m. ET on Friday, November 7, 2025. The live audio webcast will be accessible on the Company’s website and can be accessed with this link. The webcast will be archived and available for replay after the event.

About Rapid Micro Biosystems

Rapid Micro Biosystems is an innovative life sciences technology company providing mission critical automation solutions to facilitate the efficient manufacturing and fast, safe release of healthcare products such as biologics, vaccines, cell and gene therapies, and sterile injectables. The Company’s flagship Growth Direct system automates and modernizes the antiquated, manual microbial quality control (“MQC”) testing workflows used in the largest and most complex pharmaceutical manufacturing operations across the globe. The Growth Direct system brings the quality control lab to the manufacturing floor, unlocking the power of MQC automation to deliver the faster results, greater accuracy, increased operational efficiency, better compliance with data integrity regulations, and quicker decision making that customers rely on to ensure safe and consistent supply of important healthcare products. The Company is headquartered Lexington, Massachusetts and has U.S. manufacturing in Lowell, Massachusetts, with global locations in Switzerland, Germany, and the Netherlands. For more information, please visit www.rapidmicrobio.com or follow the Company on X (formerly known as Twitter) at @rapidmicrobio or on LinkedIn. 

CONTACT: Investor Contact:
Michael Beaulieu, CFA
Vice President, Investor Relations and Corporate Communications
investors@rapidmicrobio.com

Media Contact:
media@rapidmicrobio.com

Tarsus to Report Third Quarter 2025 Financial Results on Tuesday, November 4, 2025




Tarsus to Report Third Quarter 2025 Financial Results on Tuesday, November 4, 2025

IRVINE, Calif., Oct. 28, 2025 (GLOBE NEWSWIRE) — Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), today announced that it will host a live webcast at 1:30 p.m. PT / 4:30 p.m. ET on Tuesday, November 4, 2025 to report its third quarter 2025 financial results and provide a corporate update.

Participants may access the webcast here. A recorded version of the call will be available on the website shortly after the completion of the webcast and will be archived there for approximately 90 days.

About Tarsus Pharmaceuticals, Inc.
Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care and infectious disease prevention. XDEMVY^® (lotilaner ophthalmic solution) 0.25% is FDA approved in the United States for the treatment of Demodex blepharitis. Tarsus is also developing TP-04 as an ophthalmic gel for the potential treatment of Ocular Rosacea and TP-05 as an oral tablet for the potential prevention of Lyme disease, all of which are in Phase 2.

Ultragenyx to Host Conference Call for Third Quarter 2025 Financial Results and Corporate Update




Ultragenyx to Host Conference Call for Third Quarter 2025 Financial Results and Corporate Update

NOVATO, Calif., Oct. 28, 2025 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare genetic diseases, today announced that it will host a conference call at 5:00 p.m. ET on Tuesday, November 4, 2025, to discuss its financial results and corporate update for the quarter ending September 30, 2025.

The live and replayed webcast of the call will be available through the company’s website at https://ir.ultragenyx.com/events-presentations. The replay of the call will be available for three months.

About Ultragenyx Pharmaceutical Inc.
Ultragenyx is a biopharmaceutical company committed to bringing novel products to patients for the treatment of serious rare and ultra-rare genetic diseases. The company has built a diverse portfolio of approved therapies and product candidates aimed at addressing diseases with high unmet medical need and clear biology for treatment, for which there are typically no approved therapies treating the underlying disease.

The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time- and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.

For more information on Ultragenyx, please visit the company’s website at: www.ultragenyx.com.

Contact Ultragenyx

Investors
Joshua Higa
ir@ultragenyx.com

Media
Jess Rowlands
media@ultragenyx.com

AVITA Medical Welcomes Support for RECELL® in Burns in Australia




AVITA Medical Welcomes Support for RECELL® in Burns in Australia

• Australia’s Medical Services Advisory Committee (MSAC) recognizes RECELL^® as safe and effective, with benefits in healing, donor site sparing, and reduced hospital stays

VALENCIA, Calif., Oct. 28, 2025 (GLOBE NEWSWIRE) — AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (“AVITA Medical,” or the “Company”), a leading therapeutic acute wound care company, today announced that Australia’s Medical Services Advisory Committee (“MSAC”) has recommended amendments to the Medicare Benefits Schedule (“MBS”) to include the use of autologous skin cell suspension (“ASCS”) prepared with RECELL for the treatment of severe acute burn wounds in adults and children.

“MSAC’s position is a powerful endorsement of RECELL’s clinical impact and the difference it makes in patients’ lives,” said Katie Bush, PhD, Senior Vice President, Scientific & Medical Affairs. “It reflects growing confidence in RECELL as a transformative approach in burn care and represents our shared goals of improving outcomes for patients and supporting clinicians with innovative treatment options.”

MSAC concluded that RECELL is as safe and effective as traditional autologous skin grafting, while providing superior outcomes in donor site sparing and reducing the need for additional grafting procedures. MSAC further acknowledged that RECELL can shorten hospital stays, ease patient pain, and minimize scarring.

Severe burns often require surgery to close the wound, which usually involves taking healthy skin from another part of the body and grafting it onto the burn. This process can be painful, leaves lasting scars at the donor site, and often requires long hospital stays.

RECELL works differently. By taking a very small piece of the patient’s own healthy skin, doctors can prepare a suspension of skin cells that is sprayed onto the wound. This can:

• Reduce the need for large skin grafts, lowering pain and scarring at donor sites
• Shorten hospital stays, helping patients recover faster and return to daily life sooner

The MSAC recommendation supports the use of RECELL for:

• Adult patients with burns covering ≥20% of total body surface area (“TBSA”)
• Pediatric patients with burns covering ≥10% TBSA
• Whole-of-face burn wound closure

About AVITA Medical, Inc.

AVITA Medical® is a leading therapeutic acute wound care company delivering transformative solutions. Our technologies are designed to optimize wound healing, effectively accelerating the time to patient recovery. At the forefront of our platform is the RECELL^® System, approved by the U.S. Food and Drug Administration for the treatment of thermal burn and trauma wounds. RECELL harnesses the healing properties of a patient’s own skin to create Spray-On Skin™ Cells, offering an innovative solution for improved clinical outcomes at the point-of-care. In the U.S., AVITA Medical also holds the rights to manufacture and exclusive rights to market, sell, and distribute PermeaDerm^®, a biosynthetic wound matrix, and the exclusive rights to market, sell, and distribute Cohealyx™, an AVITA Medical-branded collagen-based dermal matrix.

In international markets, the RECELL System is approved to promote skin healing in a wide range of applications including thermal burn and trauma wounds, with regulatory clearances in Europe, and excluding RECELL GO, in Australia and Japan.

To learn more, visit www.avitamedical.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Forward-looking statements generally may be identified by the use of words such as “can,” could,” “usually,” “will,” “would,” and similar words or expressions, and the use of future dates. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation: failure to obtain and/or maintain regulatory approvals and comply with applicable regulations; market reaction to growth or product initiatives; market penetration of our products; changes in the legal or regulatory environments; and other business effects, including the effects of industry, as well as other economic or political conditions outside of the Company’s control. Any forward-looking statements made herein are made as of the date of this release, and the Company undertakes no obligation to publicly update or revise any of these statements, except as required by law. For additional information and other important factors that may cause actual results to differ materially from forward-looking statements, please see the “Risk Factors” section of the Company’s latest Annual Report on Form 10-K and other publicly available filings for a discussion of these and other risks and uncertainties.

Investor & Media Contact:
Ben Atkins
Phone +1-805 341 1571
investor@avitamedical.com | media@avitamedical.com

Authorized for release by the Chief Financial Officer of AVITA Medical, Inc.

Akebia Therapeutics Provides Update on Vafseo for Non-Dialysis Patients




Akebia Therapeutics Provides Update on Vafseo for Non-Dialysis Patients

Akebia does not expect to initiate VALOR clinical trial following Type C meeting feedback from U.S. FDA

CAMBRIDGE, Mass., Oct. 28, 2025 (GLOBE NEWSWIRE) — Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that after meeting with the U.S. Food and Drug Administration (FDA) it has not come to alignment on a path forward for the design of the VALOR clinical trial for the use of vadadustat to treat anemia in patients with late-stage chronic kidney disease (CKD) not on dialysis. As a result, Akebia does not plan to initiate VALOR and therefore does not expect to pursue a broad label for Vafseo for CKD non-dialysis dependent patients.

Akebia recently completed a Type C meeting with the FDA. While Akebia has not yet received final meeting minutes from the face-to-face Type C meeting, based on the FDA feedback, Akebia believes regulatory alignment for such a trial would require a significantly larger number of patients than proposed, and accordingly would require meaningfully more time and cost to complete.

“Because we remain steadfast in our belief of the significant unmet need for an oral option to treat anemia in CKD patients not on dialysis, we are disappointed in the outcome of the meeting,” said John P. Butler, Chief Executive Officer at Akebia. “We believe our decision not to pursue a broad NDD-CKD label, based on our discussion with the FDA, is in the best interests of our shareholders. We were encouraged by the discussion with FDA on smaller subgroups of CKD patients where we may be able to align on a potential clinical trial design and path forward. Importantly, everyone at Akebia will continue to work toward our goal to make Vafseo standard of care for patients on dialysis.”

In the U.S., Vafseo® (vadadustat) is approved for the treatment of anemia due to CKD in adults who have been receiving dialysis for at least three months. Nephrologists in the U.S. began prescribing Vafseo to patients January 2025.

About Akebia Therapeutics
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.

About Vafseo® (vadadustat) tablets
Vafseo® (vadadustat) tablets is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin, increasing hemoglobin and red blood cell production to manage anemia. Vafseo is approved for use in 37 countries.
INDICATION

VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.

Limitations of Use

• VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being.
• VAFSEO is not indicated for use:
  • As a substitute for red blood cell transfusions in patients who require immediate correction of anemia.
  • In patients with anemia due to CKD not on dialysis.

IMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat) tablets

WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS.

VAFSEO increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE).

Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels.

No trial has identified a hemoglobin target level, dose of VAFSEO, or dosing strategy that does not increase these risks.

Use the lowest dose of VAFSEO sufficient to reduce the need for red blood cell transfusions.

CONTRAINDICATIONS

• Known hypersensitivity to VAFSEO or any of its components
• Uncontrolled hypertension

WARNINGS AND PRECAUTIONS

• Increased Risk of Death, Myocardial Infarction (MI), Stroke, Venous Thromboembolism, and Thrombosis of Vascular Access

A rise in hemoglobin (Hb) levels greater than 1 g/dL over 2 weeks can increase these risks. Avoid in patients with a history of MI, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting VAFSEO. Targeting a Hb level of greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events. Use the lowest effective dose to reduce the need for red blood cell (RBC) transfusions. Adhere to dosing and Hb monitoring recommendations to avoid excessive erythropoiesis.

• Hepatotoxicity

Hepatocellular injury attributed to VAFSEO was reported in less than 1% of patients, including one severe case with jaundice. Elevated serum ALT, AST, and bilirubin levels were observed in 1.8%, 1.8%, and 0.3% of CKD patients treated with VAFSEO, respectively. Measure ALT, AST, and bilirubin before treatment and monthly for the first 6 months, then as clinically indicated. Discontinue VAFSEO if ALT or AST is persistently elevated or accompanied by elevated bilirubin. Not recommended in patients with cirrhosis or active, acute liver disease.

• Hypertension

Worsening of hypertension was reported in 14% of VAFSEO and 17% of darbepoetin alfa patients. Serious worsening of hypertension was reported in 2.7% of VAFSEO and 3% of darbepoetin alfa patients. Cases of hypertensive crisis, including hypertensive encephalopathy and seizures, have also been reported in patients receiving VAFSEO. Monitor blood pressure. Adjust anti-hypertensive therapy as needed.

• Seizures

Seizures occurred in 1.6% of VAFSEO and 1.6% of darbepoetin alfa patients. Monitor for new-onset seizures, premonitory symptoms, or change in seizure frequency.

• Gastrointestinal (GI) Erosion

Gastric or esophageal erosions occurred in 6.4% of VAFSEO and 5.3% of darbepoetin alfa patients. Serious GI erosions, including GI bleeding and the need for RBC transfusions, were reported in 3.4% of VAFSEO and 3.3% of darbepoetin alfa patients. Consider this risk in patients at increased risk of GI erosion. Advise patients about signs of erosions and GI bleeding and urge them to seek prompt medical care if present.

• Serious Adverse Reactions in Patients with Anemia Due to CKD and Not on Dialysis

The safety of VAFSEO has not been established for the treatment of anemia due to CKD in adults not on dialysis and its use is not recommended in this setting. In large clinical trials in adults with anemia of CKD who were not on dialysis, an increased risk of mortality, stroke, MI, serious acute kidney injury, serious hepatic injury, and serious GI erosions was observed in patients treated with VAFSEO compared to darbepoetin alfa.

• Malignancy

VAFSEO has not been studied and is not recommended in patients with active malignancies. Malignancies were observed in 2.2% of VAFSEO and 3.0% of darbepoetin alfa patients. No evidence of increased carcinogenicity was observed in animal studies.

ADVERSE REACTIONS

• The most common adverse reactions (occurring at ≥ 10%) were hypertension and diarrhea.

DRUG INTERACTIONS

• Iron supplements and iron-containing phosphate binders: Administer VAFSEO at least 1 hour before products containing iron.
• Non-iron-containing phosphate binders: Administer VAFSEO at least 1 hour before or 2 hours after non-iron-containing phosphate binders.
• BCRP substrates: Monitor for signs of substrate adverse reactions and consider dose reduction.
• Statins: Monitor for statin-related adverse reactions. Limit the daily dose of simvastatin to 20 mg and rosuvastatin to 5 mg.

USE IN SPECIFIC POPULATIONS

• Pregnancy: May cause fetal harm.
• Lactation: Breastfeeding not recommended until two days after the final dose.
• Hepatic Impairment: Not recommended in patients with cirrhosis or active, acute liver disease.

Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING and Medication Guide.

Forward-Looking Statements

Statements in this press release regarding Akebia Therapeutics, Inc.’s (“Akebia’s”) strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and include, but are not limited to, statements regarding: Akebia’s plans and expectations to not initiate the VALOR clinical trial for the use of vadadustat to treat anemia in patients with late-stage CKD not on dialysis and to not pursue a broad label for Vafseo for CKD non-dialysis dependent patients; Akebia’s beliefs and expectations about feedback from the FDA, including that it has not come to alignment on a path forward for the design of VALOR and that it believes that regulatory alignment for the VALOR trial would require a significantly larger number of patients than proposed and meaningfully more time and cost to complete; Akebia’s beliefs about the significant unmet need for an oral option to treat anemia in CKD patients not on dialysis; Akebia’s beliefs that its decision not to pursue a broad NDD-CKD label is in the best interests of its shareholders; Akebia’s expectations about its discussions with the FDA with respect to smaller subgroups of CKD patients where it may be able to align on a potential clinical trial design and path forward; and Akebia’s plans to work toward its goal to make Vafseo standard of care for patients on dialysis. The terms “intend,” “believe,” “plan,” “goal,” “potential,” “anticipate, “estimate,” “expect,” “future,” “will,” “continue,” derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: the potential therapeutic benefits, safety profile, and effectiveness of Vafseo; the results of preclinical and clinical research; decisions made by health authorities, such as the FDA, with respect to regulatory filings and other interactions; the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to, Vafseo, including estimates regarding the potential market opportunity; the competitive landscape for Vafseo, including generic entrants and the timing thereof; the ability of Akebia to attract and retain qualified personnel; Akebia’s ability to achieve and maintain profitability and to maintain operating expenses consistent with its operating plan; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; early termination of any of Akebia’s collaborations; and changes in the geopolitical environment and uncertainty surrounding U.S. trade policy on tariffs. Other risks and uncertainties include those identified under the heading “Risk Factors” in Akebia’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, and other filings that Akebia may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.
Akebia Therapeutics® and Vafseo® are registered trademarks of Akebia Therapeutics, Inc.

Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com

SS Innovations Reports Third Quarter 2025 Financial Results




SS Innovations Reports Third Quarter 2025 Financial Results

Quarterly Revenue Increased 192.5% Year over Year to $12.8 Million Driven by Higher SSi Mantra 3 Unit Sales

FORT LAUDERDALE, Fla., Oct. 28, 2025 (GLOBE NEWSWIRE) — SS Innovations International, Inc. (the “Company” or “SS Innovations”) (Nasdaq: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced unaudited financial results for the three and nine months ended September 30, 2025.   The Company also filed its Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, with the Securities and Exchange Commission on October 28, 2025.

Third Quarter 2025 Overview

• Revenue increased 192.5% to $12.8 million from $4.4 million in the third quarter of 2024.
• Gross margin of 48.1% compared to 52.8% in the third quarter of 2024.
• Gross profit rose 166.0% to $6.2 million from $2.3 million in the third quarter of 2024.
• Net loss of $3.7 million, or $(0.02) per diluted share, compared to a net loss of $3.2 million, or $(0.02) per diluted share, in the third quarter of 2024.
• SSi Mantra surgical robotic system installations totaled 27, up 350.0% from 6 installations in the third quarter of 2024 and up 17.4% from 23 installations in the second quarter of 2025.

First Nine Months 2025 Overview

• Revenue increased 123.0% to $28.0 million from $12.5 million in the first nine months of 2024.
• Gross margin expanded to 47.1% from 35.8% in the first nine months of 2024.
• Gross profit rose 193.7% to $13.2 million from $4.5 million in the first nine months of 2024.
• Net loss of $9.7 million, or $(0.05) per diluted share, compared to net loss of $17.2 million, or $(0.10) per diluted share, in the first nine months of 2024.
• SSi Mantra surgical robotic system installations totaled 63, up 152.0% from 25 installations in the first nine months of 2024.

As of September 30, 2025

• Long-term debt of $0.
• Cash and cash equivalents totaled $5.7 million, excluding restricted cash.
• SSi Mantra cumulative installed base totaled 127 in seven countries and cumulative surgeries reached 6,057, including 56 telesurgeries and 319 cardiac procedures.

CEO Commentary

Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “We delivered strong revenue growth in the third quarter of 2025, driven by higher unit sales of our advanced, cost-effective SSi Mantra 3 surgical robotic system in India and abroad. The SSi Mantra’s rapidly expanding installed base and increasing utilization reflect its cost advantages, ease of use, differentiated features, and compelling surgical outcomes.”

Dr. Srivastava continued, “We’ve become a leader in the large and growing India market and remain committed to democratizing access globally to cutting edge surgical robotic care. We now have regulatory approval for the SSi Mantra in seven countries and are taking steps to enter the U.S. and European Union markets. In September 2025, we successfully completed a human factors validation study at Johns Hopkins Hospital. This study will be an integral component of our upcoming 510(k) premarket notification, which we anticipate submitting to U.S. Food and Drug Administration (the “FDA”) in the fourth quarter of 2025. We also continue along the pathway towards a European Union CE marking certification in the first half of 2026. In conclusion, we are making good progress towards important regulatory milestones and remain well positioned for continuing robust organic growth in our existing markets.”

Select Business Highlights in Third Quarter 2025

• On September 9, 2025, the Company announced the successful completion of the first robotic telesurgery performed with the SSi Mantra surgical robotic system from the Mantra M mobile robotic telesurgery unit.
• On September 16, 2025, the Company announced the successful completion of the world’s first pediatric pyeloplasty telesurgery utilizing the SSi Mantra surgical robotic system.
• On September 26, 2025, the Company announced the appointment of Naveen Kumar Amar as Chief Financial Officer.
• In September 2025, the Company successfully completed a human factors validation study for the SSi Mantra at Johns Hopkins Hospital. This study will be a key component of the Company’s 510(k) premarket notification, which is expected to be submitted to the FDA in the fourth quarter of 2025.

Revenue Breakdown and Summary of Installations / Surgeries

¹ at period end

Upcoming Investor Conferences
SS Innovations is scheduled to participate in the following upcoming investor conferences:

UBS Global Healthcare Conference
Palm Beach Gardens, FL
Tuesday, November 11, 2025
Management will be available for one-on-one and small group meetings throughout the day.

Stifel 2025 Healthcare Conference
New York, NY
Wednesday, November 12, 2025
Group presentation: 4:40 p.m. Eastern Time
Management will be available for one-on-one and small group meetings throughout the day.

A live webcast and replay of the Stifel group presentation will be accessible on the Company’s website at https://ssinnovations.com/investor-overview/.

About SS Innovations
SS Innovations International, Inc. (Nasdaq: SSII) develops innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger segment of the global population. The Company’s product range includes its proprietary “SSi Mantra” surgical robotic system and its comprehensive suite of “SSi Mudra” surgical instruments, which support a variety of surgical procedures including robotic cardiac surgery. An American company headquartered in India, SS Innovations plans to expand the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions. Visit the Company’s website at ssinnovations.com or LinkedIn for more information and updates.

About the SSi Mantra
The SSi Mantra surgical robotic system is a user-friendly, modular, multi-arm system with many advanced technology features, including: 3 to 5 modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, a touch panel monitor for all patient related information display, a virtual real-time image of the robotic patient side arm carts, and the ability for superimposition of 3D models of diagnostic imaging. A vision cart provides the table-side team with the same magnified 3D 4K view as the surgeon to provide better safety and efficiency. The SSi Mantra utilizes over 40 different types of robotic endo-surgical instruments to support different specialties, including cardiac surgery. The SSi Mantra has been clinically validated in India in more than 100 different types of surgical procedures.

Forward Looking Statements
This press release may contain statements that are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “assume,” “believe,” “estimate,” “expect,” “will,” “intend,” “may,” “plan,” “project,” “should,” “could,” “seek,” “designed,” “potential,” “forecast,” “target,” “objective,” “goal,” or the negatives of such terms or other similar expressions to identify such forward-looking statements. These statements relate to future events or SS Innovations’ future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements.

Investor Contact:
The Equity Group        
Kalle Ahl, CFA                
T: (303) 953-9878        
kahl@theequitygroup.com

Devin Sullivan, Managing Director
T: (212) 836-9608
dsullivan@theequitygroup.com

Media Contact:
RooneyPartners LLC
Kate Barrette
T: (212) 223-0561
kbarrette@rooneypartners.com

IPSEN – Buy-back programme – Art 5 of MAR – Week 43 – 2025




IPSEN – Buy-back programme – Art 5 of MAR – Week 43 – 2025

Attachment

• EN_IPSEN – Buy-back programme – Art 5 of MAR – Week 43_2025

New Study Finds Online Tinnitus Course “Still Tinnitus” Effective




New Study Finds Online Tinnitus Course “Still Tinnitus” Effective

Independent research shows that the self-paced “Still Tinnitus” course can help reduce tinnitus symptoms and improve quality of life for people with tinnitus worldwide.

Amsterdam, The Netherlands, Oct. 28, 2025 (GLOBE NEWSWIRE) — New findings from a recent study involving 122 tinnitus patients indicate that the internet-based self-help program “Still Tinnitus” delivers clinically relevant tinnitus relief. The program is now available in the U.S., where tinnitus –a condition also called “ringing in the ears” – affects more than 50 million people.

Lead Researcher Dr. Annemarie van der Wal and Still Tinnitus developer Roel van Gorkum

A study published in Journal of Clinical Medicine (2025) assessed changes in tinnitus severity following participation in version 1 of the Still Tinnitus online self-paced tinnitus relief course. The research included 122 participants who fully completed the five-module intervention between March 2023 and July 2024, with outcomes assessed via the official Tinnitus Functional Index (TFI).

Key results included:

• Overall, 74.6% of participants achieved a clinically meaningful decrease in tinnitus-related distress.
• Participants reported an average TFI reduction of 27.2 points, indicating a notable decline in perceived tinnitus burden.
• Among those with acute tinnitus (≤3 months’ duration), 90.9% demonstrated measurable improvement, with average reduction of around 37.6 points within six months.

The Still Tinnitus program integrates four tinnitus treatment methods: Cognitive Behavioral Therapy (CBT), Tinnitus Retraining Therapy (TRT), Acceptance and Commitment Therapy (ACT), and Mindfulness-Based Stress Reduction.

“The Still Tinnitus course seems well suited for patients with acute tinnitus who wish to gain rapid access to evidence-based information and strategies,” said Dr. Annemarie van der Wal, lead researcher.

Roel van Gorkum, developer of the program, commented: “I am very pleased with the positive findings. With this study, we have clear indications that the course is a valuable alternative to traditional therapy formats, which often have long waiting times.”

About Still Tinnitus
Still Tinnitus was founded by Roel van Gorkum, who developed the program after experiencing tinnitus himself and finding few accessible care options. The online self-help course consists of 5 steps that integrate CBT, TRT, ACT, and mindfulness principles to support individuals in managing tinnitus. The updated version 2 of the course includes video lessons, a workbook, and an accompanying app. The program is fully online, allowing participants to progress at their own pace without the need for group therapy, waiting times, or travel.

CONTACT: Roel van Gorkum
Still Tinnitus
press@stilltinnitus.com
www.stilltinnitus.com