Latest news with #ChiesiGroup
Yahoo
24-06-2025
- Business
- Yahoo
Gossamer Bio Completes Enrollment for Phase 3 PROSERA Study of PAH Drug Seralutinib
Gossamer Bio Inc. (NASDAQ:GOSS) is one of the best biotech stocks to invest in now. On June 16, Gossamer Bio announced the completion of enrollment for its global registrational Phase 3 PROSERA Study. The study is evaluating seralutinib in patients with Functional Class II and III PAH. Seralutinib is being jointly developed by Gossamer Bio and the Chiesi Group under a global collaboration agreement. Enrollment for the PROSERA study officially closed on June 11. The study is a double-blind, placebo-controlled clinical trial designed to assess seralutinib's efficacy when administered in addition to standard PAH therapy. Patients in the trial are randomly assigned in a 1:1 ratio to either the seralutinib or placebo groups and will receive blinded treatment for up to 48 weeks. A hand holding up a glass vial containing a biopharmaceutical therapy. The primary endpoint for the PROSERA Study is the change in six-minute walk distance (6MWD) from baseline compared to placebo at Week 24. Key secondary endpoints include time to clinical worsening, as compared to placebo, up to Week 48, along with other secondary and exploratory endpoints, and an evaluation of safety and tolerability. Topline results from the Phase 3 PROSERA Study are anticipated in February 2026. Gossamer Bio Inc. (NASDAQ:GOSS) is a clinical-stage biopharmaceutical company that develops and commercializes seralutinib for the treatment of pulmonary arterial hypertension/PAH in the US. Chiesi Farmaceutici is a pharmaceutical firm that researches, develops, produces, and markets medicines for respiratory, neonatology, rare diseases, and special care therapeutic areas. While we acknowledge the potential of GOSS as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey.
Business Wire
19-06-2025
- Health
- Business Wire
Chiesi Global Rare Diseases Awards Research Grants to Advance Innovation in Lysosomal Diseases
PARMA, Italy--(BUSINESS WIRE)--Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative solutions for people living with rare diseases, today announced the recipients of its "Find For Rare" research grant program. The independently assessed, expert-led research grant initiative aims to improve patient care and management by recognising innovative research in three lysosomal diseases: Fabry disease, alpha-mannosidosis, and cystinosis. Chiesi Global Rare Diseases Awards Research Grants to Advance Innovation in Lysosomal Diseases Share The selected projects demonstrated significant potential to address unmet needs within these rare communities. The recipients include: Fabry disease: Mitra Tavakoli, University of Exeter, Exeter, UK, for her project "FAB-PAIN: Precise phenotyping of neuropathy using a range of novel biomarkers in Fabry Disease' Project overview: This project aims to explore a range of novel biomarkers to better understand the pain pathways and its pathophysiology in Fabry disease. The findings may lead to the development of a range of new neuropathic biomarkers, advancing the understanding of disease mechanisms and facilitating the creation of diagnostic tools and therapeutic interventions. Alpha-mannosidosis: Margarita Dinamarca, University of Basel, Basel, Switzerland, for her project "Investigating brain endothelial dysfunction in alpha-mannosidosis" Project Overview: This research is significant for its dual contributions: unraveling the mechanisms by which alpha-mannosidosis disrupts endothelial cell function and pioneering a targeted therapeutic strategy using nanocarriers Cystinosis: Francesco Bellomo, Ospedale Pediatrico Bambino Gesù – IRCCS, Rome, Italy, for his project "Study of molecular mechanisms underlying the effects of ketogenic diet in cystinosis" Project Overview: This research project investigates the potential of a ketogenic diet to treat nephropathic cystinosis, a rare genetic disorder leading to kidney disease. By studying the diet's effects in murine models, significant reductions in symptoms such as Fanconi syndrome, inflammation, and fibrosis were observed. The project aims to develop an in vitro system to further explore the molecular mechanisms behind these benefits, potentially enabling the discovery of new therapeutic options. Applications opened for submission on August 08, 2024, and a total of 82 applications from 23 countries were received. All submitted applications were evaluated by a steering committee of 10 independent leading experts in the field of Lysosomal Diseases, who received an honorarium for participating and reviewing the research projects. Details regarding the application criteria can be located here. "Fabry disease, alpha-mannosidosis, and cystinosis are rare and ultra-rare lysosomal diseases causing severe, progressive, lifelong challenges, often complicated by diagnostic delays due to their complex and gradual progression," said Enrico Piccinini, Senior Vice President, EU and International, Rare Diseases at Chiesi Group. "Further research is vital for better diagnostics, new management options, and improved patient outcomes. The selection of these three projects through 'Find For Rare' highlights our deep commitment to advancing Lysosomal Diseases care by fostering crucial innovation to meet the evolving needs of patients and their families." Chiesi hosted a ceremony on June 18, 2025, at Chiesi's headquarters in Parma, Italy, to formally recognise the grant recipients and their innovative research. 'The quality and scientific rigor of the proposals submitted to Find For Rare this year were impressive. Each selected project stood out for its potential to address real, day-to-day challenges faced by patients and caregivers affected by lysosomal diseases,' said Prof. Christina Lampe, Chair of the Find For Rare Steering Committee. 'By supporting research that is both innovative and patient-focused, this program helps accelerate the translation of science into meaningful impact for rare disease communities.' About Find For Rare The Find For Rare Research Grant Initiative has been designed to support original research projects that advance knowledge in the fields of Fabry disease, alpha-mannosidosis, and cystinosis. The categories of research eligible for funding are projects aimed at improving understanding of the factors affecting diseases, from pathogenesis to progression, and studies of patient tailored clinical management. Research grants were provided to organisations operating in the health or scientific research sector. Proposals were welcome from all global regions other than the Americas, with application documents required to be in English. About Lysosomal Diseases Lysosomal Diseases are inborn errors of metabolism that are characterised by an abnormal build-up of substances in the body's cells as a result of enzyme deficiencies. 1 The build-up of these substances can affect different parts of the body, including the skeleton, central nervous system (brain), lungs, heart, and eyes. Whilst there has been progress in clinical knowledge, more research in Lysosomal Diseases can be beneficial. 1 About Chiesi Group Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company's mission is to improve people's quality of life and act responsibly towards both the community and the environment. By adopting the legal form of Benefit Corporation in Italy, the US, France and Colombia, Chiesi's commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,500 employees. The Group's research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. About Chiesi Global Rare Diseases Chiesi Global Rare Diseases is a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases. As a family business, Chiesi Group strives to create a world where it is common to have a therapy for all diseases and acts as a force for good, for society and the planet. The goal of the Global Rare Diseases unit is to ensure equal access so as many people as possible can experience their most fulfilling life. The unit collaborates with the rare disease community around the globe to bring voice to underserved people in the health care system. UK-CHI-2500657 June 2025
Yahoo
16-06-2025
- Business
- Yahoo
Gossamer Bio Announces Completion of Enrollment in Registrational Phase 3 PROSERA Study for the Treatment of PAH
- Enrollment Completed in Ongoing Registrational PROSERA Phase 3 Study in PAH - - Topline Results Announcement from PROSERA Phase 3 Expected in February 2026 - - Blinded Preliminary Baseline Characteristics Align with Intended Study Population - SAN DIEGO, June 16, 2025--(BUSINESS WIRE)--Gossamer Bio, Inc. (Nasdaq: GOSS), a late-stage, clinical biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), today announced enrollment completion for the ongoing, global registrational Phase 3 PROSERA Study evaluating seralutinib in Functional Class II and III PAH patients. Gossamer Bio and the Chiesi Group are jointly developing seralutinib under a global collaboration agreement. "Completing enrollment for the Phase 3 PROSERA Study represents an important step forward in our mission to develop seralutinib as a potential first-in-class treatment option for PAH," said Faheem Hasnain, CEO, Chairman and Co-founder of Gossamer Bio. "We are deeply grateful to the patients, caregivers, and investigators who made this possible through their dedication and partnership." Mr. Hasnain continued, "Building on insights from the Phase 2 TORREY Study, we focused on selecting a patient population that aligns closely with the study's objectives and is more likely to exhibit a clinically significant benefit in 24 weeks. Given the preliminary baseline characteristics of PROSERA, we firmly believe that we have accomplished this patient selection goal. We are eager to be able to share topline results from this registrational study early next year." Enrollment in the ongoing Phase 3 PROSERA Study was closed on June 11th. The Phase 3 PROSERA Study is a double-blind, placebo-controlled, global registrational clinical trial evaluating seralutinib in PAH patients, on top of background PAH therapy. Patients are assigned 1:1 to either the seralutinib or placebo arms. Patients receive blinded treatment for up to 48 weeks. The primary endpoint of the PROSERA Study is change in six-minute walk distance (6MWD) from baseline as compared to placebo at week 24. Included in the key secondary endpoints is time to clinical worsening, as compared to placebo, up to week 48. In addition to other secondary and exploratory endpoints, safety and tolerability will be evaluated. The patient population enrolled in PROSERA aligns with the target demographic, as evidenced by the preliminary baseline characteristics. The PROSERA Study utilizes enrichment criteria, including the REVEAL Lite 2 Risk Score and other criteria, to identify patients more likely to show a greater magnitude of effect on 6MWD at week 24, as informed by the Phase 2 TORREY study. We expect to announce topline results from the ongoing Phase 3 PROSERA Study in February 2026. Baseline Characteristics: PROSERA Study (Phase 3) v. TORREY Study (Phase 2) PROSERA Phase 3* TORREY Phase 2 Study Participants n = 390 n = 86 Mean 6MWD 374 meters 408 meters Mean NT-proBNP 987 ng/L 628 ng/L Functional Class III Patients 289 (74%) 36 (42%) Geographic Distribution North America: 75 (19%) Rest of World: 315 (81%) North America: 59 (69%) Rest of World: 27 (31%) *Baseline characteristics are preliminary and subject to change. About Gossamer Bio Gossamer Bio is a late-stage, clinical biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Its goal is to be an industry leader in, and to enhance the lives of patients living with, pulmonary hypertension. Forward-Looking Statements Gossamer cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the anticipated timing of a data readout from our Phase 3 PROSERA Study; the potential or likelihood for a meaningful data readout from our PROSERA Study; and the first-in-class commercial potential of seralutinib. The inclusion of forward-looking statements should not be regarded as a representation by Gossamer that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Gossamer's business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; disruption to our operations from unexpected events, including clinical trial delays; the Company's dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; the success of Gossamer's clinical trials and preclinical studies for seralutinib; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of seralutinib that may limit its development, regulatory approval and/or commercialization, or may result in clinical holds, recalls or product liability claims; Gossamer's ability to obtain and maintain intellectual property protection for seralutinib; Gossamer's ability to comply with its obligations in collaboration agreements with third parties or the agreements under which it licenses intellectual property rights from third parties; unstable market and economic conditions and adverse developments with respect to financial institutions and associated liquidity risk may adversely affect our business and financial condition and the broader economy and biotechnology industry; Gossamer may use its capital resources sooner than it expects; and other risks described in the Company's prior press releases and the Company's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in the Company's annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Gossamer undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. View source version on Contacts For Investors and Media: Bryan Giraudo, Chief Operating Officer & Chief Financial OfficerGossamer Bio Investor Relationsir@ Sign in to access your portfolio
Hamilton Spectator
11-06-2025
- Business
- Hamilton Spectator
Chiesi Group Enters into Worldwide Licensing Agreement with Key2Brain AB to Advance Blood-Brain Barrier-Crossing Therapies for Lysosomal Storage Disorders
Collaboration will leverage Key2Brain's technology to develop blood-brain barrier-crossing enzyme replacement therapies for lysosomal storage disorders Agreement is built on a partnership initiated in 2022, supporting continued development led by positive in vivo proof-of-concept data demonstrating the potential of Key2Brain's technology PARMA, Italy and STOCKHOLM, June 11, 2025 (GLOBE NEWSWIRE) — Chiesi Group and Key2Brain today announced a worldwide license agreement to advance the development of two blood-brain barrier (BBB)-crossing recombinant enzyme replacement therapies (ERT) for lysosomal storage disorders (LSD), including alpha-mannosidosis (aMann) and Krabbe disease (KD), ultra-rare diseases that affect the central nervous system. The agreement also includes a framework for the parties to include additional enzymes into the collaboration, enabling the expansion of Chiesi's BBB-crossing ERT portfolio and further strengthening its development capabilities. The advancement of these programs will also contribute to Key2Brain's goal of establishing its technology as a leading BBB-crossing platform. At Chiesi Group, these programs are spearheaded by Chiesi Global Rare Diseases, the Group's dedicated business unit focused on research, development, and commercialization of therapies for rare and ultra-rare conditions. 'At Chiesi Global Rare Diseases, we are deeply committed to building a sustainable pipeline in rare diseases by embracing emerging technologies that can enhance the treatment landscape,' said Giacomo Chiesi, Executive Vice President, Chiesi Global Rare Diseases. 'This agreement exemplifies that vision— working to address areas of profound unmet medical need, including neurodegenerative manifestations of ultra-rare diseases like alpha-mannosidosis and Krabbe disease. For too many families, there are still no therapeutic options. Our goal is to bring them hope.' Under the terms of the agreement, Key2Brain will provide Chiesi Group with a worldwide, royalty- bearing license to develop and commercialize two BBB-crossing ERTs. This agreement is built on an existing research collaboration that aimed to develop the production of a BBB-crossing recombinant alpha-mannosidase. Key2Brain will receive an upfront payment and is eligible to receive development and sales-based milestone payments and tiered royalties on potential sales. Chiesi Group will fund all research, development, and subsequent commercialization worldwide. As part of this agreement, there is also a possibility, upon mutual agreement, for the parties to expand the license to Key2Brain's BBB-crossing technology platform for the development of additional BBB-crossing ERTs. 'This exciting collaboration continuation with Key2Brain represents a strategic opportunity to build on the progress we've already made together,' said Mitch Goldman, Senior Vice President R&D, Chiesi Global Rare Diseases. 'By combining our deep therapeutic expertise with Key2Brain's proprietary BBB-crossing platform technology, we aim to enhance the biodistribution, efficacy and tolerability of promising therapies that have historically faced challenges reaching the central nervous system. Together, our goal is to unlock new therapeutic pathways for patients with lysosomal storage disorders, ultimately delivering meaningful and lasting innovation.' Elisabet Sjöström, Ph.D., Founder and CEO, Key2Brain, said, 'Expanding our relationship with Chiesi Global Rare Disease allows us to build on a clinically validated foundation to address the neurological complications of lysosomal storage disorders, including alpha-mannosidosis and Krabbe disease. Through this agreement, we aim to accelerate the research of potential breakthrough therapies that address these neurodegenerative conditions. We believe this partnership serves as a testament to the versatility and competitiveness of our BBB-crossing technology, unique features that are being utilized in Key2Brain's development of our proprietary next-generation brain-targeting therapies.' This collaboration leverages Key2Brain's proprietary BBB-crossing platform technology and Chiesi Global Rare Diseases' capabilities and expertise in this ultra-rare disease landscape, creating a path to advance the ongoing aMann-K2B program as well as initiate new preclinical programs that apply Key2Brain's technology to other LSDs. About Chiesi Group Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company's mission is to improve people's quality of life and act responsibly towards both the community and the environment. By changing its legal status to a Benefit Corporation in Italy, the US, France and Colombia, Chiesi's commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,500 employees. The Group's research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. For more information visit: About Chiesi Global Rare Diseases Chiesi Global Rare Diseases is a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases. As a family business, Chiesi Group strives to create a world where it is common to have a therapy for all diseases and acts as a force for good, for society and the planet. The goal of the Global Rare Diseases unit is to ensure equal access so as many people as possible can experience their most fulfilling life. The unit collaborates with the rare disease community around the globe to bring voice to underserved people in the health care system. For more information visit: . Follow @ChiesiGlobalRareDiseases on LinkedIn, Facebook, Instagram, X and YouTube. About Key2Brain Key2Brain is a Swedish biotechnology company dedicated to developing next generation brain targeting therapeutics utilizing its proprietary blood-brain barrier-crossing (BBB-crossing) technology. The technology enables efficient brain uptake and broad distribution of CNS-therapeutics, utilizing small and flexible antibody fragments (VHHs). Key2Brain's VHHs can be integrated into a wide range of therapeutic molecules. The pipeline is being developed internally and in partnerships where Key2Brain's team leverages extensive industry experience in biologics and brain-targeting drugs, accelerating the translation from discovery to the clinic. Key2Brain was founded 2020 and is based in Stockholm. For more information visit: About Key2Brain's technology platform Key2Brain's technology enables efficient brain uptake and broad distribution of therapeutics, utilizing small (<15kDa) engineered single domain VHH antibodies with monovalent specificity for the Transferrin Receptor (TfR). The technology provides opportunities for the development of next generation brain targeting across a diverse range of therapeutic areas. Key2Brain's VHH technology can be efficiently integrated into or combined with therapeutic molecules without impacting either the disease target specificity, or the binding of transferrin to TfR. The modular and flexible platform is being applied to peptides, proteins, enzymes, and oligonucleotides. Key2Brain's VHHs can be expressed in both prokaryotic and eukaryotic systems and purified using commercial large-scale affinity purification systems. The proprietary platform includes species cross-reactive (human/primate/mouse) as well as human/primate specific binders together with a humanized TfR mouse model for translational studies. Chiesi Global Rare Diseases Media Contact Sky Striar LifeSci Communications sstriar@ Key2Brain Media Contact Benjamin Nordin, CBO Key2Brain
Reuters
05-06-2025
- Business
- Reuters
Italy's Chiesi Group plans acquisitions to boost sales to 6 billion euros by 2030
PARMA, Italy June 5 (Reuters) - Italy's Chiesi Group is aiming to significantly increase the number of patients it treats from around 10 million and its sales to 6 billion euros ($6.9 billion) by 2030, helped by acquisitions, its CEO Giuseppe Accogli said in an interview. The family-owned group, which provides treatment for rare diseases and respiratory conditions such as asthma and COPD, is scouting the market to see if there are opportunities to buy a new company to help achieve its ambition of doubling sales, but says there is no rush. "We are looking in respiratory, in specialty pharma and in rare diseases, not only in Italy, but also globally. I think every year is a good year if we find a good asset that will fit strategically with our portfolio," Accogli said. The last major acquisition by Chiesi dates back to 2023 when it bought rare diseases specialist Amryt for some $1.5 billion, shortly before Accogli took the CEO role. He declined to comment on whether the group has approached listed Italian rival Recordati ( opens new tab in the recent past. "I don't think we can share that, but we always look at everything that is available," he said in an interview at the group's headquarters in Parma, northern Italy. Chiesi has no debt and earns around 1 billion euros each year in EBITDA so the company "has firepower to grow both organically and inorganically and to reach between five and six billion euros of sales with our own resources," Accogli underlined. Regarding the sales goal, around 10-15% should come through inorganic opportunities "that we are scouting". The current year has started well and the CEO is confident of ending it with revenue "growth of more than half single digits" compared to 13% growth reached in 2024 at 3.4 billion euros. On the U.S. tariff front, Accogli said that the situation is still very confused. "Many things have been said. Right now, none of them have gone into action, which doesn't mean that they will not. So we keep monitoring and see. But things change by the day." The CEO is aware that meeting patients' growing therapeutic demand may eventually require establishing a manufacturing presence in the U.S to complement existing sites in France, Italy and Brazil but nothing concrete is planned for the moment. ($1 = 0.8754 euros)
