20.6 C
New York
Wednesday, June 10, 2026

Tag: development

Italfarmaco Announces Health Canada Acceptance and Priority Review of New Drug Submission for Givinostat as a Duchenne Muscular Dystrophy Treatment

MILAN, Italy, June 10, 2026Italfarmaco S.p.A. today announced that Health Canada has accepted for review the New Drug Submission (NDS) for givinostat (Duvyzat®) for the treatment of Duchenne muscular dystrophy (DMD). Health Canada has granted givinostat Priority Review status, a designation reserved for drugs that may provide a significant improvement in the benefit-risk profile over existing therapies.

“Families affected by Duchenne muscular dystrophy in Canada currently have limited access to treatment options that can slow functional decline,” said Dr. Jean K. Mah, a Canadian investigator for the EPIDYS and OLE studies and Director of the Pediatric Neuromuscular Program at the Alberta Children’s Hospital in Calgary, Alberta. “As a clinician treating DMD patients, I am encouraged by this positive step in the Canadian regulatory progress and givinostat’s therapeutic potential demonstrated in the EPIDYS Phase 3 study."

An estimated 1000 boys in Canada are living with DMD, one of the most severe and common forms of childhood muscular dystrophy.1 As part of its commitment to the Canadian DMD community, Italfarmaco will establish a local Canadian affiliate to lead ongoing discussions with health authorities throughout the regulatory review process and to support patients and their families as well as healthcare providers. Subject to Health Canada’s review, marketing authorisation could be granted before the end of 2026.

“Duchenne muscular dystrophy places an enormous burden on boys and their families, and we understand the urgency of bringing new treatment options to communities where significant unmet need remains,” said Francesco Di Marco, Chief Executive Officer of Italfarmaco Group. “Health Canada’s acceptance of the New Drug Submission for givinostat with Priority Review is an encouraging step forward. As we expand our presence in Canada, we are committed to working with clinicians, patient organisations, and other stakeholders to support the Duchenne community and help advance access for appropriate patients, if approved.”

The submission builds on many years of clinical research, including contributions from Canadian patients, families, investigators, and three clinical trial sites in Canada. It is supported by data from the EPIDYS Phase 3 multicentre, randomized, double-blind, placebo-controlled trial (NCT02851797) evaluating givinostat in ambulant boys with DMD aged six and older. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful difference in time to complete the four-stair climb assessment in patients treated with givinostat twice daily, in addition to corticosteroids, compared to placebo and corticosteroids. During the study, the most common treatment-related adverse events (frequency ≥1/10 boys) associated with givinostat were decreased platelet count/thrombocytopenia, increased blood triglyceride/hypertriglyceridemia, diarrhoea and abdominal pain; none of the severe or serious adverse events were treatment-related or resulted in study withdrawal. givinostat tolerability was managed with appropriate monitoring and dose adjustments. No other safety concerns were observed.2 Patients from the EPIDYS study remain under observation in a long-term study assessing tolerability and efficacy, with follow-up extending up to eleven years (NCT03373968).

Givinostat has received regulatory approvals in multiple regions, including the US, the UK, the EU, and the UAE for the treatment of DMD. Additional regulatory submissions are ongoing in other geographies, reflecting Italfarmaco’s commitment to enabling access for as many individuals living with DMD as possible.


About Duchenne Muscular Dystrophy

Finnish bio-based materials project advances 100% cellulose-based film and coating technology as a scalable alternative to fossil-based packaging

A new cellulose-based material platform developed in Finland responds to tightening regulatory requirements and industry pressure to both replace and reduce plastic in packaging,...

Trinasolar and Ecohope Solar Sign 600MW MoU to Distribute Latest Vertex G3 Modules Across Southeast Asia, the Middle East and Africa

SHANGHAI, June 10, 2026 /PRNewswire/ -- Trinasolar, a global leader in smart PV and energy storage solutions, has signed a Memorandum of Understanding (MoU)...

The Work No One Sees: Marc ter Stegen and ANTHBOT Highlight Consistency Behind Performance Ahead of New TV Campaign

New TVC on ARD and ZDF delivers how quiet discipline drives both elite sport and autonomous lawn care.DÜSSELDORF, Germany, June 10, 2026 /PRNewswire/ --...

Slovak Prime Minister Meets WeRide, Signals Support for Multi-Product Autonomous Vehicle Deployment

WeRide outlined plans to commercialize its L4 AV portfolio in Slovakia during a meeting with His Excellency Mr. Robert Fico Prime Minister of Slovakia.

JETOUR’s Return of the Cheetah: Horn of Africa Wins Telly Awards

WUHU, China, June 09, 2026 (GLOBE NEWSWIRE) -- The winners of the 47th Telly Awards were officially announced. Return of the Cheetah: Horn of Africa, a public welfare documentary co-produced by JETOUR and DISCOVERY Channel, received three major honors, including Gold Winner in General-Documentary: Short Form, Silver Winner in Craft-Videography & Cinematography, and Silver Winner in General-Nature & Wildlife. The film also won a Gold Tower Award at the New York Festivals Advertising Awards, earning international recognition for its outstanding production quality and commitment to wildlife conservation.

Propurti Geeks Incorporated Celebrates Successful Launch of AI-Powered Property Management Platform at MacEwan University

Edmonton-born PropTech company draws property managers, investors, real estate operators, technology leaders, government representatives, academia, community leaders, and media to unveil the future of AI-assisted property operations
Edmonton-born PropTech company draws property managers, investors, real estate operators, technology leaders, government representatives, academia, community leaders, and media to unveil the future of AI-assisted property operations

TGS Begins First Phase of Major Offshore Seismic Dataset in Equatorial Guinea

Oslo, Norway (10 June, 2026) TGS, a leading provider of energy data and intelligence, today announced the signing of an agreement with the Ministry of Hydrocarbon and Mining Development of the Republic of Equatorial Guinea to create an offshore MegaSurvey, a large-scale multi-client seismic product.

Shattuck Labs, Inc. Announces Pricing of $75 Million Public Offering

AUSTIN, Texas and DURHAM, N.C., June 10, 2026 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (“Shattuck” or the “Company”) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of potentially first-in-class monoclonal and bispecific DR3 blocking antibodies for the treatment of patients with inflammatory and immune-mediated diseases, today announced the pricing of its previously announced a public offering of 10,879,376 shares of its common stock at a public offering price per share of $4.00 and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to 7,870,624 shares of its common stock at a public offering price of $3.9999 per pre-funded warrant. The pre-funded warrants have an exercise price of $0.0001 per share and are exercisable immediately. The aggregate gross proceeds to Shattuck from the offering are expected to be approximately $75 million before deducting underwriting discounts and commissions and other offering expenses payable by Shattuck, excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on June 11, 2026, subject to the satisfaction of customary closing conditions. In addition, Shattuck has granted the underwriters an option for a period of 30 days to purchase up to an additional 2,812,500 shares of its common stock at the public offering price, less underwriting discounts and commissions.

Harbour BioMed Announces NMPA Acceptance of IND Application for HBM7004 for the Treatment of Advanced Solid Tumors

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, June 10, 2026 /PRNewswire/ -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the...

Zoomlion’s Humanoid Robot Z01 Shines at KOMATEK 2026, Showcasing Advances in Embodied AI and Industrial Robotics

ISTANBUL, June 10, 2026 /PRNewswire/ -- Zoomlion Heavy Industry Science & Technology Co., Ltd. ("Zoomlion") attracted widespread attention at KOMATEK 2026 in Istanbul with...

HKC, ANTGAMER, KOORUI Make Strong Debut at COMPUTEX 2026 with World-First Display Innovations

TAIPEI, June 10, 2026 /PRNewswire/ -- HKC, ANTGAMER, and KOORUI have successfully concluded their presence at COMPUTEX 2026. Under the theme "Win Beyond the...

SingPost Unveils S$30 Million Automated Sortation Hub, Announces Islandwide Rollout of ‘SingPost@MyBlock’

Dual initiatives advance Group strategy by tripling parcel processing capacity to lower cost-to-serve and enhancing public convenienceSINGAPORE, June 10, 2026 /PRNewswire/ -- Singapore Post...

Rakuten Medical Announces Executive Leadership Transition to Enhance Operational Execution and Organizational Discipline as a Global, Scalable Biotech Company

Minami Maeda appointed as CEO to drive faster, more focused execution toward U.S. commercial launchMickey Mikitani will continue to provide strategic direction and remains...

- A word from our sponsors -

spot_img

Newsletter Signup

Name(Required)
Email(Required)
Privacy(Required)
This field is for validation purposes and should be left unchanged.
HomeTagsDevelopment