PTC Therapeutics

PTC Therapeutics

3mo

PTC has been named a 2026 Gallup Exceptional Workplace Award winner. This is the company’s fifth time earning this important recognition, and it reflects the culture we have cultivated by enabling our people do their best work by leading with their Strengths....Show more

PTC Therapeutics

1y

PTC has been honored with Gallup’s 2025 Exceptional Workplace Award, marking the fourth time the Company has been recognized for fostering a strong workplace culture that empowers employees by harnessing their unique strengths. PTC leverages the Clifton Strengths assessment, providing every employee with the opportunity to discover their innate talents. Our comprehensive approach to strengths development has resulted in remarkable engagement, as evidenced by: - 90% of leaders participating in Strengths-focused learning experiences - Our Coaching and Mentoring Center of Excellence, which fosters individual growth by providing employees access to a dedicated community of experienced coaches and mentors - Strong leadership commitment to a strengths-based culture - Integration of strengths into communications, development, and processes “At PTC, we take immense pride in the recognition we’ve received from Gallup,” says Hege Sollie-Zetlmayer, Chief Human Resources Officer. “This reflects our shared commitment to fostering a strengths-based culture that drives us towards excellence and fulfillment.” This achievement is a testament to our collective dedication to nurturing a work environment that enables employees to reach their full potential....Show more

PTC Therapeutics

1y

PTC Therapeutics, Inc. (NASDAQ: PTCT) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on the marketing authorization application for Sephience™ (sepiapterin) for the treatment of children and adults living with phenylketonuria (PKU). The opinion includes a broad label inclusive of all ages and disease severities. "This positive opinion is great news for the PKU patient community in Europe for whom there remains a significant unmet medical need," said Matthew B. Klein, M.D., Chief Executive Officer of PTC Therapeutics. "We look forward to initiating the European launch immediately following the adoption of this positive opinion by the European Commission. The data collected to date continue to support the potential for Sephience to provide a safe and effective treatment that not only lowers phenylalanine levels but also enables diet liberalization even for those with the most severe disease subtypes." Launch planning in Europe is well underway with priorities in Germany and other key European markets where named patient access will be immediately available....Show more

PTC Therapeutics

1y

PTC Therapeutics announced that the FDA has accepted its filing for the New Drug Application (NDA) of sepiapterin to treat pediatric and adult patients living with phenylketonuria (PKU). A Prescription Drug User Fee Act (PDUFA) target action date is expected to be provided in the Day 74 Letter. "The FDA filing acceptance for sepiapterin is a critical milestone toward bringing this potential important therapy to children and adults living with PKU in the United States," said Matthew B. Klein, M.D., Chief Executive Officer of PTC Therapeutics. "The clinical trial data, including the evidence of enabling diet liberalization, support that sepiapterin can provide significant benefit to PKU patients, helping to meet the persistent, significant unmet need in this community."...Show more

PTC Therapeutics

1y

PTC Therapeutics announced that the FDA has granted Fast Track designation to the PTC518 program for the treatment of Huntington's disease. Fast Track designation is awarded to promising therapies for diseases of high unmet need. "The granting of Fast Track designation to the PTC518 program further supports the potential of PTC518 to provide a disease-modifying therapy to Huntington's disease patients," said Matthew B. Klein, M.D., Chief Executive Officer of PTC Therapeutics. "We look forward to working collaboratively with FDA to continue to advance the program as efficiently as possible." PTC518 was discovered using PTC's innovative splicing platform, following the successful discovery and development of Evrysdi® (risdiplam) for the treatment of spinal muscular atrophy....Show more