The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion on acoziborole Winthrop, a single-dose oral treatment for sleeping sickness (T.b. gambiense) in adults and adolescents aged 12+. The phase 2/3 study demonstrated up to 96% success rates at 18 months. Sanofi will donate the medicine to the WHO through its philanthropic foundation. This represents a significant advancement over existing treatments requiring 10-day oral regimens or injection combinations.

The European Medicines Agency's CHMP has granted a positive opinion to Acoziborole Winthrop, a single-dose oral treatment for gambiense sleeping sickness developed by DNDi and Sanofi. The therapy demonstrated up to 96% success rates at 18 months and offers a simpler alternative to existing multi-day regimens. Sanofi will donate the medicine to WHO, with approval in endemic countries expected to support WHO's goal of eliminating the disease by 2030.

Cytokinetics announced FDA approval of MYQORZO (aficamten) for symptomatic obstructive hypertrophic cardiomyopathy in December 2025, with U.S. commercial launch underway and first prescriptions dispensed. The company also received approvals from China's NMPA and European Commission. Cytokinetics reported $1.22 billion in cash and investments as of December 31, 2025, with 2026 guidance of $830-870 million in combined R&D and SG&A expenses. The company expects to report topline results from ACACIA-HCM in Q2 2026 and launch in Germany in Q2 2026.

The FDA approved Dupixent (dupilumab), a partnership between Regeneron Pharmaceuticals and Sanofi, for treating allergic fungal rhinosinusitis (AFRS) in patients aged six and older with a history of sino-nasal surgery. The approval is based on Phase 3 trial results showing effectiveness in reducing nasal symptoms and the need for systemic corticosteroids or surgery. Dupixent is now approved for nine distinct diseases driven by type 2 inflammation. However, REGN shares declined 0.77% at the time of publication, trading below key moving averages despite the approval.

The FDA granted Breakthrough Therapy Designation to Johnson & Johnson's Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for treating advanced, HPV-unrelated head and neck squamous cell carcinoma in adults. The drug is being evaluated in combination with Merck's Keytruda in an ongoing Phase 3 trial. Additionally, J&J extended its contract with Trellus Health for patient support services through mid-2026.

The Turner Syndrome market is projected to grow from USD 1.93 billion in 2025 to USD 3.67 billion by 2033, with a CAGR of 8.39%. Growth is driven by advances in genomic diagnostics, increased awareness, government-backed rare disease initiatives, and expanding hormone replacement therapies. North America leads with 37.70% market share, while Asia-Pacific is expected to grow fastest at 9.43% CAGR.

Sanofi announced the filing of its 2025 Form 20-F with the SEC and its Document d'Enregistrement Universel with the French AMF, containing complete audited financial statements. The documents are available on Sanofi's website, the SEC website, and the AMF website, with hard copies available upon request.

Sanofi announced the filing of its 2025 Universal Registration Document containing the Annual Financial Report with the French AMF and its Form 20-F with the US SEC. The documents include corporate governance reports, auditor information, share buyback programs, and sustainability information.

Teva Pharmaceutical and Sanofi announced positive results from the RELIEVE UCCD study of duvakitug, an investigational treatment for inflammatory bowel disease. The study demonstrated durable clinical efficacy over 44 weeks, with 58% of ulcerative colitis patients and 55% of Crohn's disease patients achieving primary endpoints at the 900 mg dose. TEVA shares rose 2.85% in premarket trading on the news.

Teva and Sanofi announced positive phase 2b long-term extension results for duvakitug, an investigational monoclonal antibody targeting TL1A for treating ulcerative colitis and Crohn's disease. The study showed durable clinical and endoscopic efficacy maintained over 44 weeks in patients who initially responded to induction therapy, with remission rates of 47-58% in UC and 41-55% in CD depending on dosage. The drug was well tolerated with safety consistent with prior studies, supporting ongoing phase 3 development programs.

Sanofi and Teva announced positive phase 2b long-term extension results for duvakitug, an investigational monoclonal antibody targeting TL1A for treating ulcerative colitis and Crohn's disease. The RELIEVE UCCD LTE study showed durable clinical and endoscopic efficacy maintained over 44 weeks in patients who initially responded to induction therapy, with remission rates of 47-58% in UC and 41-55% in CD depending on dosage. The drug was well tolerated with safety consistent with prior studies, supporting ongoing phase 3 development programs.

Sanofi and Teva announced positive Phase IIb results for duvakitug, an experimental monoclonal antibody targeting TL1A, in treating ulcerative colitis and Crohn's disease. The RELIEVE UCCD LTE maintenance study showed sustained clinical and endoscopic efficacy over 44 weeks in patients who responded to initial induction therapy, with remission rates of 47-58% in UC and endoscopic response rates of 41-55% in CD. The drug was well-tolerated with a safety profile consistent with earlier studies. Both companies are advancing duvakitug into Phase III trials.