Neurocrine Biosciences amends collaboration with Takeda for osavampator
- Neurocrine gains exclusive worldwide rights to develop and commercialize osavampator, excluding Japan.
- Takeda reacquires rights for osavampator in Japan, with both companies eligible for royalty payments.
- Neurocrine plans to initiate a Phase 3 program for osavampator in the first half of this year.
- Osavampator is a potential first-in-class AMPA positive allosteric modulator for major depressive disorder.
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First participant dosed in Tisento Therapeutics’ global Phase 2b PRIZM study evaluating zagociguat for the treatment of MELAS
- Tisento Therapeutics has dosed the first participant in the global Phase 2b PRIZM study for MELAS treatment.
- The study evaluates the efficacy and safety of oral zagociguat, with a crossover design involving 44 participants.
- Participants will receive zagociguat and placebo in two 12-week periods, with a 4-week washout in between.
- The study is enrolling in North America, Europe, and Australia, with potential open-label extension for participants.
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Atalanta Therapeutics secures $97 million to advance RNAi therapies for CNS diseases
- Atalanta Therapeutics completed a $97 million Series B financing to support Phase 1 trials for RNAi therapies targeting KCNT1-related epilepsy and Huntington’s disease.
- The financing was co-led by EQT Life Sciences and Sanofi Ventures, with participation from several other investors.
- The funds will help progress the company’s di-siRNA platform, which aims to silence disease-promoting genes in the brain and spinal cord.
- Atalanta plans to submit IND applications this year to initiate Phase 1 trials for their investigational therapies, ATL-201 and ATL-101.
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Sarepta Therapeutics announces results from Part 2 of the EMBARK study
- Part 2 of the EMBARK study showed sustained benefits and disease stabilization in Duchenne muscular dystrophy patients treated with ELEVIDYS.
- Crossover-treated patients improved significantly on the North Star Ambulatory Assessment (NSAA) compared to external controls.
- Two-year results indicated continued divergence from the natural history of the disease, with minimal progression in muscle pathology.
- ELEVIDYS is approved for use in several countries, with Sarepta handling U.S. commercialization and Roche responsible for global approvals.
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Anavex Life Sciences expands patent portfolio with new U.S. patent for blarcamesine
- Anavex Life Sciences has been granted a new U.S. patent for crystalline forms of blarcamesine, covering various dosage forms.
- The patent is expected to remain in force until at least July 2039, expanding Anavex's existing intellectual property portfolio.
- The patent includes transdermal patches and enteric coated oral dosage forms for neuroprotection and treatment of neurodegenerative disorders.
- This development highlights Anavex's expertise in novel therapeutic forms and formulations.
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Apellis receives approval of SYFOVRE (pegcetacoplan) in Australia for geographic atrophy
- The Therapeutic Goods Administration (TGA) has approved SYFOVRE for treating geographic atrophy (GA) in Australia.
- SYFOVRE is the first approved treatment for GA, a leading cause of blindness, in Australia.
- Approval is based on Phase 3 OAKS and DERBY studies, showing slowed GA progression and a well-tolerated safety profile.
- SYFOVRE is already approved in the United States, and this marks its expansion into the Australian market.
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