Camurus AB received a complete response letter (CRL) from the U.S. FDA for CAM-2029 (octreotide), its extended-release injection for acromegaly, due to “facility-related deficiencies” identified during a cGMP inspection of a third-party manufacturer. The Lund, Sweden-based company noted that the CRL did not indicate any concerns related to clinical efficacy or safety. Camurus will work with the FDA and the third-party manufacturer to address the concerns, said Fredrik Tiberg, president and CEO.
It’s a go for the two phase III Ensure studies of Immunic Inc.’s lead asset in treating relapsing multiple sclerosis. An unblinded data monitoring committee’s interim futility analysis concluded that the placebo-controlled, pivotal studies using vidofludimus calcium may continue as planned, with the program expected by the company to be completed in 2026.
Targeting NMDA in mental health has chalked wins but not universally, as shown by Sage Therapeutics Inc.’s failure of the placebo-controlled phase II Lightwave study testing dalzanemdor in Alzheimer's disease, which missed the primary outcome measure, another bit of bad luck from the company that was disclosed Oct. 8.
Backed by AI technology, Aigen Sciences Inc. raised ₩12 billion (US$8.8 million) in a series A financing round to further advance its cancer and rare disease drug pipelines.
Cureverse Inc. and Angelini Pharma SpA signed a potential $360 million deal for CV-01, an oral small-molecule candidate for Alzheimer’s disease and neurological disorders like epilepsy. As a novel candidate, CV-01 suppresses neuroinflammatory reactions through the Kelch-like ECH-associated protein 1 and nuclear factor erythroid 2-related factor signaling pathway.
Seaport Therapeutics Inc. has followed up its recent fundraiser with an oversubscribed $225 million series B financing that will help set it on the path to a phase IIb study in major depressive disorder. The company’s lead candidate is allopregnanolone, an endogenous neurosteroid that is taken orally and bypasses the liver. Once it is absorbed through the lymphatic system, allopregnanolone enters through a pathway that avoids the liver and the possibility of hepatoxicity and elevated liver enzyme counts, Michael Chen, Seaport’s chief scientific officer, told BioWorld.
With two complete response letters in the rearview mirror, Abbvie Inc.’s Vyalev (foscarbidopa/foslevodopa) has been approved by the U.S. FDA for treating Parkinson’s disease. The drug is the first subcutaneous 24-hour infusion of levodopa-based therapy for treating motor fluctuations in adults with advanced disease.
Backed by AI technology, Aigen Sciences Inc. raised ₩12 billion (US$8.8 million) in a series A financing round to further advance its cancer and rare disease drug pipelines.
Atavistik Bio Inc. has nominated an orally bioavailable selective allosteric AKT1 E17K inhibitor, ATV-1601, as a development candidate for AKT1 E17K-driven cancers.
Gilead Sciences Inc. terminated a potential $785 million licensing deal with Yuhan Corp. inked in 2019 to develop metabolic dysfunction-associated steatohepatitis (MASH) therapies.
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