LUNDBECK, LLC

Roche and Prothena's prasinezumab, targeting alpha-synuclein for Parkinson's, missed primary endpoint in phase 2b PADOVA trial but showed numerical delay in motor progression and positive trends on secondary endpoints. Roche plans further exploration and collaboration with Parkinson's community.

Despite headwinds, the techbio sector continues to attract significant investment and drive innovation, exemplified by the 2024 launch of Xaira, backed by over $1 billion, aiming to design novel therapeutic proteins using advanced AI. The sector is maturing through strategic consolidation, significant capital deployment, technical diversification, and steady clinical validation, as illustrated by 25 techbio organizations, including notable players like Isomorphic Labs, Generate:Biomedicines, Recursion Pharmaceuticals, and Schrödinger Inc., all leveraging AI for drug discovery. Emerging players such as Archon Biosciences, AION Labs, and Antiverse are also making strides, while established companies like Insilico Medicine and Ginkgo Bioworks continue to expand their platforms and partnerships.

Optum Rx prefers Amgen’s Amjevita over Sandoz’s Hyrimoz and Cyltezo on its 2025 commercial formularies, aiming to reduce costs and improve affordability. Humira remains on the formulary but with stricter controls. Biosimilars, including Humira’s, have struggled with adoption despite cost savings potential. Optum Rx also adds and removes various oncology and CNS medications for 2025.

Optum Rx prefers Amgen’s Amjevita over Sandoz’s Hyrimoz and Cyltezo on its 2025 commercial formularies, aiming to reduce costs and improve affordability. Humira remains on the formulary but is subject to prior authorization. Biosimilars have struggled with low adoption despite cost advantages, but large PBMs like CVS Health are shifting towards biosimilars. Optum Rx also adds and removes various oncology and CNS medications from its 2025 formulary.

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Lundbeck presents data on bexicaserin, a potential treatment for Developmental and Epileptic Encephalopathies (DEEs), at the 2024 AES Annual Meeting, highlighting its Breakthrough Therapy Designation and potential to address unmet needs in severe epilepsies.

Intra-Cellular Therapies seeks FDA approval for Caplyta as an adjunct treatment for major depressive disorder (MDD), potentially expanding its market to over $1 billion. Caplyta, already approved for schizophrenia and bipolar disorder, saw Q3 sales of $175 million, with Q4 projections at least $193 million. The MDD submission is based on Phase III trials showing symptom improvement when paired with an antidepressant. Jefferies estimates a 90–95% approval likelihood, predicting a company valuation of $9–12 billion. Intra-Cellular is also exploring Caplyta for autism and developing ITI-214 for Parkinson’s and ITI-333 for opioid use.

Lundbeck initiates MASCOT, a phase III trial assessing amlenetug's efficacy and safety for Multiple System Atrophy (MSA). Amlenetug, a monoclonal antibody targeting extracellular α-synuclein, aims to slow MSA's clinical progression. The trial includes a 72-week double-blind phase and an open-label extension, conducted globally.

Lundbeck announces new late-stage study for drug treating rare neurological disorder.