Calcitonin gene-related peptide

Satsuma Pharmaceuticals faces FDA approval delays for STS101, a dry powder intranasal migraine therapy, due to manufacturing issues. Competing with Impel Neuropharma's Trudhesa and Bausch Health's Migranal, STS101 aims to improve on Migranal's limitations. Despite setbacks, Satsuma plans to resubmit after addressing FDA concerns, without new clinical trials.

Biotech companies await key FDA decisions in January 2025, including Atara Biotherapeutics' Tab-cel for EBV+ PTLD, Biogen's Leqembi for Alzheimer's, AstraZeneca's Datopotamab Deruxtecan for breast cancer, Vertex's Suzetrigine for acute pain, and Axsome's AXS-07 for migraine.

Qulipta (atogepant), a newer migraine pill, reduces migraine risk by 37% to 61% from the first day, offering quick relief. Despite its higher cost compared to generic triptans, it significantly improves patients' quality of life by effectively blocking CGRP, a protein involved in migraine attacks.

Pain-sensing nerves and immune cells interact to worsen endometriosis in mice, suggesting CGRP-inhibiting drugs used for migraines could treat the disorder. Current treatments are limited, and endometriosis research is underfunded.

Lundbeck's Vyepti® (eptinezumab) met primary and secondary endpoints in phase III SUNRISE trial, showing significant reductions in monthly migraine days and early preventive effects, with plans to discuss regulatory approval for Asian markets.

Click Therapeutics, a software as a medical device biotech company, focuses on creating digital medicines to address cognitive deficits in the brain. The company operates a hybrid model with global pharma partnerships and internal FDA-approved assets. Click's approach is data-driven, aiming to achieve drug-like outcomes and disrupt existing drug classes. The company's strategy pivoted towards partnerships during market downturns, preserving capital and scaling the business. Click's digital drugs, like those for migraine, aim to complement existing therapies and improve patient outcomes. The FDA's PDURS guidance is seen as a game changer, potentially accelerating the digital therapeutics market by creating a pathway for combining digital drugs with traditional drugs in clinical trials.