Biogen

Vertex Pharmaceuticals' VX-548, a non-opioid pain medication, showed safety and efficacy in trials but offered modest pain relief compared to opioids. Despite the opioid crisis driven by illicit drugs, prescription opioids remain widely used due to their effectiveness and low cost. Non-opioid treatments face clinical and reimbursement challenges, with limited success in development. VX-548 aims to address chronic pain, an area with higher addiction risks. Reimbursement hurdles persist for non-opioid therapies, complicating their adoption despite the need for alternatives.

Denali Therapeutics and Sanofi's experimental ALS drug failed in a mid-stage study to slow motor function decline, marking another setback in ALS treatment development. The drug aimed to inhibit a protein contributing to neurodegeneration. Sanofi will continue testing the drug for multiple sclerosis.

Denali Therapeutics and Sanofi's ALS drug failed to slow motor function decline in a mid-stage study, marking another setback in ALS treatment development. Despite this, Sanofi will continue testing the drug for multiple sclerosis. ALS affects thousands in the U.S., with few FDA-approved treatments available.

Biogen reported disappointing Q4 results with earnings and sales missing estimates, leading to a share price drop. Gilead announced a $4.3 billion acquisition of CymaBay, adding seladelpar to its pipeline, expected to close this quarter and boost future revenue.

NeuroSense Therapeutics Ltd. regained compliance with Nasdaq's minimum bid price requirement, maintaining a closing bid price of $1.00 or more for 10 consecutive days. The company focuses on developing treatments for neurodegenerative diseases, with recent positive results from the Phase 2b PARADIGM trial for PrimeC.

In 2023, the FDA approved 55 new molecular entities, a significant increase from 37 in 2022, with 56% being small-molecule therapies. Notable approvals included Eisai and Biogen’s Leqembi for Alzheimer’s, and the first CRISPR-based treatment, Casgevy, for sickle cell disease.

Eisai announced the Scientific Advisory Group (SAG) will discuss lecanemab's Marketing Authorisation Application (MAA) in the EU, with a decision expected in Q2 2024. Lecanemab, developed with BioArctic, is a treatment for Alzheimer's, approved in the US, Japan, and China. BioArctic plans to commercialize lecanemab in the Nordic region with Eisai.

Biogen and Eisai's Alzheimer's drug Leqembi received full FDA approval, enabling broader Medicare coverage. Novavax's stock surged after amending its vaccine deal with Canada, involving a $349.6M payment. Caribou Biosciences gained from Pfizer's $25M investment, advancing its CAR-T cell therapy. Prothena secured a $55M deal with Bristol Myers Squibb for Alzheimer's treatment rights.

Biogen Inc. reported Q2 2023 earnings of $4.02 per share, beating estimates, despite a 23% year-over-year decline. Sales fell 5% to $2.46 billion, impacted by lower MS drug sales. MS revenues dropped 15%, with Tecfidera sales down 36%. Spinraza sales rose 1% to $437 million. Biogen expects MS revenues to decline in 2023 due to competition. The company is focusing on cost-saving initiatives and restructuring, aiming for $1 billion in savings by 2025.