Lecanemab

Biogen navigates the launch of Alzheimer's drug Leqembi amidst pipeline setbacks, with Leqembi's success crucial for future growth. The company faces competition from Eli Lilly's donanemab and recent pipeline failures, but potential for Leqembi's adoption and pipeline candidates like felzartamab offer growth opportunities.

Eli Lilly's Q3 earnings report on Oct. 30 will focus on Mounjaro and Zepbound sales growth, potential guidance raise, head-to-head study data against Novo Nordisk's Wegovy, tirzepatide's sleep apnea launch, liver disease competition, and updates on Alzheimer's drug Kisunla. Morningstar's fair value estimate for Eli Lilly is $580 per share, with a 1-star rating indicating overvaluation. The firm's wide economic moat is supported by patents, economies of scale, and a powerful distribution network. Financial strength is solid, with expected debt reduction and growth from tuck-in acquisitions. High Uncertainty Rating reflects variable outcomes for key drug launches, particularly Mounjaro, Zepbound, and Kisunla.

UK approves Eli Lilly's Alzheimer's drug Kisunla, but NICE deems it too costly for NHS funding, sparking advocacy campaigns. NICE cites uncertainties in benefits and costs, contrasting with Lilly's optimism. Patients may need to pay privately until a 2025 NICE decision.

Britain's drug regulator approved Alzheimer's drug Kisunla, but the government won't fund it due to cost concerns. NICE requires more evidence to prove its worth, despite FDA approval in July. Similar issues faced Leqembi's roll-out in the U.S.

Lilly’s Alzheimer’s drug Kisunla gets MHRA approval but NICE rejects it, citing lack of value for NHS.

UK approves Eli Lilly's Alzheimer's therapy Kisunla but NICE denies NHS funding due to high cost and limited benefit. Patient groups campaign for funding, highlighting the drug's potential impact. NICE awaits further evidence before a final decision in 2025.

Roche ends partnership with UCB in Alzheimer’s disease, returning rights to Phase IIa prospect bepranemab, marking Roche’s second Alzheimer’s partnership cut this year. UCB announced the partnership termination as it prepares to present Phase IIa study results at the 2024 Clinical Trials on Alzheimer’s Disease Meeting. Roche, lagging in Alzheimer’s treatment development, continues to explore early-stage assets like RG6289 and trontinemab.

Alzheimer's drug Leqembi is fully approved in the U.S. and several Asian countries but faces rejections in the UK, EU, and Australia due to safety concerns and insufficient efficacy. The UK approved Leqembi for early-stage Alzheimer's patients with zero or one copy of the ApoE4 gene, but UK Health Services won't cover it, citing poor value for money. Australia and the EU declined Leqembi, citing efficacy did not outweigh safety risks, including ARIA side effects.

EMA won't renew Translarna's permit; Novartis pays $70M for a cancer drug; Amylyx's AMX0035 shows promise in rare disease; FDA delays Ocaliva approval; Australia rejects Leqembi; Amicus settles with Teva over Galafold.

With two anti-amyloid Alzheimer’s drugs on the market, investors are focusing on new tests and biomarkers to boost treatment and prevention. The Alzheimer’s Drug Discovery Foundation, backed by billionaires and industry players, has funded companies like C2N Diagnostics and Fujirebio, which are developing more accurate detection methods. The foundation aims to diversify beyond amyloid, focusing on the biology of aging for future Alzheimer’s treatments.