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Alzheimer's Start-Ups Face A Discovery And Clinical Crossroads

 
• By Alex Lash

With big Phase III failures heating debate about the amyloid hypothesis, small biotechs must convince investors that their early research is pointed in the right direction, and larger ones must design clinical trials with care. We profile four Alzheimer's-focused start-ups in this issue: AlzProtect, Axerion Therapeutics, Cognition Therapuetics and Galantos Pharma.

The emotional, psychological and financial burden from Alzheimer's disease is extracting a significant toll in countries such as the US, where deaths from the disease increased 46% from 2000 to 2006 and annual costs for care exceed $170 billion, much of that paid by Medicare and Medicaid. Even with the vast unmet medical need, big drugmakers are anxious about spending hundreds of millions of dollars in an area so clinically ill-defined. Adding to the anxiety is growing doubt about the field's most intensely investigated target and frustrating progress toward the validation of biomarkers and tools that could save precious time and money.

Uncertainty is also exacerbating a venture funding drought. Start-ups are eager to tap into the coffers of foundations and governments,...

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Final Chance To Have Your Say: Take Scrip's Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

Galapagos Expands Point-Of-Care CAR-T Study To The US

 
• By Andrew McConaghie

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 
• By Andrew McConaghie

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

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China Signals Restarting IPOs For Unprofitable Biotechs

 
• By Dexter Jie Yan

The China Securities Regulatory Commission has proposed a new “growth tier” for the STAR Market of the Shanghai Stock Exchange, to reinstate the market’s listing standards for unprofitable firms.

BIO Notebook: Woodcock Calls For Doing The Right Thing, Dealmaking Remains Constrained

 
• By Mandy Jackson, Joseph Haas, and Sarah Karlin-Smith

Highlights from Day Four of the BIO International Convention include Woodcock offering practical advice on rare disease trials, the sorry state of dealmaking mid-year, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Syncona Looks To Go Private As Market Decline Deepens

 
• By Andrew McConaghie

While some are calling for Syncona to be wound up, the UK-based company believes many existing and new investors will back the creation of new private fund.