January 27, 2026

The need-to-know this morning

Roche plans to launch Phase 3 studies of its leading obesity candidate this quarter after reporting that the drug led to significant weight loss in a mid-stage trial.
Intellia Therapeutics said the FDA lifted a clinical hold on a Phase 3 study of its CRISPR gene-editing therapy for a condition called transthyretin amyloidosis, or ATTR, that mostly affects nerves. A clinical hold on a separate Phase 3 study of the therapy in ATTR that affects the heart remains in place.

biotech

New startup to develop a GLP-1 drug for addiction

A company called Baseline Therapeutics launched today with a focus on studying a GLP-1 drug for various substance use disorders.

The company has a GLP-1 agonist, BT-001, that it plans to start studying in two Phase 3 trials for alcohol use disorder in the first quarter this year. It also plans to start a Phase 2/3 trial in cocaine and methamphetamine use disorders in the third quarter this year, according to its website.

CEO Nicholas Reville said the lead molecule is licensed from another company but would not specify further.

Reville isn't typical of biotech entrepreneurs. For the past few years, he's been at an organization he founded called the Center for Addiction Science, Policy, and Research, a policy and research group focused on treatments for addiction.

While a growing volume of research suggests that GLP-1 drugs may help with addiction, few drug companies have studied this indication. Eli Lilly, though, is running two Phase 3 trials testing a GLP-1 and GIP dual agonist called brenipatide in alcohol use disorder.

policy

U.K. urged to screen for more diseases as gene therapies come to market

The U.K. has historically been slow to update its list of diseases that all newborns are screened for, but doctors and patient advocates are urging the country to add diseases more quickly as new gene therapies become available.

Drugmakers making these medicines are also invested — they want to make sure their medicines can reach as many patients as possible.

However, the committee that advises the U.K. on the screening list has raised questions about the costs of therapies and potential harms from blanket screening. The arguments are representative of the broader debate around the utility and drawbacks of newborn genetic screening.

markets

Biotech investor debuts SPAC as industry rebounds

We've joked internally at STAT that we need to launch a “biotech-is-back meter,” as more startups announce major crossover financing rounds and more companies go public. In the latest sign that the biotech industry may be bouncing back from its prolonged downturn, a new SPAC has debuted.

As a quick reminder, a SPAC — or special purpose acquisition company — is a shell organization that raises money through an IPO and later acquires a privately held company, offering a back door onto the stock market.

Cormorant Asset Management, a biotech investment firm, said yesterday that it raised $150 million in a initial public offering of a SPAC called Helix Acquisition Corp. III.

Cormorant's previous two SPACs merged with MoonLake Immunotherapeutics in 2022 and BridgeBio Oncology last year.

drug payment

Hospitals ask for Trump's help in fight against Lilly

Eli Lilly will soon be requiring hospitals that are part of a drug discount program to submit comprehensive claims data. But hospitals argue this move will vastly increase their costs and burdens, and they're now asking the Trump administration to stop Lilly.

The conflict centers around the the 340B discount program, which allows hospitals that care for low-income and rural patients to buy drugs at a discount.

Pharma companies have sought to change the program. They claim that hospitals abuse it and divert payments to uses other than caring for low-income patients. Drugmakers are concerned about hospitals receiving overlapping discounts.