Eli Lilly

A large trial showed that a high dose of Eli Lilly and Co.’s Mounjaro helped people with type 2 diabetes who were also obese or overweight to lose nearly 16% of their body weight, or over 34 pounds (15kg) on average, the company said on Thursday.

FDA

The FDA has placed a partial clinical hold on a Phase I study of Foghorn Therapeutics’ investigational protein degrader FHD-609 after a patient developed a grade 4 QTc prolongation event, the company announced Monday.

With a potential $2.9 billion on the line, Ionis Pharmaceuticals and AstraZeneca announced new results from the Phase III study of eplontersen in hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). The results will be presented Monday at the American Academy of Neurology (AAN) 2023 Annual Meeting in Boston.

Eli Lilly presented the first clinical data on its KRAS G12 inhibitor at the American Association for Cancer Research (AACR) meeting in Orlando on Monday. Lilly investigators said they hoped to differentiate their Phase I candidate from the competitive KRAS space by making it the first to gain approval as a first-line treatment.

Moderna

Moderna Inc. said on Tuesday its closely watched flu vaccine did not meet the criteria for early success in a late-stage trial, sending its shares down nearly 5% premarket.

CRISPR

Currently, there are no gene editing–based treatments on the market, but the technology continues its march toward potential FDA approval, with several products in mid- and late-stage trials. As these programs mature, 2023 could be a pivotal year for companies in the space.

At the World Vaccine Congress in Washington, D.C. on Wednesday, Maryland-based Novavax presented data on its COVID-19 booster and COVID-influenza combination vaccine candidate. Novavax shares rose 12 percent Thursday following the presentation. 

Gilead Sciences Inc. on Tuesday unveiled data from the first human study of its experimental oral COVID-19 antiviral, saying the results in healthy volunteers cleared the way for two large Phase III trials of the drug that have begun enrolling patients.

Novo Nordisk logo

Patients discontinuing the use of weight-loss drugs such as Wegovy risk regaining their original body weight in about five years, a company official said on Wednesday.

Amgen

In a complaint filed on Monday night in Manhattan federal court, a Detroit-based pension fund said Amgen artificially inflated its stock price by concealing the dispute over its international tax strategy between July 2020 and April 2022.