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After GSK’s return of Wave Life Sciences’ WVE-006 as well as the mid-stage failure of Korro Bio’s candidate, the alpha-1 antitrypsin deficiency landscape is coming into focus, with Wave and Beam Therapeutics leading the way.

While GSK did not provide a specific reason for returning Wave Life Sciences’ WVE-006, the decision comes after the asset in September 2025 came below analyst expectations in a Phase Ib/IIa AATD study.

The facility, which is part of Lilly’s $50 billion reshoring drive, will make obesity drugs such as tirzepatide and retatrutide when it starts operations in 2031.

Sanofi will take venglustat to regulators for Gaucher disease but an application for Fabry disease is less clear after the failure of a Phase III trial.

The program will allow for frequent communication with the FDA, giving manufacturers timely input and guidance regarding the design of their facilities.

Corcept’s relacorilant was rejected for hypercortisolism late last year—a decision which CEO Joseph Belanoff expressed surprise with at the time.

A Phase III readout in September 2024 for rocatinlimab, on which Amgen and Kyowa Kirin were collaborating in atopic dermatitis, appeared underwhelming to analysts, with Jefferies noting that the data “came in at the lower end of efficacy and expectations.”

Follow along as BioSpace tracks job cuts and restructuring initiatives.

Opening up about drug pricing decisions is not optional for biopharma anymore. For the sake of credibility, companies should embrace it.

AstraZeneca’s $15 billion pledge to its China operations highlights the country’s advantages. But other regions are also hoping to host more clinical studies.

In what is shaping up to be a back-loaded month, the FDA is set to release a slew of regulatory decisions in February, including two that would expand the labels of blockbuster drugs.

With Lykos’ regulatory failure now squarely in the rearview mirror, Compass Pathways and Definium are leading what one analyst suspects will be “a very big year for psychedelics.”

• The capacity expansion in Bubendorf reached another important milestone with the inspection of Building K. The announced start-up is proceeding according to plan. • In Vista, CA, Bachem acquired a property adjacent to its existing facility. The acquisition will enable a future capacity expansion at the Vista site, thereby strengthening Bachem’s presence in the US market.

Dedicated solutions for these complex products can help enable confidence in the accuracy of analytical results

◆ VIAL-INHBE is a novel, GalNAc-conjugated INHBE (Activin E) siRNA for the treatment of obesity and other cardiometabolic indications with a projected Q6M dosing intervall ◆ VIAL-INHBE DIO mouse model data demonstrated compelling fat-selective weight-loss and lean mass preservation ◆ Combination therapy with a low-dose GLP-1 resulted in synergistic weight loss and lean mass preservation that was maintained off-GLP-1 treatment ◆ A Phase 1 open-label study in Australia is initiating to evaluate safety, pharmacokinetics, and pharmacodynamic responses ◆ Interim subcutaneous safety and pharmacokinetic data are expected in H1 2026