News

In this episode of Denatured, you’ll be listening to Jane Hughes, President of R&D and Co-founder of Verdiva Bio, and Jon Rees, CEO and Co-founder of MitoRx Therapeutics. We’ll discuss next-generation obesity solutions tackling GLP-1’s muscle loss and adherence challenges, through innovative muscle preservation, oral administration and combination therapy.
FEATURED STORIES
Many scientists-turned-CEOs paradoxically abandon scientific principles when it comes to commercializing their innovations. But applying the scientific method to business decisions can help life science entrepreneurs avoid common pitfalls, attract investment and ultimately bring transformative technologies to market.
FDA vouchers are normally a coveted prize for biopharma companies, but a surprise rejection for Disc Medicine’s rare disease drug has biopharma reconsidering.
PitchBook’s 2025 biopharma VC analysis clocked $33.8 billion in capital dispatched in 2025, mainly to companies with later-stage programs ready to roll into the clinic.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
FDA
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
THE LATEST
The Dutch biotech’s stock dropped about 10% Tuesday morning after the company reported that its injectable Vyvgart Hytrulo missed the primary and secondary endpoints in an immune thrombocytopenia study.
Building on a previous 2021 collaboration, Bristol Myers Squibb is paying $100 million upfront for the development of five cardiovascular targets utilizing Avidity Biosciences’ antibody oligonucleotide conjugates.
The biotech blames contract research organization Fortrea for incorrectly coding the dosing sequence in a psoriatic arthritis trial, which it contends resulted in some patients being given the wrong treatments.
Aldeyra Therapeutics is planning to run another trial, in line with the regulator’s requirements, and is expecting top-line data and a New Drug Application resubmission in the first half of 2024.
FDA
The Ogsiveo tablets are the first approval therapy for the rare subtype of soft tissue sarcomas, which can lead to severe pain and disability and previously were treated primarily through surgery.
While XEN1101 failed to hit the primary endpoint in a Phase II trial, the Canadian company is “actively exploring” further development of the program based on the totality of the data.
Pegozafermin showed statistically significant improvements in treating patients with nonalcoholic steatohepatitis, notching a win in the race to get the first treatment to market for the condition.
New data show the biologic significantly reduced exacerbations in chronic obstructive pulmonary disease, confirming positive results from an earlier trial.
A year after exiting the U.S. market, GSK is setting the stage for the antibody-drug conjugate’s possible return in relapsed/refractory multiple myeloma.
The biopharma company remains committed to its investigational BET inhibitor pelabresib after it failed to meet one of two key endpoints.