Pfizer CEO Albert Bourla on Monday flagged issues with the leadership of the U.S. Food and Drug Administration's vaccine department.
"I think the current director is not following the recommendations of his staff," Bourla said at the TD Cowen healthcare conference.
As Novartis completed its $12 billion takeover of Avidity, a new cardiology-focused biotech was spun out – Atrium Therapeutics – with two preclinical programmes and funding of $270 million.
Atrium is led by Kathleen Gallagher, who was chief programme officer at Avidity before it was acquired by Novartis and will now take responsibility for taking two siRNA-based therapies for rare genetic cardiomyopathies into clinical development, with another two undisclosed cardiomyopathy programmes following after.
The new company is chaired by Sarah Boyce, who served as CEO of Avidity and said the new management team will "urgently move its pipeline forward."
The two preclinical assets are ATR 1072 for PRKAG2 syndrome, an inherited metabolic disorder that leads to the accumulation of glycogen in the heart, and ATR 1086 for PLN cardiomyopathy, caused by a genetic mutation that disrupts calcium regulation in heart cells.
Studies to support the start of clinical trials and initial manufacturing is underway for ATR 1072, with ATR 1086 to follow shortly, with investigational new drug (IND) filings due in the second half of 2026 and 2027, respectively.
"Patients and families facing these genetically driven rare cardiomyopathies have few if any options that address the underlying cause," said Gallagher.
"Building on Avidity's pioneering work in targeted RNA delivery, Atrium is positioned to advance precision medicines designed to directly target the biologic drivers of cardiac disease," she added.
The company's R&D platform relies on the marriage of tissue-targeting molecules, such as antibodies, that can penetrate into muscular tissue and deliver a gene-editing oligonucleotide payload.
Atrium emerges with a Nasdaq listing already in place, inherited from Avidity, which went public with a $298 million IPO in 2020, although the trading symbol has changed from RNA to RNAM. The stock was trading a little above $14 at the time of writing, down slightly on its $14.79 starting price.
With the completion of the acquisition, RNA specialist Avidity is now an indirect, wholly owned subsidiary of Novartis, strengthening the group's late-stage R&D pipeline with antibody-oligonucleotide conjugate (AOC) candidates for neuromuscular disorders, including Duchenne muscular dystrophy (DMD), myotonic dystrophy type 1 (DM1), and facioscapulohumeral muscular dystrophy (FSHD).
The Swiss pharma group has said Avidity's pipeline offers "potential multi-billion-dollar opportunities for DM1 and FSHD" and gives it access to a differentiated RNA-targeting delivery platform.
The takeover was the largest of four acquisitions completed by Novartis last year – along with 10 licensing deals – as it deals with the largest patent cliff in its history.
https://pharmaphorum.com/news/new-biotech-atrium-born-out-novartisavidity-marriage
