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13 March, 2026 |
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sponsored by
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Built for Speed: Integrated Early‑to‑Late Phase CDMO Solutions
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| Avid Bioservices delivers solution‑focused capabilities and the capacity biopharma innovators need to advance programs with confidence. Our new Early Phase Center of Excellence, centrally located in Costa Mesa, California, provides rapid, flexible support for early development with a direct, seamless transition into our late‑stage and commercial manufacturing facility. This integrated approach reduces handoffs, accelerates timelines, and helps keep your therapy moving efficiently toward patients.
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Nominations are now open for Endpoints’ annual LGBTQ+ Leaders in Biopharma report. Have someone in mind? You can nominate them here. |
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Alexis Kramer |
Editor, Endpoints News
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Roivant CEO Matt Gline at #BIO24 (Brian Benton Photography) |
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by Max Bayer
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These days, if you ask the CEO of Roivant if he’s open to selling another late-stage drug to a larger company, he refers you to a spoof video clip. It’s the scene from "Toy Story" where the alien toys are watching the arcade claw descend upon them, and Woody and Buzz Lightyear are trying to escape the machine. In the video, the aliens are labeled as biotechs ripe for a buyout, the claw is big pharma and
Woody is Roivant. Matt Gline’s point? Roivant isn’t begging for a buyer. “Building businesses sitting around waiting for some other mercurial master to come around and decide whether you're good enough for their appeal or not is, in addition to being a bad way to build businesses, it's just boring,” the CEO said in an interview at the company’s Manhattan headquarters. | |
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by Alex Hoffman, Kyle LaHucik, Max Bayer
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→ Michelle Werner has stepped down as CEO of Flagship startup Alltrna, saying on LinkedIn that the decision "is the right one for me and my family," and she's headed to Ipsen as president of North America on March 23. She closes out a four-year tenure after joining Alltrna and Flagship from Novartis, where she was the global franchise head for solid tumors. Werner had worked on advancing a pipeline of tRNA assets at the startup, with a lead program currently in IND-enabling studies. It's unclear who may replace
Werner at Alltrna, if anyone. But CFO Joanne Protano has been named president of the company following the decision. Lovisa Afzelius is also slightly shifting positions, now the executive chair of Alltrna. Werner will continue to be a member of the board as well as a company advisor. | |
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by Andrew Dunn
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A few years ago, the oncology world wondered if it had found its next big breakthrough: a third major checkpoint inhibitor beyond PD-1 and CTLA-4. The FDA
in 2022 approved Bristol Myers Squibb's LAG-3-targeting Opdualag. Many drugmakers hoped that would be the start of a new class of cancer immunotherapy. But there have been few positive updates in the LAG-3 world since then. A tiny Australian biotech added to the list of failures on Friday. Immutep said its lead LAG-3 drug candidate flunked an interim futility analysis for a Phase 3 lung cancer study, triggering
plans to wind down the trial. | |
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by Ayisha Sharma
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Ultragenyx said its gene therapy candidate for a rare metabolic disease has hit one of two primary endpoints in a late-stage study. The drug is being tested in 37 people with ornithine transcarbamylase deficiency, a rare genetic disease. Patients have a mutation in the OTC gene which, in healthy people, makes an enzyme that turns ammonia into
urea for excretion through urine. But in people with the mutation, the complete or partial lack of the enzyme leads to the buildup of ammonia in the blood to dangerous and potentially fatal levels. Ultragenyx's therapy, called DTX301, delivers a functional copy of the OTC gene. In the Phase 3 trial, it led to an 18% reduction in 24-hour plasma ammonia compared with placebo at 36 weeks, the company said in a press release. Ultragenyx called the result “statistically significant and clinically mean­ |
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