Sarepta Therapeutics Inc. CEO Douglas Ingram said he expects “ferocious” demand for gene therapy Elevidys (delandistrogene moxeparvovec), granted full approval by the U.S. FDA for Duchenne muscular dystrophy (DMD). Shares of the Cambridge, Mass.-based firm closed June 21 at $16.72, up $37.22, or about 30% on the news.
Alzheon Inc. has raised $100 million in a series E financing round to push its oral drug candidate for early Alzheimer’s disease (AD), ALZ-801 (valiltramiprosate), through a late-stage, Apolloe4 study.
Quoted biotech investor Syncona Ltd. is still struggling with the fallout from one of the worst bear markets on record, reporting its net asset value fell from £1.25 billion (US$1.58 billion) to £1.24 billion in its 2023-24 financial results on June 20. That is despite a restructuring toward more mature companies, with 70% of the portfolio now invested in clinical-stage assets.
Now that it has some experience with interchangeable biosimilars under its belt, the U.S. FDA is proposing an update to its interchangeability guidance that could eliminate the need for switching studies in some instances.
The U.S. CMS has floated an alternative payment model dubbed the Transforming Episode Accountability Model for Medicare beneficiaries in fee-for-service care, but some in industry have misgivings about the proposal.
Dexcom Inc. and Insulet Corp. both reported introductions of their products into new countries on the eve of the 2024 American Diabetes Association annual meeting in Orlando, Fla. The two firms also announced the U.S. launch of Insulet’s Omnipod 5 tubeless automated insulin delivery system with connectivity to Dexcom’s G7, the company’s latest generation continuous glucose monitor.
The recent licensing agreement that Alzpath Inc. signed with Roche AG for use of its pTau217 antibody to develop and commercialize an Alzheimer's disease diagnostic blood test will not only transform the company but also allow patients access to a more cost-effective test, Venkat Shastri, CEO of Alzpath told BioWorld.
After a rocky year, Akili Inc. received U.S. FDA clearance for use of its non-prescription product, Endeavorotc, for treatment of adults with attention deficit/hyperactivity disorder (ADHD). Endeavorotc employs a video game format to improve attention in individuals with inattentive or combined-type ADHD.
Inosys Korea Co. Ltd. gained U.S. FDA 510(k) clearance for Unispace, a cervical spine cage manufactured with 3D printing technology. Unispace can be used during spinal fusion surgery, Busan-based Inosys said, wherein operators can remove a patient’s diseased or damaged disc and replace it with the cervical cage to maintain the original length of the spine.
A week after generating buzz with its proposed Nasdaq listing and plans to raise about $200 million, Telix Pharmaceuticals Ltd. withdrew its U.S. IPO filing, citing market conditions. The Australian radiopharma firm’s shares continue trading on the Australian Securities Exchange (TLX), where they closed June 14 at AU$16.61 (US$10.98), up AU15 cents.
RSS
