→ Saeed Motahari is leaving Insys Therapeutics on the second anniversary of his appointment as CEO. The Purdue Pharma vet is succeeded by his CFO, Andrew Long, who is stepping up as the company struggles to stay afloat. A month ago, Insys revealed that the strategic counsel it hired raised “substantial doubt” about its ability to continue as a going concern due to losses and uncertainty as to whether it can generate enough cash for its legal fees and settlements. Its former executives are embroiled in court for allegedly bribing doctors to prescribe its potent, addictive fentanyl spray Subsys off-label. Meanwhile, the drugmaker’s billionaire founder and former chief John Kapoor is on trial for racketeering and conspiracy associated with Subsys sales. In conjunction with Long’s ascent to the top, Andrece Housley, the current corporate controller, will move up to fill its previous role. And Insys has promoted Venkat Goskonda to CSO, overseeing what remains of the company’s R&D and manufacturing activities.
→ GenScript — the lesser known parent company of CAR-T dark horse Legend Biotech — has begun construction of a commercial manufacturing center specializing in plasmids and viruses manufacturing. The Hong Kong-listed CRO expects to build China’s first and largest hub for R&D of cell and gene therapies as well as antibodies, with capacity for late-stage development and commercial production. Located in Zhenjiang, the new 133,000-square-meter facility complements a US site set to become operational soon.
→ The FDA has cleared a hydrogel capsule developed by PureTech affiliate Gelesis for marketing as a prescription aid in weight management. Made by cross-linking cellulose and citric acid, Plenity is designed to swell up in the stomach so that people feel fuller before meals and eat less. While it hit a goal of helping overweight subjects lose at least 5% of their body weight, the pivotal study failed on a co-primary on mean difference between treatment and placebo, but the low risk of taking the product likely convinced regulators to give their green light.
→ Months after reporting positive mid-stage depression data for its lead experimental pill, AXS-05, Axsome $AXSM on Monday posted Phase II results that showed the drug — a combination of dextromethorphan (DM) and bupropion (BUP) — met the main goal as a smoking cessation treatment. The data “could add incremental upside to the stock because we don’t think that the Street has factored smoking cessation into its models…the BUP comparator arm in this Phase II falls within the efficacy range of what has been used in registrational trials for (GSK‘s) Zyban, the BUP monotherapy that is currently approved for smoking cessation,” SVB Leerink’s Marc Goodman wrote in a note.
→ CNS-focused EIP Pharma is betting big on its lead experimental drug neflamapimod. The drug — which inhibits the enzyme p38 alpha — is being evaluated in an ongoing proof-of-concept trial in patients with early Alzheimer’s disease, which is expected to readout this fall. In the meantime, the company has raised $11.2 million to explore the use of the drug in dementia with Lewy bodies and for the cognitive deficits in Huntington’s disease — Phase II studies for these new indications are expected to commence in the second quarter.
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