Sanofi SA will not seek approval of amlitelimab in atopic dermatitis (AD) as previously planned, stating that the OX40-ligand monoclonal antibody “would not represent a meaningful improvement to the standard of care” for patients with moderate to severe disease. The company said the decision, which marks an about-face as Sanofi had been looking to amlitelimab as a possible successor to its Regeneron Pharmaceuticals Inc.-partnered blockbuster AD drug Dupixent (dupilumab), comes as part of an ongoing assessment of the pipeline.
Continuing the year’s strong IPO activity, Scribe Therapeutics Inc. priced an upsized offering at the high end of its price range, offering 8.6 million shares at $15 apiece for gross proceeds of about $129 million. The company, which is developing CRISPR-based therapies targeting cardiovascular and metabolic diseases, began trading on Nasdaq under the ticker SCTX, with shares getting a warm welcome, opening at $25 and ending the day at $21.65, up 44.3%.
About a week after closing its $10.6 billion acquisition of Nuvalent Inc., GSK plc has reaped the first reward, announcing U.S. FDA approval of zidesamtinib in non-small-cell lung cancer (NSCLC). Branded Jideytro, the ROS1 selective inhibitor is indicated for use in adults with locally advanced or metastatic ROS1-positive disease who have received a prior ROS1 kinase inhibitor.
Once again, Arrowhead Pharmaceuticals Inc.’s Redemplo (plozasiran) is hot on the heels of Ionis Pharmaceuticals Inc.’s Tryngolza (olezarsen). Less than a month after the latter gained U.S. FDA approval for use in severe hypertriglyceridemia (sHTG), Arrowhead reported positive top-line results from its phase III studies in sHTG, with findings described by one analyst as “best-case scenario,” setting the stage for a supplemental NDA filing with the FDA before year-end.
For the second time in two months, Celcuity Inc. failed to generate investor excitement despite disclosing positive news, this time following the U.S. FDA approval of Revtorpyk (gedatolisib) in a subset of breast cancer patients, marking the firm’s first foray into the commercial space and introducing a new treatment option for patients. Wall Street instead focused on an unanticipated launch delay, sending shares of Celcuity (NASDAQ:CELC) down 17.6% to close July 15 at $91.51.
While the emergence of immune checkpoint inhibitor (ICI) therapy in recent years has significantly improved cancer outcomes, some patients have been unable to experience the full therapeutic benefits of ICIs due to significant gastrointestinal inflammation linked to treatment. Seres Therapeutics Inc. is looking to change that with its live biotherapeutic candidate, SER-155, offering impressive findings from phase I data in ICI-related enterocolitis, or irEC.
Vera Therapeutics Inc. looks to get an almost five-month head start over a competitor, Vertex Pharmaceuticals Inc., as the U.S. FDA cleared its Trutakna (atacicept) as the first dual BAFF/APRIL inhibitor for treating immunoglobulin A nephropathy (IgAN). The accelerated approval, which came on the July 7 PDUFA date, indicates Trutakna for use in reducing proteinuria in adults with primary IgAN at risk for disease progression. The drug is administered once weekly via auto-injector.
Orca Bio Inc. is bringing to market a precision-engineered cell therapy approach designed to improve outcomes in patients with hematologic malignancies undergoing allogeneic hematopoietic stem cell transplantation (HSCT) following U.S. FDA approval of Tregzi, a first-of-its-kind, personalized cell therapy.
One company was looking to add to its royalty stream and R&D portfolio. The other was seeking strategic alternatives in the wake of clinical misfires over the last few years. In an agreement aimed at satisfying both goals, Zymeworks Inc. will acquire Theravance Biopharma Inc., paying $17 per share, or about $929 million, though the transaction is structured in a way that minimizes the former’s current capital position.
Antares Therapeutics Inc. drew Novartis AG to the table for a potential $1.9 billion collaboration, including a $105 million up-front payment, to discover small-molecule programs against oncology targets considered to be undruggable. It’s Antares’ first partnership since spinning out of Scorpion Therapeutics Inc. about a year ago.
