Today, a brief rundown of news involving Johnson & Johnson and Enliven Therapeutics, as well as updates from Beren Therapeutics, MBX Biosciences and Neion Bio that you may have missed.
Johnson & Johnson said its autoimmune drug Imaavy, touted as a top seller for the company, succeeded in a Phase 2/3 trial against a rare disease linked to anemia. The pharmaceutical giant said Thursday its drug, which is already used to treat myasthenia gravis, produced durable hemoglobin levels in people with warm autoimmune hemolytic anemia when compared to placebo after 24 weeks. The study enrolled 115 adults who received either Imaavy at two different doses or placebos. The data will be presented at the annual European Hematology Association meeting and support a drug label expansion to treat people with this disease, which has no approved treatment options, J&J said. — Delilah Alvarado
Enliven Therapeutics said its experimental cancer drug ELVN-001 helped people with chronic myeloid leukemia significantly reduce the percentage of or maintain low levels of diseased red blood cells in a Phase 1 trial. At the 80 milligram daily oral dose that Enliven selected for its Phase 3 trial, 61% of the people who’d been on treatment for at least 24 weeks were in “major molecular response” — a measure predictive of longer-term benefit. Of those who weren’t in major molecular response at the trial’s start, 48% achieved that benchmark, while 100% of those who were maintained it. ELVN-001 will be competing with Merck & Co.’s TERN-701, which Merck acquired through the $6.7 billion purchase of Terns Pharmaceuticals, as well as Novartis’ newer blockbuster drug Scemblix and older drugs from the same class like Takeda’s Iclusig. Following release of the data, Enliven also announced it plans on selling $250 million worth of new shares. — Jonathan Gardner
Neion Bio said Thursday it closed a $23 million Series A round that will advance the company’s biologics manufacturing platform and expand its pipeline. Founded in 2024, Neion aims to use genetic engineering to utilize “the egg to produce biological medicines with unprecedented efficiency, scalability, and environmental sustainability.” The biotech said it will use the capital to expand its pipeline across biosimilars, innovative medicines, animal health and critical reagents. The round was led by early investor Caffeinated Capital, with participation from Digitalis Ventures, Ensemble VC and Trust Ventures, among others. — Delilah Alvarado
In an effort to support the launch of its drug adrabetadex, Beren Therapeutics has banked $300 million to bring its therapy for infantile-onset Niemann-Pick disease to market. Up to $165 million of that figure comes through a debt and royalty deal with Hercules Capital, while $135 million comes from an equity financing, according to a Thursday statement. Beren is waiting on U.S. regulators to approve its application to sell adrabetadex, a therapy that aids in “cholesterol trafficking” and has shown in clinical testing that it slows disease progression and improves survival rates. That decision is expected by mid-November. — Gwendolyn Wu
MBX Biosciences unveiled one-year data for its experimental drug in people with chronic hypoparathyroidism, saying over half of participants responded positively to a once-weekly dose of canvuparatide. From the one-year analysis, MBX said its treatment was well tolerated, with no new safety signals. The company additionally reported full results from its Phase 2 trial, in which 63% of participants met the primary composite endpoint at 12 weeks, compared to 31% on placebo. “Overall, we believe the results met company expectations and broadly aligned with our investor survey,” Mizuho Securities analyst Uy Ear wrote in a note to clients. Investors didn’t seem so convinced, however, as shares for MBX were down more than 8% by late Friday morning. — Delilah Alvarado
