Vertex Pharmaceuticals Inc. is on track to complete a BLA by the end of March seeking potential U.S. accelerated approval for povetacicept, its dual inhibitor of the BAFF and APRIL cytokines, to treat immunoglobulin A nephropathy (IgAN), following a successful phase III Rainier trial. An interim analysis showed the trial met the primary objective, with the interim analysis population achieving a 52% reduction from baseline in urine protein to creatinine ratio (UPCR) at week 36, representing a statistically significant 49.8% UPCR reduction compared to placebo. It is “the highest placebo-adjusted proteinuria response in any phase III IgAN trial to date,” noted H.C. Wainwright analyst Andrew Fein. Vertex’s shares (NASDAQ:VRTX) rose 8% to $499.25 in early trading March 10. At this point, Vertex is aiming to be third to market, behind Otsuka Pharmaceutical Co. Ltd.’s approved APRIL inhibitor, Voyxact (sibeprenlimab), and Vera Therapeutics Inc.’s dual BAFF/APRIL inhibitor, atacicept, which has a July 7, 2026, PDUFA date. Vera’s shares (NASDAQ:VERA) were also up midday by 8.9% to $42.44.

FDA green-lights leucovorin for CFD-FOLR1 with ‘autistic features’

The U.S. FDA approved the expanded use of Wellcovorin (leucovorin calcium) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (CFD-FOLR1). Regulators based their go-ahead not on a clinical trial but on the review of the published literature, including case reports with patient-level information, plus mechanistic findings – i.e., real-world data. Marty Makary, commissioner of the agency, said the drug may help CFD-FOLR1 patients “who have developmental delays with autistic features,” which represents a minor subset of those with autism. GSK plc developed leucovorin more than 40 years ago but hasn’t marketed it since 1997 and it has since become available from various generic drugmakers. A prescription form of vitamin B9, the compound is used as an antidote to the harmful effects of methotrexate and to prevent certain kinds of anemia. Paired with fluorouracil, it’s also a treatment for colon cancer. The label add-on for CFD-FOLR1 happened by way of GSK’s sNDA, which came in response to a request from the FDA.

Latest benchmark shows 35% decline in antibiotics pipeline in past 5 years

Twelve years on from the World Health Organization formally raising the alarm, antimicrobial resistance (AMR) continues to grow, and despite numerous public and private incentives and initiatives, the pipeline of antibiotics in development is thinner than ever. That is the sobering finding of the 2026 Antimicrobial Resistance Benchmark, which reports that compared to the 2020 Benchmark, there has been a 35% decrease – from 92 projects to 60 – in the number of AMR projects in pharmaceutical company pipelines. And as things stand, only three pharma companies invest directly in antimicrobial research.

US FDA draft guidance eases another biosimilar requirement

In releasing its latest revision of a draft guidance on biosimilars, the U.S. FDA took another step this week in streamlining the development of the follow-ons by eliminating unnecessary clinical pharmacokinetic (PK) testing. That includes the so-called bridging studies the agency has required when a biosimilar sponsor used a comparator product approved outside the U.S. to establish biosimilarity, instead of the U.S.-licensed version of the same biologic. The move is expected to save sponsors up to 50% of their PK study costs, or about $20 million, and ultimately help lower drug costs, according to the FDA.

Medtronic continues M&A momentum with $550M Scientia Vascular buy

Medtronic plc has agreed to buy Scientia Vascular Corp. for $550 million, as it makes good on its promise to embark on more strategic acquisitions this year. The acquisition will bolster its neurovascular business as it adds a portfolio of guidewires and catheters, which uses Scientia’s microfabrication technology to simplify complex neurovascular procedures.

Med-tech financings open 2026 with record deal volume

Med-tech financings totaled $6.08 billion in the first two months of 2026, slightly below the $6.31 billion raised in January–February 2025, a year-over-year decline of about 4%. Financing activity accelerated in the first two months of 2026, with 78 deals recorded, the highest January-to-February total in BioWorld’s medical technology archives. The figure surpasses the previous high of 66 deals in early 2025.

Telix advances PSMA radiotherapy challenger to Pluvicto

Australia’s Telix Pharmaceuticals Ltd. is advancing a potential challenger to Novartis plc’s dominant prostate cancer radioligand therapy, Pluvicto (lutetium [177Lu] vipivotide tetraxetan), after reporting that the safety lead-in portion of its global phase III Prostact trial met its primary objectives. The results support the tolerability of Telix’s PSMA-targeted radiopharmaceutical, TLX591-Tx (lutetium-177, rosopatamab tetraxetan), in metastatic castration-resistant prostate cancer and clear the way for the randomized expansion stage of the pivotal study. The radiopharma company said TLX-591-Tx demonstrated an acceptable safety profile when combined with standard-of-care therapy, and Telix plans to submit the data to the U.S. FDA to amend its IND and advance the study’s larger phase III component in the U.S.

Rapport’s RAP-219 gets more phase III funding with Tenacia deal

Rapport Therapeutics Inc. added $20 million to its cash runway for its lead phase III oral seizure drug, RAP-219, through a potential $328 million license deal signed with Tenacia Biotechnology Co. Ltd. The agreement, announced March 9, is expected to support Rapport’s TARPγ8-specific AMPA receptor negative allosteric modulator through final registrational studies. A successful phase III program, expected to begin in the second quarter of 2026, would realize a “multibillion-dollar opportunity,” CEO Abraham N. Ceesay said.

Synthetic peptide and CAR-A each clear amyloid-β in Alzheimer’s

If one could sweep the brain clean and send the toxic substances that drive neurodegeneration to the recycling bin, perhaps one could treat Alzheimer’s disease. Researchers at the Chinese Academy of Sciences propose a new therapeutic strategy that uses synthetic peptides that bind to amyloid-β (Aβ) and direct it toward lysosomes. In addition, researchers at the Washington University School of Medicine in St. Louis have genetically modified astrocytes in vivo to express chimeric antigen receptors (CARs) that recognize and phagocytose Aβ plaques.

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