lorundrostat(Mineralys Therapeutics, Inc.) · Dec 22, 2026
Hypertension that won't come down on standard medicines — the patients who still miss their blood-pressure goal on multiple drugs.
Lorundrostat is an aldosterone synthase inhibitor — it targets the enzyme that produces aldosterone rather than blocking the hormone's downstream receptor, the route most current therapies take. Mineralys is seeking approval for adults with hypertension, given in combination with other antihypertensive drugs — an add-on for the large population that can't reach goal blood pressure on standard ACE inhibitor, ARB, and diuretic regimens. The FDA accepted the NDA under standard review with a December 22, 2026 target action date. Aldosterone is a long-suspected driver of hard-to-control blood pressure; watch whether the eventual label covers uncontrolled hypertension broadly or stays narrowly defined.
Anitocabtagene autoleucel (anito-cel)(Arcellx, Inc.) · Dec 23, 2026 BLA (BCMA CAR-T)+anito-cel(Arcellx, Inc.) · Dec 23, 2026 BLA
Multiple myeloma that has relapsed or stopped responding after several prior lines of treatment.
Anitocabtagene autoleucel is an autologous CAR-T cell therapy: a patient's own T cells are re-engineered to recognize BCMA, a protein on myeloma cells, then reinfused to attack the cancer. Arcellx's BLA — now advancing under Gilead, which acquired the company — targets fourth-line relapsed/refractory multiple myeloma and carries Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy (RMAT) designations. It would enter a BCMA CAR-T field where two cell therapies are already approved, so the durability and safety of its single infusion will shape its positioning. The PDUFA action date is December 23, 2026; watch how the FDA weighs benefit and safety in heavily pretreated patients with few remaining options.
Imlifidase(Hansa Biopharma AB) · Dec 19, 2026 BLA+Imlifidase(Hansa Biopharma AB) · Dec 19, 2026
Highly sensitized kidney-transplant candidates whose own antibodies would immediately reject an available donor organ.
Some patients waiting for a kidney have built up antibodies — from prior transplants, transfusions, or pregnancy — that produce a positive crossmatch and rule out otherwise-available donors, leaving them stuck on dialysis for years. Imlifidase is an enzyme that cleaves circulating IgG antibodies, rapidly lowering the donor-specific antibodies behind that crossmatch so a transplant can proceed. Hansa Biopharma's BLA seeks desensitization of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor, and carries Fast Track and Orphan Drug designations. The PDUFA action date is December 19, 2026. Watch whether the FDA accepts a desensitize-then-transplant approach for a population with few alternatives.
Zanzalintinib (XL-092) + atezolizumab(Exelixis, Inc.) · Dec 3, 2026 NDA+zanzalintinib(EXELIXIS, INC.) · Dec 3, 2026 NDA
Previously treated metastatic colorectal cancer — a common cancer with limited later-line options.
Zanzalintinib is a multi-targeted tyrosine kinase inhibitor that blocks signaling through receptors including VEGFR2, MET, and AXL — pathways tumors use to build blood supply and resist treatment. Exelixis is pairing it with the PD-L1 immunotherapy atezolizumab to test whether blocking those pathways makes immunologically 'cold' colorectal tumors responsive to checkpoint blockade. The combination was studied in the STELLAR-303 trial in previously treated metastatic colorectal cancer. The FDA accepted the NDA under standard review, with no special designations, and set a December 3, 2026 target action date. Watch the survival readout from STELLAR-303 — checkpoint inhibitors alone have historically shown little benefit in the microsatellite-stable tumors that make up most colorectal cancer.
