Daily briefings
Editor’s Briefing: November 13, 2026
In Short. A Regeneron antibody reduced the heart-rate rise on standing in a mid-stage POTS trial. Candel plans a prostate-cancer filing in mid-2027. Taiho asked the FDA to approve a lung-cancer pill. ARPA-H will fund groundwork for U.S. ibogaine trials.
Regeneron reports Phase 2 POTS results for baloncibart
POSTURAL ORTHOSTATIC tachycardia syndrome, called POTS, is a condition in which the heart rate rises abnormally when a person stands. There are no FDA-approved treatments. On Thursday Regeneron reported Phase 2 PINNACLE results for baloncibart in adults with POTS (announcement). Baloncibart is an experimental antibody designed to block a blood-volume receptor called natriuretic peptide receptor 1. The trial assigned a single injection under the skin of 150 milligrams (27 people), 450 milligrams (28 people), or placebo (27 people). The main measure was the change in heart rate from lying down to standing, taken at day 8. The trial set no formal test of success in advance, so its p-values, a standard measure of how likely a result is due to chance, are labeled nominal. At 450 milligrams, that rise was 11.4 beats per minute smaller than on placebo at day 8 (nominal p=0.0007). It was 7.4 beats per minute smaller at day 29 (nominal p=0.0124). At 150 milligrams it was 9.5 beats per minute smaller at day 8 (nominal p=0.0045), a difference not maintained at day 29. Unwanted effects were reported in 13 of 27 people (48.1%) on placebo, 18 of 27 (66.7%) on 150 milligrams, and 19 of 28 (67.9%) on 450 milligrams. Two serious events were a headache on 150 milligrams and a fainting episode on 450 milligrams. Regeneron plans a potentially pivotal Phase 3 trial in the first half of 2027.
Candel plans a mid-2027 prostate-cancer filing
Localized prostate cancer is cancer still confined to the prostate. Aglatimagene is an experimental, ready-made virus that cannot multiply and is designed to deliver a herpes-virus gene into the tumor. Patients then take the antiviral medicine valacyclovir, which is meant to kill the cells that received the gene. On Thursday Candel Therapeutics said it is in ongoing talks with the FDA about a Biologics License Application for aglatimagene in prostate cancer (announcement). That application is the formal request to license a biologic medicine. Because of timelines tied to work to refine a laboratory test used in the filing, the company now plans to submit in mid-2027, pending the result of that dialogue.
Taiho and Cullinan complete a zipalertinib application in lung cancer
Non-small cell lung cancer is the most common form of lung cancer. A defined subset carries a change in the EGFR gene known as an exon 20 insertion, which can drive tumor growth. On Thursday Cullinan Therapeutics said its partner Taiho Oncology had completed a New Drug Application for zipalertinib used with platinum-based chemotherapy (announcement). That application is the formal request for FDA approval of a small-molecule medicine. The intended use is previously untreated, locally advanced or metastatic disease that has that EGFR change. The submission is under the FDA's Real-Time Oncology Review program, which lets sponsors send clinical data before the complete application is in. The application is based on the Phase 3 REZILIENT3 trial, which at an interim analysis met its main goal. That goal was a statistically significant and clinically meaningful improvement in how long people lived without the cancer worsening, compared with chemotherapy alone. Zipalertinib is an experimental oral medicine designed to block EGFR, including variants with exon 20 insertions.
ARPA-H funds groundwork for ibogaine trials
Ibogaine is a plant-derived compound that some clinics outside the United States have used for post-traumatic stress and other serious mental illness, with only anecdotal reports. It can cause serious safety problems, including potentially life-threatening disturbances of the heart's rhythm. On Thursday the Advanced Research Projects Agency for Health, or ARPA-H, announced awards of up to $4.9 million over five years (ARPA-H announcement). Beond will generate clinical data on safety, dosing, how well the compound works, and how long any benefit lasts. Mark Cuban Cost Plus Drug Company will work on regulatory and manufacturing steps for ibogaine hydrochloride in the United States. The Department of Health and Human Services said the awards fund regulatory and manufacturing groundwork for future trials (HHS announcement). They do not fund treatment of patients or research in human volunteers, and they do not authorize clinical trials or establish FDA approval. The aim is data and a drug product that could support later trial applications.
What to watch
By November 14 the FDA is due to decide on Cytokinetics’ aficamten, for a thickening of the heart muscle that can obstruct blood flow. A decision is also due on a new at-home use of Teva’s IGALMI, a film of dexmedetomidine placed under the tongue, for agitation in bipolar disorder or schizophrenia. Capricor’s deramiocel for Duchenne muscular dystrophy is due on November 22.