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New Drug Applications and key trial readouts punctuated July for endocrinology, with treatments for hypocalcemia, diabetes, and more.
July 2026 was relatively quiet for endocrinology. The US Food and Drug Administration (FDA) had no significant approvals, instead accepting 2 exciting New Drug Applications (NDAs) for the treatment of hypocalcemia and acromegaly, respectively. Additionally, key trials for type 1 diabetes (T1D), type 2 diabetes (T2D), and weight maintenance following GLP-1 RA discontinuation had topline results read out over the course of the month, moving major candidates like encaleret and tegoprubart further down the treatment pipeline towards an FDA decision.
The HCPLive editorial team has collected 5 of the most impactful headlines from the past 31 days below. As we move into the final month of summer, catch up on some of the news you might’ve missed in July this year:
On July 22, 2026, the FDA accepted an NDA for encaleret for autosomal dominant hypocalcemia type 1 (ADH1). Announced by parent company BridgeBio, this decision positions the orally administered small molecule, designed to selectively negatively modulate the calcium sensing receptor, to become the first and only therapy specifically indicated for patients with ADH1. Encaleret has been assigned a Prescription Drug User Fee Act (PDUFA) date of May 8, 2027.
On July 16, 2026, the FDA announced its acceptance of a resubmitted NDA for CAM2029, an investigative, once-monthly subcutaneous octreotide depot, for patients with acromegaly. This follows a complete response letter (CRL) issued on June 10, 2026, which cited observations from a current good manufacturing practice inspection of a third-party manufacturer. However, no safety or efficacy concerns were identified in the letter, according to parent company Camurus. CAM2029 has been assigned a PDUFA date of December 18, 2026.
Following a banner month in June, retatrutide has successfully met the primary weight loss endpoints in the TRIUMPH-2 and TRIUMPH-3 trials, which included patients with T2D and obesity or overweight and patients with a BMI ≥35 and established cardiovascular disease. In addition to these topline results, parent company Eli Lilly has also announced its intention to submit a Biologics License Application (BLA) to the FDA in the first quarter of 2027, following completion of its chemistry, manufacturing, and controls package.
New 1-year data from the REMAIN-1 Midpoint Cohort, announced by parent company Fractyl Health on July 15, 2026, have shown the potential of the Revita Duodenal Mucosal Resurfacing (DMR) System as the first durable procedural therapy for weight maintenance after discontinuing GLP-1 RA treatment. The procedure demonstrated successful weight reduction compared to sham, with no serious adverse events related to either the procedure or the device. Fractyl Health expects to receive topline data from the REMAIN-1 Pivotal Cohort in early Q4 2026.
Eledon’s investigator-initiated trial of islet cell transplantation for T1D saw its 12th and final patient discontinued from external insulin following transplant and treatment with tegoprubart. The humanized monoclonal antibody selectively inhibits CD40 ligand, which is involved in the activation of T cells. In addition to demonstrating effective treatment with optimal tolerability in islet cell transplantation, tegoprubart is also being investigated in xenotransplantation, liver and kidney allograft transplantation, and amyotrophic lateral sclerosis.