{"id":971827,"date":"2026-06-14T14:48:05","date_gmt":"2026-06-14T18:48:05","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/crinetics-presents-long-term-data-at-endo-2026-confirming-palsonify-paltusotine-provides-durable-consistent-acromegaly-control\/"},"modified":"2026-06-14T14:48:05","modified_gmt":"2026-06-14T18:48:05","slug":"crinetics-presents-long-term-data-at-endo-2026-confirming-palsonify-paltusotine-provides-durable-consistent-acromegaly-control","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/crinetics-presents-long-term-data-at-endo-2026-confirming-palsonify-paltusotine-provides-durable-consistent-acromegaly-control\/","title":{"rendered":"Crinetics Presents Long Term Data at ENDO 2026 Confirming PALSONIFY\u2122 (paltusotine) Provides Durable, Consistent Acromegaly Control"},"content":{"rendered":"
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\n Data from up to two years of treatment in PATHFNDR-1 and PATHFNDR-2 open-label extension studies show PALSONIFY maintained lower IGF-1 levels and stable symptoms<\/em>\n <\/p>\n

\n Treatment also resulted in stable or reduced pituitary tumor volumes for up to 48 weeks<\/em>\n <\/p>\n

\n Additional ENDO highlights include long-term ACROBAT data demonstrating PALSONIFY and cabergoline combination improves biochemical control of acromegaly<\/em>\n <\/p>\n

SAN DIEGO, June 14, 2026 (GLOBE NEWSWIRE) — Crinetics Pharmaceuticals, Inc.<\/u><\/a> (Nasdaq: CRNX) today announced new long-term data from its clinical development program evaluating novel PALSONIFYTM<\/sup> (paltusotine) in acromegaly during an oral presentation at the Endocrine Society\u2019s Annual Meeting, ENDO 2026. Notably, pooled data from the open-label extension (OLE) trials of PATHFNDR-1 and PATHFNDR-2 show that after two years of treatment, PALSONIFY was effective and well-tolerated in patients who were switched from standard-of-care monthly injectable somatostatin receptor ligands (SRLs) and those who were medically untreated, respectively, when oral, once-daily PALSONIFY was initiated.<\/p>\n

\u201cTo assess acromegaly disease control while on medication, endocrinologists carefully monitor control of IGF-1 levels, control of acromegaly symptoms, and stabilization of pituitary tumors,\u201d said Dr. Alan Krasner, M.D., Chief Endocrinologist, Crinetics. \u201cAt this year\u2019s ENDO meeting, long-term safety and efficacy data from the PATHFNDR OLE trials will be presented. These studies indicate that Palsonify is well tolerated and maintains control of all three aspects of disease control with long-term follow-up. Since its launch late last year, we are learning that Palsonify is already making a meaningful difference in the lives of many people with acromegaly, and we hope these data will be helpful for patients and for their health care providers.\u201d<\/p>\n

\n
\n Pooled OLE Efficacy and Safety Results<\/u>
\n <\/strong>\n <\/p>\n

\n PATHFNDR-1 Data<\/strong>
\n
The PATHFNDR-1 Phase 3 trial enrolled adults with acromegaly who were biochemically controlled on monthly injectable SRLs. Following a 36-week randomized, placebo-controlled period, 53 of 57 participants (93%) entered the ongoing single-arm open-label extension (OLE) trial.<\/p>\n

Baseline mean IGF-1 levels for OLE participants (n=53) was 0.91x Upper Limit of Normal (ULN). These levels remained stable at both 48 weeks (n=50) and 96 weeks (n=47) of the study: 0.82x ULN and 0.81, respectively. Symptoms associated with acromegaly, as measured by the Acromegaly Symptom Diary (ASD), remained stable from baseline at assessed timepoints. Additionally, pituitary tumor volumes were reported as stable in all patients at week 48, relative to OLE baseline.<\/p>\n

\n PATHFNDR-2 Data<\/strong>
\n
The PATHFNDR-2 trial evaluated once-daily oral PALSONIFY in adults with biochemically uncontrolled acromegaly (baseline IGF-1 > 1.3 \u00d7 ULN). After a 24-week randomized controlled (RC period, 103 of 106 completers (97.2%) entered the ongoing OLE, along with 11 additional patients who were eligible for the RC phase but enrolled directly into the OLE.<\/p>\n

Baseline mean IGF-1 levels for OLE participants (n=114) was 1.64\u00d7ULN. These levels decreased from baseline at both 48 weeks (n=98) and 72 weeks (n=78) of the study: 1.06\u00d7ULN and 0.96\u00d7ULN, respectively.<\/p>\n

Relative to OLE baseline, pituitary tumor volume was reduced by >20% in 7 of 83 PATHFNDR-2 patients\u00a0with available MRI scans at OLE Week 24. Tumor volume was reported as stable in the other 76 participants.<\/p>\n

In both OLEs, median ASD scores were stable at the timepoints assessed. Symptoms associated with acromegaly, as measured by the Acromegaly Symptom Diary (ASD), remained stable from baseline at assessed timepoints.<\/p>\n

No new safety signals were found. In the pooled OLE population (n=167), the most common adverse events (incidence>10%) were diarrhea (15.6%), arthralgia (11.4%), headache (11.4%), and urinary tract infection (10.2%). Four patients (2.4%) discontinued from an OLE due to adverse events as of this analysis.<\/p>\n

These results were included in an oral presentation at ENDO 2026 titled \u201cEfficacy and Safety of Once-Daily Oral Paltusotine in Patients with Acromegaly: Up to 2 Years in the PATHFNDR-1 and PATHFNDR-2 Open-Label Extension Studies.\u201d<\/p>\n

Additionally, an analysis was presented at ENDO 2026 that evaluated the safety and efficacy of PALSONIFY in combination with oral cabergoline in patients with acromegaly who have been followed for up to four years in ACROBAT Advance, an ongoing, single-arm, open-label extension phase 2 study. IGF-I levels on paltusotine monotherapy were similar to parent study baseline values (on injected SRL), but for those in whom IGF-1 had not yet normalized, it further improved when oral cabergoline was added. Combination therapy was well tolerated.<\/p>\n

Crinetics\u2019 ENDO 2026 presentations can be found at: https:\/\/crinetics.com\/news-events\/endo-2026\/<\/a><\/p>\n

\n PALSONIFY\u2122 (paltusotine) INDICATION:<\/strong>
\n
PALSONIFY is a somatostatin receptor agonist indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and\/or for whom surgery is not an option.<\/p>\n

\n IMPORTANT SAFETY INFORMATION<\/strong>\n <\/p>\n

\n WARNINGS AND PRECAUTIONS:<\/strong>\n <\/p>\n