Gilead Sciences (NASDAQ: GILD) presented 52-week open-label extension (OLE) long-term data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials of twice-yearly subcutaneous lenacapavir (Yeztugo, FDA-approved June 2025) for HIV prevention (pre-exposure prophylaxis, PrEP) at AIDS 2026 Wednesday July 29, 2026. PURPOSE 1 documented zero new HIV infections among participants receiving twice-yearly lenacapavir across more than 7,178 person-years of open-label follow-up at Week 52; PURPOSE 2 documented one HIV infection among participants continuing lenacapavir across 5,295 person-years. The 52-week OLE data confirms continued high efficacy, high adherence (participants generally reliably return for the twice-yearly injection), and consistent safety profile across broad and geographically diverse populations. Yeztugo has now been deployed in 10 priority sub-Saharan African countries including South Africa (national program launched June 5, 2026 by President Cyril Ramaphosa in Secunda, Mpumalanga), Zambia, and Eswatini through PEPFAR and Global Fund investments. Generic versions from Dr. Reddy's Laboratories, Hetero Labs, and four other manufacturers are expected in 2027 at approximately $40 per person per year across 120 low- and lower-middle-income countries.
Crinetics Pharmaceuticals (Nasdaq: CRNX) presented data on June 14 from up to two years of efficacy and pooled safety follow-up in the PATHFNDR-1 and PATHFNDR-2 open-label extensions of Palsonify, the once-daily oral SST2 nonpeptide agonist for acromegaly. Palsonify maintained lowered IGF-1 levels, stable symptoms, and stable or reduced pituitary tumor volumes through 48 weeks across 167 patients. Pooled safety data identified no new safety signals; common adverse events were diarrhea, arthralgia, headache, and UTI. A separate ACROBAT Advance analysis showed safety and efficacy with up to four years of Palsonify + oral cabergoline combination therapy in patients whose IGF-1 had not normalized on Palsonify alone. With Camurus's rival monthly octreotide depot Oclaiz pushed to a 2027 US launch after the June 10 second CRL, Palsonify now stands alone as the next-generation acromegaly therapy in the US market.
Crinetics Pharmaceuticals (Nasdaq: CRNX) will present an oral abstract Sunday June 14 (1:45-3:15 PM CT, Room W183BC) covering up to two years of efficacy and pooled safety data from the Palsonify (once-daily oral paltusotine) PATHFNDR-1 and PATHFNDR-2 open-label extensions in acromegaly, plus long-term combination data with cabergoline from the ACROBAT Advance trial. The presentation lands four days after Camurus's second Complete Response Letter on Oclaiz (CAM2029), the rival monthly subcutaneous octreotide depot, leaves the US acromegaly market with only one approved next-generation entrant (Palsonify, approved September 2025) through at least H1 2027. Crinetics will also present six total abstracts at ENDO including Phase 2 atumelnant data in congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome.
MBX Biosciences (Nasdaq: MBX) on June 12 reported full 12-week Phase 2 Avail data and one-year open-label extension results for once-weekly canvuparatide, a precision PTH peptide for chronic hypoparathyroidism. The trial hit its primary endpoint with a 63% responder rate versus 31% on placebo at 12 weeks; the OLE delivered a 79% responder rate at six months and 57% at one year. Patients showed normalized serum calcium, reduced urine calcium excretion, restored bone metabolism, and improved eGFR; 90% of OLE patients remained on study at one year with no new safety signals. A registrational Phase 3 in chronic hypoparathyroidism starts Q3 2026.