Paltusotine

PALSONIFY is an FDA-approved once-daily, oral therapy for the treatment of acromegaly ELK GROVE VILLAGE, Ill., Sept. 26, 2025 /PRNewswire/ -- Orsini, a leader in rare disease pharmacy solutions, has been chosen by Crinetics Pharmaceuticals, Inc., as a specialty pharmacy partner for PALSONIFY™ (paltusotine), a nonpeptide, selectively-targeted somatostatin receptor type 2 nonpeptide (SST2) agonist. PALSONIFY is now the first once-daily, oral treatment approved for adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Read the full Prescribing Information at . Acromegaly develops when a benign pituitary tumor forms and secretes increased levels of growth hormone (GH). Acromegaly is characterized by somatic overgrowth (often in the hands, feet and face), and other physical changes, joint pain, metabolic disorders, cardiovascular disease, and respiratory problems, among others. When left untreated, acromegaly can lead to premature mortality. PALSONIFY is the fifth therapy to join Orsini's Endocrinology Center of Excellence. "We're honored to stand alongside Crinetics and the acromegaly community to provide access to Palsonify," Brandon Tom, Orsini's CEO, said. "For those living with acromegaly, every step toward effective treatment matters. Orsini is committed to walking that path with patients and healthcare providers, offering compassionate, meaningful support every step of the way." About Orsini Providing patients with comprehensive and compassionate care since 1987, Orsini is a leader in rare diseases and gene therapies. Orsini partners with biopharma innovators, healthcare providers and payors to support patients and their families in accessing revolutionary treatments for rare diseases. Through integrated rare disease pharmacy solutions including pharmacy distribution, patient services, clinical management and convenient home infusion services, Orsini simplifies how patients connect to advanced therapies. Orsini's high-touch care model centers on experienced and trained therapy care teams that provide personalized patient care to ensure that No Patient is Left Behind™. Orsini holds accreditations with the Accreditation Commission for Health Care (ACHC), The Joint Commission, URAC and NABP. Orsini has earned URAC's Rare Disease Pharmacy Center of Excellence Designation and ACHC's Distinction in Rare Diseases and Orphan Drugs. For more information, visit . SOURCE Orsini WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Crinetics Pharmaceuticals on Thursday said the FDA greenlit its nonpeptide somatostatin receptor type 2 (SST2) agonist Palsonify (paltusotine), making a first-line once-daily oral option available for adults with acromegaly who are refractory to or unsuitable for surgery. The product, which could offer patients freedom from frequent injections of current therapies, is expected to hit the shelves early next month — with a $290,000 yearly treatment price.Palsonify’s clearance “marks a new era for those living with acromegaly,” said Scott Struthers, chief executive of Crinetics, adding that the “approval is the first to come from our deep pipeline of first-in-class, small molecule drugs.” The FDA decision was supported by two Phase III pivotal trials, PATHFNDR-1 and PATHFNDR-2, which enrolled previously treated and treatment-naïve adults with acromegaly, respectively. In both studies, A significantly higher proportion of participants receiving Palsonify maintained IGF-1 levels ≤1 times the upper limit of normal compared with those on placebo, alongside significant reductions in acromegaly-associated symptoms. Moreover, 91% of PATHFNDR-1 and 97% of PATHFNDR-2 participants enrolled in open-label extension studies, highlighting durable IGF-1 control and sustained symptom improvements.Analysts’ predictions materialiseAnalysts at HC Wainwright last month said they were pretty confident of an approval for Palsonify, with a label enabling broad use across treatment-naïve patients, those switching from injectables, and those who discontinued therapy. They anticipate “treatment-naïve patients to drive the first wave of adoption post launch, with the other two groups to pick up momentum over time.”The optimism was echoed by Citizens JMP analysts, assigning a 90% probability of approval.. Considering patients with acromegaly visit endocrinologists infrequently, they expect a modest early launch, modelling revenues of $2 million this year and $45 million in 2026.While injectables, including somatostatin analogues and growth hormone receptor antagonists, make up the bulk of the acromegaly treatments, the FDA in 2020 approved Chiesi’s oral somatostatin analogue Mycapssa (octreotide) for long-term maintenance in injectable somatostatin responders. However, Palsonify is the first oral therapy okayed for front-line use in this condition.The drug remains under review in the EU, with a decision expected in the first half of next year. At the same time, Crinetics is partnering with Sanwa Kagaku Kenkyuso to develop and commercialise the therapy in Japan. Crinetics is also investigating the SST2 agonist in a Phase III study for carcinoid syndrome. With cash reserves of $1.2 billion providing a runway into 2029, the company’s pipeline also boasts  ACTH antagonist atumelnant being studied in congenital adrenal hyperplasia and Cushing’s syndrome, and a non-peptide drug conjugate CRN09682 for neuroendocrine tumours among others..