MedPath

Paltusotine

Generic Name
Paltusotine
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C27H22F2N4O
CAS Number
2172870-89-0
Unique Ingredient Identifier
F2IBD1GMD3
Background

Paltusotine is under investigation in clinical trial NCT04261712 (A Study to Evaluate the Long-term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)).

Associated Conditions
-
Associated Therapies
-
morningstar.com
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Crinetics Announces FDA Acceptance of New Drug Application for Paltusotine for Adult Acromegaly

Crinetics Pharmaceuticals announced the FDA accepted its NDA for paltusotine, a potential once-daily oral treatment for acromegaly. The NDA submission included data from Phase 3 trials PATHFNDR-1 and PATHFNDR-2. The FDA target action date is September 25, 2025, with no advisory committee meeting anticipated.
stocktitan.net
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Crinetics' Breakthrough Oral Acromegaly Drug Advances as FDA Accepts NDA for ...

Crinetics Pharmaceuticals announced FDA acceptance of its NDA for paltusotine, a once-daily oral treatment for adult acromegaly patients, with a target action date of September 25, 2025. The NDA included data from Phase 3 trials PATHFNDR-1 and PATHFNDR-2, and paltusotine received Orphan Drug Designation in July 2020.

Promising Outlook for Crinetics Pharmaceuticals' Paltusotine in Phase 3 Trial Drives Buy Rating

Cory Jubinville, PhD from LifeSci Capital maintains a Buy rating on Crinetics Pharmaceuticals (CRNX) with a $82.00 price target, citing promising developments in paltusotine's Phase 3 trial for carcinoid syndrome (CS). Earlier Phase 2 results showed robust efficacy, supporting the Buy rating. Morgan Stanley also maintains a Buy rating with a $70.00 price target.
stocktitan.net
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Crinetics Unveils Breakthrough Cancer Drug Platform, Reports Positive Phase 2 Trial Results

Crinetics Pharmaceuticals to present at NANETS 2024, showcasing CRN09682, a nonpeptide drug conjugate targeting SST2-expressing tumors, with IND submission planned for early 2025, and Phase 2 data for paltusotine, an oral SST2 agonist for carcinoid syndrome, showing reduced symptom frequency and severity.
morningstar.com
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Crinetics Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides ...

Crinetics Pharmaceuticals reports financial results for Q3 2024, including the submission of an NDA for paltusotine for acromegaly, a $575M common stock offering, and the debut of a novel nonpeptide drug conjugate platform at NANETS. Four new drug candidates are in IND-enabling studies, and the company expects to fund operations into 2029.
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