Company: CRNX
Filing Date: 2025-02-27
Form Type: 10-K
Source: 0000950170-25-029050
Chunk: 115

Company: Crinetics Pharmaceuticals, Inc.
Filing Date: 2025-02-27
Form: 10-K
Item: Item 1
Chunk 115
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 abdominal pain (17% paltusotine vs. 11% PBO) and nausea (10% paltusotine vs. 7% PBO). The frequency of adverse events considered related to acromegaly was notably lower in paltusotine treated participants compared to placebo treated participants (30% vs. 86% respectively). 

In March 2024, we reported positive topline results from the PATHFNDR-2 study. The study met statistical significance (p<0.0001) on the primary endpoint, based on the proportion of participants on paltusotine (56%) who achieved an IGF-1 level ≤ 1.0 xULN compared to those taking placebo (5%). All secondary endpoints also met statistical significance. In PATHFNDR-2, paltusotine was generally well-tolerated and no serious adverse events were reported in participants treated with paltusotine. The most commonly reported TEAEs in paltusotine-treated participants included: diarrhea (33% paltusotine vs. 18% PBO), headache (20% paltusotine vs. 33% PBO), arthralgia (11% paltusotine vs. 23% PBO) and abdominal pain (11% paltusotine vs. 4% PBO. The open label extension phases of the PATHFNDR trials are ongoing. We believe that the results of the two trials could support global marketing applications for the use of paltusotine for all acromegaly patients who require pharmacotherapy, including untreated patients and those switching from other therapies. On September 26, 2024, we announced that we had submitted an NDA to the FDA for paltusotine for the proposed treatment and long-term maintenance therapy of acromegaly. We received notification of acceptance from the FDA on the status of the NDA submission in December 2024, with a PDUFA Target Action Date of September 25, 2025. The FDA has granted orphan drug designation 

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for paltusotine for the treatment of acromegaly. We are also planning to file an MAA, with the European Medicines Agency in the first half of 2025.

Paltusotine in people living with carcinoid syndrome

In March 2024, we reported positive topline results from our randomized, open-label, parallel group, multi-center Phase 2 study to assess safety, tolerability, pharmacokinetics