SAN DIEGO - Crinetics Pharmaceuticals Inc . (NASDAQ:CRNX) reported on Monday significant clinical advancements for its investigational drug paltusotine, aimed at treating acromegaly, a rare endocrine disorder. The data, presented at the Endocrine Society's Annual Meeting, ENDO2024, and published in The Journal of Clinical Endocrinology & Metabolism, highlighted positive outcomes from a series of trials.
The Phase 3 PATHFNDR-2 study, a double-blind, placebo-controlled trial, enrolled 111 participants with active acromegaly who had not received prior pharmacological treatment. Paltusotine achieved the primary endpoint with 56% of patients reaching normalized insulin-like growth factor 1 (IGF-1) levels compared to 5% in the placebo group. The response was rapid within two to four weeks and sustained throughout the treatment period.
In a separate analysis of the Phase 3 PATHFNDR-1 trial, patient-reported outcomes showed that paltusotine lessened the frequency of breakthrough symptom exacerbations versus standard of care injections. These findings suggest a potential improvement in day-to-day symptom management for those treated with paltusotine.
Long-term data from the open-label ACROBAT Advance extension study demonstrated durable safety and efficacy of paltusotine treatment for up to 42 months. The results indicated consistent IGF-1 and symptom control, comparable to injected somatostatin receptor ligands (SRLs), the current standard treatment.
Crinetics expects to complete its New Drug Application submission for paltusotine in the second half of 2024. If approved, paltusotine, an oral once-daily somatostatin receptor type 2 (SST2) agonist, could offer a convenient alternative to the painful and burdensome monthly injections currently used.
Acromegaly is typically caused by a benign tumor in the pituitary gland, leading to excessive growth hormone and IGF-1 levels. This can result in serious complications, such as bone and organ enlargement and increased risk of cardiovascular and respiratory diseases. Current treatments involve surgery and pharmacotherapy, with many patients requiring ongoing medication.
The information reported is based on a press release statement from Crinetics Pharmaceuticals.
InvestingPro Insights
Crinetics Pharmaceuticals Inc. (NASDAQ:CRNX) has shown promising clinical results for its investigational drug paltusotine, but what does the financial health and market sentiment around the company look like? Here are some insights based on the latest data from InvestingPro.
InvestingPro Data:
- Market Cap (Adjusted): $3.59B USD
- P/E Ratio (Adjusted) last twelve months as of Q1 2024: -15.56
- Revenue Growth last twelve months as of Q1 2024: -53.93%
While the company's clinical advancements are noteworthy, financial metrics suggest a challenging landscape. Crinetics holds a high market capitalization amidst a significant revenue decline over the last twelve months as of Q1 2024. The adjusted P/E ratio also indicates that the company is not currently profitable, a situation reflected in the broader financials with a substantial decrease in revenue growth during the same period.
InvestingPro Tips:
1. Crinetics Pharmaceuticals is trading at a high revenue valuation multiple, which could be a concern for value-focused investors.
2. Despite a high return over the last year, analysts have revised their earnings downwards for the upcoming period and do not anticipate the company will be profitable this year.
These InvestingPro Tips highlight the dichotomy between the company's clinical progress and its financial performance. While the potential of paltusotine is clear, investors may need to temper their expectations with the reality of the company's current financial health. For those interested in a deeper dive into Crinetics Pharmaceuticals' financials, there are 10 additional InvestingPro Tips available at https://www.investing.com/pro/CRNX. Use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.