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SAN DIEGO - Crinetics Pharmaceuticals, Inc. (NASDAQ: NASDAQ:CRNX) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for paltusotine, a novel treatment option for acromegaly. This drug is a once-daily, oral therapy specifically targeting somatostatin receptor type 2, which is significant as it offers a potential alternative to the current injectable treatments that are the standard of care.
The NDA is based on data from 18 clinical trials, including two pivotal Phase 3 trials that met all primary and secondary endpoints. These trials demonstrated that paltusotine was well-tolerated and effective in controlling biochemical markers and symptoms of acromegaly, both in patients who were previously untreated and those switching from injectable therapies.
Acromegaly is a rare disease typically caused by a benign tumor on the pituitary gland, leading to excessive growth hormone and insulin-like growth factor-1 production. This can result in serious health complications and a decreased quality of life. Current treatments involve surgery when possible, followed by pharmacotherapy, which usually requires monthly injections.
Paltusotine represents Crinetics Pharmaceuticals' commitment to developing oral medications for endocrine diseases and endocrine-related tumors. The company's pipeline includes other oral treatments targeting various endocrine conditions.
The FDA's decision on the NDA submission is expected in December. This announcement is based on a press release statement from Crinetics Pharmaceuticals.
In other recent news, Crinetics Pharmaceuticals announced the pending departure of its Chief Commercial Officer, James Hassard. Meanwhile, the company has seen significant progress in its drug development pipeline. Its investigational drug, paltusotine, has shown promising results for treating acromegaly, with plans to complete its New Drug Application submission in the second half of 2024. The company's drug candidate, atumelnant, has also demonstrated effectiveness in treating patients with Congenital Adrenal Hyperplasia (CAH) and ACTH-dependent Cushing's syndrome.
Piper Sandler and Oppenheimer have maintained their positive outlook on Crinetics. Piper Sandler reaffirmed its Overweight rating with a steady price target of $97.00, while Oppenheimer maintained an Outperform rating with a steady price target of $74.00. This follows a strategic partnership between Radionetics Oncology, a company spun off by Crinetics, and pharmaceutical giant Eli Lilly (NYSE:LLY).
Additionally, Crinetics has entered into an at-the-market sales agreement with Leerink Partners LLC and Cantor Fitzgerald & Co. These recent developments highlight the ongoing activities within Crinetics Pharmaceuticals.
InvestingPro Insights
As Crinetics Pharmaceuticals, Inc. (NASDAQ: CRNX) awaits the FDA's decision on their New Drug Application, investors and industry watchers are looking at the company's financial health and market performance for clues on its future prospects. According to InvestingPro data, Crinetics Pharmaceuticals holds a market capitalization of 4.06 billion USD, which reflects the market's valuation of the company based on its potential growth and profitability.
Despite the promising clinical trial results for paltusotine, InvestingPro data indicates a significant sales decline, with a revenue growth rate of -71.35% over the last twelve months as of Q2 2024. Additionally, the company's gross profit margin stands at an alarming -2252.13% for the same period, highlighting challenges in cost management and profitability. The InvestingPro Tips highlight that analysts have revised their earnings estimates downwards for the upcoming period and do not anticipate the company will be profitable this year. This could be a point of concern for investors considering the long-term financial sustainability of Crinetics Pharmaceuticals.
On a more positive note, one of the InvestingPro Tips points out that Crinetics Pharmaceuticals has a high return over the last year, with a 75.85% one-year price total return as of the date provided, signaling strong market confidence in the short term. Furthermore, the company holds more cash than debt on its balance sheet, which may provide some financial stability as it navigates the commercialization phase of paltusotine, should it receive FDA approval.
For investors seeking a deeper dive into Crinetics Pharmaceuticals' financials and market performance, there are additional InvestingPro Tips available at InvestingPro, offering comprehensive analysis and proprietary metrics that could guide investment decisions.
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