SAN DIEGO, Oct. 08, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, announced today that it intends to offer and sell, subject to market and other conditions, $400.0 million of shares of its common stock in a proposed underwritten public offering. In addition, Crinetics intends to grant the underwriters a 30-da ...

On October 3, Representative Josh Gottheimer of New Jersey's 5th district disclosed a September 25 investment in Crinetics Pharmaceuticals (NASDAQ: CRNX), a mid-cap stock that no U.S. politician had previously traded. At that time, the CRNX share price was $50.58, and the representative's total purchase ranged from $1,001 to $15,000. Since then, CRNX stock has been on a sustained upward trend — at press time, trading at $56.48, an increase of 11.66% since Gottheimer's purchase. Depending on the amount inves ...

SAN DIEGO, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for paltusotine, the first once-daily, oral, selectively-targeted somatostatin receptor type 2 nonpeptide agonist in development for the proposed treatment and long-term maintenance therapy of acromegaly. "This NDA submission brings us one step closer to our goal of delivering a new generation of therapy tha ...

Company Overview - Crinetics Pharmaceuticals, Inc. is a clinical stage pharmaceutical company focused on discovering, developing, and commercializing novel therapeutics for endocrine diseases and endocrine-related tumors [4] - The company's lead development candidate, paltusotine, is an investigational, first-in-class, oral, once-daily somatostatin receptor type 2 (SST2) agonist currently in Phase 3 clinical development for acromegaly and in Phase 2 for carcinoid syndrome associated with neuroendocrine tumors [4] - Crinetics is also developing atumelnant (CRN04894), an investigational, first-in-class, oral ACTH antagonist, which is completing Phase 2 clinical studies for congenital adrenal hyperplasia and Cushing's disease [4] - All drug candidates are orally delivered, small molecule new chemical entities resulting from in-house drug discovery efforts, addressing various endocrine conditions such as hyperparathyroidism, polycystic kidney disease, Graves' disease, diabetes, obesity, and GPCR-targeted oncology indications [4] Upcoming Events - Company management will participate in fireside chats at the Morgan Stanley 22nd Annual Global Healthcare Conference on September 4, 2024, at 5:35 p.m. Eastern Time [2] - Additionally, management will participate in the Cantor Global Healthcare Conference on September 18, 2024, at 8:35 a.m. Eastern Time [2] - Live and archived webcasts of these events will be accessible on the Events & Presentations page in the Investors section of the Crinetics' website [2]

Financial Data and Key Metrics Changes - Crinetics ended Q2 2024 with approximately $863 million in cash and investments, projected to fund operations into 2028 [28] - Research and development expenses increased to $58.3 million in Q2 2024 from $40.6 million in Q2 2023, primarily due to higher personnel costs and development activities [29] - General and Administrative expenses rose to $24.8 million in Q2 2024 from $13.3 million in Q2 2023, attributed to increased personnel costs and outside services [29] - Net loss for Q2 2024 was $74.1 million compared to a net loss of $51 million in Q2 2023, with revenues of $0.4 million in Q2 2024 down from $1 million in Q2 2023 [30] Business Line Data and Key Metrics Changes - The company is advancing its lead candidate paltusitine for acromegaly, with plans to file an NDA this year [12][18] - Atumelnant is showing promising results in Phase 2 studies for Congenital Adrenal Hyperplasia (CAH) and Cushing's disease, with data presented at the Endocrine Society annual meeting [6][15] - The company is also developing a Parathyroid Hormone receptor antagonist for hyperparathyroidism and an SST3 agonist for autosomal dominant polycystic kidney disease (ADPKD) [8][9] Market Data and Key Metrics Changes - Crinetics is focusing on the acromegaly market, which has not seen new molecules in over a decade, aiming to establish paltusitine as a new standard of care [19] - The company is preparing to engage with regulators for a Phase 3 program in carcinoid syndrome, with expectations to initiate the trial by the end of 2024 [14] Company Strategy and Development Direction - The overarching strategy is to disrupt the acromegaly marketplace with a clinically differentiated once-daily oral medication [19] - The company is committed to a patient-centric approach, actively seeking patient input throughout the drug development process [16] - Crinetics is also exploring partnerships to advance its pipeline, particularly in nephrology for the ADPKD program [41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of paltusitine and Atumelnant, with plans to continue advancing clinical and regulatory milestones [31] - The company is focused on building awareness of the patient experience and addressing the disconnect between physician perceptions and patient realities [20][64] Other Important Information - Marc Wilson, the Chief Financial Officer, will be stepping down for personal reasons, with a search for a successor underway [11] - The company has a partnership with Radionetics Oncology, which received $140 million upfront from Eli Lilly for a strategic relationship [10] Q&A Session Summary Question: Insights from Phase 2 updates in CAH and Cushing's - Management expects to provide final or top-line results in CAH and Cushing's disease later this year, which will support the design of the Phase 3 program [33][34] Question: Engagement with the agency for carcinoid syndrome - The company is ready to start engaging with the FDA and expects to initiate the trial by the end of the year [37] Question: Advancing the ADPKD program - The decision to partner or advance independently will depend on the company's nephrology capabilities and the potential for faster development with a partner [39][41] Question: Pricing strategy for Atumelnant - It is too early to discuss pricing, but the company is engaged with payers and sharing the value proposition [45] Question: Clinical outcomes in Tucan - A variety of clinical parameters, including menstrual function and metabolic control, are being observed in the trials [48] Question: Carcinoid regulatory feedback - The company intends to include both previously treated and naive patients in the trial, with plans for a placebo comparator arm [50][51] Question: Investigating paltusitine in neuroendocrine tumors - The company will observe tumors in the Phase 3 study but is not designing the trial to measure anti-tumor activities [53] Question: Role of SST3 agonism in ADPKD - The company is exploring the potential of SST3 agonism in ADPKD, with ongoing research to support this hypothesis [56] Question: Next steps in CAH - The company is optimistic about moving forward to a pivotal trial based on the data generated from the current cohorts [59][60]

Crinetics Pharmaceuticals, Inc. (CRNX) came out with a quarterly loss of $0.94 per share versus the Zacks Consensus Estimate of a loss of $0.86. This compares to loss of $0.94 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -9.30%. A quarter ago, it was expected that this company would post a loss of $0.84 per share when it actually produced a loss of $0.93, delivering a surprise of -10.71%. Over the last four quarters, the c ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38583 Crinetics Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 26-3744114 (State or other ju ...

The market expects Crinetics Pharmaceuticals, Inc. (CRNX) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2024. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report, which is expected to be released on August 8, 2024, might help the stock move higher if the ...

SAN DIEGO, July 18, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that it will report second quarter 2024 financial results on Thursday, August 8, 2024 after the market closes. Company management will host a conference call at 4:30 p.m. ET that day to discuss financial results and provide a business update. Conference Call & Webcast | --- | --- | |----------------|-----------------------------------| | | | | | | | | Thursday, August 8th @ 4:30 PM ET | | Domestic: | ...

The 2021 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Crinetics, or following a bona fide period of non-employment, as an inducement material to such individuals' entering into employment with Crinetics, pursuant to Nasdaq Listing Rule 5635(c) (4). The options have an exercise price of $50.80 per share, which is equal to the closing price of Crinetics' common stock on The Nasdaq Global Select Market on July 10, 2024. The shares subjec ...