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Crinetics Pharmaceuticals, Inc. reports news on the commercialization of PALSONIFY and the development of therapies for endocrine diseases and endocrine-related tumors. The company’s lead product, PALSONIFY (paltusotine), is a once-daily oral treatment approved for adults with acromegaly who had an inadequate response to surgery or for whom surgery is not an option. Recurring updates include product revenue, commercial launch activity, regulatory approvals and submissions, and financial results.
Crinetics’ pipeline news also covers paltusotine in carcinoid syndrome associated with neuroendocrine tumors, atumelnant in congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome, and CRN09682 for SST2-expressing neuroendocrine tumors and other solid tumors. The company also reports discovery work involving GPCR-targeted small molecules and other endocrine targets.
Crinetics Pharmaceuticals (CRNX) has granted non-qualified stock options to sixteen new non-executive employees under its 2021 Employment Inducement Incentive Award Plan. The options allow purchase of 146,400 shares at an exercise price of $57.17 per share, matching CRNX's closing price on Nasdaq Global Select Market on December 10, 2024. The stock options will vest over four years, with 25% vesting after one year and the remainder vesting in 36 monthly installments, contingent on continued employment. These grants comply with Nasdaq Listing Rule 5635(c)(4) as inducement awards for new employees.
Crinetics Pharmaceuticals (Nasdaq: CRNX) announced FDA acceptance of its New Drug Application (NDA) for paltusotine, a treatment for adult acromegaly patients. The FDA set a target action date of September 25, 2025. If approved, paltusotine will become the first once-daily, oral, selective somatostatin receptor type 2 nonpeptide agonist for acromegaly.
The NDA submission included data from two Phase 3 clinical trials: PATHFNDR-1 and PATHFNDR-2, which evaluated the drug's safety and efficacy in previously treated and untreated adults. The FDA indicated no advisory committee meeting is anticipated during review. Paltusotine received Orphan Drug Designation in July 2020 for treating acromegaly, a rare disease affecting fewer than 200,000 people in the US.
Crinetics Pharmaceuticals (Nasdaq: CRNX), a clinical stage pharmaceutical company specializing in endocrine diseases and tumors, has announced its participation in three major investor conferences this December. The company will present at the Piper Sandler 36th Annual Healthcare Conference in New York, and both the Citi Global Healthcare Conference and Evercore 7th Annual HealthCONx Conference in Miami. Management will conduct fireside chats on December 3rd at 7:30 AM ET (Evercore), December 4th at 9:30 AM ET (Citi), and December 5th at 1:00 PM ET (Piper Sandler). Live and archived webcasts will be available on the company's website.
Crinetics Pharmaceuticals (NASDAQ: CRNX) will present two abstracts at NANETS 2024, showcasing advancements in neuroendocrine tumor treatments. The company will debut its nonpeptide drug conjugate platform, featuring CRN09682, a lead candidate targeting SST2-expressing tumors, with IND submission planned for early 2025. The presentation includes preclinical data demonstrating CRN09682's potent and selective anti-tumor activity. Additionally, Phase 2 trial data for paltusotine, an oral SST2 agonist for carcinoid syndrome treatment, will be presented, showing reduced symptom frequency and severity across 36 trial participants.
Crinetics Pharmaceuticals (NASDAQ: CRNX) announced two key presentations at NANETS 2024, showcasing advancements in their neuroendocrine tumor pipeline. The company will present preclinical data for CRN09682, a first-in-class nonpeptide drug conjugate targeting SST2-expressing tumors, planned for IND submission in early 2025. Additionally, they will share Phase 2 trial results for paltusotine, demonstrating reduced frequency and severity of carcinoid syndrome symptoms in patients with functional NETs. The presentations include data from all 36 trial participants, supporting further clinical development. A company-sponsored symposium will feature both drug candidates and their novel nonpeptide approaches to treating carcinoid syndrome and neuroendocrine tumors.
Crinetics Pharmaceuticals (CRNX) reported Q3 2024 financial results, highlighting the submission of its New Drug Application for paltusotine for acromegaly treatment. The company completed an upsized public offering raising $575M and advanced four drug candidates to IND-enabling studies. Q3 financial results showed R&D expenses of $61.9M and G&A expenses of $25.9M, with a net loss of $76.8M. Cash position strengthened to $862.7M as of September 30, 2024, with additional $575M raised in October, extending runway into 2029.
Crinetics Pharmaceuticals (Nasdaq: CRNX) has announced that its Compensation Committee granted stock option awards to eleven new non-executive employees on November 10, 2024. The awards, totaling 99,500 shares, were granted under the 2021 Employment Inducement Incentive Award Plan at an exercise price of $60.69 per share. The options will vest over four years, with 25% vesting after one year and the remainder vesting monthly over 36 months, contingent on continued employment. These grants were made as employment inducements in accordance with Nasdaq Listing Rule 5635(c)(4).
Crinetics Pharmaceuticals (Nasdaq: CRNX) has announced the granting of non-qualified stock options to 27 new non-executive employees on October 10, 2024. The Compensation Committee of Crinetics' Board of Directors approved these awards under the company's 2021 Employment Inducement Incentive Award Plan. The grants, totaling 258,800 shares of common stock, are in line with Nasdaq Listing Rule 5635(c)(4) and serve as inducements for new employees joining Crinetics.
Key details of the stock options include:
- Exercise price: $51.78 per share, matching the closing price of Crinetics' common stock on The Nasdaq Global Select Market on October 10, 2024
- Vesting schedule: 25% after one year, with the remainder vesting in 36 equal monthly installments
- Vesting is subject to continued employment with Crinetics
Crinetics Pharmaceuticals (Nasdaq: CRNX) has announced the pricing of an upsized public offering of 10,000,000 shares of its common stock at $50.00 per share. The gross proceeds are expected to be $500.0 million. Crinetics has also granted underwriters a 30-day option to purchase up to an additional 1,500,000 shares. The offering is set to close around October 10, 2024.
The company plans to use the net proceeds to fund research and development of clinical-stage product candidates, other research programs, pre-commercialization activities, and general corporate purposes. Crinetics may also consider in-licensing, acquiring, or investing in complementary businesses or technologies.
Joint bookrunning managers for the offering include Leerink Partners, Morgan Stanley, Piper Sandler, and Cantor. The securities are being offered pursuant to a shelf registration statement filed with the SEC.
Crinetics Pharmaceuticals (Nasdaq: CRNX), a clinical-stage pharmaceutical company focused on endocrine diseases and tumors, has announced a proposed public offering of common stock. The company aims to offer $400.0 million of shares, with an additional 30-day option for underwriters to purchase up to $60.0 million more. Leerink Partners and Morgan Stanley are acting as joint bookrunning managers.
The net proceeds will be used to fund research and development of clinical-stage product candidates, other research programs, pre-commercialization activities, and general corporate purposes. Crinetics may also consider using a portion for in-licensing, acquisitions, or investments in complementary businesses or technologies. The offering is subject to market conditions and there is no assurance of its completion or final terms.