CRNX 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• We are a pharmaceutical company committed to transforming the treatment of endocrine diseases and endocrine-related tumors through science rooted in patient needs. We are focused on discovering, developing, and commercializing novel therapies, with a core expertise in targeting GPCRs with small mole…

• •Key metrics for the first quarter 2026 reflect broad and deep uptake from patients and healthcare providers as well as favorable feedback from payers.

• •Received 232 Enrollment Forms during the first quarter of 2026. Breadth and depth of PALSONIFY prescribers continued to grow, with 263 unique HCPs having prescribed PALSONIFY within the first two quarters of launch. Approximately 70% of patients treated with PALSONIFY at the end of the first quarte…

• •In February 2026, the CHMP of the EMA adopted a positive opinion and in April 2026, the EC approved PALSONIFY for the medical treatment of adults with acromegaly.

• •In March 2026, we submitted a MAA to Brazil’s ANVISA for PALSONIFY for the treatment of acromegaly in adults.

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• We are a pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors. We have built a highly productive drug discovery and development organization with extensive expertise in endocrine G protein coupled…

• Our first approved therapy is PALSONIFY™ (paltusotine), which has been approved by the U.S. Food and Drug Administration, or FDA, in the United States for the treatment of acromegaly. Additionally, PALSONIFY is under review by regulatory agencies in Europe for the treatment of acromegaly. Paltusotin…

• The following represents a summary of notable business updates and events:

• •On September 25, 2025, the FDA approved PALSONIFY for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.

• •Our research suggests that there are approximately 36,000 people living with acromegaly in the United States, of which 17,000 or more are undiagnosed, 7,500 are not in active follow-up for treatment, and 11,500 are actively managed. Our research further suggests that of the 11,500 actively managed …

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

• As required by Exchange Act Rule 13a-15(b), we carried out an evaluation, under the supervision and with the participation of our management, including our chief executive officer and chief financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures …

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• As required by Exchange Act Rule 13a-15(b), we carried out an evaluation, under the supervision and with the participation of our management, including our chief executive officer and chief financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures …

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• During the three months ended March 31, 2026, the following members of our Board of Directors and/or officers adopted, modified, terminated a trading arrangement that is intended to satisfy the affirmative defense condition of Rule 10b5-1(c).

• NameTitle of Director or OfficerActionDate of ActionDuration of PlanTotal Shares of Common Stock to be Sold

• Stephen BetzChief Scientific OfficerAdoption of 10b5-1 plan2/19/2026

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• None of our officers (as defined in Rule 16a–1(f)) or directors adopted or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement, as each such term is defined in Item 408 of Regulation S-K.