The FDA just handed this clinical-stage biotech its golden ticket -- but at a $4.3 billion valuation, the market's already pricing in a fair amount of commercial success.Crinetics Pharmaceuticals (CRNX 27.92%) faces the ultimate biotech paradox: Its newly approved drug Palsonify could either justify the stock's $4.3 billion valuation or expose it as dangerously overpriced. The U.S. Food and Drug Administration (FDA) approval on Sept. 25 transforms this clinical-stage company into a commercial powerhouse wit ...

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BREAKING: Bullish Rebound Pares Market's Weekly Losses Shares of Crinetics Pharmaceuticals (CRNX) surged Friday after the Food and Drug Administration approved the company's acromegaly drug, Palsonify. Acromegaly is a rare condition in which the pituitary gland produces too much growth hormone. This causes some bones, organs and other tissues to grow bigger. The late wrestler and actor Andre Rene Roussimoff — widely known as "Andre the Giant" — suffered from acromegaly. Palsonify will cost $290,000 a year, ...

智通财经APP获悉，周五，Crinetics(CRNX.US)盘初暴涨23%，创8个月新高，报44.30美元。消息面上， 此前FDA批准了其用于治疗肢端肥大症的药物，这是一种导致体内生长激素过多产生的罕见疾病。这种 名为Palsonify的药物是一种每日一次的口服治疗药物，公司预计它将在十月初在美国上市。此次批准基 于两项三期试验的数据，试验中药物耐受性良好，并带来了快速且一致的生化控制和症状减轻。 （原标题：美股异动 | Crinetics(CRNX.US)盘初暴涨23% FDA批准其生长激素紊乱治疗方案） ...

周五，Crinetics(CRNX.US)盘初暴涨23%，创8个月新高，报44.30美元。消息面上，此前FDA批准了其 用于治疗肢端肥大症的药物，这是一种导致体内生长激素过多产生的罕见疾病。这种名为Palsonify的药 物是一种每日一次的口服治疗药物，公司预计它将在十月初在美国上市。此次批准基于两项三期试验的 数据，试验中药物耐受性良好，并带来了快速且一致的生化控制和症状减轻。 ...

Summary of Crinetics Pharmaceuticals Conference Call Company and Industry - **Company**: Crinetics Pharmaceuticals (NasdaqGS:CRNX) - **Industry**: Pharmaceuticals, specifically focusing on endocrine disorders, particularly acromegaly Key Points and Arguments 1. **FDA Approval of Palsonify**: Palsonify has been approved by the FDA for treating adults with acromegaly, marking a significant advancement in patient care [5][16][42] 2. **Patient-Centric Approach**: The company engaged with the acromegaly community early in the development process to shape their therapeutic strategies based on patient insights [6][13] 3. **Disease Overview**: Acromegaly is a chronic endocrine disorder caused by excess growth hormone, leading to severe health complications and a significant impact on patients' quality of life [7][8][10] 4. **Current Treatment Limitations**: Existing treatments, such as injectable somatostatin receptor analogues, have limitations including painful administration and inconsistent symptom control [10][11][20] 5. **Broad Label for Palsonify**: The approval includes a broad label allowing its use as a first-line treatment for patients who have not responded adequately to surgery or other therapies [16][17] 6. **Clinical Data**: Clinical trials demonstrated that 57% of patients who were uncontrolled on prior therapy achieved biochemical control at week 24 with Palsonify [18] 7. **Symptom Management**: Palsonify is the only treatment with a label that includes symptom control as a prespecified endpoint, showing significant improvements in key symptoms [19][20] 8. **Safety Profile**: The safety data from clinical trials indicated that Palsonify was well tolerated, with a low discontinuation rate due to adverse events [21][22] 9. **Launch Strategy**: The company has a comprehensive launch strategy focusing on patient activation, healthcare provider education, and ensuring broad access to the treatment [22][26][30] 10. **Market Opportunity**: There are approximately 11,500 addressable acromegaly patients in the U.S., with a significant portion being treatment naive or currently on suboptimal therapies [29][31] 11. **Pricing Strategy**: The annual price for Palsonify is set at approximately $290,000, which is competitive within the market for acromegaly treatments [36][68] 12. **Patient Support Programs**: The company has implemented programs to ensure quick access to Palsonify, including a Quick Start program for immediate treatment initiation [37][113] Other Important Content 1. **Unmet Needs**: There is a high level of unmet needs among acromegaly patients, with many not receiving adequate treatment or having discontinued therapy altogether [12][54] 2. **Awareness Campaigns**: The company plans to run awareness campaigns targeting both healthcare providers and patients to improve diagnosis and treatment rates [48][49] 3. **Real-World Data**: Ongoing open-label extension studies will provide real-world data to support the efficacy and safety of Palsonify over time [95][96] 4. **Adoption Patterns**: The adoption of Palsonify is expected to vary, with both experienced centers and community practitioners likely to trial the drug based on patient responses [88][90] 5. **Insurance Coverage**: The company anticipates that most payers will require prior authorization but expects a smooth transition to formulary inclusion within six to nine months post-launch [70][84] This summary encapsulates the critical insights from the conference call regarding Crinetics Pharmaceuticals' recent FDA approval and the strategic direction for Palsonify in the acromegaly treatment landscape.