Nuvalent: NVL-655 and Zidesamtinib are Convincing in pre-Treated Patients: Nuvalent (NUVL) Gets Additional Analyst Support.

Nuvalent (NUVL) is an approximately $5.6 billion clinical-stage biopharmaceutical company focused on developing targeted therapies for cancer patients. Its first lead product candidate, NVL-520, is being developed for patients with ROS1-positive non-small cell lung cancer (NSCLC). NVL-520 is a novel, ROS1-selective inhibitor designed to address the clinical challenges of emerging treatment resistance, central nervous system (CNS)-related side effects and brain metastases that may limit the use of currently available ROS1 tyrosine kinase inhibitors (TKIs).

Nuvalent presented data on its two lead programs at the ESMO Congress 2024 in Barcelona. These include zidesamtinib, a novel ROS1 inhibitor, and NVL-655, an ALK inhibitor. Both drugs are in advanced clinical trials for the treatment of patients with ROS1- and ALK-positive NSCLC. In the phase 1 trials, patients, especially those with previous therapies, showed promising results. Zidesamtinib achieved a high response rate, especially in patients with resistance. NVL-655 also showed strong results in heavily pre-treated patients. Both programs are expected to deliver critical data in 2025 to drive potential approvals.

Stifel analysts raised the price target from $115 to $135 on Monday (September 15). The upside potential is 50% on Friday's SK. The quality of the updated NVL-655 Phase 1 data presented at ESMO is reinforced by the rapid enrollment of Phase 2 cohorts, suggesting that researchers understand the best-in-class profile. Based on the data and progress, analysts have updated their model to advance the approval of NVL-655 for Second and Third-line therapy and for First-line therapy by one year each to 2026 and 2029, respectively.

Nuvalent (ISIN US6707031075): The stock broke out massively after the positive news.

Want to keep reading?

You can find the entire story in The Trader Times. Get a 4-week trial subscription now and access the entire archive!

array (
  'ID' => '746',
  'post_date' => '2023-09-15 17:23:38',
  'post_date_gmt' => '2023-09-15 15:23:38',
  'post_content' => '',
  'post_title' => 'Top Stories from The Trader Times',
  'post_type' => 'page',
  'post_excerpt' => '/top-stories/',
  'post_status' => 'publish',
  'post_name' => 'en-top-stories',
  'post_modified' => '2024-10-15 19:25:43',
  'post_modified_gmt' => '2024-10-15 17:25:43',
  'post_parent' => '29',
  'commercial_a' => '',
  'commercial_a_free_sample' => 'Free Sample Issue',
  'commercial_a_label_subscribe' => 'Subscribe Now',
  'commercial_a_text' => 'You can find the entire story in The Trader Times.',
  'commercial_a_text_download' => 'Read the full issue now',
  'commercial_a_text_subscribe' => 'Get a 4-week trial subscription now and access the entire archive!',
  'commercial_a_title' => 'Want to keep reading?',
  'download_label' => 'Read the issue',
  'order_alert' => 'Tip: Try our newspaper today with a 4-week trial subscription!',
  'order_label' => 'Get a trial subscription',
  'seo_description' => '',
  'seo_image' => '',
  'seo_title' => '',
  'link' => '/top-stories/',
)