Welcome to our dedicated page for Nuvalent news (Ticker: NUVL), a resource for investors and traders seeking the latest updates and insights on Nuvalent stock.
Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company developing precisely targeted kinase inhibitors for oncogene-driven cancers, with a focus on non-small cell lung cancer (NSCLC). The NUVL news feed on Stock Titan aggregates company announcements, press releases, and related coverage so readers can follow how its pipeline and regulatory interactions progress over time.
According to Nuvalent’s disclosures, its lead investigational programs include zidesamtinib, a ROS1-selective inhibitor for ROS1-positive NSCLC, and neladalkib, an ALK-selective inhibitor for ALK-positive NSCLC. News items often highlight pivotal and preliminary data from the ARROS-1 and ALKOVE-1 Phase 1/2 trials, updates on the ALKAZAR Phase 3 trial in TKI-naïve ALK-positive NSCLC, and information about design features such as brain penetrance and activity against resistance mutations.
Investors and observers can also find coverage of Nuvalent’s regulatory milestones, including FDA breakthrough therapy and orphan drug designations, New Drug Application (NDA) submissions and acceptances, and PDUFA target action dates. Corporate developments such as public equity offerings, cash runway guidance, royalty arrangements on future net sales of zidesamtinib and neladalkib, and board appointments are regularly disclosed through press releases and Form 8-K filings and are reflected in the news flow.
For those tracking NUVL, this news stream provides a centralized view of clinical trial readouts, conference presentations, financing activities, and strategic updates that shape the company’s outlook in targeted oncology. Bookmarking the NUVL news page on Stock Titan can help readers quickly review new disclosures and place them in the context of Nuvalent’s broader development strategy.
Nuvalent (Nasdaq: NUVL), a clinical-stage biopharmaceutical company, has announced a $350 million public offering of Class A common stock. The company is offering all shares and plans to grant underwriters a 30-day option to purchase up to an additional 15% of shares. J.P. Morgan, TD Cowen, Jefferies, and Stifel are acting as joint book-running managers for the offering.
The offering is being made through an automatically effective shelf registration statement filed with the SEC. A preliminary prospectus supplement will be filed, detailing the terms of the offering. The completion, size, and terms of the offering are subject to market conditions and cannot be guaranteed.
Nuvalent (NUVL) presented updated Phase 1 data for its lead ROS1 and ALK inhibitors at ESMO 2024, highlighting potential best-in-class profiles. Key updates include:
1. Rapid enrollment in Phase 2 trials for both programs, with pivotal data now expected in 2025.
2. Zidesamtinib (ROS1 inhibitor) showed 44% ORR in pre-treated ROS1+ NSCLC patients, with 83% having 6+ month response duration.
3. NVL-655 (ALK inhibitor) demonstrated 38% ORR in heavily pre-treated ALK+ NSCLC patients at the recommended Phase 2 dose.
4. Both drugs were well-tolerated with favorable safety profiles.
5. A Phase 3 trial (ALKAZAR) for NVL-655 in treatment-naïve ALK+ NSCLC patients is planned for H1 2025.
These updates suggest accelerated development timelines and potential for both drugs to address unmet needs in ROS1+ and ALK+ NSCLC treatment paradigms.
Nuvalent (Nasdaq: NUVL) has published a manuscript in Cancer Discovery detailing the design and characterization of NVL-655, their ALK-selective inhibitor for ALK-positive non-small cell lung cancer (NSCLC). The publication highlights:
1. NVL-655's activity against ALK single and compound resistance mutations
2. Its selectivity for ALK over TRK family, potentially reducing neurological adverse events
3. Preclinical studies demonstrating brain penetrance and intracranial activity
4. Three case studies from the ALKOVE-1 trial showing tumor responses without CNS effects
The ongoing global Phase 2 portion of the ALKOVE-1 trial is designed with registrational intent. Updated Phase 1 data will be presented at the ESMO Congress 2024 in Barcelona.
Nuvalent (NUVL) announced updated Phase 1 data for its ALK-selective inhibitor NVL-655 and ROS1-selective inhibitor zidesamtinib at ESMO Congress 2024. Key highlights:
- NVL-655 showed 38% overall response rate (ORR) in heavily pre-treated ALK+ NSCLC patients, with 9.2 month median duration of response (DOR)
- Zidesamtinib demonstrated 38% ORR in ROS1+ NSCLC patients previously treated with ROS1 TKIs, with median DOR not reached
- Both drugs showed promising intracranial activity and favorable safety profiles
- Phase 2 trials with registrational intent are ongoing for both drugs in TKI-naïve and pre-treated patients
The company believes these results support the potential for NVL-655 and zidesamtinib to become best-in-class therapies for ALK+ and ROS1+ NSCLC, respectively.
Nuvalent, a clinical-stage biopharmaceutical company (Nasdaq: NUVL), has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference. The event will take place on September 5, 2024, at 1:05 p.m. ET in New York City.
Key details:
- CEO James Porter, Ph.D., and CFO Alexandra Balcom will participate in a fireside chat
- A live webcast will be available on the company's website
- The webcast will be archived for 30 days after the presentation
Nuvalent focuses on developing precisely targeted therapies for clinically proven kinase targets in cancer. This conference participation provides an opportunity for investors and stakeholders to gain insights into the company's progress and future plans.
Nuvalent (Nasdaq: NUVL) reported Q2 2024 financial results and pipeline progress. Key highlights include:
- $658.0 million in cash, cash equivalents, and marketable securities, expected to support operations into 2027
- Ongoing enrollment in Phase 2 trials for NVL-655 (ALK program) and zidesamtinib (ROS1 program)
- FDA breakthrough therapy designation granted for both NVL-655 and zidesamtinib
- Initiation of HEROEX-1 trial for NVL-330 (HER2 program)
- Plans to present updated Phase 1 data at ESMO Congress 2024
Financial results for Q2 2024:
- R&D expenses: $49.2 million
- G&A expenses: $16.0 million
- Net loss: $57.2 million
Nuvalent aims to deliver at least one pivotal dataset in 2025 towards potential product approval in 2026.
Nuvalent (Nasdaq: NUVL) has announced the initiation of HEROEX-1, a Phase 1a/1b clinical trial evaluating its novel HER2-selective inhibitor, NVL-330, for pre-treated patients with HER2-altered non-small cell lung cancer (NSCLC). The trial aims to assess the safety, tolerability, and preliminary anti-tumor activity of NVL-330, as well as determine the recommended Phase 2 dose and characterize its pharmacokinetic profile.
NVL-330 has shown potential in preclinical studies to maintain activity against HER2 exon 20 mutations, be selective for HER2 versus wild-type EGFR, and demonstrate brain penetrance. These characteristics address key needs in HER2-mutant NSCLC treatment, for which there are currently no approved tyrosine kinase inhibitors (TKIs).
This marks Nuvalent's third program to enter clinical development in under three years, highlighting the company's commitment to rapid progress in developing targeted cancer therapies.
Nuvalent (Nasdaq: NUVL) announced upcoming presentations of updated data from two clinical trials at the ESMO Congress 2024 in Barcelona. The presentations will focus on:
1. NVL-655, an ALK-selective inhibitor, from the ALKOVE-1 Phase 1/2 trial in ALK-positive solid tumors.
2. Zidesamtinib (NVL-520), a ROS1-selective inhibitor, from the ARROS-1 Phase 1/2 trial in ROS1 fusion-positive solid tumors.
Additionally, Nuvalent will present new preclinical data on zidesamtinib's intracranial activity. These presentations highlight Nuvalent's progress in developing targeted therapies for clinically proven kinase targets in cancer.
Nuvalent, a clinical-stage biotech firm, has promoted Dr. Henry Pelish to Chief Scientific Officer. In this role, Dr. Pelish will continue to oversee discovery and early-stage development initiatives. Dr. Pelish, who joined Nuvalent in 2018, has been instrumental in developing three novel kinase inhibitors, two of which have shown preliminary clinical proof-of-concept. CEO Dr. James Porter praised Pelish's contributions to the company's innovative approach to cancer therapy. Dr. Pelish holds a Ph.D. in chemistry from Harvard and has over 15 years of experience in cancer biology and chemistry. He expressed excitement about advancing Nuvalent's mission to deliver targeted therapies for cancer patients.
Nuvalent, a clinical-stage biopharmaceutical company specializing in targeted cancer therapies, announced its participation in the 2024 Jefferies Global Healthcare Conference. The event will feature a fireside chat with CEO James Porter and CFO Alexandra Balcom on June 5, 2024, at 4:30 p.m. ET. The session will be live-streamed and available on the company's website for 30 days.