Nuvalent Submits NDA for neladalkib
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4 days ago
0mins
Should l Buy NUVL?
Nuvalent announced the submission to the FDA of the company's NDA for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated advanced ALK-positive NSCLC. "The advancement of neladalkib from first clinical trial initiation to NDA submission in less than four years represents a remarkable pace in oncology drug development, underscoring the vigor and urgency our team brought to this program and our deep commitment to the ALK-positive NSCLC community," said Darlene Noci, chief development officer at Nuvalent. "We would like to extend our sincere gratitude to the patients, families and investigators who have made this progress possible, and are committed to working closely with the FDA throughout the NDA review process toward our goal of bringing neladalkib to patients as quickly as possible."
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Analyst Views on NUVL
Wall Street analysts forecast NUVL stock price to rise
16 Analyst Rating
16 Buy
0 Hold
0 Sell
Strong Buy
Current: 104.590
Low
125.00
Averages
140.86
High
158.00
Current: 104.590
Low
125.00
Averages
140.86
High
158.00
About NUVL
Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer. It develops small molecules that have the potential to overcome resistance, minimize adverse events, and address brain metastases. It is advancing a robust pipeline with investigational candidates for ROS proto-oncogene 1 (ROS1)-positive, anaplastic lymphoma kinase (ALK)-positive, and human epidermal growth factor receptor 2 (HER2)-positive non-small cell lung cancer, and multiple discovery-stage research programs. Its product candidate, Zidesamtinib (NVL-520), is being developed for patients with ROS1-positive non-small cell lung cancer (NSCLC). NVL-520 is a novel ROS1-selective inhibitor. Its product candidate, Neladalkib (NVL-655), is being developed for patients with ALK-positive NSCLC. NVL-655 is a brain-penetrant ALK-selective inhibitor. Its product candidate, NVL-330, is a brain-penetrant HER2-selective inhibitor.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Nuvalent Submits NDA for Neladalkib in Advanced NSCLC
- NDA Submission: Nuvalent, Inc. has submitted an NDA to the FDA for neladalkib, an ALK-selective inhibitor designed for TKI-pretreated advanced ALK-positive NSCLC patients, marking a significant milestone in oncology drug development.
- Clinical Trial Data: The application is supported by data from the ALKOVE-1 Phase 1/2 clinical trial, demonstrating neladalkib's efficacy in TKI-pretreated patients, which enhances its market potential and attractiveness to investors.
- Rapid Development Timeline: Chief Development Officer Darlene Noci noted that the transition from the first clinical trial initiation to NDA submission in less than four years showcases the accelerated pace of oncology drug development, potentially drawing more investor interest in the company's future.
- Positive Market Reaction: Nuvalent's shares rose 0.38% to $104.10 in pre-market trading on Nasdaq, reflecting a positive market response to the NDA submission and confidence in the company's growth prospects.
See More
Nuvalent Submits NDA for ALK-Selective Inhibitor in Advanced NSCLC
- NDA Submission: Nuvalent has submitted an NDA to the FDA for neladalkib, an ALK-selective inhibitor targeting TKI-pretreated advanced ALK-positive NSCLC patients, marking a remarkable four-year timeline from clinical trial initiation to submission, showcasing the company's rapid advancement in oncology drug development.
- Clinical Trial Results: In the global registration-directed ALKOVE-1 trial, neladalkib demonstrated encouraging overall activity in TKI-pretreated patients, including intracranial responses, indicating its potential to address key drivers of disease progression while maintaining a favorable safety profile consistent with its ALK-selective design.
- Breakthrough Therapy Designation: Neladalkib has received FDA breakthrough therapy designation for patients with locally advanced or metastatic ALK-positive NSCLC previously treated with two or more ALK tyrosine kinase inhibitors, highlighting its unique value and market potential in the treatment landscape.
- Future Development Plans: Nuvalent plans to present detailed clinical results at an upcoming medical meeting, further enhancing neladalkib's market acceptance, and is committed to working closely with the FDA to expedite the drug's approval process to meet urgent patient needs.
See More
Nuvalent Submits NDA for ALK-Selective Inhibitor in Advanced NSCLC
- NDA Submission: Nuvalent has submitted a New Drug Application (NDA) to the FDA for neladalkib, an ALK-selective inhibitor targeting advanced ALK-positive NSCLC patients previously treated with TKIs, marking a remarkable four-year progression from clinical trial initiation to NDA submission, showcasing the company's rapid advancement in oncology drug development.
- Clinical Trial Results: In the global registration-directed ALKOVE-1 trial, neladalkib demonstrated encouraging overall activity in TKI-pretreated patients, including intracranial responses, indicating its effectiveness in addressing key drivers of disease progression, while maintaining a well-tolerated safety profile consistent with its ALK-selective design.
- Breakthrough Therapy Designation: Neladalkib has received FDA breakthrough therapy designation for patients with locally advanced or metastatic ALK-positive NSCLC who have been previously treated with two or more ALK tyrosine kinase inhibitors, highlighting its potential significance in the treatment landscape.
- Future Development Plans: Nuvalent plans to present detailed clinical trial results at an upcoming medical meeting, further advancing the clinical application of neladalkib, while the company is committed to working closely with the FDA to expedite the drug's approval process.
See More
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Wells Fargo Begins Coverage of Nuvalent, Inc. with Overweight Rating and $116 Target Price
Company Overview: Nuvalent, Inc. is a company involved in the pharmaceutical sector, focusing on innovative treatments.
Market Activity: The company has initiated coverage with an overweight rating and a target price set at $116.
See More
S&P 500 Futures Decline in Pre-Market Trading; Nuvalent and Figure Tech Solutions Take the Lead
Market Opening: U.S. stock markets are set to open in two hours.
Nuvalent Inc. Performance: Nuvalent Inc. Cl A (NUVL) saw a 7.0% increase in pre-market trading.
Figure Technology Solutions Performance: Figure Technology Solutions Inc. (FIGR) also experienced a 7.0% rise in pre-market trading.
Overall Market Sentiment: The pre-market gains indicate a positive sentiment among investors for these stocks.
See More
Nuvalent Submits NDA for Neladalkib in Advanced NSCLC
- NDA Submission: Nuvalent, Inc. has submitted an NDA to the FDA for neladalkib, an ALK-selective inhibitor designed for TKI-pretreated advanced ALK-positive NSCLC patients, marking a significant milestone in oncology drug development.
- Clinical Trial Data: The application is supported by data from the ALKOVE-1 Phase 1/2 clinical trial, demonstrating neladalkib's efficacy in TKI-pretreated patients, which enhances its market potential and attractiveness to investors.
- Rapid Development Timeline: Chief Development Officer Darlene Noci noted that the transition from the first clinical trial initiation to NDA submission in less than four years showcases the accelerated pace of oncology drug development, potentially drawing more investor interest in the company's future.
- Positive Market Reaction: Nuvalent's shares rose 0.38% to $104.10 in pre-market trading on Nasdaq, reflecting a positive market response to the NDA submission and confidence in the company's growth prospects.
See More
Nuvalent Submits NDA for ALK-Selective Inhibitor in Advanced NSCLC
- NDA Submission: Nuvalent has submitted an NDA to the FDA for neladalkib, an ALK-selective inhibitor targeting TKI-pretreated advanced ALK-positive NSCLC patients, marking a remarkable four-year timeline from clinical trial initiation to submission, showcasing the company's rapid advancement in oncology drug development.
- Clinical Trial Results: In the global registration-directed ALKOVE-1 trial, neladalkib demonstrated encouraging overall activity in TKI-pretreated patients, including intracranial responses, indicating its potential to address key drivers of disease progression while maintaining a favorable safety profile consistent with its ALK-selective design.
- Breakthrough Therapy Designation: Neladalkib has received FDA breakthrough therapy designation for patients with locally advanced or metastatic ALK-positive NSCLC previously treated with two or more ALK tyrosine kinase inhibitors, highlighting its unique value and market potential in the treatment landscape.
- Future Development Plans: Nuvalent plans to present detailed clinical results at an upcoming medical meeting, further enhancing neladalkib's market acceptance, and is committed to working closely with the FDA to expedite the drug's approval process to meet urgent patient needs.
See More
Nuvalent Submits NDA for ALK-Selective Inhibitor in Advanced NSCLC
- NDA Submission: Nuvalent has submitted a New Drug Application (NDA) to the FDA for neladalkib, an ALK-selective inhibitor targeting advanced ALK-positive NSCLC patients previously treated with TKIs, marking a remarkable four-year progression from clinical trial initiation to NDA submission, showcasing the company's rapid advancement in oncology drug development.
- Clinical Trial Results: In the global registration-directed ALKOVE-1 trial, neladalkib demonstrated encouraging overall activity in TKI-pretreated patients, including intracranial responses, indicating its effectiveness in addressing key drivers of disease progression, while maintaining a well-tolerated safety profile consistent with its ALK-selective design.
- Breakthrough Therapy Designation: Neladalkib has received FDA breakthrough therapy designation for patients with locally advanced or metastatic ALK-positive NSCLC who have been previously treated with two or more ALK tyrosine kinase inhibitors, highlighting its potential significance in the treatment landscape.
- Future Development Plans: Nuvalent plans to present detailed clinical trial results at an upcoming medical meeting, further advancing the clinical application of neladalkib, while the company is committed to working closely with the FDA to expedite the drug's approval process.
See More
Latest Wall Street Rating Updates
- UBS Upgrade: UBS upgrades Adecoagro from Neutral to Buy, raising the price target from $8 to $16.2, indicating the company is poised to benefit from the ongoing Middle East conflict, which is expected to enhance its financial performance.
- HSBC Bullish on Carnival: HSBC upgrades Carnival from Hold to Buy, asserting that the current share price undervalues the resilience of experience-led demand, which is likely to improve the company's market performance in the near future.
- Morgan Stanley Reiterates Meta: Morgan Stanley lowers its price target for Meta from $825 to $775 but maintains it as a top investment idea, suggesting that market sentiment has bottomed out, making it an opportune time to buy.
- Deutsche Bank Upgrades Colgate: Deutsche Bank upgrades Colgate-Palmolive from Hold to Buy, highlighting the company's core business as having long-term investment value and the ability to weather current market volatility effectively.
See More
Wells Fargo Begins Coverage of Nuvalent, Inc. with Overweight Rating and $116 Target Price
Company Overview: Nuvalent, Inc. is a company involved in the pharmaceutical sector, focusing on innovative treatments.
Market Activity: The company has initiated coverage with an overweight rating and a target price set at $116.
See More
S&P 500 Futures Decline in Pre-Market Trading; Nuvalent and Figure Tech Solutions Take the Lead
Market Opening: U.S. stock markets are set to open in two hours.
Nuvalent Inc. Performance: Nuvalent Inc. Cl A (NUVL) saw a 7.0% increase in pre-market trading.
Figure Technology Solutions Performance: Figure Technology Solutions Inc. (FIGR) also experienced a 7.0% rise in pre-market trading.
Overall Market Sentiment: The pre-market gains indicate a positive sentiment among investors for these stocks.
See More
