FDA grants breakthrough therapy status for Nuvalent's NVL-655 [Yahoo! Finance]
Nuvalent, Inc. - Class A (NUVL)
NASDAQ:AMEX Investor Relations:
nuvelinc.com/company/investor_relations.html
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Source: Yahoo! Finance
kinase (ALK)-selective tyrosine kinase inhibitor (TKI), NVL-655 for the treatment of non-small cell lung cancer (NSCLC). NVL-655 is intended to treat patients with locally advanced or metastatic ALK-positive NSCLC and have previously been treated with two or more ALK TKIs. This asset is designed to address the clinical challenges of emergent treatment resistance, brain metastases, and off-target central nervous system (CNS) adverse events. These issues are commonly associated with the hindering of the structurally related tropomyosin receptor kinase (TRK) family. The FDA granted BTD based on the initial efficacy and safety data from the Phase I segment of the Phase I/II ALKOVE-1 clinical trial. The Phase II portion of the ALKOVE-1 trial is currently enrolling participants, with Nuvalent planning to present updated data in the second half of this year. BTD status is given to expedite the development and review of drugs intended to treat serious conditions, where initial evi
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NUVL
News
- Nuvalent to Participate in the 2024 Jefferies Global Healthcare ConferencePR Newswire
- Nuvalent, Inc. (NASDAQ: NUVL) had its "outperform" rating re-affirmed by analysts at Wedbush. They now have a $99.00 price target on the stock.MarketBeat
- Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-655 [Yahoo! Finance]Yahoo! Finance
- Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-655PR Newswire
- Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2024 Financial Results [Yahoo! Finance]Yahoo! Finance
NUVL
Earnings
- 5/9/24 - Miss
NUVL
Sec Filings
- 5/29/24 - Form 4
- 5/17/24 - Form 4
- 5/16/24 - Form 8-K
- NUVL's page on the SEC website