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GSK Lands FDA Approval for Nuvalent-Acquired Jideytro for NSCLC
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Key Takeaways
GSK received early FDA approval for Jideytro in previously treated ROS1-positive NSCLC patients.
Jideytro delivered a 44% response rate with durable responses in the phase I/II ARROS-1 study.
GSK expanded its NSCLC pipeline through Nuvalent, adding the neladalkib and NVL-330 candidates.
GSK plc (GSK - Free Report) announced that the FDA has approved Jideytro (zidesamtinib) for previously treated ROS1-positive non-small cell lung cancer (NSCLC). Jideytro was added as a late-stage candidate to GSK’s oncology portfolio through the recently closed acquisition of Nuvalent.
Jideytro is a next-generation, highly selective ROS1 inhibitor and has become GSK's first approved therapy for lung cancer.
The regulatory authority granted approval nearly one month ahead of the original PDUFA target date of Sept.18, 2026, enabling an earlier-than-expected commercial launch.
Year to date, GSK’s shares have risen 5.3% compared with the industry’s 3% growth.
Image Source: Zacks Investment Research
FDA Approval Backed by GSK’s ARROS-1 Phase I/II Study
The FDA approval of Jideytro was based on data from the global phase I/II ARROS-1 study, which evaluated Jideytro in patients with advanced or metastatic ROS1-positive NSCLC previously treated with a ROS1 inhibitor. The study demonstrated durable clinical responses, including in patients with brain metastases and ROS1 resistance mutations.
In the overall study population, Jideytro achieved an objective response rate of 44% and response durability was maintained in most patients at both six and 12 months.
The safety profile was manageable, with the most common adverse events being edema, peripheral neuropathy, constipation, fatigue and dyspnea.
The ARROS-1 study remains ongoing and is continuing to evaluate Jideytro in additional patient populations, including as a first-line treatment for patients with ROS1-positive NSCLC who have not previously received a ROS1 inhibitor.
Acquisition of Jideytro Strengthens GSK's Precision Oncology Franchise
The Nuvalent acquisition strengthened GSK's growing oncology business by adding a portfolio of targeted therapies for genetically defined forms of NSCLC.
Beyond Jideytro, GSK's acquired pipeline includes neladalkib, an investigational ALK inhibitor currently under FDA review with a PDUFA target date of Nov. 27, 2026, and NVL-330, a HER2-targeted therapy that is being evaluated in phase I studies for HER2-altered NSCLC.
Over the past 90 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have risen from $8.00 to $9.44. Over the same period, earnings per share (EPS) estimates for 2027 have increased from $9.48 to $10.79. NBIX shares have gained 21.8% year to date.
Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 9.08%.
Over the past 90 days, estimates for loss per share for AMRN have narrowed from $6.36 to 65 cents for 2026. Over the same period, estimates for loss per share have also narrowed from $4.64 to 51 cents for 2027. AMRN shares have lost 1.7% year to date.
Amarin Corp.’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 50.02%.
Over the past 90 days, estimates for Liquidia’s 2026 EPS have increased to $3.02 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.92 from $2.91. LQDA shares have gained 152.4% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
View the Zacks #1 Rank List
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GSK Lands FDA Approval for Nuvalent-Acquired Jideytro for NSCLC
Key Takeaways
GSK plc (GSK - Free Report) announced that the FDA has approved Jideytro (zidesamtinib) for previously treated ROS1-positive non-small cell lung cancer (NSCLC). Jideytro was added as a late-stage candidate to GSK’s oncology portfolio through the recently closed acquisition of Nuvalent.
Jideytro is a next-generation, highly selective ROS1 inhibitor and has become GSK's first approved therapy for lung cancer.
The regulatory authority granted approval nearly one month ahead of the original PDUFA target date of Sept.18, 2026, enabling an earlier-than-expected commercial launch.
Year to date, GSK’s shares have risen 5.3% compared with the industry’s 3% growth.
Image Source: Zacks Investment Research
FDA Approval Backed by GSK’s ARROS-1 Phase I/II Study
The FDA approval of Jideytro was based on data from the global phase I/II ARROS-1 study, which evaluated Jideytro in patients with advanced or metastatic ROS1-positive NSCLC previously treated with a ROS1 inhibitor. The study demonstrated durable clinical responses, including in patients with brain metastases and ROS1 resistance mutations.
In the overall study population, Jideytro achieved an objective response rate of 44% and response durability was maintained in most patients at both six and 12 months.
The safety profile was manageable, with the most common adverse events being edema, peripheral neuropathy, constipation, fatigue and dyspnea.
The ARROS-1 study remains ongoing and is continuing to evaluate Jideytro in additional patient populations, including as a first-line treatment for patients with ROS1-positive NSCLC who have not previously received a ROS1 inhibitor.
Acquisition of Jideytro Strengthens GSK's Precision Oncology Franchise
The Nuvalent acquisition strengthened GSK's growing oncology business by adding a portfolio of targeted therapies for genetically defined forms of NSCLC.
Beyond Jideytro, GSK's acquired pipeline includes neladalkib, an investigational ALK inhibitor currently under FDA review with a PDUFA target date of Nov. 27, 2026, and NVL-330, a HER2-targeted therapy that is being evaluated in phase I studies for HER2-altered NSCLC.
GSK’s Zacks Rank & Stock to Consider
GSK currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Neurocrine Biosciences (NBIX - Free Report) , Amarin Corporation (AMRN - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks Rank #1 stocks here.
Over the past 90 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have risen from $8.00 to $9.44. Over the same period, earnings per share (EPS) estimates for 2027 have increased from $9.48 to $10.79. NBIX shares have gained 21.8% year to date.
Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 9.08%.
Over the past 90 days, estimates for loss per share for AMRN have narrowed from $6.36 to 65 cents for 2026. Over the same period, estimates for loss per share have also narrowed from $4.64 to 51 cents for 2027. AMRN shares have lost 1.7% year to date.
Amarin Corp.’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 50.02%.
Over the past 90 days, estimates for Liquidia’s 2026 EPS have increased to $3.02 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.92 from $2.91. LQDA shares have gained 152.4% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.