Nuvalent (NUVL) PT Raised to $155 at H.C. Wainwright

H.C. Wainwright analyst Swayampakula Ramakanth raised the price target on Nuvalent (NASDAQ: NUVL) to $155.00 (from $130.00) while maintaining a Buy rating.

The analyst commented: "On Nov 17, Nuvalent reported positive topline data from the ongoing ALKOVE-1 study which we believe paves the way for neladalkib to be filed as a 2L therapy for ALK-positive NSCLC patients by mid-2026. Based on the ALKOVE-1 enrollment timeline, 648 patients enrolled into the trial in 18 months between February 2024 and August 2025 in the Phase 2 portion, suggesting that there is a huge unmet need in the 2L/3L setting for this patient population. Neladalkib achieved an ORR of 46% (29/63) in TKI pre-treated loratinib naïve patients (2L patient cohort, n=63) and 83% (10/12) in the 2L patient cohort that harbored the G1202R mutation (n=12), the most frequent ALK mutation that results in resistance to both alectinib and lorlatinib. The median DOR has not yet been reached in both these groups. True to its design as an ALK selective TRK sparing CNS penetrant drug, neladalkib showed good intracranial activity in the 2L patient cohort (n=24) with an IC-ORR of 63% and an IC-CR of 21% with a median DOR of 21.6 months. Recall, lorlatinib, the currently approved drug in the 2L setting, has an ORR of 31-40% and mDOR of 7.1-9.6 months with significant CNS-related toxicities due to TRK inhibition limiting its tolerability. Additionally, in a 44-patient exploratory TKI-naïve cohort, the drug achieved an ORR of 86% (38/44) with 4 CRs, in the 9 patients with measurable intracranial lesions, 4 experienced an IC-CR. We believe this bodes well for the ongoing Phase 3 ALKAZAR study evaluating neladalkib vs. alectinib as a 1L therapy. Regarding safety, neladalkib was well tolerated with transient elevations of ALT and AST. In the 656-patient safety cohort, 17% of patients experienced dose reductions and 5% of patients discontinued due to TEAEs. We adjusted our financial model to reflect the positive ALKOVE-1 data and as a result our 12-month price target is $155, up from $130."

You May Also Be Interested In

• Fiserv (FISV) PT Lowered to $60 at Freedom Broker
• Intuitive Machines Inc. (LUNR) PT Lowered to $32 at Cantor Fitzgerald, Reaffirms Overweight Rating
• Mosaic sets pricing for tender offers on up to $1.4B in debt