Nuvalent, Inc. SEC Filings

Form 4 Overview – Nuvalent, Inc. (NUVL)

On 06/26/2025, Chief Development Officer Darlene Noci reported a series of option exercises and related open-market sales under a pre-arranged Rule 10b5-1 trading plan dated 11/18/2024.

• Option exercise: 4,000 Class A common shares were acquired via option exercise at an exercise price of $27.85 per share.
• Dispositions: The exact 4,000 shares were immediately sold in three blocks: 85 sh at a weighted average $77.38, 3,609 sh at $78.70, and 306 sh at $79.15. Aggregate proceeds approximate $311 k, implying a spread of roughly $50 per share over the exercise price.
• Post-transaction holdings: Noci’s direct ownership declined from 52,034 to 48,034 shares (-7.7%). She retains 138,329 stock options expiring 01/06/2033.

No other equity classes or derivative instruments were reported. All transactions were effected under a 10b5-1 plan, suggesting routine portfolio management rather than discretionary selling.

Nuvalent, Inc. (NUVL) – Form 4 insider transaction summary

Chief Scientific Officer Henry E. Pelish reported a series of option exercises and related open-market sales executed on 06/25/2025 and 06/27/2025 under a Rule 10b5-1 trading plan adopted on 11/01/2024.

• Options exercised (Code “M”): 10,800 Class A shares in four tranches – 3,677 and 347 shares at a $27.85 strike (options granted 01/06/2023) and 4,953 and 1,823 shares at a $29.33 strike (options granted 03/01/2023).
• Shares sold (Code “S”): 10,800 Class A shares at weighted-average prices of $79.87 (range $79.80-$79.92) on 06/25/2025 and $79.92 (range $79.80-$80.00) on 06/27/2025.
• Ownership impact: Pelish’s direct Class A common-stock holding remains unchanged at 63,101 shares after the paired exercise-and-sell transactions, indicating a cashless exercise structure.
• Remaining derivative holdings: 28,328 options at a $27.85 strike (expiring 01/06/2033) and 25,299 options at a $29.33 strike (expiring 03/01/2033) are still outstanding.

No new shares were added to, or removed from, insider ownership; the activity primarily generated liquidity while maintaining the existing equity stake. Investors typically view such neutral, plan-based sales as having limited informational content, though they can add modest selling pressure near the $80 trading level.

Nuvalent officer Alexandra Balcom filed Form 144 indicating intent to sell 129,480 shares of Class A common stock with an aggregate market value of $10,358,400 through J.P. Morgan Securities. The planned sale represents approximately 0.2% of the company's 66.37 million outstanding shares.

The securities to be sold were acquired through two transactions:

• 122,396 shares via stock option exercise on June 27, 2025
• 7,084 shares from RSU vesting on January 6, 2025

The sale is being executed under a Rule 10b5-1 trading plan adopted on December 12, 2024. Some transactions will involve cashless option exercises within 3 months of filing. Notably, Balcom has not sold any company securities in the past 3 months. The filing includes standard attestation that the seller has no knowledge of material adverse non-public information.

Nuvalent Officer Darlene Noci has filed Form 144 indicating intent to sell 12,000 shares of Class A Common Stock through J.P. Morgan Securities, with an aggregate market value of $948,840. The sale is planned for June 26, 2025, on the NASDAQ exchange.

The securities were acquired through a stock option exercise on June 26, 2025. The filing reveals a consistent pattern of previous sales by Noci over the past three months:

• March 27, 2025: 4,000 shares ($292,482)
• April 29, 2025: 4,000 shares ($298,232)
• May 29, 2025: 4,000 shares ($285,238)

The sales are part of a Rule 10b5-1 trading plan adopted on November 18, 2024, and will be executed through cashless option exercises within three months of the filing date. Total shares outstanding: 66,373,511.

Nuvalent, Inc. (NASDAQ: NUVL) filed an 8-K disclosing pivotal Phase 1/2 data and regulatory progress for its lead ROS1-selective inhibitor, zidesamtinib, in ROS1-positive non-small cell lung cancer (NSCLC).

Pivotal dataset – TKI pre-treated setting (n = 117)

• Objective response rate (ORR, RECIST 1.1, BICR): 44 % (51/117; 95 % CI 34-53).
• Durability: Kaplan-Meier probability of remaining in response ≥6, ≥12 and ≥18 months was 84 %, 78 % and 62 %, respectively; emerging median DOR 22.0 months.
• Activity across resistance profiles: ORR 54 % in patients with ROS1 G2032R mutation (n = 26) and 51 % in those with only one prior TKI (crizotinib or entrectinib; n = 55).
• Intracranial efficacy (baseline measurable CNS disease, n = 56): IC-ORR 48 % with 20 % complete responses; IC-DOR ≥ 12 months 71 %.
• Safety (n = 432 at RP2D): most frequent TEAEs ≥15 % were peripheral edema (36 %), constipation (17 %), CPK increase (16 %), fatigue (16 %), dyspnea (15 %); dose reductions 10 %, discontinuations 2 %.

Preliminary TKI-naïve data (n = 35)

• ORR 89 % (31/35); DOR ≥6 & ≥12 months 96 %.
• Intracranial subset (n = 6): IC-ORR 83 % with 67 % CR; no CNS progression among responders.
• Global enrollment for the TKI-naïve cohort has reached 104 patients.

Regulatory & pipeline milestones

• Completed pre-NDA meeting; FDA agreed to accept zidesamtinib NDA into the Real-Time Oncology Review (RTOR) pilot.
• Rolling NDA submission to begin July 2025, targeted completion Q3 2025; company is also discussing “line-agnostic” expansion with FDA.
• Front-line strategy advances: first preliminary data from TKI-naïve cohort reported; Phase 3 ALKAZAR trial of neladalkib vs. alectinib in ALK-positive NSCLC set to initiate enrollment early H2 2025.

Investor takeaways: The pivotal efficacy, durability and intracranial activity in a heavily pre-treated population, combined with an RTOR-enabled NDA timeline and a diversified front-line development plan, collectively strengthen Nuvalent’s near-term commercial prospects and strategic positioning in the competitive ROS1/ALK TKI landscape.