Highest-materiality recent filing
GSK completes $10.6B acquisition of Nuvalent; tender offer accepted, merger effective July 15, 2026
Tender offer closed with 91.3% of shares tendered; all validly tendered shares accepted at $124.00 per share.
GSK to acquire Nuvalent for $124/share (~$10.6B); assets under FDA review for 2026 approval
All-share tender offer at $124.00 per share; aggregate equity value ~$10.6B; net cash investment ~$9.4B.
Nuvalent submits NDA for neladalkib in ALK+ NSCLC; zidesamtinib PDUFA Sept 18, 2026
NDA for neladalkib in TKI pre-treated ALK+ NSCLC submitted; pivotal data at ASCO 2026.
Nuvalent submits NDA to FDA for neladalkib in ALK-positive lung cancer
NDA submitted to FDA on April 7, 2026, for neladalkib in TKI pre-treated advanced ALK-positive NSCLC.
Nuvalent reports Q4 and FY2025 net loss; zidesamtinib PDUFA set for Sept 18, 2026
Net loss of $118.7M in Q4 2025 and $425.4M for full year 2025.
Nuvalent reports $1.4B cash, zidesamtinib PDUFA Sep 18, 2026; pipeline milestones
Preliminary cash, cash equivalents and securities ~$1.4B as of Dec 31, 2025; runway into 2029.
Royalty Pharma buys 1.5% royalty on Nuvalent's pipeline for up to $315M
Royalty Pharma acquired a preexisting 1.5% net-sales royalty on neladalkib and zidesamtinib from an undisclosed third party.
Nuvalent prices $500M public offering at $101/share; net proceeds ~$472M
Pricing of 4,950,496 shares at $101.00/share for gross proceeds of ~$500M.
Neladalkib achieved 31% ORR (79/253) in TKI pre-treated ALK+ NSCLC; median DOR not reached at 11.3 months follow-up.
Nuvalent Q3 net loss $122.4M; completes NDA for zidesamtinib; cash $943M into 2028
Completed rolling NDA submission for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC.
Nuvalent completes NDA submission to FDA for zidesamtinib in ROS1-positive NSCLC
Completed NDA submission to FDA for zidesamtinib.
Nuvalent Q2 2025 net loss $99.7M; rolling NDA for zidesamtinib initiated
Net loss $99.7M; R&D $80.9M, G&A $23.7M; cash $1.0B funding into 2028.
Nuvalent initiates Phase 3 ALKAZAR trial of neladalkib in ALK-positive NSCLC
First patient dosed in Phase 3 ALKAZAR trial evaluating neladalkib for TKI-naïve advanced ALK-positive NSCLC.
Zidesamtinib achieved 44% ORR (51/117) in TKI pre-treated ROS1+ NSCLC; intracranial ORR 48% (27/56) with 20% complete responses.
Cash $1.1B at March 31, 2025; expected to fund operations into 2028.
Nuvalent reports Q4 net loss $74.8M, cash $1.1B; pivotal data on track for 2025
Net loss $74.8M (Q4 2024) and $260.8M (FY 2024); cash & equivalents $1.1B, expected to fund into 2028.
As of Dec 31, 2024, 430 patients enrolled in ARROS-1 trial of zidesamtinib for ROS1-positive NSCLC.
Nuvalent reports Q3 net loss $84.3M; cash $1.2B; pipeline on track for 2025 pivotal data
Net loss $84.3M for Q3 2024; R&D expenses $60.6M, G&A $15.8M.
Nuvalent prices upsized $500M public offering of 5M shares at $100/sh
Offering of 5,000,000 shares at $100.00/share; gross proceeds ~$500M.
Nuvalent reports promising Phase 1 data for zidesamtinib and NVL-655; pivotal data expected 2025
Zidesamtinib ORR 44% in pre-treated ROS1+ NSCLC; 72% in G2032R mutation subset.
Nuvalent reports $658M cash, FDA breakthrough therapy for two candidates, net loss $57.2M in Q2
Cash, equivalents and securities $658.0M as of June 30, 2024; operating runway into 2027.
Nuvalent doses first patient in Phase 1 trial of HER2-selective inhibitor NVL-330 for NSCLC
Initiated HEROEX-1 Phase 1a/1b trial evaluating NVL-330 in pre-treated patients with HER2-altered NSCLC.
FDA grants Breakthrough Therapy designation to Nuvalent's NVL-655 for ALK+ NSCLC
NVL-655 received FDA Breakthrough Therapy designation for ALK-positive non-small cell lung cancer.
Nuvalent reports Q1 net loss of $44.5M; cash $691.8M; pipeline milestones on track
Q1 2024 net loss of $44.5M; R&D expense $38.6M, G&A $14.0M.
Nuvalent reports Q4 net loss $38.3M; cash $719.9M; NVL-520 gets FDA BTD
Cash, cash equivalents and marketable securities $719.9M at Dec 31, 2023; operating runway into 2027.
Nuvalent reports $719.9M cash; launches 'OnTarget 2026' plan targeting first approval in 2026
Cash, cash equivalents and marketable securities of $719.9M as of Dec 31, 2023 (unaudited); expected to fund operations into 2027.
Nuvalent Q3 net loss $33.6M; cash runway into 2027 after $300M offering; ALK/ROS1 data positive
Net loss of $33.6M ($0.59 per share) for Q3 2023; R&D expenses $29.6M, G&A $9.2M.
Nuvalent prices $300M public offering of 5.36M shares at $56.00/share
Sold 5,357,143 shares at $56.00 each; gross proceeds ~$300M.
Nuvalent reports Phase 1 ALKOVE-1 data: NVL-655 shows 39% ORR in heavily pre-treated ALK+ NSCLC
ORR 39% (20/51) in response-evaluable NSCLC patients; 44% (18/41) at ≥50 mg QD dose levels.
Nuvalent reports NVL-655 Phase 1 data: 45% ORR in evaluable ALK+ NSCLC patients
57 patients received 15–200 mg once daily; 51% had baseline CNS metastases; 77% post-lorlatinib.
Q3 net loss $19.7M ($0.41/sh); cash $240.1M; with $264.5M offering extends runway into H2 2025.
Nuvalent prices $230M public offering of 6.87M shares at $33.50/share
6,865,672 shares of Class A common stock priced at $33.50/share; gross proceeds ~$230M.
Nuvalent reports preliminary Phase 1 data for NVL-520: 48% ORR in heavily pre-treated ROS1+ NSCLC
48% ORR (10/21) in heavily pre-treated ROS1+ NSCLC; 78% (7/9) in G2032R mutation patients.
Nuvalent reports Q2 2022 net loss of $18.5M; pipeline on track with NVL-520 data expected H2 2022
Net loss of $18.5M ($0.38 per share); cash, equivalents and marketable securities $257.0M expected to fund operations into 2024.
Nuvalent reports Q1 net loss $17.5M; cash $272.7M; ALK trial expected Q2 2022
Net loss of $17.5M ($0.36 diluted EPS); R&D expenses $12.7M, G&A $5.0M.
Justin T. Huang and Kevin T. Ryan, the directors of Purchaser immediately prior to the Effective Time, became the directors of the Company
each of the directors of the Company (James R. Porter, Ph.D.; Grant C. Bogle; Michael L. Meyers, M.D., Ph.D.; Christy Oliger; Anna Protopapas; Ron Squarer; Sapna Srivastava, Ph.D.; and Cameron A. Wheeler, Ph.D.) resigned from his or her respective position as a member of the Company’s board of directors
Justin T. Huang as President and Secretary, Kevin T. Ryan as Vice President and Treasurer, and Hatixhe Hoxha as Assistant Secretary
each of the directors of the Company (James R. Porter, Ph.D.; Grant C. Bogle; Michael L. Meyers, M.D., Ph.D.; Christy Oliger; Anna Protopapas; Ron Squarer; Sapna Srivastava, Ph.D.; and Cameron A. Wheeler, Ph.D.) resigned from his or her respective position as a member of the Company’s board of directors
each of the directors of the Company (James R. Porter, Ph.D.; Grant C. Bogle; Michael L. Meyers, M.D., Ph.D.; Christy Oliger; Anna Protopapas; Ron Squarer; Sapna Srivastava, Ph.D.; and Cameron A. Wheeler, Ph.D.) resigned from his or her respective position as a member of the Company’s board of directors
each of the directors of the Company (James R. Porter, Ph.D.; Grant C. Bogle; Michael L. Meyers, M.D., Ph.D.; Christy Oliger; Anna Protopapas; Ron Squarer; Sapna Srivastava, Ph.D.; and Cameron A. Wheeler, Ph.D.) resigned from his or her respective position as a member of the Company’s board of directors
each of the directors of the Company (James R. Porter, Ph.D.; Grant C. Bogle; Michael L. Meyers, M.D., Ph.D.; Christy Oliger; Anna Protopapas; Ron Squarer; Sapna Srivastava, Ph.D.; and Cameron A. Wheeler, Ph.D.) resigned from his or her respective position as a member of the Company’s board of directors
Justin T. Huang as President and Secretary, Kevin T. Ryan as Vice President and Treasurer, and Hatixhe Hoxha as Assistant Secretary
each of the directors of the Company (James R. Porter, Ph.D.; Grant C. Bogle; Michael L. Meyers, M.D., Ph.D.; Christy Oliger; Anna Protopapas; Ron Squarer; Sapna Srivastava, Ph.D.; and Cameron A. Wheeler, Ph.D.) resigned from his or her respective position as a member of the Company’s board of directors
each of the directors of the Company (James R. Porter, Ph.D.; Grant C. Bogle; Michael L. Meyers, M.D., Ph.D.; Christy Oliger; Anna Protopapas; Ron Squarer; Sapna Srivastava, Ph.D.; and Cameron A. Wheeler, Ph.D.) resigned from his or her respective position as a member of the Company’s board of directors
each of the directors of the Company (James R. Porter, Ph.D.; Grant C. Bogle; Michael L. Meyers, M.D., Ph.D.; Christy Oliger; Anna Protopapas; Ron Squarer; Sapna Srivastava, Ph.D.; and Cameron A. Wheeler, Ph.D.) resigned from his or her respective position as a member of the Company’s board of directors
Justin T. Huang as President and Secretary, Kevin T. Ryan as Vice President and Treasurer, and Hatixhe Hoxha as Assistant Secretary
Max materiality 1.00 · Median 0.68 · Most common event other_material