Neladalkib (NVL-655) — Competitive Intelligence Brief

Neladalkib (NVL-655) (Neladalkib (NVL-655)) competitive landscape: 1 comparator, recent regulatory actions, upcoming PDUFA, patent timeline. Class: ALK inhibitor. Area: Oncology.

phase 3 ALK inhibitor ALK (anaplastic lymphoma kinase) Oncology Small molecule

Target snapshot

Neladalkib (NVL-655) (Neladalkib (NVL-655)) — Nuvalent Inc.. Neladalkib is a selective ALK (anaplastic lymphoma kinase) inhibitor that blocks ALK-driven signaling in cancer cells.

Comparator set (1 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Neladalkib (NVL-655) TARGET	Neladalkib (NVL-655)	Nuvalent Inc.	phase 3	ALK inhibitor	ALK (anaplastic lymphoma kinase)
Lorlatinib with chemotherapy 2	lorlatinib-with-chemotherapy-2	Pfizer	marketed	ALK inhibitor	ALK

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (ALK inhibitor class)

1. ALK-Abelló A/S · 2 drugs in this class
2. ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) · 1 drug in this class
3. Astellas Pharma Global Development, Inc. · 1 drug in this class
4. Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair · 1 drug in this class
5. Nuvalent Inc. · 1 drug in this class
6. Pfizer · 1 drug in this class
7. Takeda · 1 drug in this class