This section highlights FDA-related milestones and regulatory updates for drugs developed by Whitehawk Therapeutics (WHWK).
Over the past two years, Whitehawk Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
HWK-007 and Protein. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
HWK-007 FDA Regulatory Events
HWK-007 is a drug developed by Whitehawk Therapeutics for the following indication: PTK7-targeted antibody-drug conjugate (ADC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- HWK-007
- Announced Date:
- January 8, 2026
- Indication:
- PTK7-targeted antibody-drug conjugate (ADC)
Announcement
Whitehawk Therapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for HWK-007, its PTK7-targeted ADC. .
AI Summary
Whitehawk Therapeutics announced the U.S. Food and Drug Administration has cleared the Investigational New Drug application for HWK-007, its PTK7-targeted antibody-drug conjugate. The Phase 1 trial is actively recruiting and will initially evaluate activity in lung and ovarian cancers, and endometrial cancer, all known to express PTK7.
HWK-007 is a next-generation ADC that targets Protein Tyrosine Kinase 7 (PTK7), a membrane protein frequently overexpressed in cancers. HWK-007-101 is a multicenter, open-label Phase 1 dose-escalation and expansion trial to evaluate safety, pharmacokinetics and preliminary antitumor activity in patients with advanced or metastatic tumors refractory to standard therapies.
The program uses Whitehawk’s ADC platform with a stable yet cleavable linker to deliver a DNA topoisomerase I inhibitor payload. The company says the design aims to maximize tumor targeting while limiting off-target toxicity, and it expects initial clinical data in early 2027.
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Protein Tyrosine Kinase 7 FDA Regulatory Events
Protein Tyrosine Kinase 7 is a drug developed by Whitehawk Therapeutics for the following indication: in adult tissues and frequent overexpression in a wide range of cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Protein Tyrosine Kinase 7
- Announced Date:
- October 24, 2025
- Indication:
- in adult tissues and frequent overexpression in a wide range of cancers
Announcement
Whitehawk Therapeutics, Inc. today presented data from a real-world analysis of Protein Tyrosine Kinase 7 (PTK7) at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.
AI Summary
Whitehawk Therapeutics presented real-world data on Protein Tyrosine Kinase 7 (PTK7) at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. In collaboration with Tempus AI and the Clinical Proteomic Tumor Analysis Consortium, the company analyzed over 157,000 tumor samples—including nearly half from metastatic lesions—to robustly characterize PTK7 expression across solid tumors.
The study found PTK7 is expressed in about 70% of solid tumors, making it the third most abundant ADC target after HER2 and HER3. PTK7 levels remained stable across histologic subtypes, disease stages and metastatic status. The highest median mRNA expression appeared in endometrial, ovarian, head and neck, non-small cell lung and breast cancers. In lung, ovarian and endometrial cancers, PTK7 expression was comparable to or higher than other key targets such as HER2, Trop-2 and FRα.
These findings support PTK7 as a pan-tumor target and reinforce Whitehawk’s development of HWK-007, a PTK7-directed ADC that uses a cleavable linker to deliver a Topoisomerase I inhibitor payload.
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