This section highlights FDA-related milestones and regulatory updates for drugs developed by Bolt Biotherapeutics (BOLT).
Over the past two years, Bolt Biotherapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BDC-4182 and BDC-3042. 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.
BDC-4182 FDA Regulatory Events
BDC-4182 is a drug developed by Bolt Biotherapeutics for the following indication: patients with gastric and gastroesophageal cancer.
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:
- BDC-4182
- Announced Date:
- October 1, 2025
- Indication:
- patients with gastric and gastroesophageal cancer.
Announcement
Bolt Biotherapeutics announced an update on the ongoing Phase 1 dose escalation study of BDC-4182, a next-generation Boltbody™ ISAC clinical candidate targeting claudin 18.2, a clinically validated target in oncology.
AI Summary
Bolt Biotherapeutics has updated the ongoing Phase 1 dose escalation study of BDC-4182, a next-generation Boltbody™ ISAC clinical candidate targeting claudin 18.2, a validated oncology target. At the first dose levels, patients showed a strong immune response. To build on these results, the company will revise the trial protocol to include step-up dosing, a method already used commercially with T-cell engagers. Preclinical studies of BDC-4182 support this dosing approach.
As a result of these changes, initial clinical data is now expected in the third quarter of 2026. To maintain its financial stability, Bolt will reduce its workforce by about 50%. This move is designed to extend the company’s cash runway into 2027. Bolt’s leadership said this restructuring will help focus resources on advancing BDC-4182 toward later clinical stages and on partnerships that boost long-term shareholder value.
Read Announcement
BDC-3042 FDA Regulatory Timeline and Events
BDC-3042 is a drug developed by Bolt Biotherapeutics for the following indication: For the treatment of cancer.
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:
- BDC-3042
- Announced Date:
- May 8, 2025
- Indication:
- For the treatment of cancer
Announcement
Bolt Biotherapeutics announced it will host a key opinion leader (KOL) conference call and webcast featuring Ecaterina Dumbrava, M.D., associate professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center and investigator on the Phase 1 dose-escalation clinical study of BDC-3042, on Monday, May 12, 2025 at 2:30 p.m. PT / 5:30 p.m. ET.
AI Summary
Bolt Biotherapeutics has scheduled a key opinion leader conference call and webcast on Monday, May 12, 2025 at 2:30 p.m. PT / 5:30 p.m. ET. The event will feature Dr. Ecaterina Dumbrava, an associate professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center. As an investigator on the Phase 1 dose-escalation clinical study of BDC-3042, Dr. Dumbrava will discuss the latest clinical study results and key findings. In addition, Bolt’s management team will outline partnering strategies for BDC-3042, provide updates on the clinical development of BDC-4182, and review the first quarter 2025 financial performance. A live Q&A session will follow, offering participants a chance to interact directly with the team. This conference call and webcast provide a valuable opportunity for investors and stakeholders to learn about the advancements in Bolt’s cancer immunotherapy programs.
Read Announcement- Drug:
- BDC-3042
- Announced Date:
- April 25, 2025
- Indication:
- For the treatment of cancer
Announcement
Bolt Biotherapeutics announced results from its Phase 1 dose-escalation clinical study of BDC-3042 at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30, 2025, in Chicago, Illinois.
AI Summary
Bolt Biotherapeutics announced promising results from its Phase 1 dose-escalation study of BDC-3042 at the AACR Annual Meeting in Chicago, April 25–30, 2025. The study evaluated the safety and biologic activity of this novel immunotherapy, an agonist antibody targeting dectin-2 on tumor-associated macrophages. BDC-3042 was well tolerated at doses up to 10 mg/kg administered every two weeks, with no dose-limiting toxicities or drug-related serious adverse events observed. The trial also showed clear dose-dependent increases in proinflammatory cytokines and chemokines, indicating strong immune activation. Notably, there were early signs of anti-tumor activity, including an unconfirmed partial response in one non-small cell lung cancer patient and stable disease in several others. Based on these positive findings, Bolt Biotherapeutics is now actively seeking a partner to accelerate further development and commercialization of BDC-3042.
Read Announcement- Drug:
- BDC-3042
- Announced Date:
- March 25, 2025
- Indication:
- For the treatment of cancer
Announcement
Bolt Biotherapeutics announced it will present data from the Phase 1 dose-escalation clinical study of BDC-3042 in patients with advanced cancers at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30, 2025, in Chicago, Illinois.
AI Summary
Bolt Biotherapeutics announced it will share results from its Phase 1 dose-escalation study of BDC-3042 at the upcoming American Association for Cancer Research (AACR) Annual Meeting. The study tests BDC-3042, a first-in-class agonist antibody that targets dectin-2, an immune-activating receptor on tumor-associated macrophages, in patients with advanced cancers, including metastatic or unresectable solid tumors. This trial is key in evaluating safety and early signs of efficacy in patients battling various hard-to-treat malignancies.
Presented by Dr. Ecaterina E. Dumbrava from The University of Texas MD Anderson Cancer Center, the poster session titled “BDC-3042, a first-in-class Dectin-2 agonist, in patients with advanced malignancies” will occur on April 29, 2025, in Chicago, Illinois. The data could offer promising insights for developing new cancer immunotherapies.
Read Announcement
