This section highlights FDA-related milestones and regulatory updates for drugs developed by Akari Therapeutics (AKTX).
Over the past two years, Akari Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AKTX-101 and AR-V7. 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.
AKTX-101 FDA Regulatory Timeline and Events
AKTX-101 is a drug developed by Akari Therapeutics for the following indication: in pancreatic cancer driven by K-Ras mutations.
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:
- AKTX-101
- Announced Date:
- August 18, 2026
- Indication:
- in pancreatic cancer driven by K-Ras mutations
Announcement
Akari Therapeutics, Plc announced new preclinical data demonstrating the potential of AKTX-101, the Company's proprietary TROP2-targeted ADC utilizing its novel PH1 RNA spliceosome modulating payload, as a differentiated therapeutic approach for urothelial cancer in disease settings where currently available ADC therapies may have limited clinical benefit.
Read Announcement- Drug:
- AKTX-101
- Announced Date:
- May 28, 2026
- Indication:
- in pancreatic cancer driven by K-Ras mutations
Announcement
Akari Therapeutics, Plc announced that its CEO participated in a Virtual Investor "What This Means" interview focused on the Company's recently accepted abstract at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.
AI Summary
Akari Therapeutics said its CEO, Abizer Gaslightwala, took part in a Virtual Investor “What This Means” interview about the company’s recently accepted abstract for the 2026 ASCO Annual Meeting. He discussed early data showing that AKTX-101 may work well with adagasrib in KRAS-driven cancers. The company said the results point to possible synergy and support its goal of improving anti-tumor effects.
Gaslightwala also explained what he believes makes Akari’s approach different in the growing ADC field. The company is using a novel RNA splicing modulation method that may help broaden use across several solid tumors. He also pointed to future milestones, including continued progress on Akari’s PH1 spliceosome-modulating payload platform and plans to begin a Phase 1 first-in-human clinical trial by mid-2027.
Read Announcement- Drug:
- AKTX-101
- Announced Date:
- May 21, 2026
- Indication:
- in pancreatic cancer driven by K-Ras mutations
Announcement
Akari Therapeutics, Plc announced positive preclinical data featured in an online abstract released in connection with the American Society of Clinical Oncology (ASCO) Annual Meeting 2026 highlighting synergistic cytotoxic activity of AKTX-101 in combination with KRAS inhibition in KRAS-mutated pancreatic cancer models. Access the abstract here.
AI Summary
Akari Therapeutics said new preclinical results from an ASCO 2026 online abstract show that AKTX-101, its lead TROP2-targeting antibody-drug conjugate, works especially well when paired with KRAS inhibition in pancreatic cancer models. The studies found strong, synergistic cell-killing activity against KRAS-mutated pancreatic cancers, including models with KRAS G12D and G12C mutations. Akari said the data support a wider use for its RNA spliceosome-modulating payload, PH1, in hard-to-treat KRAS-driven cancers.
The company said AKTX-101 stands out from other TROP2 ADCs because it uses PH1 instead of the more common topoisomerase I inhibitor payloads. Akari also said the payload may do more than kill cancer cells, since it is designed to disrupt RNA splicing and may also activate immune responses. The findings expand the potential value of AKTX-101 beyond the company’s current development plan.
Read Announcement- Drug:
- AKTX-101
- Announced Date:
- April 20, 2026
- Indication:
- in pancreatic cancer driven by K-Ras mutations
Announcement
Akari Therapeutics, Plc announced the presentation of positive preclinical data for its lead TROP2-targeting ADC, AKTX-101, at the American Association for Cancer Research (AACR) Annual Meeting 2026.
AI Summary
Akari Therapeutics announced positive preclinical results for AKTX-101, its lead TROP2-targeting antibody-drug conjugate (ADC), presented at the American Association for Cancer Research (AACR) Annual Meeting 2026. AKTX-101 uses a novel RNA spliceosome-targeting payload called PH1, differing from current TROP2 ADCs that carry Topoisomerase I inhibitor payloads.
In head-to-head lab models, AKTX-101 showed greater potency and/or higher maximum cancer cell killing than Topoisomerase I inhibitor TROP2 ADCs across bladder, lung and breast tumor models. It achieved sub-nanomolar potency in all bladder cancer lines tested and in several non-small cell lung cancer lines driven by EGFR, BRAF and SMARCA4. It also killed HER2 breast cancer cells that are resistant to existing Topoisomerase I inhibitor ADCs like trastuzumab deruxtecan.
Because PH1 targets RNA splicing and may activate immune responses, Akari says AKTX-101 could overcome resistance seen with Topoisomerase I ADCs. The data support advancing AKTX-101 into Phase 1 studies and suggest potential to expand the TROP2 ADC class across multiple solid tumors.Read Announcement
- Drug:
- AKTX-101
- Announced Date:
- December 23, 2025
- Indication:
- in pancreatic cancer driven by K-Ras mutations
Announcement
Akari Therapeutics announced the initiation of GMP manufacturing activities to support the development of AKTX-101, the Company's lead ADC program.
AI Summary
Akari Therapeutics announced it has started GMP manufacturing activities to support development of its lead antibody-drug conjugate, AKTX-101. The company selected WuXi XDC, a global leader in ADC development and manufacturing, to perform the IND-enabling work and produce GMP-grade drug material. Akari said the partnership is meant to accelerate and ensure high-quality production ahead of clinical testing.
AKTX-101 carries Akari’s novel PH1 payload, a spliceosome modulator that disrupts RNA splicing in cancer cells and aims to combine direct tumor killing with immune activation. Preclinical results suggest strong activity and possible synergy with checkpoint inhibitors. The GMP work is intended to support a planned Phase 1 first-in-human study in about 12 months (targeting late 2026 or early 2027), subject to regulatory clearance. Akari and WuXi XDC described the effort as a key step toward taking AKTX-101 into the clinic.
Read Announcement- Drug:
- AKTX-101
- Announced Date:
- December 9, 2025
- Indication:
- in pancreatic cancer driven by K-Ras mutations
Announcement
Akari Therapeutics, Plc announced key preclinical data demonstrating the therapeutic potential of its novel ADC targeting Trop2, AKTX-101, in pancreatic cancer driven by K-Ras mutations, one of the deadliest and most treatment-resistant forms of cancer.
AI Summary
Akari Therapeutics reported preclinical data showing its Trop2-targeting antibody-drug conjugate AKTX-101 killed pancreatic cancer cell lines driven by the K-Ras G12V mutation. AKTX-101 showed single-digit nanomolar cytotoxic potency across tested K‑Ras G12V PDAC lines and outperformed daraxonrasib in multiple cell models. The K‑Ras G12V mutation drives about one third of pancreatic ductal adenocarcinoma (PDAC), a lethal disease with median overall survival around 1.4 years and very few effective targeted therapies.
AKTX-101 delivers a novel PH1 spliceosome‑modulating payload into Trop2‑positive tumor cells; Trop2 is often highly expressed in PDAC and higher in K‑Ras mutated tumors. PH1 disrupts RNA splicing to kill cancer cells and may stimulate immune responses. Akari plans to advance AKTX-101 toward a first‑in‑human trial in late 2026 and is exploring partnerships to develop PH1 for other ADCs. These results support further development in this hard-to-treat cancer.
Read Announcement
AR-V7 FDA Regulatory Events
AR-V7 is a drug developed by Akari Therapeutics for the following indication: for the treatment of tumors fueled by alternative splicing-drivers, such as the Androgen Receptor splice variant 7 (AR-V7) in prostate 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:
- AR-V7
- Announced Date:
- September 24, 2025
- Indication:
- for the treatment of tumors fueled by alternative splicing-drivers, such as the Androgen Receptor splice variant 7 (AR-V7) in prostate cancer.
Announcement
Akari Therapeutics announced key preclinical data demonstrating the potential of its novel antibody drug conjugate (ADC) spliceosome modulating payload, PH1, for the treatment of tumors fueled by alternative splicing-drivers, such as the Androgen Receptor splice variant 7 (AR-V7) in prostate cancer.
AI Summary
Akari Therapeutics announced preclinical data showing its new antibody drug conjugate (ADC) payload, called PH1, can lower the levels of the AR-V7 receptor that drives metastatic castration-resistant prostate cancer. AR-V7–driven tumors do not respond to current androgen receptor inhibitors like Xtandi or Erleada, creating a pressing need for targeted treatments.
In lab tests with a hormone-refractory cell model (22Rv1), PH1 dramatically reduced AR-V7 expression, while standard AR pathway inhibitors had no effect. In a different, hormone-sensitive prostate cancer model (LnCAP), PH1 alone slowed tumor cell growth and showed added benefit when combined with Xtandi or Erleada.
Akari believes that pairing PH1-conjugated ADCs with AR inhibitors could delay or prevent resistance by lowering AR-V7 and slowing cancer progression. The company plans further studies to test this approach against different prostate cancer targets and explore first-line combination regimens.
Read Announcement
Free AKTX Stock Alerts