Prelude Therapeutics (PRLD) Company Report

Prelude Therapeutics received FDA clearance for its Investigational New Drug (IND) application for PRT12396, a mutant-selective JAK2V617F inhibitor.
This clearance allows the company to initiate a Phase 1 trial for PRT12396 in polycythemia vera and myelofibrosis, with dosing expected in the second quarter of 2026.
Following the announcement, Prelude's shares increased by approximately 8-9%, and the stock has doubled over the past year.
The company, a small clinical-stage precision oncology firm with a market capitalization near $138 million, reported revenue of $10.5 million and significant negative profitability metrics, including an operating margin of -1,152.85% and a net margin of -1,064.5%.

4 days ago

Morningstar

Prelude Therapeutics Receives FDA Clearance for PRT12396 IND

PRLD

New Projects/Investments

Product Launch

Prelude Therapeutics Incorporated announced that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug Application (IND) for PRT12396.
PRT12396 is a mutant-selective JAK2V617F inhibitor being developed for the treatment of patients with certain myeloproliferative neoplasms (MPNs).
The company anticipates initiating a Phase 1 study for PRT12396 in patients with polycythemia vera and myelofibrosis by Q2 2026.
This JAK2V617F inhibitor program is subject to an exclusive option agreement with Incyte announced in November 2025.

4 days ago

8-K

Prelude Therapeutics Details Pipeline Advancement and Financial Outlook

PRLD

New Projects/Investments

Guidance Update

Prelude Therapeutics Inc. anticipates initiating Phase 1 clinical trials for its JAK2V617F mutant selective JH2 inhibitors in 2Q 2026 and for its KAT6A selective degraders in 2H 2026.
The JAK2V617F program is subject to an exclusive option agreement with Incyte, announced in November 2025, which provides significant capital.
The company's cash runway is anticipated into the second quarter of 2027 based on current projections.
Preclinical data for the JAK2V617F program and the mCALR DAC program were presented as oral abstracts at ASH 2025.

Jan 9, 2026, 12:30 PM

8-K

Perspective Therapeutics Presents Updated Interim Data for [212Pb]VMT-α-NET Clinical Trial

PRLD

New Projects/Investments

Perspective Therapeutics announced updated interim results from its ongoing Phase 1/2a clinical trial of [212Pb]VMT-α-NET in patients with neuroendocrine tumors at the 2026 ASCO Gastrointestinal Cancers Symposium.
The drug [212Pb]VMT-α-NET continues to be well-tolerated, with no dose-limiting toxicities, treatment-related discontinuations, serious renal complications, dysphagia, or clinically significant treatment-related myelosuppression reported in 56 patients. Grade 3 or higher treatment-emergent adverse events were reported in 21 patients (37.5%).
Updated efficacy analysis suggests durable disease control and deepening of tumor response in the first 23 patients in Cohort 2 and both patients in Cohort 1. Objective response was observed in 39% of patients in Cohort 2, and 19 of 25 patients (76%) were without progression and remained alive.
The Cohort 3 (6.0 mCi) dose limiting toxicities assessment is complete, and the company is cleared to treat more patients. Perspective Therapeutics plans to have meaningful engagement with regulatory agencies during 2026 to proceed with VMT-α-NET into a registrational trial.

Jan 9, 2026, 12:00 PM

Press Release

Prelude Therapeutics Presents Preclinical Data for MPN Programs at ASH 2025

PRLD

Product Launch

New Projects/Investments

Prelude Therapeutics presented new preclinical data on its JAK2V617F mutant selective JH2 inhibitors and mCALR-targeted degrader antibody conjugate (DAC) discovery program at the ASH 67th Annual Meeting on December 6, 2025.
The lead JAK2V617F inhibitor candidate, PRT12396, demonstrated disease-modifying potential in myeloproliferative neoplasms and is on track for IND filing and Phase 1 study initiation in Q1 2026.
The JAK2V617F inhibitor program is subject to an exclusive option agreement with Incyte, announced in November 2025.
The mCALR-targeted DAC program also showed promising preclinical results, indicating deep mutant-selective killing and a potential for a favorable therapeutic index.

Dec 6, 2025, 4:00 PM

Press Release

Prelude Therapeutics Refocuses R&D and Secures Incyte Option Agreement

PRLD

New Projects/Investments

M&A

Guidance Update

Prelude Therapeutics has made strategic decisions to sharpen its R&D focus, optimize capital allocation, and align its business strategy with high-probability programs, which has enhanced its financial position and provided an additional cash runway into 2027.
The company is rapidly advancing two development candidates into clinical development in 2026: a JAK2 V617F selective inhibitor for myeloproliferative neoplasms (MPN), with an IND filing planned for Q1 2026 and Phase 1 initiation in H1 2026 , and a KAT6A selective degrader for ER-positive breast cancer, with an IND filing on track for mid-2026 and Phase 1 start expected in H2 2026.
Prelude entered into an exclusive option agreement with Incyte for its JAK2 V617F program, receiving an upfront payment of $35 million and Incyte purchasing $25 million of Prelude non-voting common stock. The deal has a total potential value of up to $910 million in cash payments and future milestones, plus single-digit royalties.
The company also amended and expanded its collaboration with Exselera for degrader antibody conjugates (DACs), enabling the licensing of proprietary degrader payloads to other potential partners.

Nov 12, 2025, 1:00 PM

Transcript

Prelude Therapeutics Reports Q3 2025 Financial Results and Pipeline Updates

PRLD

Earnings

Guidance Update

New Projects/Investments

Prelude Therapeutics reported a net loss of $19.7 million (or $(0.26) per share) for Q3 2025, an improvement from a $32.3 million net loss (or $(0.43) per share) in Q3 2024, with revenue increasing to $6.5 million from $3.0 million in the prior year period.
The company's cash, cash equivalents, restricted cash, and marketable securities stood at $58.2 million as of September 30, 2025, and is projected to fund operations into 2027 following a $60 million payment from Incyte in November 2025.
Key pipeline advancements include the mutant selective JAK2V617F JH2 inhibitor program, with an IND filing expected in Q1 2026, and the oral KAT6A selective degrader program, with an IND filing expected in mid-2026. Preclinical data for both programs, along with the mCALR DAC program, will be presented at the ASH 67th Annual Meeting in December 2025.

Nov 12, 2025, 12:07 PM

8-K

Prelude Therapeutics Announces Exclusive Option Agreement with Incyte

PRLD

M&A

New Projects/Investments

Guidance Update

Prelude Therapeutics (PRLD) announced an exclusive option agreement with Incyte (INCY) for its mutant selective JAK2V617F JH2 inhibitor program, effective November 3, 2025.
Under the agreement, Prelude will receive $60 million in capital, consisting of a $35 million upfront payment and a $25 million equity investment from Incyte, which includes the purchase of 6.25 million shares of Prelude non-voting common stock at $4.00 per share.
If Incyte exercises the option, Prelude is eligible for an additional $100 million and up to $775 million in potential clinical and regulatory milestones, plus single-digit royalties on global net sales, with total potential cash payments reaching up to $910 million excluding royalties.
This capital is expected to extend Prelude's cash runway into 2027, and potentially into the third quarter of 2028 if the option is exercised.

Nov 4, 2025, 1:53 PM

8-K

Prelude Therapeutics Announces Strategic Program Prioritization and Incyte Agreement

PRLD

New Projects/Investments

Management Change

Guidance Update

Prelude Therapeutics is prioritizing the development of its mutant selective JAK2V617F JH2 inhibitor and KAT6A selective degrader programs, while pausing its SMARCA2 selective degrader programs.
The company entered into an exclusive option agreement with Incyte for its JAK2V617F program, which includes an upfront payment of $35 million, a $25 million equity investment, and a potential $100 million if the option is exercised.
As of October 31, 2025, Prelude had approximately $52 million in cash, cash equivalents, and marketable securities, and expects to receive an additional $60 million from Incyte. This is projected to extend the cash runway into 2027, and potentially into the third quarter of 2028 if the Incyte option is exercised.
Jane Huang, M.D., President and Chief Medical Officer, has departed, with board member Victor Sandor, M.D.C.M., providing strategic and operational oversight of clinical development.

Nov 4, 2025, 12:05 PM

Press Release

Prelude Therapeutics Announces Exclusive Option Agreement with Incyte

PRLD

M&A

New Projects/Investments

Prelude Therapeutics has entered into an exclusive option agreement with Incyte for its mutant selective JAK2V617F JH2 inhibitor program, which has disease-modifying potential for patients with myeloproliferative neoplasms (MPNs).
Prelude will receive $60 million in capital, consisting of a $35 million upfront payment and a $25 million strategic equity investment from Incyte.
If Incyte exercises its option to acquire the program, Prelude would receive an additional $100 million.
Prelude is eligible for up to $775 million in additional potential milestones and royalties on net sales, with total potential cash payments (excluding royalties) reaching up to $910 million.
Prelude will continue to develop all JAK2V617F program assets during the option period.