PV Reporter

05/26/2026

🔬 Incyte Advances Pipeline with New Phase 3 Trial and Breakthrough Designation

​Biotech giant Incyte is making major moves in its hematology and oncology pipeline! The company has announced plans to launch a Phase 3 trial for its mutant CALR antibody 989 around mid-year, targeting essential thrombocythemia (ET).

​Backed by a "highly collaborative" relationship with the FDA and an official Breakthrough Therapy designation, this study features an accelerated 24-week timeline to get results faster.

​Beyond antibody 989, Incyte is pushing forward on several exciting fronts:
👉 Developing a highly anticipated subcutaneous version of the therapy for long-term patient convenience.
👉 Gearing up for key data presentations at the upcoming ASCO and EHA meetings.
👉 Expanding commercial opportunities for Jakafi XR and its immunology pipeline (including Povorcitinib and Opzelura).

​Read the full breakdown of their pipeline updates, upcoming regulatory milestones, and what this means for the future of mutation-specific therapies.

Incyte (NASDAQ:INCY) Chief Medical Officer Steven Stein outlined the company’s development priorities across hematology, oncology and immunology, with a particular focus on its mutant CALR antibody 989, during a company news event. Stein said myeloproliferative neoplasms remain “front and center...

05/25/2026

05/22/2026

PharmaEssentia to Present New Clinical Data Supporting the Use of Ropeginterferon Alfa-2b in Essential Thrombocythemia at ASCO and EHA 2026

Home News Business Wire PharmaEssentia to Present New Clinical Data Supporting the Use of Ropeginterferon Alfa-2b in Essential Thrombocythemia at ASCO and EHA 2026 PharmaEssentia to Present New Clinical Data Supporting the Use of Ropeginterferon Alfa-2b in Essential Thrombocythemia at ASCO and EHA 2...

05/13/2026

EHA Abstract:

Ajax Therapeutics Announces Oral Presentation of Clinical Results from AJX-101, a Phase I study of AJ1-11095, a First-in-Class Type II JAK2 Inhibitor, at the European Hematology Society (EHA) 2026 Congress

– Company unveils first proof-of concept clinical data of AJ1-11095 in patients with myelofibrosis who have been previously treated with a type I JAK2 Inhibi...

05/13/2026

DEVELOPMENT OF A G6B DIRECTED ANTIBODY DRUG CONJUGATE FOR THE TREATMENT OF MYELOPROLIFERATIVE NEOPLASMS

https://library.ehaweb.org/eha/2026/eha-2026/4206764/adam.mead.development.of.a.g6b.directed.antibody.drug.conjugate.for.the.html

05/07/2026

Seven years. Two medications. Five failed doctors.

When I was diagnosed with polycythemia vera in 2009, no one told me remission was possible. The only treatment I was offered, phlebotomy, guaranteed it wouldn't be.

Today my blood counts are normal. The molecular markers driving my PV are undetectable.

I just published the most personal article I've ever written. It covers how I got here, what it cost, the moment at ASH 2015 that changed everything, and what I want every PV patient to know.

This isn't a typical outcome. I won't pretend it is. But most patients are never told deeper responses are even on the table, and they deserve to know.

📖 Read the full story:

David Wallace's account of achieving complete molecular remission from PV using combination interferon and Jakafi therapy. What your doctor may not tell you.

05/02/2026

🚨 BREAKING: The FDA just approved Jakafi XR

A once-daily tablet of ruxolitinib for MF, PV and GVHD patients. Same proven medication, one pill a day. Available at pharmacies as early as May 8. This is big news for our community. 💊

Read the full story: https://pvreporter.com/one-pill-once-a-day-fda-approves-jakafi-xr/

---> Talk with your MPN specialists folks, this will be news to many and more information will be forthcoming.

The FDA just approved Jakafi XR, a once-daily ruxolitinib tablet for MF, PV and GVHD patients. Same proven treatment, simpler daily routine.

04/27/2026

Eli Lilly is expanding its footprint in the blood cancer space with the acquisition of Ajax Therapeutics.

This move is centered on advancing new, targeted therapies for patients living with myelofibrosis and polycythemia vera. It’s an exciting step forward for innovation in hematology! 🧬

/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Ajax Therapeutics, Inc. ("Ajax"), a biopharmaceutical company developing next generation JAK inhibitors...

04/24/2026

🔬 Big news for ET patients with a CALR mutation.
A first-in-class antibody, INCA033989, is rapidly normalizing platelet counts and shrinking the mutant clone in most patients treated. FDA Breakthrough Therapy designation granted December 2025. Phase 3 planned for mid-2026.
From ASH 2025 (ET cohort):
• ~90% hematologic response at higher doses
• 83% complete hematologic response
• Most patients saw their CALR mutant clone shrink
• No dose-limiting toxicities
No existing ET therapy reliably reduces the CALR mutant clone. This one does.
📖 https://pvreporter.com/breakthrough-calr-therapy-shows-high-response-rate-in-et/

* This replaces my earlier post with tighter numbers from the ASH 2025 abstract.

Incyte’s INCA033989 targets CALR mutations in ET patients, delivering high response rates and potential disease modification with minimal side effects.

04/20/2026

The MPN community lost one of its greatest champions this week.

Dr. Richard T. Silver passed away on April 17, 2026, at the age of 97. For those of us living with polycythemia vera or another MPN, his name means everything. though many may not even know it yet.

He helped write the rules of modern hematology. He trained the doctors who treat us today. He founded a cancer research charity that has given away $17 million. He explored the Amazon. He played the clarinet.

And he never stopped caring about patients.
I had the privilege of meeting him in person in 2023. I wrote this piece to make sure our community knows who he was, and what we owe him.

Rest in peace, Dr. Silver. 🙏

Dr. Richard T. Silver, the Weill Cornell hematologist who introduced interferon for MPNs and helped launch imatinib for CML, has died at 97. A tribute.