BioPharmSignal logoBioPharmSignal

Biotech News

Disc Medicine Receives Complete Response Letter from FDA for Bitopertin for the Treatment of EPP

Disc Medicine (IRON)Disc MedicineFDA / regulatory

FDA acknowledged that AURORA and BEACON provided sufficient evidence that bitopertin significantly lowers PPIX and that there is a strong mechanistic and biological plausibility supporting the use of the PPIX biomarker in protoporphyria FDA indicated a need to see the results of the ongoing Phase 3

Related news

IRONDisc Medicine2026-06-09 12:30 EST

Disc Medicine Provides Update from FDA Type A Meeting for Bitopertin in Erythropoietic Protoporphyria

IRONDisc Medicine2026-01-12 13:30 EST

Disc Medicine Highlights Recent Achievements and Key Business Objectives and Milestones for 2026

RCKTRocket Pharmaceuticals2025-10-14 11:00 EST

Rocket Pharmaceuticals Announces FDA Acceptance of BLA Resubmission of KRESLADI™ for the Treatment of Severe Leukocyte Adhesion Deficiency-I (LAD-I)

RCKTRocket Pharmaceuticals2026-09-15 11:00 EST

Rocket Pharmaceuticals Announces FDA Alignment on Path to Complete Pivotal Phase 2 Trial of RP-A501 in Danon Disease

RIGLRigel Pharmaceuticals2026-08-13 12:05 EST

Rigel Announces Availability of VEPPANU™ (vepdegestrant) for Patients with ER+/HER2-, ESR1-Mutated Advanced or Metastatic Breast Cancer

KPTIKaryopharm Therapeutics2026-08-31 11:30 EST

Karyopharm Submits Supplemental New Drug Application to the FDA for XPOVIO® (selinexor) Plus Ruxolitinib for Patients with Myelofibrosis

KPTIKaryopharm Therapeutics2026-07-30 20:06 EST

Karyopharm Plans to Submit sNDA for Selinexor Plus Ruxolitinib in Myelofibrosis Under Accelerated Approval Pathway

APTOAptose Biosciences, Inc.2026-03-31 21:22 EST

Aptose Biosciences Announces Results of Special Shareholders Meeting; Announces Receipt of Final Court Approval of Plan of Arrangement; Reports Year End 2025 Results and Corporate Highlights

APTOAptose Biosciences, Inc.2026-06-15 11:30 EST

Aptose Presents Safety, Response, and MRD Clinical Data from TUSCANY Phase 1/2 Clinical Trial of Tuspetinib Triplet Therapy in Newly Diagnosed AML at the 2026 EHA Congress in Oral Presentation

SNDXSyndax Pharmaceuticals2026-05-12 14:31 EST

Syndax Highlights 12 Revuforj® (revumenib) Abstracts Accepted for EHA 2026, Advancing Leadership in Menin Inhibition

View all latest news

Disc Medicine

Hematology Drug Development Disc Medicine develops therapies for serious hematologic diseases by targeting pathways involved in heme biosynthesis and iron regulation. Its portfolio addresses both rare red-blood-cell disorders and anemia associated with chronic disease. Bitopertin in EPP Bitopertin is being evaluated in the Phase 3 APOLLO...

Recent company news

IRONDisc Medicine2026-09-09 23:25 EST

Disc Medicine Presents Initial Results from RESTORE-PV Phase 2 Trial in Patients with Polycythemia Vera (PV) at the 14th Society of Hematologic Oncology (SOHO) Annual Meeting

IRONDisc Medicine2026-09-02 12:00 EST

Disc Medicine to Participate in Upcoming Investor Conferences

IRONDisc Medicine2026-08-31 22:00 EST

Disc Medicine Announces Multiple Presentations Across Portfolio at the Society of Hematologic Oncology (SOHO) 2026 Annual Meeting

IRONDisc Medicine2026-07-30 12:30 EST

Disc Medicine Reports Second Quarter 2026 Financial Results and Provides Business Update

IRONDisc Medicine2026-06-12 12:30 EST

Disc Medicine Presents Positive Clinical Updates at the 2026 European Hematology Association (EHA) Annual Meeting

Stock data

Close
69.18 USD
Market cap
2.6B USD
Exchange
NASDAQ
Sector
Biopharma
Location
United States