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Mon, Jun 29, 2026

33 updates
FDMT
8:00 AM

4DMT Completes Enrollment for 4FRONT-2 Global Phase 3 Clinical Trial of 4D-150 in Wet AMD

4FRONT-2 global enrollment completed approximately 4 months ahead of initial projections 4FRONT-2 over-enrolled (anticipated N>500), with final patient randomization expected in Q3 2026, reflecting strong interest from investigators and patients 4FRONT-2 52-week topline data is expected in H2 2027

Enrollment • Phase 3Enrollment completion Mon, Jun 29, 20264dmoleculartherapeutics.com
SPRB
8:00 AM

Spruce Biosciences Joins the Russell 3000® Index

Inclusion Reflects Spruce’s Momentum as the Company Advances Toward a Planned Biologics License Application (BLA) Submission and Potential Commercial Launch of Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) for Sanfilippo Syndrome Type B (MPS IIIB) SOUTH SAN FRANCISCO, Calif.

sprucebiosciences.com
XLO
7:30 AM

Xilio Therapeutics Appoints Ben Harshbarger as Chief Legal Officer

WALTHAM, Mass., June 29, 2026 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing masked immuno-oncology therapies for people living with cancer, today announced the appointment of Ben Harshbarger as chief legal officer.

xiliotx.com
ZURA
7:30 AM

Zura Bio Exceeds Enrollment Target in Both Hidradenitis Suppurativa (HS) & Systemic Sclerosis (SSc) Phase 2 Studies and Expands Tibulizumab Program

Tibulizumab is the first and only bispecific antibody targeting both BAFF and IL-17 in clinical development TibuSHIELD has completed enrollment, exceeding enrollment target with 247 participants randomized in HS; topline data expected Q4 2026 TibuSURE has exceeded the 80 participant enrollment

Enrollment • Phase 2Enrollment milestone Mon, Jun 29, 2026zurabio.com
BHVN
7:30 AM

Biohaven Advances a New Class of Precision Immunology Therapies: First MoDE Extracellular Protein Degrader, BHV-1300, Begins Phase 3 Pivotal Trial in Graves' Disease

BHV-1300 is the first MoDE™ extracellular protein degrader to enter a pivotal trial, pioneering a new class of precision immunology medicines that eliminate the disease-driving antibodies at the root of autoimmune disease. BHV-1300 targets the TSHR-IgG1 autoantibody that drives Graves' disease, not

Trial Start • Phase 3Trial initiation Mon, Jun 29, 2026biohaven.com
RGNX
7:05 AM

REGENXBIO Announces First Patient Dosed in Phase IIb/III NAAVIGATE Trial of Surabgene Lomparvovec in Diabetic Retinopathy; Company to Receive $100 Million Milestone

New long-term data from diabetic retinopathy and wet AMD programs to be presented at American Society of Retina Specialists (ASRS) 2026 ROCKVILLE, Md., June 29, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the first patient has been dosed in the Phase IIb/III NAAVIGATE

Trial Start • Phase 2/3Trial initiation Mon, Jun 29, 2026, 7:05 AM EDTregenxbio.com
DNTH
7:00 AM

Dianthus Therapeutics Announces Initiation of Phase 3 Emerge Trial of Claseprubart in Generalized Myasthenia Gravis

EMERGE is a global, randomized, multicenter, placebo-controlled Phase 3 trial that will evaluate claseprubart 300mg/2mL S.C. dosed Q2W and Q4W vs. placebo, with top-line results anticipated in 2H’28 Advancing a neuromuscular franchise with claseprubart, a highly potent investigational classical

Trial Start • Phase 3Trial initiation Mon, Jun 29, 2026, 7:00 AM EDTdianthustx.com
BCRX
7:00 AM

BioCryst Sharpens Scientific Focus on External Innovation with Wind Down of Internal Discovery Programs and Closure of Birmingham Research Facility

—Advances strategic shift toward a disciplined research model prioritizing external innovation to accelerate rare disease pipeline growth— —Completes enrollment in Phase 3 ALPHA-ORBIT for navenibart, largest pivotal HAE study to date— —Resolves previously disclosed manufacturing delay of ORLADEYO ®

Enrollment • Phase 3Enrollment completion Mon, Jun 29, 2026biocryst.com
SGMT
7:00 AM

Sagimet Biosciences Joins the Russell 2000® and Russell 3000® Indexes

SAN MATEO, Calif., June 29, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that the Company has been added to the broad-market Russell

sagimet.com
NBP
7:00 AM

NovaBridge Biosciences Appoints Dr. Srishti Gupta as Chief Executive Officer

ROCKVILLE, Md., June 29, 2026 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (Nasdaq: NBP) (“NovaBridge” or the “Company”), a clinical-stage biopharmaceutical company advancing innovative medicines for areas of significant unmet need, today announced the appointment of Srishti Gupta, MD MPP as Chief

novabridge.com
NGNE
7:00 AM

Neurogene Reports Positive Long-term Clinical Data from Phase 1/2 Trial of NGN-401 Gene Therapy for Rett Syndrome

4 7 total developmental milestones gained across 10 participants, with durable treatment effect and no plateau or milestone loss through 30 months of follow-up 100% of participants improved in CGI-I score and gained ≥1 developmental milestone, with an average of 4.7 milestones per participant, and

Trial Results • Phase 1/2Results call Mon, Jun 29, 2026, 8:00 AM ETneurogene.com
BIIB
6:59 AM

Biogen to Highlight Breadth of Alzheimer’s Disease Portfolio at AAIC 2026, Including Phase 2 CELIA Data for Diranersen

Diranersen presentation will feature Phase 2 CELIA data in early Alzheimer’s disease, including clinical, biomarker and safety results for Biogen’s investigational tau-targeting ASO, following topline results announced in May 2026 Lecanemab presentations will highlight emerging data on subcutaneous

Presentation / Abstract • Phase 2Oral presentation Tue, Jul 14, 2026, 2:00 PM BSTbiogen.com
VTRS
6:59 AM

Viatris Announces Positive Top-Line Results from Phase 3 Study of VR-205 in Japanese Adults with Primary Immunoglobulin A Nephropathy

VR-205 Met Primary Endpoint and Key Secondary Endpoints and Was Well Tolerated VR-205 Efficacy and Safety Profile in Japanese Patients Was Consistent with the Profile Observed in Global Studies Japanese New Drug Application Submission Targeted by End of 2026 PITTSBURGH and TOKYO, June 29, 2026

Trial Results • Phase 3Top-line results Mon, Jun 29, 2026, 6:59 AM EDTviatris.com
LRMR
6:30 AM

Larimar Therapeutics Reports Positive Open Label Data and Submission of First Module of Rolling BLA for Accelerated Approval of Nomlabofusp for Friedreich’s Ataxia

FDA alignment on submission of BLA data package in multi-disciplinary Type B pre-BLA meeting minutes; first module of rolling BLA submitted with remaining modules expected 2H 2026 Daily nomlabofusp increased and sustained skin FXN levels at 1 year and 18 months; 100% (9/9) of participants achieved

Interim Data • Phase 2Open label data release Mon, Jun 29, 2026, 6:30 AM EDTlarimartx.com
ZYME
6:00 AM

Zymeworks to Acquire Theravance Biopharma, Inc.

Acquisition adds YUPELRI ® (revefenacin), the first and only approved nebulized long-acting muscarinic antagonist (LAMA) for the maintenance treatment of COPD to Zymeworks' portfolio Acquisition of Theravance Biopharma at $17 per share is supported by an innovative non-recourse financing

zymeworks.com
AZN
2:41 AM

Enhertu approved in EU for HER2+ solid tumours

29 June 2026 Enhertu approved in the EU as first tumour agnostic HER2-directed therapy and antibody drug conjugate for patients with previously treated HER2-positive metastatic solid tumours Based on three Phase II trials of AstraZeneca and Daiichi Sankyo's Enhertu which demonstrated clinically meaningful responses across a broad range of tumours...

astrazeneca.com
AZN
2:00 AM

Datroway recommended for approval in EU for TNBC

29 June 2026 Datroway recommended for approval in the EU by CHMP as 1st-line treatment for patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy Recommendation based on TROPION-Breast02 Phase III trial where AstraZeneca and Daiichi Sankyo's Datroway showed a statistically significant and clinically meaningful...

astrazeneca.com

Sun, Jun 28, 2026

1 updates

Fri, Jun 26, 2026

16 updates
MNPR
4:05 PM

Monopar Presents New Analyses of Phase 3 FoCus Data at EAN 2026 Showing Greater Neurologic and Global Clinical Benefit with ALXN1840 Versus Standard of Care in Wilson Disease

WILMETTE, Ill., June 26, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced that new analyses from the Phase 3 FoCus randomized controlled clinical trial of ALXN1840 (tiomolibdate...

Presentation / Abstract • Phase 3EAN 2026 poster presentation Sat, Jun 27, 2026monopartx.com