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Mon, Sep 14, 2026

37 updates
AMGN
9:00 AM

FDA APPROVES REDUCED MONITORING TIME FOR FIRST TWO DOSES OF IMDELLTRA®

Update Supports Broader Access to IMDELLTRA in Community Settings for People Living with Extensive-Stage Small Cell Lung Cancer THOUSAND OAKS, Calif., Sept. 14, 2026 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) approved an update to the

amgen.com
EVAX
8:00 AM

Evaxion applies its AI-Immunology™ platform in autoimmune diseases

Autoimmune diseases are characterized by high unmet medical need with most current treatments only addressing symptoms. Evaxion will apply AI-Immunology™ to target underlying pathologies The unique capabilities of AI-Immunology™ could potentially help develop new treatments with higher efficacy and

evaxion.ai
AKBA
8:00 AM

Akebia Therapeutics Announces First Patient Dosed in Phase 2 Basket Trial of Ebribafusp in Rare Complement-Mediated Kidney Diseases

Open-label Phase 2 trial evaluating ebribafusp for the treatment of IgA nephropathy, lupus nephritis and C3 glomerulopathy Initial data is expected in 2027 WALTHAM, Mass., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Akebia Therapeutics ®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to

Trial Start • Phase 2Trial initiation Mon, Sep 14, 2026, 8:00 AM EDTakebia.com
CGEM
7:00 AM

Cullinan Therapeutics to Host Virtual Analyst and Investor Event Today to Feature Zipalertinib Plus Chemotherapy Phase 3 REZILIENT3 Data Presented at the IASLC 2026 World Conference on Lung Cancer

Company to host a virtual event today at 8:00 a.m. ET CAMBRIDGE, Mass., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases

Results Call • Phase 3Results call Mon, Sep 14, 2026, 8:00 AM ETcullinantherapeutics.com
BNTX
4:00 AM

BioNTech and OncoC4 Present Updated Data Showing Gotistobart Nearly Doubled Median Overall Survival versus Standard-of-Care Chemotherapy in Previously Treated Squamous Non-Small Cell Lung Cancer Patients

Gotistobart continues to show potential as chemotherapy-free monotherapy to reignite anti-tumor immunity in previously treated patients with squamous non-small cell lung cancer, where median survival with current standard of care treatments is less than one year 1 Gotistobart demonstrated a median

Presentation / Abstract • Phase 3WCLC presentation Mon, Sep 14, 2026biontech.de
NBTX
2:00 AM

NANOBIOTIX Announces Complete Full Cohort Phase 1 Results for JNJ-1900 (NBTXR3) in Inoperable, Recurrent Non-Small Cell Lung Cancer

All 24 patients completed treatment with no dose-limiting toxicities, no Grade 3 or higher adverse events related to JNJ-1900 (NBTXR3 or to the injection procedure, and intratumoral injection was deemed feasible One-year locoregional control rate was 79%, one-year local progression-free survival

Presentation / Abstract • Phase 1WCLC presentation Mon, Sep 14, 2026, EDTnanobiotix.com
AZN
2:00 AM

Update on SERENA-4 Phase III trial

This announcement contains inside information 14 September 2026 Update on SERENA-4 Phase III trial of Etcamah in combination with palbociclib in upfront 1st-line advanced ER-positive breast cancer SERENA-4 trial did not meet primary objective of statistically significant improvement in progression-free survival, however a numerical improvement was observed...

Trial Results • Phase 3SERENA-4 trial results Mon, Sep 14, 2026, 8:00 AM CETastrazeneca.com

Sun, Sep 13, 2026

5 updates
CGEM
7:15 PM

Zipalertinib Plus Chemotherapy Demonstrates 6-Month Median Progression-Free Survival Benefit in REZILIENT3 Phase 3 Trial in First-Line EGFR Exon 20 Insertion Mutation Non-Small Cell Lung Cancer

Results from the Phase 3 REZILIENT3 trial were featured in a Presidential Symposium at WCLC 2026 and demonstrated a statistically significant improvement in progression-free survival in first-line EGFR exon 20 insertion mutation NSCLC at a planned interim analysis PRINCETON, N.J., TOKYO, Japan,

Trial Results • Phase 3WCLC Presidential Symposium presentation Mon, Sep 14, 2026, 8:00 AM KSTcullinantherapeutics.com

Sat, Sep 12, 2026

1 updates
RHHBY
8:00 PM

Roche’s collaborator MediLink announces phase III data for Tam-Peli showing significantly improved overall survival in Chinese patient population with relapsed small-cell lung cancer

Tambotatug pelitecan (Tam-Peli) demonstrated statistically significant efficacy over topotecan in a phase III study conducted in China, reducing the risk of death by 54% and disease progression by 71%, while achieving an objective response rate of 59.1% vs 9.7% 1 The novel B7-H3-targeted antibody-drug conjugate with a dual release mechanism of the payload...

Trial Results • Phase 3Phase III trial results Sun, Sep 13, 2026roche.com

Fri, Sep 11, 2026

7 updates
CLLS
4:30 PM

Cellectis to Host Conference Call and Webcast on September 14 to Provide a Business Update

New York, NY - September 11, 2026 - Cellectis (the "Company") (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, today announced that it will host a conference call and webcast on Monday, September 14, 2026 to provide a business update....

cellectis.com
KRRO
4:05 PM

Korro Bio Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

CAMBRIDGE, Mass., Sept. 11, 2026 (GLOBE NEWSWIRE) -- Korro Bio, Inc. (Korro) (Nasdaq: KRRO), a biopharmaceutical company leveraging a novel Oligonucleotide Promoted Editing of RNA (OPERA ®) platform to develop a new class of genetic medicines for rare and highly prevalent diseases, today announced

korrobio.com
FDMT
4:05 PM

4DMT Announces New Employment Inducement Grants

EMERYVILLE, Calif., Sept. 11, 2026 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to

4dmoleculartherapeutics.com
TPST
8:00 AM

Tempest Therapeutics Announces Up to $7.5 Million Private Placement

$2.5 million upfront with up to approximately $5 million of potential aggregate gross proceeds upon the exercise in full of warrants BRISBANE, Calif., Sept. 11, 2026 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST) (the “Company”), a clinical-stage biotechnology company pioneering the

tempesttx.com