September 2026 biotech catalysts

Name: Bio Catalyst Calendar — source-anchored biotech/pharma catalyst dates
Creator: Bio Catalyst Calendar
License: https://www.usa.gov/government-works

75 verified catalyst event(s) dated in September 2026, each linked to its official source. Verified as of 2026-09-20.

Date	Event	Company	Drug	Official source & verification
2026-09-08 12d ago CONFIRMED	APPROVED TRIAMCINOLONE ACETONIDE	MICRO LABS	TRIAMCINOLONE ACETONIDE	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-08 12d ago CONFIRMED	APPROVED BRIVARACETAM	ZHEJIANG JUTAI PHARM	BRIVARACETAM	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-09 11d ago CONFIRMED	APPROVED ROPINIROLE HYDROCHLORIDE	ALEMBIC LTD	ROPINIROLE HYDROCHLORIDE	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-09 11d ago CONFIRMED	APPROVED AMELUZ	BFRI Biofrontera Inc.	AMELUZ	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-09 11d ago CONFIRMED	APPROVED HYRNUO	BAYER HEALTHCARE	HYRNUO	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-10 10d ago CONFIRMED	APPROVED ASENAPINE MALEATE	ALEMBIC	ASENAPINE MALEATE	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-10 10d ago CONFIRMED	APPROVED LISDEXAMFETAMINE DIMESYLATE	ASCENT PHARMS INC	LISDEXAMFETAMINE DIMESYLATE	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-10 10d ago CONFIRMED	APPROVED ISOTRETINOIN	AUROBINDO PHARMA LTD	ISOTRETINOIN	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-10 10d ago CONFIRMED	APPROVED SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	RUBICON RESEARCH	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-10 10d ago CONFIRMED	APPROVED ANNOVERA	MAYNE PHARMA	ANNOVERA	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-11 9d ago CONFIRMED	APPROVED CARBIDOPA AND LEVODOPA	ACTAVIS ELIZABETH	CARBIDOPA AND LEVODOPA	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-11 9d ago CONFIRMED	APPROVED PACLITAXEL	TEVA PHARMS	PACLITAXEL	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-11 9d ago CONFIRMED	APPROVED CARBIDOPA AND LEVODOPA	SUN PHARM INDS	CARBIDOPA AND LEVODOPA	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-11 9d ago CONFIRMED	APPROVED GABAPENTIN	INVAGEN PHARMS	GABAPENTIN	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-11 9d ago CONFIRMED	APPROVED POLYETHYLENE GLYCOL 3350	STRIDES PHARMA	POLYETHYLENE GLYCOL 3350	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-11 9d ago CONFIRMED	APPROVED ITRACONAZOLE	APOTEX	ITRACONAZOLE	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-11 9d ago CONFIRMED	APPROVED DASATINIB	MSN	DASATINIB	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-11 9d ago CONFIRMED	APPROVED IMDELLTRA	AMGN AMGEN INC	IMDELLTRA	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-11 9d ago CONFIRMED	APPROVED ISEMBYLD	SRRK Scholar Rock Holding Corp	ISEMBYLD	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-11 9d ago CONFIRMED	APPROVED KYBELLA	ABBV AbbVie Inc.	KYBELLA	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-11 9d ago CONFIRMED	APPROVED JOENJA	PHAR Pharming Group N.V.	JOENJA	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-11 9d ago CONFIRMED	APPROVED PIXCLARA	TLX Telix Pharmaceuticals Ltd	PIXCLARA	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-14 6d ago CONFIRMED	APPROVED COLISTIMETHATE SODIUM	SAGENT PHARMS INC	COLISTIMETHATE SODIUM	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-14 6d ago CONFIRMED	APPROVED PRIMAQUINE PHOSPHATE	ALVOGEN	PRIMAQUINE PHOSPHATE	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-14 6d ago CONFIRMED	APPROVED PRIMAQUINE PHOSPHATE	UNICHEM	PRIMAQUINE PHOSPHATE	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-14 6d ago CONFIRMED	APPROVED ITRACONAZOLE	AMNEAL PHARMS	ITRACONAZOLE	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-14 6d ago CONFIRMED	APPROVED ITRACONAZOLE	ALEMBIC	ITRACONAZOLE	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-14 6d ago CONFIRMED	APPROVED DOXYCYCLINE HYCLATE	CHANGZHOU PHARM	DOXYCYCLINE HYCLATE	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-14 6d ago CONFIRMED	APPROVED CLOBAZAM	MICRO LABS	CLOBAZAM	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-14 6d ago CONFIRMED	APPROVED EPINEPHRINE	ZYDUS PHARMS	EPINEPHRINE	openFDA (drugsfda) ↗ ✓ Source-checked 2026-09-20 Actual/recorded date
2026-09-16 4d ago CONFIRMED	ADCOM Pediatric Advisory Committee (PAC) Pediatric Advisory Committee (PAC)	Pediatric Advisory Committee (PAC)	AdComm review	Federal Register (FDA notice) ↗ ✓ Source-checked 2026-09-20 Scheduled FDA meeting date
2026-09-21 in 1d ESTIMATED	READOUT CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3) Phase 3 · Recurrent Pericarditis	CRDL Cardiol Therapeutics Inc.	CardiolRx	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-22 in 2d ESTIMATED	READOUT A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and i Phase 1/2 · Solid Tumor, Melanoma	ImmVira Pharma Co. Ltd	T3011, T3011 + pembrolizumab	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-22 in 2d ESTIMATED	READOUT A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Mono Phase 2 · Waldenstrom Macroglobulinemia, Waldenstrom's Macroglobulinemia Recurrent	ONC BeOne Medicines Ltd.	Sonrotoclax, Zanubrutinib	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-22 in 2d ESTIMATED	READOUT Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 an Phase 1/2 · Norovirus Acute Gastroenteritis	ModernaTX, Inc.	mRNA-1403, mRNA-1405	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-23 in 3d ESTIMATED	READOUT Study to Test the Safety and Tolerability of PF-07220060 in Participants With Ad Phase 2 · Liposarcoma, Prostate Cancer	PFE PFIZER INC	PF-07220060, Letrozole, Fulvestrant, Mid	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-23 in 3d CONFIRMED	ADCOM Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee	Molecular and Clinical Genetics Pa	AdComm review	Federal Register (FDA notice) ↗ ✓ Source-checked 2026-09-20 Scheduled FDA meeting date
2026-09-24 in 4d ESTIMATED	READOUT An Open-label, Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 Phase 1/2 · Systemic Lupus Erythematosus, Lupus Nephritis	NVS NOVARTIS AG	YTB323	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-27 in 7d ESTIMATED	READOUT A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whethe Phase 3 · Lupus Erythematosus, Systemic	BIIB BIOGEN INC.	Litifilimab	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-28 in 8d ESTIMATED	READOUT A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Phase 2 · Cutaneous Squamous Cell Carcinoma	INCY INCYTE CORP	INCB099280	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-28 in 8d ESTIMATED	READOUT A Study of AT-02 in Subjects With Systemic Amyloidosis. Phase 2 · Amyloidosis; Systemic	Attralus, Inc.	AT02	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-28 in 8d ESTIMATED	READOUT A Phase 2/3 Trial to Assess the Efficacy and Safety of OCU410ST for Stargardt Di Phase 2/3 · Stargardt Disease	OCGN Ocugen, Inc.	OCU410ST	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-28 in 8d ESTIMATED	READOUT An Open-label, Single-arm Study to Evaluate Pharmacokinetics and Safety of Subcu Phase 3 · Hidradenitis Suppurativa	MLTX MoonLake Immunotherapeutics	Sonelokimab	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-29 in 9d ESTIMATED	READOUT Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Rela Phase 3 · Eosinophilic Granulomatosis With Polyangiitis	GlaxoSmithKline	Depemokimab, Mepolizumab	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-29 in 9d ESTIMATED	READOUT Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Pa Phase 2 · Asthma	SNY Sanofi	Amlitelimab	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT An Adaptive Phase II/III, Two-Part, Double-Blind, Randomized, Placebo-controlled Phase 2/3 · Refractory Schizophrenia	SyneuRx International (Taiwan) Cor	NaBen®	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib i Phase 1/2 · Indolent B-Cell Non-Hodgkin Lymphoma	BioInvent International AB	BI-1206, Rituximab, Acalabrutinib	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, RO Phase 1/2 · Locally Advanced Solid Tumors, Metastatic Solid Tumors	TPB Turning Point Brands, Inc.	Oral repotrectinib (TPX-0005)	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT Linerixibat Long-term Safety, and Tolerability Study Phase 3 · Cholestasis	GlaxoSmithKline	Linerixibat	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Part Phase 3 · Carcinoma, Non-Small-Cell Lung	Hoffmann-La Roche	Entrectinib, Crizotinib	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whethe Phase 3 · Lupus Erythematosus, Systemic	BIIB BIOGEN INC.	Litifilimab	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Particip Phase 3 · Stereotypical Prolonged Seizures	UCB Biopharma SRL	Staccato alprazolam	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizum Phase 3 · Gastric Neoplasms, Gastroesophageal Adenocarcinoma	JAZZ Jazz Pharmaceuticals plc	Zanidatamab, Tislelizumab, Trastuzumab,	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab Phase 3 · Non-Small Cell Lung Cancer	AZN ASTRAZENECA PLC	Durvalumab, Oleclumab, Monalizumab	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Phase 1/2 · KRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small Cell Lung	NVS NOVARTIS AG	JDQ443, trametinib, Ribociclib, cetuxima	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT A Phase 1/2 Study to Evaluate the Safety, Tolerability and PK of JIN-A02 in Pati Phase 1/2 · EGFR Mutant Advanced Non-small Cell Lung Cancer	J Ints Bio	JIN-A02	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G Phase 2 · Advanced NSCLC, Metastatic Lung Cancer	Mirati Therapeutics Inc.	Adagrasib oral dose of 400 mg twice dail	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia Phase 1/2 · Congenital Adrenal Hyperplasia	H. Lundbeck A/S	Lu AG13909	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Phase 2 · Recurrent Wheezing, Wheezing Lower Respiratory Illness	OM Pharma SA	OM-85	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Phase 2 · Advanced Solid Tumor	INCY INCYTE CORP	INCB099280	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced S Phase 1/2 · Advanced Solid Tumors	BMY BRISTOL MYERS SQUIBB CO	BMS-986449, Nivolumab	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT Azeliragon in MGMT Unmethylated Glioblastoma Phase 2 · Glioblastoma	Cantex Pharmaceuticals	Azeliragon	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT Safety, Tolerability, and Exploratory Efficacy Study of Intrathecally Administer Phase 1/2 · Amyotrophic Lateral Sclerosis	UniQure Biopharma B.V.	AMT-162	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Phase 2 · Basal Cell Carcinoma	Stamford Pharmaceuticals, Inc.	SP-002, Vismodegib	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as Phase 1/2 · Extensive Stage-small Cell Lung Cancer	Daiichi Sankyo	Ifinatamab deruxtecan, Atezolizumab, Car	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osime Phase 3 · Metastatic Non-small Cell Lung Cancer	AZN ASTRAZENECA PLC	Dato-DXd, Osimertinib, Pemetrexed, Carbo	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT A Study to Evaluate Solrikitug in Participants With COPD (ZION) Phase 2 · COPD	Uniquity One (UNI)	Biological: Solrikitug low dose, Biologi	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cel Phase 3 · Small Cell Lung Cancer	Hansoh BioMedical R&D Company	HS-20093, Topotecan	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT An Extension and Crossover Vaccination Study on the Immune Response and Safety o Phase 3 · Respiratory Syncytial Virus Infections	GlaxoSmithKline	RSVPreF3 OA vaccine	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With R Phase 2/3 · Diabetic Macular Edema (DME)	EyeBiotech Ltd.	Ranibizumab, EYE103	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT A Clinical Study to Investigate the Effect of Oral Neflamapimod on Motor Recover Phase 2 · Moderate to Severe Acute Ischaemic Stroke, Ischaemic Stroke	EIP Pharma Inc	Neflamapimod	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balina Phase 2 · Colitis Ulcerative, Crohn's Disease	SNY Sanofi	balinatunfib, balinatunfib-matching plac	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT Study of ARO-DIMERPA in Adult Participants With Mixed Hyperlipidemia Phase 1/2 · Hyperlipidemia; Mixed	ARWR ARROWHEAD PHARMACEUTICALS, I	ARO-DIMERPA	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruqu Phase 2 · Colorectal Cancer	Kahr Bio Australia Pty Ltd	DSP107 + Atezolizumab, Fruquintinib	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change
2026-09-30 in 10d ESTIMATED	READOUT Clinical Study to Collect and Analyze Dental Plaque and Oral Health Measures in Phase 4 · Gingivitis, Plaque	CL COLGATE PALMOLIVE CO	sodium monofluorophosphate toothpaste	ClinicalTrials.gov ↗ ✓ Source-checked 2026-09-20 Sponsor-projected date — can change