FDA Drug Approval Calendar

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Main Company	Current Price	30-Day Price Change	Drug	Status	Event
ONC BeOne Medicines	$253.39 -0.9%	-3.8%	Tislelizumab Recurrent or Metastatic Nasopharyngeal Cancer	EC Approval	7/10/2025 - Approved BeOne Medicines Ltd. announced that the European Commission has approved TEVIMBRA® (tislelizumab), i… Full Summary
MRK Merck & Co., Inc.	$84.06 +0.4%	+3.4%	Doravirine/Islatravir In adults with HIV-1 infection	NDA	7/10/2025 - FDA review Merck announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Dru… Full Summary
PFE Pfizer	$25.77 +0.8%	+6.1%	XTANDI (Enzalutamide) Metastatic Hormone-Sensitive Prostate Cancer	Phase 3	7/10/2025 - Top-line results Pfizer Inc. and Astellas Pharma Inc announced positive topline results from the overall survival (O… Full Summary
TNXP Tonix Pharmaceuticals	$42.36 +10.4%	+12.2%	TNX-801 Potential Vaccine to Prevent Mpox and Smallpox		7/10/2025 - Presentation Tonix Pharmaceuticals announced the presentation of new findings on TNX-801 (recombinant horsepox,… Full Summary
STOK Stoke Therapeutics	$12.04 +0.2%	+6.0%	zorevunersen For the treatment of Dravet syndrome with a confirmed mutation,	Phase 3	7/10/2025 - Presentation Stoke Therapeutics, Inc and Biogen Inc announced the presentation of data from an analysis that inf… Full Summary
CGTX Cognition Therapeutics	$0.70 +31.7%	+123.2%	CT1812 Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.	Phase 2	7/10/2025 - FDA Meeting Cognition Therapeutics, Inc., announced that it conducted an end-of-Phase 2 meeting with the U.S. F… Full Summary
BCTX Briacell Therap	$2.07 -1.9%	-40.3%	Bria-IMT Metastatic breast cancer (breast cancer that has spread beyond the breast)	Phase 2	7/10/2025 - updated results BriaCell Therapeutics Corp announced updated results from its ongoing Phase 2 study of Bria-IMT™ in… Full Summary
LGND Ligand Pharmaceuticals	$124.98 +2.1%	+10.2%	ZELSUVMI For the Treatment of Molluscum Contagiosum		7/10/2025 - Provided Update Pelthos Therapeutics Inc. announced the launch of ZELSUVMI™ (berdazimer) topical gel, 10.3%, for the… Full Summary
PDSB PDS Biotechnology	$1.30 -1.5%	-22.6%	PDS01ADC For the treatment of recurrent prostate cancer		7/10/2025 - Provided Update PDS Biotechnology announced patient recruitment has been completed in Stage 1 of a clinical trial o… Full Summary
ABOS Acumen Pharmaceuticals	$1.30 +4.0%	+10.2%	Sabirnetug for Early Alzheimer's Disease		7/10/2025 - Presentation Acumen Pharmaceuticals, will present new findings at the upcoming Alzheimer's Association Internati… Full Summary
COCP Cocrystal Pharma	$1.56	-3.1%	CDI-988 For Pandemic Norovirus and Coronavirus		7/10/2025 - Oral presentation Cocrystal Pharma, Inc announces that its first-in-class pan-viral protease inhibitor CDI-988 has be… Full Summary
RCUS Arcus Biosciences	$9.51 +1.9%	-5.3%	quemliclustat For Pancreatic Cancer	Orphan Drug	7/10/2025 - Designation Grant Arcus Biosciences, Inc announced that quemliclustat, an investigational small molecule CD73 inhibito… Full Summary
AAPG Ascentage Pharma Group International	$40.74 -2.7%	+36.3%	lisaftoclax In Venetoclax-Refractory Patients	NMPA Approval	7/10/2025 - Approved Ascentage Pharma announced that its proprietary novel Bcl-2 selective inhibitor lisaftoclax (APG-25… Full Summary
LLY Eli Lilly and Company	$790.23 +0.4%	-2.2%	Kisunla For the Treatment of Early Symptomatic Alzheimer's Disease		7/9/2025 - FDA approved Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved a la… Full Summary
EXAS Exact Sciences	$53.32 -3.6%	-5.1%	Oncodetect™ Molecular Residual Disease Test		7/9/2025 - Provided Update Exact Sciences Corp announced that its Oncodetect™ molecular residual disease (MRD) test has recei… Full Summary
KRYS Krystal Biotech	$149.74 +0.6%	+8.3%	KB801 For the Treatment of Neurotrophic Keratitis	Phase 1/2	7/9/2025 - Dose Update Krystal Biotech, Inc announced that the first patient has been dosed in its Phase 1/2 clinical trial… Full Summary
RZLT Rezolute	$5.25 -0.6%	+19.6%	Ersodetug For Hypoglycemia Due to Congenital Hyperinsulinism	Phase 3	7/9/2025 - Abstract Rezolute, Inc announced that the abstract titled "Preliminary Patient Demographics And Baseline Char… Full Summary
BCTX Briacell Therap	$2.07 -1.9%	-40.3%	Bria-OTS In metastatic breast cancer		7/9/2025 - Provided Update BriaCell Therapeutics Corp announced the sustained complete resolution of lung metastasis in a patie… Full Summary
ALT Altimmune	$4.40 -7.2%	-34.7%	pemvidutide for the treatment of obesity and MASH	Phase 2	7/9/2025 - Enrollment Update Altimmune, Inc. announced that it has enrolled the first patient in the RESTORE Phase 2 trial evalua… Full Summary
ARTL Artelo Biosciences	$28.50 +31.9%	+326.0%	ART26.12 For the prevention of chemotherapy-induced peripheral neuropathy, a debilitating and often treatment-altering side effect of cancer therapy.		7/9/2025 - Data Presentation Artelo Biosciences, announced the presentation of preclinical data in an osteaoarthritis (OA) pain … Full Summary
BIVI BioVie	$7.57 -6.0%	-31.2%	Bezisterim For Parkinson's Disease Patients		7/9/2025 - Provided Update BioVie Inc. presented "Bezisterim Epigenetic Effects on Aging and Neurodegeneration" at the 7th Worl… Full Summary
EOLS Evolus	$9.73 +0.7%	-1.4%	Nuceiva® For the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients2.		7/9/2025 - Provided Update Evolus, Inc announced it has partnered with Symatese to commence distribution of Nuceiva® (botulinu… Full Summary
BHC Bausch Health Cos	$6.65 +0.8%	+30.7%	CABTREO For the Treatment of Acne Vulgaris		7/9/2025 - Provided Update Bausch Health, Canada Inc announced that PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl … Full Summary
KZIA Novogen	$10.36 +8.7%	+97.0%	Paxalisib Atypical rhabdoid / teratoid tumors (AT/RT), a rare and highly-aggressive childhood brain cancer	Phase 1b	7/9/2025 - Preliminary Results Kazia Therapeutics announce preliminary results from the first patient in its Phase 1b trial evalua… Full Summary
KALA KALA BIO	$6.90 +9.5%	+45.6%	KPI-012 Clinical diagnosis of PCED		7/9/2025 - Enrollment Completion KALA BIO, Inc. announced the completion of patient enrollment in the CHASE (Corneal Healing After SE… Full Summary
KALA KALA BIO	$6.90 +9.5%	+45.6%	KPI-012 Clinical diagnosis of PCED	Target date: 2025-Q3	7/9/2025 - Top-line results KALA BIO, Inc. announced that Topline results from the CHASE trial expected by end of Q3 2025 -- Full Summary
RYTM Rhythm Pharmaceuticals	$89.04 +0.0%	+32.2%	bivamelagon In patients with acquired hypothalamic obesity.	Phase 2	7/9/2025 - Top-line results Rhythm Pharmaceuticals, Inc. announced positive topline results from its Phase 2 trial evaluating bi… Full Summary
LIXT Lixte Biotechnology	$4.22 +53.5%	+222.1%	LB100 For Ovarian and Colorectal cancers		7/9/2025 - Publication LIXTE Biotechnology Holdings, Inc. announced that the medical journal Nature has published findings… Full Summary
BHC Bausch Health Cos	$6.65 +0.8%	+30.7%	PrCABTREOTM For Treatment Of Acne Vulgaris		7/9/2025 - Provided Update Bausch Health, Canada Inc., part of Bausch Health Companies Inc. announced that PrCABTREOTM (clinda… Full Summary
BNTC Benitec Biopharma	$13.79 -0.4%	-14.8%	BB-301 Oculopharyngeal Muscular Dystrophy (OPMD)	Phase 1b/2a	7/9/2025 - Enrollment Update Benitec Biopharma Inc. announced the recommendation of the independent Data Safety Monitoring Board… Full Summary
ELAN Elanco Animal Health	$15.06 +1.9%	+5.4%	TruCan™ Ultra Canine Influenza Vaccine		7/9/2025 - Approved Elanco Animal Health announced the U.S. Department of Agriculture (USDA) has approved TruCan Ultra … Full Summary
ASBP Aspire Biopharma	$0.35 +6.2%	-8.1%	BUZZ BOMB New Sublingual Pre-Workout Supplement		7/9/2025 - Positive Feedback Aspire Biopharma Holdings, Inc. announced positive initial consumer feedback from the Company's samp… Full Summary
MTVA MetaVia	$0.72 +3.9%	-7.4%	DA-1726 For The Treatment Of Obesity	Phase 1	7/9/2025 - Dosing Update MetaVia Inc. announced dosing of the first patient in the 48 mg, multiple ascending dose (MAD) coho… Full Summary
MTVA MetaVia	$0.72 +3.9%	-7.4%	DA-1726 For The Treatment Of Obesity	Target date: 2025-Q4	7/9/2025 - Top-line data MetaVia Inc. announced that Top-Line Data Expected in the Fourth Quarter of 2025 Full Summary
CNTB Connect Biopharma	$1.15 +5.6%	+44.7%	Rademikibart For Moderate-To-Severe Atopic Dermatitis	NDA	7/9/2025 - NDA Filing Connect Biopharma Holdings Limited announced that the Company's collaborator and exclusive licensee… Full Summary
TNXP Tonix Pharmaceuticals	$42.36 +10.4%	+12.2%	TNX-102 SL Fibromyalgia	Phase 3	7/9/2025 - Results Tonix Pharmaceuticals announced that full results from its confirmatory Phase 3 RESILIENT trial of … Full Summary
RARE Ultragenyx Pharmaceutical	$31.03 -25.1%	-17.3%	UX143 (setrusumab) Osteogenesis Imperfecta (OI)	Phase 3	7/9/2025 - evaluation Ultragenyx Pharmaceutical announced that the randomized, placebo-controlled Phase 3 portion of the O… Full Summary
MRK Merck & Co., Inc.	$84.06 +0.4%	+3.4%	MK-8527 novel nucleoside reverse transcriptase translocation inhibitor		7/8/2025 - New Data Merck announced that new data from its research pipeline for HIV prevention and treatment will be p… Full Summary
ETON Eton Pharmaceuticals	$15.56 -1.3%	-1.0%	ET-600 For the treatment of an endocrinology	NDA	7/8/2025 - FDA review Eton Pharmaceuticals, Inc announced the Company's New Drug Application (NDA) for ET-600, a propriet… Full Summary
ETON Eton Pharmaceuticals	$15.56 -1.3%	-1.0%	ET-600 For the treatment of an endocrinology	NDA Target date: 2026-02-25	7/8/2025 - PDUFA Date Eton Pharmaceuticals, Inc announced that NDA has been assigned a Prescription Drug User Fee Act (… Full Summary
LRMR Larimar Therapeutics	$3.48 +0.6%	+19.6%	nomlabofusp For Friedreich's Ataxia		7/8/2025 - Publication Larimar Therapeutics, announced the publication of two peer-reviewed articles highlighting nonclin… Full Summary
EPRX Eupraxia Pharmaceuticals	$5.57 +2.0%	+40.0%	EP-104GI For Treatment of Eosinophilic Esophagitis	Phase 2b	7/8/2025 - Dose Update Eupraxia Pharmaceuticals Inc. announced the first patient dosed in the Phase 2b randomized, placebo-… Full Summary
UPB Upstream Bio	$11.84 +1.2%	+2.2%	Verekitug In Chronic Obstructive Pulmonary Disease (COPD)	Phase 2	7/8/2025 - Dose Update Upstream Bio, Inc. announced that the first patient has been dosed in the Company's Phase 2 clinica… Full Summary
PSTV Plus Therapeutics	$0.35 -0.5%	+0.3%	REYOBIQ™ For Patients with Leptomeningeal Metastases		7/8/2025 - Provided Update Plus Therapeutics, Inc. announced the treatment of its initial patients in the Company's ReSPECT-LM… Full Summary
ARWR Arrowhead Pharmaceuticals	$18.86 -0.1%	+11.1%	Zodasiran For the Treatment of Homozygous Familial Hypercholesterolemia	Phase 3	7/8/2025 - Dose Update Arrowhead Pharmaceuticals, Inc. announced that it has dosed the first subject in the YOSEMITE Phase … Full Summary
BCLI Brainstorm Cell Therapeutics	$1.22 -1.6%	-2.4%	NurOwn Progressive Multiple Sclerosis (MS)		7/8/2025 - Provided Update BrainStorm Cell Therapeutics Inc today acknowledged that the U.S. Food and Drug Administration's (F… Full Summary
ITCI Intra-Cellular Therapies	$131.87		CAPLYTA (Lumateperone) Depressive Episodes associated with Bipolar	supplemental New Drug Application (sNDA)	7/8/2025 - sNDA Filing Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the U.S.… Full Summary
JNJ Johnson & Johnson	$157.72 +0.9%	+0.8%	CAPLYTA (Lumateperone) Depressive Episodes associated with Bipolar	supplemental New Drug Application (sNDA)	7/8/2025 - sNDA Filing Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the U.S.… Full Summary
ONCY Oncolytics Biotech	$1.12 -6.7%	+162.3%	Pelareorep In Breast Cancer		7/8/2025 - Clinical Data Oncolytics Biotech® Inc announced a strategic update highlighting its compelling clinical data from… Full Summary
MAT Mattel	$20.22 +0.4%	+4.8%	Barbie type 1 diabetes (T1D)		7/8/2025 - Provided Update Mattel, Inc announced that Barbie® is debuting the first Barbie doll with type 1 diabetes (T1D). Full Summary
RYTM Rhythm Pharmaceuticals	$89.04 +0.0%	+32.2%	bivamelagon In patients with acquired hypothalamic obesity.	Phase 2	7/8/2025 - Provided Update Rhythm Pharmaceuticals, Inc announced the Company will hold a conference call and webcast on Wednes… Full Summary
SLDB Solid Biosciences	$5.42 -1.8%	+12.2%	SGT-501 For the treatment of catecholaminergic polymorphic ventricular tachycardia (CPVT)	IND	7/8/2025 - FDA Approval Solid Biosciences Inc. announced approval of its Investigational New Drug (IND) application by the … Full Summary
SLDB Solid Biosciences	$5.42 -1.8%	+12.2%	SGT-501 For the treatment of catecholaminergic polymorphic ventricular tachycardia (CPVT)	Phase 1b	7/8/2025 - Clinical Trial Solid expects to initiate Phase 1b clinical trial of SGT-501 in the fourth quarter of 2025 - Full Summary
KALV KalVista Pharmaceuticals	$15.51 -3.0%	+9.1%	sebetralstat Therapy for hereditary angioedema (HAE).		7/7/2025 - FDA Approval KalVista Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has approv… Full Summary
TNXP Tonix Pharmaceuticals	$42.36 +10.4%	+12.2%	TNX-801 Potential Vaccine to Prevent Mpox and Smallpox		7/7/2025 - Data Presentation Tonix Pharmaceuticals announced that Sina Bavari, PhD, Executive Vice President of Infectious Diseas… Full Summary
NTRA Natera	$163.36 +1.0%	-1.1%	Latitude™ For Colorectal Cancer		7/7/2025 - Data Natera, Inc announced data from a colorectal cancer (CRC) study of its tissue-free Latitude™ MRD as… Full Summary
BSX Boston Scientific	$103.80 +0.8%	+4.6%	FARAPULSE™ A nonthermal treatment in which electric fields selectively ablate heart tissue in patients with atrial fibrillation (AF).		7/7/2025 - FDA Approval Boston Scientific Corporation announced that it has received U.S. Food and Drug Administration (FDA… Full Summary
BYSI BeyondSpring	$2.25 -2.6%	-10.4%	plinabulin Patients with non-small cell lung cancer		7/7/2025 - Publication BeyondSpring Inc. announced publication of a human clinical study in Med (Cell Press) demonstrating… Full Summary
COGT Cogent Biosciences	$10.85 +4.3%	+46.2%	bezuclastinib In patients with non-advanced systemic mastocytosis		7/7/2025 - Top-line results Cogent Biosciences, Inc. announced positive top-line results from the registration-directed Part 2 … Full Summary
OGN Organon & Co.	$10.03 +1.2%	0.0%	VTAMA (tapinarof) cream Plaque psoriasis		7/7/2025 - Recommendation Organon announced that VTAMA® (tapinarof) cream, 1%,was granted a strong recommendation by the Ameri… Full Summary
JSPR Jasper Therapeutics	$3.55 -3.5%	-38.5%	Briquilimab To address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU)	Phase 1b/2a	7/7/2025 - Updated data Jasper Therapeutics is reporting updated data from Company's BEACON Phase 1b/2a study of subcutaneo… Full Summary
ARTL Artelo Biosciences	$28.50 +31.9%	+326.0%	ART12.11 For overcoming problematic drug properties which allows for precise control over purity, potency, and consistency.		7/7/2025 - Data Presentation Artelo Biosciences announced the presentation of compelling new preclinical data on its Cannabidiol… Full Summary
URGN Urogen Pharma	$14.64 +6.0%	+107.7%	UGN-103 For Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer	Phase 3	7/7/2025 - Enrollment Completion UroGen Pharma Ltd. announced that it has completed patient enrollment in its Phase 3 UTOPIA clinica… Full Summary
DNLI Denali Therapeutics	$15.35 +2.3%	+0.6%	tividenofusp For the treatment of Hunter syndrome (MPS II)	BLA	7/7/2025 - FDA review Denali Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for… Full Summary
DNLI Denali Therapeutics	$15.35 +2.3%	+0.6%	tividenofusp For the treatment of Hunter syndrome (MPS II)	BLA Target date: 2026-01-05	7/7/2025 - PDUFA Date Denali Therapeutics Inc. announced that The FDA granted the BLA Priority Review with a Prescription… Full Summary
KALA KALA BIO	$6.90 +9.5%	+45.6%	KPI-012 Clinical diagnosis of PCED		7/7/2025 - Provided Update KALA BIO, Inc. announced that the Company will host a webcast event with Key Opinion Leaders (KOLs… Full Summary
AGEN Agenus	$5.92 +14.3%	+10.2%	BOT/BAL In Metastatic MSS Colorectal Cancer	Phase 3	7/7/2025 - Provided Update Agenus also confirmed that it has reached agreement with the U.S. Food and Drug Administration (FDA)… Full Summary
FBIO Fortress Biotech	$1.99	-4.3%	MB-101 Leptomeningeal brain tumors	Orphan Drug	7/7/2025 - Designation Grant Mustang Bio, Inc announced that the U.S. Food and Drug Administration ("FDA") has granted Orphan Dr… Full Summary
MBIO Mustang Bio	$2.68 -13.8%	+111.0%	MB-101 Leptomeningeal brain tumors	Orphan Drug	7/7/2025 - Designation Grant Mustang Bio, Inc announced that the U.S. Food and Drug Administration ("FDA") has granted Orphan Dr… Full Summary
IINN Inspira Technologies OXY B.H.N.	$1.37 -4.9%	+95.1%	ART100 Cardio-Pulmonary Bypass Device		7/7/2025 - Provided Update Inspira™ Technologies OXY B.H.N. Ltd. announced that it is engaged in high-level talks with a gover… Full Summary
IMMX Immix Biopharma	$2.71 -1.5%	+12.4%	NXC-201 NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.		7/7/2025 - Provided Update Immix Biopharma, Inc. announced accelerated U.S. NEXICART-2 clinical trial progress in relapsed/ref… Full Summary
ASND Ascendis Pharma A/S	$176.49 +0.4%	+2.4%	TransCon PTH Adult Hypoparathyroidism		7/7/2025 - Oral presentation Ascendis Pharma A/S announced two oral presentations at ENDO 2025, the annual meeting of the Endoc… Full Summary
APGE Apogee Therapeutics	$38.57 +4.2%	-8.2%	APG777 For the Treatment for Atopic Dermatitis and Other Inflammatory Diseases	Phase 2	7/6/2025 - Data Apogee Therapeutics, Inc announced it will report Part A 16-week data from the Phase 2 APEX trial o… Full Summary
NVS Novartis	$123.69 +0.6%	+4.3%	secukinumab In adults with newly diagnosed or relapsing giant cell arteritis (GCA).	Phase 3	7/3/2025 - Top-line results Novartis announced top-line results from the Phase III GCAptAIN study evaluating Cosentyx® (secukinu… Full Summary
BCAB BioAtla	$0.39 -0.3%	-20.3%	BA3182 In Patients with Treatment Refractory Metastatic Adenocarcinoma		7/3/2025 - Data Presentation BioAtla, Inc today presented first-in-human data in a poster titled "Preliminary Results from a Fir… Full Summary
MIRA MIRA Pharmaceuticals	$1.20 +6.2%	-4.0%	MIRA-55 Potential treatment for anxiety and cognitive decline.		7/3/2025 - Preclinical Data MIRA Pharmaceuticals, Inc. announced positive preclinical data demonstrating that Mira-55, the Com… Full Summary
VRTX Vertex Pharmaceuticals	$479.53 +0.1%	+6.2%	exagamglogene autotemcel For severe sickle cell disease		7/3/2025 - Positive Data Vertex Pharmaceuticals announced positive longer-term data for PrCASGEVY® (exagamglogene autotemcel… Full Summary
BLTE Belite Bio	$62.03 -3.3%	+1.4%	Tinlarebant In Stargardt Disease	Phase 3	7/2/2025 - Enrollment Update Belite Bio, Inc announced the completion of enrollment in the PHOENIX trial, a global, 24-month Phas… Full Summary
TIL Instil Bio	$26.76 +4.4%	-28.8%	AXN-2510 In Relapsed/Refractory Solid Tumors	IND	7/2/2025 - FDA Clearance Instil Bio, Inc. announced the clearance of an Investigational New Drug (IND) application for AXN-25… Full Summary
MRK Merck & Co., Inc.	$84.06 +0.4%	+3.4%	sotatercept-csrk In adults with pulmonary arterial hypertension	BLA Priority Review	7/2/2025 - FDA GRANT Merck announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority r… Full Summary
MRK Merck & Co., Inc.	$84.06 +0.4%	+3.4%	sotatercept-csrk In adults with pulmonary arterial hypertension	BLA Priority Review Target date: 2025-10-25	7/2/2025 - PDUFA Date Merck announced that The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date… Full Summary
CTSO Cytosorbents	$1.14 +2.7%	+7.5%	DrugSorb-ATR Antithrombotic Removal System		7/2/2025 - Regulatory Update CytoSorbents Corporation today provided a regulatory update on its marketing applications for DrugS… Full Summary
TNXP Tonix Pharmaceuticals	$42.36 +10.4%	+12.2%	TNX-1700 Recombinant human TFF2-human serum albumin or HSA) for the treatment of colon and gastric cancers.		7/2/2025 - Publication Tonix Pharmaceuticals Holding Corp announced the publication of a paper entitled, "A CXCR4 Partial… Full Summary
OGN Organon & Co.	$10.03 +1.2%	0.0%	OG-6219 In Patients with Endometriosis-Related Pain	Phase 2	7/2/2025 - Endpoint Missed Organon announced that the Phase 2 ELENA proof-of-concept study evaluating the investigational cand… Full Summary
VYNE VYNE Therapeutics	$1.38 -4.2%	+43.7%	VYN202 A Novel BD2-Selective BET Inhibitor	Phase 1b	7/2/2025 - Provided Update VYNE Therapeutics Inc today provided a program update for VYN202 following the clinical hold issue… Full Summary
CERS Cerus	$1.55 +4.0%	+7.6%	INTERCEPT Blood System for platelets, plasma, IFC, and red blood cells		7/2/2025 - Regulatory Update Cerus Corporation announced a European regulatory update on the INTERCEPT RBC program. Full Summary
IINN Inspira Technologies OXY B.H.N.	$1.37 -4.9%	+95.1%	ART100 Cardio-Pulmonary Bypass Device		7/2/2025 - Provided Update Inspira™ Technologies OXY B.H.N. Ltd. announced it has secured a binding $22.5 million purchase or… Full Summary
REGN Regeneron Pharmaceuticals	$559.76 +1.3%	+6.9%	linvoseltamab-gcpt For Treatment of Relapsed or Refractory Multiple Myeloma		7/2/2025 - FDA GRANT Regeneron Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has grant… Full Summary
IMAB I-Mab	$2.05 -11.3%	-22.3%	Givastomig In patients with advanced cancers	Phase 1b	7/2/2025 - Positive Data I-Mab announced the presentation of positive Phase 1b combination data for givastomig, in combinati… Full Summary
IVA Inventiva	$3.31 -1.9%	-9.5%	Lanifibranor Nonalcoholic steatohepatitis (NASH)	Phase 2b	7/2/2025 - Publication Inventiva announces the publication in Journal of Hepatology Reports, a peer-reviewed, scientific jo… Full Summary
FDMT 4D Molecular Therapeutics	$4.35 -1.6%	-2.7%	4D-150 Intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi.	Phase 3	7/2/2025 - Provided Update 4D Molecular Therapeutics announced the acceleration of the 4D-150 4FRONT Phase 3 program in wet ag… Full Summary
ATAI atai Life Sciences	$2.73 +2.6%	+21.3%	BPL-003 In Patients With Treatment Resistant Depression	Phase 2b	7/1/2025 - Top-line results atai Life Sciences and Beckley Psytech Limited jointly announced positive topline results from the… Full Summary
NVCR NovoCure	$18.46 +1.5%	+0.4%	Tumor Treating Fields - PANOVA-3 Locally advanced pancreatic cancer	Phase 3	7/1/2025 - Results Novocure announced that it will present the final secondary endpoint results from the Phase 3 PANOV… Full Summary
BTAI BioXcel Therapeutics	$2.00 +0.3%	+0.5%	BXCL501 (SERENITY) Schizophrenia and bipolar disorders		7/1/2025 - Recommendation BioXcel Therapeutics announced the second positive recommendation by an independent Data Safety Moni… Full Summary
BTAI BioXcel Therapeutics	$2.00 +0.3%	+0.5%	BXCL501 (SERENITY) Schizophrenia and bipolar disorders	Target date: 2025-Q3	7/1/2025 - Top-line data BioXcel Therapeutics, Inc announced that Topline data expected in Q3 2025. Full Summary
ADPT Adaptive Biotechnologies	$12.08 +1.3%	+15.5%	clonoSEQ Treatments for patients with lymphoid malignancies.		7/1/2025 - Provided Update Adaptive Biotechnologies announced the integration of Adaptive's clonoSEQ® test for measurable resi… Full Summary
SLNO Soleno Therapeutics	$80.32 -9.2%	+0.7%	VYKAT XR To Treat Hyperphagia in Prader-Willi Syndrome		7/1/2025 - Abstract Presentation Soleno Therapeutics, announced that two abstracts featuring data on VYKAT™ XR (diazoxide choline) ex… Full Summary
JAZZ Jazz Pharmaceuticals	$112.48 +0.8%	-0.5%	Ziihera For the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)	European Commission Conditional Marketing Authorization	7/1/2025 - Marketing authorization Jazz Pharmaceuticals plc announced that the European Commission (EC) has granted conditional market… Full Summary
FBIO Fortress Biotech	$1.99	-4.3%	MB-101 Leptomeningeal brain tumors	Orphan Drug	7/1/2025 - Designation Grant Mustang Bio Receives FDA Orphan Drug Designation For MB-101 Treatment Of Malignant Glioma Full Summary
MBIO Mustang Bio	$2.68 -13.8%	+111.0%	MB-101 Leptomeningeal brain tumors	Orphan Drug	7/1/2025 - Designation Grant Mustang Bio Receives FDA Orphan Drug Designation For MB-101 Treatment Of Malignant Glioma Full Summary

More FDA Event Resources from MarketBeat

FDA Event Stage Terminology & Abbreviation Guide

• NDA: New Drug Application
• ANDA: Abbreviated New Drug Application
• sNDA: Supplemental New Drug Application
• BLA: Biologics License Application
• sBLA: Supplemental Biologics License Application
• FDA Approved: Approved by the FDA
• EMA: European Medicines Agency
• CE Mark: European Union Certification
• NMPA: China National Medical Products Administration
• MHLW: Japanese Ministry of Health
• FDA Meeting: Consultation with FDA
• Pre-IND: Pre-Investigational New Drug Meeting
• Breakthrough Therapy: Special FDA designation for promising therapies
• Fast Track: Accelerated FDA approval pathway
• Orphan Drug: Designation for rare disease treatments
• RPD: Rare Pediatric Disease Designation
• RMAT: Regenerative Medicine Advanced Therapy
• DSMB Review: Data Safety Monitoring Board Review
• IDMC Review: Independent Data Monitoring Committee
• MAA: MHRA Marketing Authorization Application
• RTF: Refusal to File (Rejected Application)
• 510(k): FDA Clearance for Medical Devices
• Rolling Submission: Staggered regulatory review process

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