Recent FDA Drug Approval Process Events

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Main Company	Current Price	30-Day Price Change	Drug	Status	Event
AGEN Agenus	$7.06 +19.3%	+36.8%	AgenT-797 Multiple myeloma		7/11/2025 - Publication MiNK Therapeutics, Inc. announced the publication of another landmark case in Nature's Oncogene des… Full Summary
MIST Milestone Pharmaceuticals	$1.56 -39.1%	-9.3%	Etripamil For Treatment in Paroxysmal Supraventricular Tachycardia		7/11/2025 - FDA review Milestone® Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has acce… Full Summary
CAPR Capricor Therapeutics	$7.64 -33.0%	-41.9%	deramiocel For the treatment of Duchenne muscular dystrophy (DMD)	BLA	7/11/2025 - Complete Response Letter Capricor Therapeutics announced that it has received a Complete Response Letter (CRL) from the U.S.… Full Summary
MIST Milestone Pharmaceuticals	$1.56 -39.1%	-9.3%	Etripamil For Treatment in Paroxysmal Supraventricular Tachycardia	Target date: December 13, 2025	7/11/2025 - PDUFA Date Milestone® Pharmaceuticals Inc announced that The FDA has assigned a new Prescription Drug User Fee… Full Summary
BCTX Briacell Therap	$2.02 -2.4%	-42.1%	Bria-IMT Metastatic breast cancer (breast cancer that has spread beyond the breast)	Phase 2	7/11/2025 - Survival data BriaCell Therapeutics Corp announced updated Phase 2 survival data for its lead immunotherapy candi… Full Summary
INKT MiNK Therapeutics	$64.17 +730.1%	+745.5%	AgenT-797 Multiple myeloma		7/11/2025 - Publication MiNK Therapeutics, Inc. announced the publication of another landmark case in Nature's Oncogene des… Full Summary
MIRA MIRA Pharmaceuticals	$1.28 +6.7%	+5.8%	SKNY-1 For Obesity		7/11/2025 - Results MIRA Pharmaceuticals, Inc. announced new preclinical results from SKNY-1, an oral drug candidate fo… Full Summary
RGNX REGENXBIO	$8.68 -4.2%	-14.9%	RGX-202 Duchenne Muscular Dystrophy		7/10/2025 - Publication REGENXBIO Inc. announced the publication of preclinical results comparing a microdystrophin gene the… Full Summary
ABOS Acumen Pharmaceuticals	$1.40 +7.7%	+22.8%	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
CGTX Cognition Therapeutics	$0.57 -18.9%	+78.9%	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	$2.02 -2.4%	-42.1%	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
RCUS Arcus Biosciences	$9.35 -2.0%	+2.9%	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
MRK Merck & Co., Inc.	$83.35 -0.8%	+3.8%	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
TNXP Tonix Pharmaceuticals	$40.87 -3.5%	+8.4%	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
AAPG Ascentage Pharma Group International	$38.24 -6.1%	+28.5%	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
PFE Pfizer	$25.65 -0.5%	+4.9%	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
LGND Ligand Pharmaceuticals	$121.70 -2.6%	+5.5%	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
ONC BeOne Medicines	$250.30 -1.2%	-4.6%	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
STOK Stoke Therapeutics	$11.86 -1.5%	+3.1%	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
PDSB PDS Biotechnology	$1.24 -4.6%	-29.1%	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
KALA KALA BIO	$5.85 -15.2%	+33.6%	KPI-012 Clinical diagnosis of PCED	Target date: Q3 2025	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
EOLS Evolus	$9.48 -2.6%	-7.4%	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
BNTC Benitec Biopharma	$12.78 -7.3%	-22.8%	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
RZLT Rezolute	$5.26 +0.2%	+20.9%	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
EXAS Exact Sciences	$51.91 -2.6%	-6.7%	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
KZIA Novogen	$10.80 +4.2%	+13.2%	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
KRYS Krystal Biotech	$148.17 -1.0%	+6.1%	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
BIVI BioVie	$7.14 -5.7%	-35.7%	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
KALA KALA BIO	$5.85 -15.2%	+33.6%	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
LLY Eli Lilly and Company	$793.34 +0.3%	-1.8%	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
CNTB Connect Biopharma	$1.52 +32.2%	+85.6%	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
BHC Bausch Health Cos	$6.43 -2.9%	+20.8%	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
ELAN Elanco Animal Health	$14.90 -1.0%	+4.5%	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
BCTX Briacell Therap	$2.02 -2.4%	-42.1%	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
MTVA MetaVia	$0.72	-4.6%	DA-1726 For The Treatment Of Obesity	Target date: Q4 2025	7/9/2025 - Top-line data MetaVia Inc. announced that Top-Line Data Expected in the Fourth Quarter of 2025 Full Summary
TNXP Tonix Pharmaceuticals	$40.87 -3.5%	+8.4%	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
MTVA MetaVia	$0.72	-4.6%	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
RARE Ultragenyx Pharmaceutical	$29.51 -4.9%	-21.3%	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
ARTL Artelo Biosciences	$23.88 -16.2%	+231.7%	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
RYTM Rhythm Pharmaceuticals	$86.70 -2.6%	+33.7%	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
ASBP Aspire Biopharma	$0.33 -4.7%	-17.2%	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
LIXT Lixte Biotechnology	$3.97 -5.9%	+222.8%	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
ALT Altimmune	$4.14 -5.9%	-36.7%	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
BHC Bausch Health Cos	$6.43 -2.9%	+20.8%	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
LRMR Larimar Therapeutics	$3.38 -2.9%	+9.0%	nomlabofusp For Friedreich's Ataxia		7/8/2025 - Publication Larimar Therapeutics, announced the publication of two peer-reviewed articles highlighting nonclin… Full Summary
MRK Merck & Co., Inc.	$83.35 -0.8%	+3.8%	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
ARWR Arrowhead Pharmaceuticals	$18.31 -2.9%	+9.4%	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
PSTV Plus Therapeutics	$0.36 +2.5%	+9.0%	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
JNJ Johnson & Johnson	$156.87 -0.5%	+1.1%	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
EPRX Eupraxia Pharmaceuticals	$5.44 -3.2%	+38.4%	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
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
MAT Mattel	$19.97 -1.2%	+3.7%	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
ONCY Oncolytics Biotech	$1.18 +5.8%	+106.1%	Pelareorep In Breast Cancer		7/8/2025 - Clinical Data Oncolytics Biotech® Inc announced a strategic update highlighting its compelling clinical data from… Full Summary
ETON Eton Pharmaceuticals	$14.49 -6.9%	-4.0%	ET-600 For the treatment of an endocrinology	NDA Target date: February 25, 2026	7/8/2025 - PDUFA Date Eton Pharmaceuticals, Inc announced that NDA has been assigned a Prescription Drug User Fee Act (… Full Summary
RYTM Rhythm Pharmaceuticals	$86.70 -2.6%	+33.7%	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
BCLI Brainstorm Cell Therapeutics	$1.20 -1.6%	-3.2%	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
SLDB Solid Biosciences	$5.26 -3.0%	+14.1%	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
ETON Eton Pharmaceuticals	$14.49 -6.9%	-4.0%	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
UPB Upstream Bio	$11.48 -3.0%	-1.7%	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
SLDB Solid Biosciences	$5.26 -3.0%	+14.1%	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
MBIO Mustang Bio	$2.65 -1.1%	+107.0%	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
AGEN Agenus	$7.06 +19.3%	+36.8%	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
TNXP Tonix Pharmaceuticals	$40.87 -3.5%	+8.4%	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
JSPR Jasper Therapeutics	$3.51 -1.1%	-37.3%	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
KALV KalVista Pharmaceuticals	$14.52 -6.4%	+7.9%	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
BYSI BeyondSpring	$2.31 +2.7%	-20.6%	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
NTRA Natera	$160.43 -1.8%	-3.8%	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
KALA KALA BIO	$5.85 -15.2%	+33.6%	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
URGN Urogen Pharma	$14.24 -2.7%	+95.1%	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
COGT Cogent Biosciences	$10.98 +1.2%	+51.2%	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
BSX Boston Scientific	$103.16 -0.7%	+3.8%	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
OGN Organon & Co.	$9.94 -0.8%	-1.6%	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
DNLI Denali Therapeutics	$14.52 -5.4%	-4.4%	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	$14.52 -5.4%	-4.4%	tividenofusp For the treatment of Hunter syndrome (MPS II)	BLA Target date: January 05, 2026	7/7/2025 - PDUFA Date Denali Therapeutics Inc. announced that The FDA granted the BLA Priority Review with a Prescription… Full Summary
ARTL Artelo Biosciences	$23.88 -16.2%	+231.7%	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
FBIO Fortress Biotech	$1.89 -5.0%	-10.0%	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.	$1.20 -12.4%	+50.2%	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	$2.65 -2.2%	+9.1%	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	$174.96 -0.9%	+1.9%	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	$38.14 -1.1%	-10.1%	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	$120.93 -2.3%	+2.5%	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
MIRA MIRA Pharmaceuticals	$1.28 +6.7%	+5.8%	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
BCAB BioAtla	$0.38 -0.8%	-17.1%	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
VRTX Vertex Pharmaceuticals	$468.85 -2.2%	+3.6%	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
CTSO Cytosorbents	$1.06 -7.0%	-2.8%	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	$40.87 -3.5%	+8.4%	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
MRK Merck & Co., Inc.	$83.35 -0.8%	+3.8%	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
OGN Organon & Co.	$9.94 -0.8%	-1.6%	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
IINN Inspira Technologies OXY B.H.N.	$1.20 -12.4%	+50.2%	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
CERS Cerus	$1.45 -6.5%	+2.1%	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
VYNE VYNE Therapeutics	$1.42 +2.9%	+54.0%	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
MRK Merck & Co., Inc.	$83.35 -0.8%	+3.8%	sotatercept-csrk In adults with pulmonary arterial hypertension	BLA Priority Review Target date: October 25, 2025	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
IVA Inventiva	$3.35 -0.9%	-5.4%	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
TIL Instil Bio	$24.49 -8.5%	-33.0%	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
BLTE Belite Bio	$63.22 +1.9%	+3.5%	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
FDMT 4D Molecular Therapeutics	$4.28 -1.6%	-1.8%	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
IMAB I-Mab	$2.13 +3.9%	-14.5%	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
REGN Regeneron Pharmaceuticals	$567.74 +1.4%	+9.5%	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
CUE Cue Biopharma	$0.77 -3.8%	+19.9%	CUE-101 HPV+ recurrent/metastatic head and neck cancer		7/1/2025 - Provided Update Cue Biopharma, provided an update on its most advanced clinical stage asset, CUE-101, representative… Full Summary
ATAI atai Life Sciences	$2.62 -4.0%	+17.5%	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

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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