FDA Calendar and Recent FDA News

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CAMPCAMP4 Therapeutics Corporation	CMP-002 treat a broad range of genetic diseases	—	—	—	2026-Q4	2026-Q4	10/27/2026 8:00 AM	Clinical Trial	CAMP4 Therapeutics announced that the Company on track to initiate ASCEND clinical trial in 4Q 2026 View Source →	Get Alert
SMMTSummit Therapeutics Inc	Ivonescimab For Lung cancer	—	—	—	2026-Q4	2026-Q4	10/21/2026 6:05 AM	Clinical Trial	Summit Therapeutics Inc. announced Clinical Trial Site Activations in the United States Expected to Begin Q4 2026 View Source →	Get Alert
AQSTAquestive Therapeutics Inc	Anaphylm For epinephrine prodrug candidate product	—	—	—	2026-Q4	2026-Q4	10/15/2026 7:00 AM	Provided Update	Aquestive Therapeutics, Inc. announced that the Ex-U.S. strategy remains on track with Canadian NDS planned for Q4 2026 View Source →	Get Alert
TRDAEntrada Therapeutics, Inc.	ELEVATE-44-201 For Duchenne Muscular Dystrophy	—	—	—	2026-LATE	2026-LATE	10/14/2026 7:00 AM	Data	Entrada Therapeutics, Inc. announced that the Company to receive ELEVATE-44-201 data from Cohort 1 open-label period by year-end 2026 View Source →	Get Alert
PRLDPrelude Therapeutics Inc	PRT13722 Oral KAT6A Selective Degrader	—	—	—	2026-Q4	2026-Q4	10/13/2026 7:00 AM	Enrollment Update	Prelude Therapeutics Incorporated announced that its on track to initiate enrollment in the fourth quarter of 2026 View Source →	Get Alert
LIFEaTyr Pharma Inc	Efzofitimod Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)	—	—	—	2026-Q4	2026-Q4	09/24/2026 6:00 AM	Provided Update	aTyr Pharma, Inc. announced that the Company expects to initiate study-related activities in the fourth quarter of 2026. View Source →	Get Alert
ORKAOruka Therapeutics Inc	ORKA-001 Inhibitor IL-23p19	—	—	—	2026-Q4	2026-Q4	09/23/2026 7:00 AM	Data	Oruka Therapeutics, announced that the 16-week EVERLAST-B data expected in 4Q 2026 View Source →	Get Alert
OCULOcular Therapeutix Inc	AXPAXLI In Diabetic Retinopathy	—	—	—	2026-Q4	2026-Q4	09/15/2026 7:00 AM	NDA submission	Ocular Therapeutix, Inc announced that it remains on track to submit the NDA in the fourth quarter of 2026. View Source →	Get Alert
TNYATenaya Therapeutics, Inc.	TN-401 For the treatment of arrhythmogenic right ventricular cardiomyopathy (ARVC) caused by Plakophilin-2 (PKP2) gene mutations.	—	—	—	2026-Q4	2026-Q4	09/14/2026 8:30 AM	Additional data	Tenaya Therapeutics, Inc. announced Additional Data and Updates on Regulatory Discussions Anticipated in 4Q 2026 View Source →	Get Alert
LPCNLipocine Inc	LPCN 1154 Postpartum depression (PPD)	—	—	—	2026-Q4	2026-Q4	09/14/2026 8:00 AM	Dose Update	Lipocine Inc announced that the first participant dosing expected in early Q4 2026 View Source →	Get Alert
CAMPCAMP4 Therapeutics Corporation	CMP-002 treat a broad range of genetic diseases	—	—	—	2026-Q4	2026-Q4	09/10/2026 7:33 AM	Clinical Trial	CAMP4 Therapeutics Corporation announced that the Company anticipates initiation of the clinical trial in 4Q 2026 View Source →	Get Alert
PRLDPrelude Therapeutics Inc	PRT13722 Oral KAT6A Selective Degrader	—	—	—	2026-Q4	2026-Q4	09/10/2026 7:01 AM	Enrollment Update	Prelude Therapeutics Incorporated announced that the Company expects to begin enrolling patients in the fourth quarter of 2026. View Source →	Get Alert
COCPCocrystal Pharma Inc	CDI-988 For Pandemic Norovirus and Coronavirus	—	—	—	2026-LATE	2026-LATE	09/09/2026 7:00 AM	Results	Cocrystal Pharma, Inc announced that the Preliminary efficacy results expected in late 2026 or early 2027 View Source →	Get Alert
ACETAdicet Bio Inc	ADI-212 treatment of patients with metastatic castration-resistant prostate cancer	Phase 1	—	—	2026-Q4	2026-Q4	08/27/2026 4:00 PM	Initiation	Adicet Bio, Inc. announced that The Company plans to initiate Phase 1 enrollment in patients with mCRPC in the fourth quarter of 2026. View Source →	Get Alert
	denifanstat treatment of moderate to severe acne.	Phase 3	—	—	2026-Q4	2026-Q4	08/25/2026 7:00 AM	Enrollment Update	Sagimet Biosciences Inc. announced that its AURORA Phase 3 clinical trial of FASN inhibitor denifanstat in moderate to severe acne is on track to initiate enrollment in Q4 2026. View Source →	Get Alert
EYPTEyePoint Pharmaceuticals Inc	DURAVYU In patients with non-proliferative diabetic retinopathy (NPDR).	—	—	—	2026-Q4	2026-Q4	08/17/2026 7:00 AM	Top-line data	EyePoint, Inc. announced that the Topline data from LUCIA, the second pivotal Phase 3 clinical trial in wet AMD, expected in Q4 2026 View Source →	Get Alert
ARTLArtelo Biosciences Inc	ART27.13 (CAReS) Cancer anorexia and Weight loss	—	—	—	2026-Q4	2026-Q4	08/10/2026 8:47 AM	Study Results	Artelo Biosciences announced that Initial DREAM Study Results Anticipated in Q4 2026 View Source →	Get Alert
	NPM-139 Subdermal GLP-1 implant in development for chronic weight management	—	—	—	2026-11	2026-11	08/06/2026 8:00 AM	Top-line data	Vivani Medical, Inc. announced that the Top-line data from the 20-participant trial is expected in November of 2026. View Source →	Get Alert
NAMSNewAmsterdam Pharma Company N.V	Obicetrapib CETP inhibitor	—	—	—	2026-H2	2026-H2	07/24/2026 8:00 AM	Provided Update	NewAmsterdam Pharma Company N.V announced that the European Commission decision expected in 2H26 View Source →	Get Alert
PFEPfizer Inc	TALZENNA Oral inhibitor of poly ADP-ribose polymerase	supplemental New Drug Application (sNDA) Priority Review	—	—	2026-Q4	2026-Q4	07/22/2026 4:32 PM	PDUFA Date	Pfizer Inc announced that the FDA has set a Prescription Drug User Fee Act (PDUFA) action date in the last quarter of 2026. View Source →	Get Alert
ERNAErnexa Therapeutics	IL-15 In ovarian tumors	Phase 2b	—	—	2026-Q4	2026-Q4	07/07/2026 7:00 AM	Provided Update	Teva Pharmaceutical Industries Ltd. announced plans to advance its TEV-’408, an investigational anti-interleukin-15 monoclonal antibody, into a Phase 2b study in vitiligo in the fourth quarter of 2026. View Source →	Get Alert
OCUPOcuphire Pharma Inc	OPGx-LCA5 For LCA5	Phase 3	—	—	2026-Q4	2026-Q4	07/06/2026 7:00 AM	Dosing Update	Opus Genetics, Inc announced that the Company expects to initiate Phase 3 dosing in 4Q 2026 View Source →	Get Alert
ADCTADC Therapeutics SA	ZYNLONTA In patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).	—	—	—	2026-Q4	2026-Q4	06/30/2026 7:15 AM	Data	ADC Therapeutics SA announced that the Full data expected in fourth quarter of 2026 View Source →	Get Alert
BBIOBridgeBio Pharma Inc	BBO-11818 Potent panKRAS Inhibitor	—	—	—	2026-H2	2026-H2	04/20/2026 4:05 PM	Clinical Data	BridgeBio Oncology Therapeutics, Inc. announced that the Updated Phase 1 clinical data are expected in the second half of 2026 View Source →	Get Alert
ENTAEnanta Pharmaceuticals Inc	EDP-978 Treatment of Urticaria	—	—	—	2026-Q4	2026-Q4	04/13/2026 7:00 AM	Top-line data	Enanta Pharmaceuticals, Inc announced that the Topline Data Expected in Q4 2026 View Source →	Get Alert
ACRSAclaris Therapeutics Inc	ATI-045 In Atopic Dermatitis (AD)	—	—	—	2026-Q4	2026-Q4	03/18/2026 6:55 AM	Top-line results	Aclaris Therapeutics, Inc. announced that the Top line results are expected in the fourth quarter of 2026. View Source →	Get Alert
MIRMMirum Pharmaceuticals Inc	Maralixibat Alagille Syndrome	—	—	—	2026-Q4	2026-Q4	03/16/2026 8:00 AM	Top-line data	Mirum Pharmaceuticals, Inc. announced that the Topline data expected in Q4 2026 View Source →	Get Alert
VRCAVerrica Pharmaceuticals Inc	YCANTH™ (cantharidin) For molluscum contagiosum, which is primarily a pediatric disease.	—	—	—	2026-Q4	2026-Q4	10/20/2025 4:05 PM	Provided Update	Verrica is initiating activities to support this regulatory submission, which could be filed as early as Q4 2026 View Source →	Get Alert
ACETAdicet Bio Inc	ADI-001 B cell non-Hodgkin's lymphoma (NHL)	Phase 1	—	—	2026-H2	2026-H2	10/16/2025 7:00 AM	Preclinical Data	Adicet Bio, Inc. announced that Preliminary clinical data from the Phase 1 trial expected in 2H/2026 View Source →	Get Alert
RGNXRegenxbio Inc	surabgene lomparvovec for Wet AMD	—	—	—	2026-Q4	2026-Q4	10/06/2025 7:05 AM	Top-line data	REGENXBIO Inc. announced that Topline pivotal data expected in Q4 2026 View Source →	Get Alert
	TYRA-300 For the Treatment of Achondroplasia	—	—	—	2026-H2	2026-H2	08/21/2025 8:40 AM	Initial Results	Tyra Biosciences, Inc. announced that Initial results from safety sentinel cohort expected in 2H 2026- View Source →	Get Alert
RNAAvidity Biosciences Inc	Delpacibart Braxlosiran In People Living with Facioscapulohumeral Muscular Dystrophy	Biologics License Applications (BLA)	—	—	2026-H2	2026-H2	06/09/2025 7:12 AM	BLA Filing	Avidity Biosciences, Inc. announced that Planning accelerated approval BLA submission in H2 2026 View Source →	Get Alert
KNSAKiniksa Pharmaceuticals Ltd	KPL-387 In recurrent pericarditis	Phase 2	—	—	2026-H2	2026-H2	06/05/2025 7:14 AM	Data	Kiniksa Pharmaceuticals International announced that Phase 2 data expected in 2H 2026 View Source →	Get Alert
ANNXAnnexon Inc	ANX007 Geographic Atrophy	Phase 3	—	—	2026-H2	2026-H2	12/05/2024 8:07 AM	Provided Update	Annexon, Inc. Pivotal Phase 3 ARCHER II in GA Actively Enrolling with Data Expected Second Half 2026 View Source →	Get Alert
ANNXAnnexon Inc	ANX007 Geographic Atrophy	Phase 3	—	—	2026-H2	2026-H2	10/15/2024 8:41 AM	Pivotal Study	Annexon, Inc. announced that Phase 3 Data from Ongoing ARCHER II Pivotal Program Expected Second Half 2026 View Source →	Get Alert
ANNXAnnexon Inc	ANX007 Geographic Atrophy	—	—	—	2026-H2	2026-H2	09/09/2024 8:15 AM	Data	Annexon, Inc. announced that ARCHER II Phase 3 Pivotal Program in GA Underway with Data Expected Second Half 2026 View Source →	Get Alert
	DNTH103 In Generalized Myasthenia Gravis (gMG)	Phase 2	—	—	2026-H2	2026-H2	06/12/2024 7:14 AM	Top-line results	Dianthus Therapeutics, Inc announced Top-line results from Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy anticipated in 2H 2026 View Source →	Get Alert
	obefazimod to severely active Crohn's disease	Phase 2	—	—	2026-H2	2026-H2	02/02/2024 3:12 AM	Data Presentation	Abivax SA announced that 12-week induction data read-out expected in 2H 2026 View Source →	Get Alert

Recent FDA Approvals

What is an FDA Calendar?

Biotech investing is risk-fraught, as stocks are at the mercy of several catalysts – most of which are make-or-break events, aka binary events. A prudent investment strategy is to make informed decisions, being in the know of when to expect these events, how these events will pan out and the potential stock reaction in the run-up to the event and post the event.

Benzinga’s FDA calendar is a meaningfully designed, user friendly, dynamically updated and simplistic investment tool that is a ‘must-have’ for those looking to make money from the volatility that is typic of trading in biotech stocks.

The calendar lists down all key catalysts that can materially impact stocks, including:

PDUFA dates, or in other words FDA decision dates
Filing schedules for regulatory applications such as new drug application, or NDA, supplemental NDA, Biologic License Application, or BLA, supplemental BLA, Premarket Approval Application, or Premarket Notification 510(k), etc
FDA decisions (approvals/complete response letter/delay)
According to special statuses for treatment options, including orphan drug designation, rare disease designation, accelerated approval, priority review etc.
FDA’s Advisory Committee, or Adcom, meetings
Review meetings with FDA (pre-investigational new drug application meetings, end-of-phase meetings, Type A, Type B and Type C meetings)
Decisions by overseas regulatory agencies
Clinical data readouts
Presentation of data at various scientific conferences.

The calendar allows data screening, based on company names or tickers, events, date-wise or based on a date range. They are designed to serve as a ‘one-stop shop’ for data needs of investors, both existing and potential, to capitalize on the opportunities these catalysts throw up or cut the losses from an adverse development.

What is a Catalyst?

A catalyst is any event/development that has the potential to swing the stock, usually in an appreciable way, in either direction, depending on how it materializes.

Biotech Stock Movers

Regulatory actions and clinical readouts are stock-moving catalysts. The magnitude of the impact is usually disproportionate. Most clinical-stage biotechs, or companies which are yet to commercialize a product, do not generate revenues. The exceptions are those which may have out-licensed therapies-in-development to another company and as a result generate revenues in the form of licensing revenues. So, it will be years of investment (time money and efforts) into drug development, which usually takes about 10-15 years, on the promise of generating future returns.

A promising outcome in a particular stage of drug development is perceived by the market as an incremental step in bringing the company closer to that distant goal of marketing a potential blockbuster drug that could fetch it billions in revenues. This explains the huge positive move in a stock when a company reports a positive clinical readout.

Similarly, an unfavorable or a partially successful outcome could suggest all the investment the company may have made in the investigational therapy could go down the drain. Quite appropriately, investors punish the stock by selling it in droves.

PDUFA and Adcom events are binary events that have two outcomes, triggering moves in stock depending on which outcome materializes.

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Frequently Asked Questions

What is an FDA PDUFA date?

Prescription Drug User Fee Act date, in short, PDUFA date, refers to the date/period by which the FDA is mandated to give its verdict on the regulatory application filed by the sponsor company. The verdict can be an ‘approved’ decision, or a ‘complete response letter’ or a delay due to reasons specific to the company or extraneous to the company.

PDUFA was passed in the U.S. in 1992, which allows the FDA to collect fees from the sponsor company to fund the review process.

A CRL is issued by the FDA when it deems that the regulatory application is not complete in its current form. The deficiencies usually that lead to rejection could be the need for additional clinical studies to establish the efficacy and/or safety of the treatment option, problems with chemistry, manufacturing and controls, etc.

A delay in the review period may stem from the FDA needs additional time to review any additional data/information that may have been tabled subsequent to the submission of the regulatory application or the FDA’s inability to complete site inspections where the drug ingredients are being made etc.

The FDA may mention a specific date or a period (say Q1, Q2, Q3, Q4, first-half, second-half, the name of the month) as the timeline by which a decision will be given. If the FDA does not mention any timeline, the company may roughly calculate a timeline based on the data of filing the regulatory application. If the company doesn’t provide a timeline either, it is left to the investors to do the calculations.

How long does an FDA approval take?

A regulatory application (NDA, sNDA, BLA, sBLA, etc.) is usually accepted for standard review or priority review. A standard review will mean the FDA has to hand out its verdict within 10 months of filing the application. The review window for a priority review gets shortened to six months.

Once a company files for a regulatory application, the FDA takes up to 60 days to respond with an ‘accepted for review’ or ‘refuse-to-file’ decision.

How do you find FDA approvals?

A Catalysts Calendar is one way of tracking all the decisions in a single place. Usually, the FDA puts out a release and/or communicates to the company, which in turn will issue a press release.

What is an FDA Calendar?

The calendar lists down all key catalysts that can materially impact stocks, including:

PDUFA dates, or in other words FDA decision dates
Filing schedules for regulatory applications such as new drug application, or NDA, supplemental NDA, Biologic License Application, or BLA, supplemental BLA, Premarket Approval Application, or Premarket Notification 510(k), etc
FDA decisions (approvals/complete response letter/delay)
According to special statuses for treatment options, including orphan drug designation, rare disease designation, accelerated approval, priority review etc.
FDA’s Advisory Committee, or Adcom, meetings
Review meetings with FDA (pre-investigational new drug application meetings, end-of-phase meetings, Type A, Type B and Type C meetings)
Decisions by overseas regulatory agencies
Clinical data readouts
Presentation of data at various scientific conferences.

What is a Catalyst?

A catalyst is any event/development that has the potential to swing the stock, usually in an appreciable way, in either direction, depending on how it materializes.