FDA Calendar and Recent FDA News

Binary Events Only

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ARQTArcutis Biotherapeutics Inc	roflumilast To treat inflammatory dermatoses	Health Canada Approval	—	—	—	—	08/20/2026 1:47 PM	Approved	Arcutis Canada, Inc announced that Health Canada has approved PrZORYVE® (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis (AD) in pediatric patients 2 to 5 years of age. View Source →	Get Alert
CELZCreative Medical Technology Holdings Inc	CELZ-201 Novel Cell Therapy for the Treatment of Type 1 Diabetes	—	—	—	—	—	08/20/2026 9:15 AM	Enrollment Update	Creative Medical Technology Holdings, Inc announced that all patients have now been enrolled and treated across the Company’s entire FDA-cleared ADAPT clinical trial evaluating CELZ-201 / Olastrocel, including the original study cohorts and the FDA-cleared opioid expansion cohort. View Source →	Get Alert
	ECUR-506 For the Treatment of Neonatal Onset Ornithine Transcarbamylase (OTC) Deficiency	—	—	—	—	—	08/20/2026 8:00 AM	Data	iECURE, Inc. announced that data from the ongoing OTC-HOPE clinical trial evaluating ECUR-506 for neonatal-onset ornithine transcarbamylase (OTC) deficiency will be featured in an oral presentation at the Annual Symposium of the Society for the Study of Inborn Errors of Metabolism (SSIEM), taking place August 25-28, 2026, in Helsinki, Finland. View Source →	Get Alert
PTIXProtagenic Therapeutics Inc	PT00114 Depression, PTSD, Anxiety and Addiction	Type B Meeting	—	—	—	—	08/20/2026 8:30 AM	Provided Update	Protagenic Therapeutics, Inc. announced that it has received written responses from the U.S. Food and Drug Administration (FDA) to its Type B pre-Investigational New Drug (pre-IND) meeting request for PT00114, the Company's leading investigational neuropeptide product candidate, for the treatment of generalized anxiety disorder (GAD). View Source →	Get Alert
ALRNAileron Therapeutics Inc RNTXRein Therapeutics	LTI-03 In Idiopathic Pulmonary Fibrosis	Fast Track Designation	—	—	—	—	08/20/2026 8:00 AM	Designation Grant	Rein Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to LTI-03 for the treatment of idiopathic pulmonary fibrosis. View Source →	Get Alert
TTRXTurn Therapeutics Inc	GX-03 Atopic Dermatitis Treatment	—	—	—	—	—	08/20/2026 8:00 AM	Publication	Turn Therapeutics Inc. announced the publication of new peer-reviewed research providing in-vivo evidence that its lead investigational therapy, GX-03, selectively reduces several important inflammatory signals associated with inflammatory skin disease. View Source →	Get Alert
ALZNAlzamend Neuro, Inc. ALECAlector Inc	AL001 A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients	—	—	—	—	—	08/20/2026 8:00 AM	Abstract	Alzamend Neuro, Inc. announced that an abstract reporting resting-state functional magnetic resonance imaging ("fMRI") findings for AL001, Alzamend's novel organic lithium salt, has been accepted for poster presentation at Neuroscience 2026, the annual meeting of the Society for Neuroscience ("SfN"), to be held November 14–18, 2026 in Washington, DC. View Source →	Get Alert
NUVBNuvation Bio Inc.	Safusidenib Treatment of Grade 2 IDH1-Mutant Glioma in Neuro-Oncology	Fast Track Designation	—	—	—	—	08/20/2026 8:00 AM	Designation Grant	Nuvation Bio Inc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for safusidenib, the company's investigational, oral, brain-penetrant selective inhibitor of mutant IDH1. View Source →	Get Alert
	ProSense Cryoablation System T1 invasive breast cancer and/or patients not suitable for surgical alternatives for the treatment of breast cancer	—	—	—	—	—	08/20/2026 8:10 AM	Provided Update	IceCure Medical Ltd. announced that the Institutional Review Board (JHM-IRB) of West Cancer Center & Research Institute in Germantown, Tennessee, has granted approval for the Company's post-marketing study ("ChoICE Study") for ProSense® cryoablation in the local treatment of low-risk breast cancer. View Source →	Get Alert
	Swoop® System Sequences Portable MR Imaging® System	—	—	—	—	—	08/20/2026 8:15 AM	FDA Clearance	Hyperfine, Inc announced that it has received FDA clearance for its latest Optive AI™ software update. This advancement is Hyperfine’s second FDA-cleared software package since the launch of its next-generation Swoop system in mid-2025. View Source →	Get Alert
IONSIonis Pharmaceuticals Inc	Olezarsen (Formerly IONIS-APOCIII-L) Severe hypertriglyceridemia	—	—	—	—	—	08/20/2026 7:00 AM	Data Presentation	Ionis Pharmaceuticals, Inc announced that new data in the management of severe hypertriglyceridemia (sHTG) will be presented at the European Society of Cardiology (ESC) Congress 2026, taking place August 28 – 31 in Munich. View Source →	Get Alert
RADXRadiopharm Theranostics	RAD202 to treat HER2-positive advanced and metastatic cancers	—	—	—	—	—	08/20/2026 7:00 AM	Recommendation	Radiopharm Theranostics announced that it has received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance its clinical-stage radiotherapeutic asset, 177Lu-RAD202 (RAD202), to the next dose level of 180mCi in the Phase 1 ‘HEAT’ clinical trial in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors1. View Source →	Get Alert
HROWHarrow Health Inc	IHEEZO Chloroprocaine hydrochloride ophthalmic gel	—	—	—	—	—	08/20/2026 7:00 AM	Positive Results	Harrow announced positive results from a prospective, randomized, contralateral-eye study evaluating IHEEZO® (chloroprocaine hydrochloride ophthalmic gel) 3%, an ophthalmic gel indicated for ocular surface anesthesia, in patients undergoing same-day bilateral intravitreal injections. View Source →	Get Alert
ACIUAC Immune SA	ACI-19764 an orally administered small molecule inhibitor of the NLRP3 inflammasome.	Phase 1	—	—	—	—	08/20/2026 7:00 AM	Positive Results	AC Immune SA announced positive interim results from a Phase 1 first-in-human clinical study evaluating ACI-19764, its wholly-owned, orally administered small molecule inhibitor of the NLRP3 inflammasome. View Source →	Get Alert
BNTXBioNTech SE	BNT316/ONC-392 (gotistobart) Combination therapy in various cancer indications.	—	—	—	—	—	08/20/2026 5:30 AM	Data Presentation	BioNTech SE will present new clinical data from its diversified development program in lung cancer treatment at the IASLC 2026 World Conference on Lung Cancer ("WCLC") in Seoul, Republic of Korea, from September 12-15, 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.