FDA Calendar and Recent FDA News

Binary Events Only

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AMRNAmarin Corporation plc	REDUCE-IT Increased Residual Cardiovascular Risk	—	—	—	—	—	08/28/2026 8:15 AM	Analysis	Amarin Corporation plc today highlighted a new post hoc analysis from the landmark REDUCE-IT® cardiovascular outcomes trial, presented at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany. View Source →	Get Alert
LLYEli Lilly and Co	tirzepatide For obesity or overweight with weight-related comorbidities, excluding type 2 diabetes.	—	—	—	—	—	08/28/2026 7:00 AM	FDA approved	Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) approved Mounjaro (tirzepatide), a dual GIP and GLP-1 hormone receptor agonist, to lower the risk of major adverse cardiovascular (CV) events (MACE), including CV death, non-fatal heart attack, or non-fatal stroke in adults with type 2 diabetes who are at high risk for these events. View Source →	Get Alert
CYTKCytokinetics Inc	Aficamten Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)	—	—	—	—	—	08/28/2026 5:45 AM	Preliminary Results	Cytokinetics, Incorporated announced the primary results from ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) were presented in a Hot Line Session at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany, and simultaneously published in The New England Journal of Medicine.1 View Source →	Get Alert
SKVISkinvisible Inc QNRXQuoin Pharmaceuticals Ltd.	QRX003 Nethertons Syndrome	Phase 2/3	—	—	—	—	08/28/2026 6:00 AM	Interim Results	Quoin Pharmaceuticals Ltd. announced positive interim results from CL-QRX003-004, its ongoing Phase 2/3 study of QRX003 4% lotion in patients with Netherton Syndrome. View Source →	Get Alert
MRNAModerna Inc	SPIKEVAX (COVID-19 Vaccine, mRNA) COVID-19 in individuals 18 years of age and older	supplemental Biologics License Applications (sBLA)	—	—	—	—	08/27/2026 3:56 PM	FDA approved	Moderna, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for the 2026-2027 formulas for Spikevax® (COVID-19 Vaccine, mRNA) and mNEXSPIKE® (COVID-19 Vaccine, mRNA), containing the JN.1-lineage XFG subvariant of SARS-CoV-2 to help prevent COVID-19. View Source →	Get Alert
ACETAdicet Bio Inc	ADI-212 treatment of patients with metastatic castration-resistant prostate cancer	Investigational New Drug (IND)	—	—	—	—	08/27/2026 4:00 PM	FDA Clearance	Adicet Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-212 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). View Source →	Get Alert
PFEPfizer Inc BNTXBioNTech SE	COMIRNATY® XFG; COVID-19 Vaccine, mRNA COVID-19	supplemental New Drug Application (sNDA)	—	—	—	—	08/27/2026 4:30 PM	FDA approved	Pfizer Inc and BioNTech SE announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ 2026-2027 COVID-19 vaccine formula targeting the XFG variant (COMIRNATY® XFG; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.1 View Source →	Get Alert
GILDGilead Sciences Inc	Bixlenvo treatment of HIV in adults who are virologically suppressed.	—	—	—	—	—	08/27/2026 5:54 PM	FDA approved	Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Bixlenvo™ (bictegravir 75 mg/lenacapavir 50 mg), the smallest once-daily single tablet regimen (STR) for the treatment of HIV in adults who are virologically suppressed. View Source →	Get Alert
HCMHutchison China Meditech Ltd	HMPL-523 Hematological cancers and immune disease	China National Medical Products Administration (NMPA) Approval	—	—	—	—	08/27/2026 8:00 PM	Conditional approval	HUTCHMED (China) Limited announces that the New Drug Application (NDA) for fanregratinib (HMPL-453), a novel, selective, oral inhibitor targeting FGFR 1/2/3, has been granted conditional approval by the China National Medical Products Administration ("NMPA") for the treatment of adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma ("ICC") with fibroblast growth factor receptor ("FGFR") 2 fusion or rearrangement who have previously received systemic therapy. Fanregratinib will be marketed in China under the brand name ATLED®. View Source →	Get Alert
FBLGFibroBiologics Inc	CYWC628 Treatment of Refractory Diabetic Foot Ulcers	—	—	—	—	—	08/27/2026 8:30 AM	Provided Update	FibroBiologics, Inc announced the release of the third batch of its CYWC628 drug product and its shipment to Australia in support of the ongoing Phase 1/2 clinical trial in patients with diabetic foot ulcers (DFUs). View Source →	Get Alert
	ECUR-506 For the Treatment of Neonatal Onset Ornithine Transcarbamylase (OTC) Deficiency	—	—	—	—	—	08/27/2026 8:00 AM	Data	iECURE, Inc View Source →	Get Alert
CTMXCytomX Therapeutics Inc	Varseta-M late-line metastatic CRC.	Fast Track Designation	—	—	—	—	08/27/2026 8:00 AM	Designation Grant	CytomX Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Varseta-M for the treatment of patients with relapsed/refractory metastatic colorectal cancer. View Source →	Get Alert
MBXMBX Biosciences Inc	canvuparatide for Hypoparathyroidism	—	—	—	—	—	08/27/2026 8:00 AM	Dose Update	MBX Biosciences, Inc announced that the first patient has been dosed in its pivotal Phase 3 oPTimize clinical trial evaluating once-weekly canvuparatide for the treatment of chronic hypoparathyroidism (HP). View Source →	Get Alert
VRCAVerrica Pharmaceuticals Inc	YCANTH™ (cantharidin) For molluscum contagiosum, which is primarily a pediatric disease.	Phase 3	—	—	—	—	08/27/2026 8:00 AM	Enrollment Update	Verrica Pharmaceuticals announced completion of enrollment of the first pivotal clinical trial (COVE-2) of its global Phase 3 program evaluating YCANTH® (VP-102) for the treatment of common warts. View Source →	Get Alert
BLRXBioLine Rx Ltd CRVSCorvus Pharmaceuticals Inc	Soquelitinib For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma	Phase 1/1b	—	—	—	—	08/27/2026 7:30 AM	Peer-reviewed publication	Corvus Pharmaceuticals, Inc announced the publication of peer-reviewed final data from its Phase 1/1b trial of soquelitinib in patients with T cell lymphoma. View Source →	Get Alert
ABBVAbbVie Inc	SKYRIZI (risankizumab-rzaa) PsA Active Psoriatic Arthritis	European Medicines Agency (EMA)	—	—	—	—	08/27/2026 2:00 AM	Application Submitted	AbbVie announced that it has submitted an application to the European Medicines Agency (EMA) seeking approval for SKYRIZI® (risankizumab) for subcutaneous (SC) induction for the treatment of adult patients with moderately to severely active Crohn's disease (CD). View Source →	Get Alert
AMGNAmgen Inc	TEZSPIRE In chronic obstructive pulmonary disease	Phase 3	—	—	—	—	08/27/2026 2:00 AM	Top-line results	Amgen announced positive top-line results from the Phase 3 CROSSING trial of TEZSPIRE® (tezepelumab-ekko) in patients living with eosinophilic esophagitis (EoE). 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.

Gainers

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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.