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.
Frequently Asked Questions
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.
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.
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.