Recent FDA Approvals

REGN: Regeneron Pharmaceuticals Announces Dupixent Approved In The U.S. As The First-Ever Biologic Medicine For Patients With COPD

BGNE, BMY, MRK: FDA Casts Doubt On Use Of Merck, Bristol Myers' PD-1 Cancer Drugs For Certain Type Of Gastric Cancer Patients

MRK: Merck's Experimental Favezelimab/Keytruda Combo Fails In Late-Stage Colorectal Cancer Study

RHHBY: Roche's Antiviral Drug Reduces Transmission Of Influenza Viruses, Late-Stage Study Shows

BIIB, LLY, NVS, PFE: Lilly Gets FDA Approval for Eczema Drug Ebglyss

Recent FDA News

BIIB, FULC, KRYS, SAGE: SAGE, BIIB End Collaboration for Neurology Candidate SAGE-324

LLY: FDA Oks Eli Lilly's Selpercatinib For Medullary Thyroid Cancer

A New Era For Kratom: What The Latest FDA Study Reveals About Kratom Leaf

GEHC: FDA Approves GE Healthcare's Flyrcado

ASML, AVGO, IFNNF, KRRO: 3 Stocks That Could Rise on European Bank Interest Rate Cuts

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