In the table below are the Food and Drug Administration (FDA) announcements scheduled for February 2020.
|Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY)||The Prescription Drug User Fee Act (PDUFA) target action date for givosiran.||February 4, 2020|
|Blueprint Medicines Corporation (NASDAQ: BPMC)||FDA grants priority review and sets PDUFA date for avapritinib.||February 14, 2020|
|Merck (NYSE: MRK)||The Prescription Drug User Fee Act (PDUFA) target action date to update the dosing frequency for KEYTRUDA.||February 18, 2020|
|Baudax Bio, Inc. (NASDAQ: BXRX)||PDUFA Date for the FDA’s decision on the New Drug Application (NDA) for intravenous (IV) meloxicam.||February 20, 2020|
|Alder BioPharmaceuticals, Inc. (NASDAQ: ALDR)||the Prescription Drug User Fee Act (PDUFA) target action date for eptinezumab.||February 21, 2020|
|Esperion (NASDAQ: ESPR)||The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the bempedoic acid NDA review.||February 21, 2020|
|Global Blood Therapeutics, Inc. (NASDAQ: GBT)||The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the voxelotor NDA review.||February 26, 2020|
|BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160)||The FDA granted Priority Review for the NDA for zanubrutinib and has set a Prescription Drug User Fee Act (PDUFA)||
February 27, 2020
The Standard FDA Calendar contains more information regarding future announcements and their accompanying press releases.
How FDA Announcements Impact Stock Prices
It is very important to keep up with FDA announcements and drug approvals as they are extremely common news catalysts for price movement in biopharmaceutical stocks.
In most cases, an FDA approval can lead to higher stock prices for the company it can now begin selling the drug and, if the drug is successful, lead to sales growth. However, while FDA approval often leads to a quick surge in share prices, these price jumps are often followed by price drops.
Conversely, FDA non-approvals tend to translate in share price drops. If the FDA rules against a pharma candidate, this could have major adverse effects on the overall company depending on its size. Drug development, such as testing, clinical trials, and other initial steps, require significant upfront capital just to reach the point of an FDA approval review. If millions of dollars have been spent on a drug candidate, only to be disqualified for ineffectiveness, safety reasons, etc., this could lead to massive financial consequences.
As such, it’s important to consider other factors, such as the company’s reputation, the size of the market for the specific drug, and similar ideas before jumping on any of these announcements. FDA announcements can increase volatility to the up or down side, depending on the nature of the bulletin. As such, it is important for investors to be aware of the these potential risks.
Article By: Connor Beam