A total of seven new molecular entities (NME) have been approved by the U.S. FDA this year, while another seven therapies received dreaded complete response letters from the agency. Out of 9 FDA approvals in February, including two BLAs, three NDAs, three supplemental applications, and one abbreviated NDA, were three NME clearances.
Two years ago, BioWorld reported on 30 therapeutics and vaccines in development for COVID-19, about 3,000 people had died from the disease, and societal lockdowns began. Today, therapeutics and vaccines have ballooned to 1,048, deaths are at 6 million, and the world remains on edge due to highly transmissible variants and breakthrough infections. One thing remains the same: Scientists still do not know where the SARS-CoV-2 virus originated.
The deadly SARS-CoV-2 virus that has cost nearly 6 million lives worldwide and disrupted global economies has brought the biopharma industry $82 billion in sales revenue since the start of the pandemic, with guidance for another $88 billion this year.
Med-tech financings in 2022 appear to be off to a bumpy start. The total amount raised in the first six weeks of the year is at its lowest point in comparison with each of the previous three years. Nevertheless, venture capital rounds, showing no signs of slowing from 2021’s record year, are accounting for the bulk of the activity.
The biopharmaceutical sector is stumbling through the early months of 2022, as investors appear to be pulling back from the enthusiasm that marked much of the last two years. BioWorld’s Biopharmaceutical Index (BBI) is down 4.2% through last week and the Nasdaq Biotechnology Index shows a drop of more than 15%, while the Dow Jones Industrial Average (DJIA) has likewise fallen 5.58%. In contrast, BBI had a 10.5% gain in 2020 and a 5.93% gain in 2021. While each of those years represent the top two years for financings in the history of the industry, 2022 appears to be lagging in that regard as well, with January financings down by 55% over the prior year.
Med-tech deals are showing a 136% increase in value, partially due to rising interest in digital health technologies, and despite decreasing activity focused on the COVID-19 pandemic. While deal values are up, the opposite is true for M&A values. They have fallen by 15% in comparison with the same time frame last year.
The number of biopharma deals with nonprofits or government entities has dropped over last year, partly due to fewer COVID-19-related alliances, but the activity in 2022 is still strong in comparison to pre-pandemic years.
An increasing number and rising value of high-money biopharma deals has placed early 2022 above all recent years, even though there are fewer partnerships overall.
Stocks that make up BioWorld’s Drug Developers Index have tumbled by more than 17% since the start of the year, with only five of the 30 component companies showing a rise in share price. The Nasdaq Biotechnology Index and the Dow Jones Industrial Average also are down by 12.2% and 2.41%, respectively, indicating the biotech industry, which has experienced huge stock surges during the past two years, is now struggling, dropping more sharply than the broader markets.
