Investment Banking
FDA and IRA Insights (1H'23)
July 20, 2023
Oppenheimer’s latest FDA and IRA insights is now available upon request.
Key Takeaways:
Number of FDA Approvals in 2023 on Track to Exceed Historical Median
- 2022 challenges within the FDA including staffing shortages, remote work, policy changes and mounting backlogs seem to have mostly vanished
- At the current run rate and with ~80 upcoming PDUFA dates lined up, we anticipate 2023 drug approval figures to exceed historical median
- Oncology and CNS / Neuromuscular indications and small molecule drugs are leading the pack for 1H 2023 drug approvals
The Inflation Reduction Act (IRA) Ushers in a Significant Shift in the Healthcare Industry with Broad Implications for Life Sciences Companies
- Heightened risk may press investors to be more circumspect about allocation of capital
- Companies will need to be more thoughtful about indication expansion strategies
- However, despite initial concerns about a potential scaling back of venture funding, the private markets have remained robust
Please reach out to Michael Margolis, R.Ph. ([email protected]) or Zelyn Kwok ([email protected]) directly to request a copy.
Name:
Michael A. Margolis, R.Ph.
Title:Senior Managing Director, Co-Head of Healthcare, Head of Healthcare Life Sciences
DISCLOSURES
This notice is provided for informational purposes only, and is not intended as a recommendation or an offer or solicitation for the purchase or sale of any security or financial instrument. Nothing contained herein shall constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such offer or solicitation would be prohibited.
This notice may contain statistical data cited from third-party sources believed to be reliable, but Oppenheimer & Co. Inc. does not represent that any such third-party statistical information is accurate or complete, and it should not be relied upon as such. All market prices, data and other information are not warranted as to completeness or accuracy and are subject to change without notice.
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