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On February 18, 2026, FDA Commissioner Martin Makary and Vinay Prasad, then-Chief Medical and Scientific Officer and Director of the Center for Biologics Evaluation and Research, published a landmark policy announcement in the New England Journal of Medicine that a single adequate and well-controlled pivotal trial — supplemented by confirmatory evidence — is now the…
Welcome to Part 2 of our 2026 Life Sciences Industry Outlook series. Today, we are focusing on life sciences capital markets activity in 2025 and expectations for 2026. The life sciences equity capital markets in 2025 were defined by a stark “tale of two halves,” beginning with intense volatility that effectively shuttered deal activity. The…
Despite positive momentum in the life sciences capital markets throughout 2024 and expectations for increased favorability in both public and private investment avenues in 2025, the second quarter of 2025 continued a trend of subdued activity for the sector. As of mid-2025, life sciences companies continue to navigate a challenging financing environment, as evidenced by…
It’s a tale as old as time for many small- and mid-cap biotech companies…you file a new Form S-3 shelf registration statement in connection with your Form 10-K filing in late February or March and are eager to do a shelf takedown after some promising investor meetings. The SEC confirms that it is not reviewing…
Melanie Neary, Branden Berns, and Ryan Murr of Gibson Dunn, along with Bud O’Hara of Jefferies, hosted a Life Sciences 2025 Outlook: Capital Markets webcast on Wednesday, March 19, 2025, breaking down capital market trends, deal activity, and industry expectations for life sciences in 2025.
The Securities and Exchange Commission (SEC) has expanded confidential submission privileges for Form S-1 filings, benefiting many life sciences companies. As of March 3, 2025, public companies, including those that became public through reverse mergers and those subject to “baby shelf” limitations, can now submit draft registration statements for confidential review.