What are the key takeaways from this Biotech Hangout episode?

Key insights include: **Biotech relative performance:** XBI is up approximately 2% year-to-date while the S&P 500 is down 6%, an 8-percentage-point spread in three months. Investors tracking sector rotation should note biotech outperforms on up days by roughly 4x the S&P and declines less on down days, suggesting sustained institutional appetite despite macro uncertainty.; **FDA approval pace shift:** Following Vinay Prasad's departure from CBER, the FDA approved three drugs in one week — Denali's Avolaya for Hunter Syndrome, Rocket's gene therapy for LAD-1, and Imvax's Lofurli — several ahead of PDUFA dates. Companies with orphan or rare disease applications should consider filing now while regulatory flexibility appears elevated under commissioner pressure.; **Oral psoriasis market expansion:** J&J's icicotide approval plus upcoming AAD data from Alumis and Takeda signal the first genuinely efficacious oral psoriasis therapies. Dermatology investors should model market expansion from $20–30 billion toward $40+ billion as millions of patients currently using only topicals gain access to convenient, biologic-comparable oral options.

What did Grace Colon and Josh Schimmer discuss on Biotech Hangout?

Biotech Hangout Episode 177 covers the week of March 27, 2026, examining roughly $10 billion in M&A activity including Gilead's $2.2 billion Ouro acquisition and Merck's $6 billion Tern deal, alongside FDA regulatory shifts post-Vinay Prasad, and clinical data from Beam, Sarepta, and Maze Therapeutics. Key topics include: **Biotech relative performance:** XBI is up approximately 2% year-to-date while the S&P 500 is down 6%, an 8-percentage-point spread in three months. Investors tracking sector rotation should note biotech outperforms on up days by roughly 4x the S&P and declines less on down days, suggesting sustained institutional appetite despite macro uncertainty.; **FDA approval pace shift:** Following Vinay Prasad's departure from CBER, the FDA approved three drugs in one week — Denali's Avolaya for Hunter Syndrome, Rocket's gene therapy for LAD-1, and Imvax's Lofurli — several ahead of PDUFA dates. Companies with orphan or rare disease applications should consider filing now while regulatory flexibility appears elevated under commissioner pressure..

How long is this episode of Biotech Hangout?

This episode is 55 minutes long. SignalCast provides an AI-generated summary so you can get the key insights in about 3 minutes.

Biotech Hangout

Episode 177 - March 27, 2026

March 27, 2026

55 min episode · 2 min read

Grace Colon,Josh Schimmer,Eric Schmidt

Episode

55 min

Read time

2 min

Topics

Investing, Fundraising & VC, Sales & Revenue

AI-Generated Summary

Published Mar 28, 2026

Key Takeaways

✓Biotech relative performance: XBI is up approximately 2% year-to-date while the S&P 500 is down 6%, an 8-percentage-point spread in three months. Investors tracking sector rotation should note biotech outperforms on up days by roughly 4x the S&P and declines less on down days, suggesting sustained institutional appetite despite macro uncertainty.
✓FDA approval pace shift: Following Vinay Prasad's departure from CBER, the FDA approved three drugs in one week — Denali's Avolaya for Hunter Syndrome, Rocket's gene therapy for LAD-1, and Imvax's Lofurli — several ahead of PDUFA dates. Companies with orphan or rare disease applications should consider filing now while regulatory flexibility appears elevated under commissioner pressure.
✓Oral psoriasis market expansion: J&J's icicotide approval plus upcoming AAD data from Alumis and Takeda signal the first genuinely efficacious oral psoriasis therapies. Dermatology investors should model market expansion from $20–30 billion toward $40+ billion as millions of patients currently using only topicals gain access to convenient, biologic-comparable oral options.
✓Tern/Merck acquisition premium warning: Merck acquired Tern Pharmaceuticals — developer of TRN-701, a best-in-class CML drug comparable to Novartis' Scemblix — at only a 6% premium to market price. Biotech boards and investors should scrutinize low-premium acquisitions carefully, as selling at market price eliminates future optionality that existing shareholders may have already priced in.
✓APOL1 kidney disease market sizing risk: Maze Therapeutics' MZ-829 data showed strong UPCR reductions in FSGS patients with two APOL1 alleles but minimal effect in diabetic APOL1 patients, sending the stock down 40%. Investors in Vertex's enaxaplan Phase 3 program should reassess addressable market assumptions — the opportunity may be closer to FSGS-only patients than the 250,000-patient APOL1-broad estimate.

What It Covers

Biotech Hangout Episode 177 covers the week of March 27, 2026, examining roughly $10 billion in M&A activity including Gilead's $2.2 billion Ouro acquisition and Merck's $6 billion Tern deal, alongside FDA regulatory shifts post-Vinay Prasad, and clinical data from Beam, Sarepta, and Maze Therapeutics.

Key Questions Answered

•Biotech relative performance: XBI is up approximately 2% year-to-date while the S&P 500 is down 6%, an 8-percentage-point spread in three months. Investors tracking sector rotation should note biotech outperforms on up days by roughly 4x the S&P and declines less on down days, suggesting sustained institutional appetite despite macro uncertainty.
•FDA approval pace shift: Following Vinay Prasad's departure from CBER, the FDA approved three drugs in one week — Denali's Avolaya for Hunter Syndrome, Rocket's gene therapy for LAD-1, and Imvax's Lofurli — several ahead of PDUFA dates. Companies with orphan or rare disease applications should consider filing now while regulatory flexibility appears elevated under commissioner pressure.
•Oral psoriasis market expansion: J&J's icicotide approval plus upcoming AAD data from Alumis and Takeda signal the first genuinely efficacious oral psoriasis therapies. Dermatology investors should model market expansion from $20–30 billion toward $40+ billion as millions of patients currently using only topicals gain access to convenient, biologic-comparable oral options.
•Tern/Merck acquisition premium warning: Merck acquired Tern Pharmaceuticals — developer of TRN-701, a best-in-class CML drug comparable to Novartis' Scemblix — at only a 6% premium to market price. Biotech boards and investors should scrutinize low-premium acquisitions carefully, as selling at market price eliminates future optionality that existing shareholders may have already priced in.
•APOL1 kidney disease market sizing risk: Maze Therapeutics' MZ-829 data showed strong UPCR reductions in FSGS patients with two APOL1 alleles but minimal effect in diabetic APOL1 patients, sending the stock down 40%. Investors in Vertex's enaxaplan Phase 3 program should reassess addressable market assumptions — the opportunity may be closer to FSGS-only patients than the 250,000-patient APOL1-broad estimate.

Notable Moment

A single patient in Beam Therapeutics' AATD base-editing trial developed an infection post-treatment — typically dangerous for this condition — yet the corrected gene automatically upregulated healthy protein production in response, demonstrating that the therapy restored natural biological stress response rather than simply supplementing a missing protein.

Know someone who'd find this useful?