Yaron Werber

Josh Schimmer × Paul Matteis × Eric Schmidt × Yaron Werber × Allison DeAngelis

Record biotech secondaries are following better-than-expected data, while Angelini’s $4.1B Catalyst deal and UCB’s $2B-upfront Candid acquisition signal renewed dealmaking.Capital favors development stories over commercial biotech, while Agios’s thalassemia launch may leave 2026 consensus threefold too low and FDA turmoil keeps regulatory credibility in focus.

Graig Suvannavejh × Josh Schimmer × Yaron Werber × Sam Fazeli × Oliver Barnes

XBI has rebounded 84% from its Liberation Day low to a fresh 52-week high, with financing and IPO activity pointing to improving risk appetite.Merck’s $6.7B Terns deal shows updated data can erase bidding leverage, while Gilead’s $3.15B Tubulis acquisition backs a differentiated ADC platform; Replimune’s second CRL leaves the FDA’s bar unclear, and obesity pricing competition remains a catalyst.

Mike Yee × Eric Schmidt × Matt Gline × Yaron Werber

Biotech posted its strongest IPO quarter in four years, with $2B of Q1 IPOs and a $2.5B run rate.Roivant’s Moderna settlement could reach $2.25B, with $950M cash in July and up to $1.3B tied to the §1498 appeal.Paying the contingent amount could leave roughly “two and change” years of cash, while GLP-1 orals broaden a $100B market and threaten consumer categories.

Josh Schimmer × Sam Fazeli × Brian Skorney × Yaron Werber × John Crowley

BIO CEO John Crowley says rising US trial costs and regulatory uncertainty make capital flowing to China “perfectly rational.”His FDA prescription—stability, consistency, transparency, and modernization—puts “the next 6 months” in focus.MFN codification could be “devastating” and “unmanageable” before Section 232 action due by the last week of March, while ReGenix’s PLAG1 integration tests AAV safety.

Eric Schmidt × Yaron Werber × Tess Cameron × Sam Fazeli

Biotech M&A is setting records across stages: Alkermes appears to have won Avadel at $2.4B, while J&J paid $3B for Phase 1 Halda, the highest-priced Phase 1 acquisition ever per Tess Cameron.Competition is intensifying as pharma prices in 2026-27 patent cliffs, but 82% of surveyed companies worry about FDA function; early-program delays could last two or three years, while falling drug prices make volume response a key watchpoint.

John Maraganore × Yaron Werber × Ami Fadia × Allison DeAngelis × Drew Armstrong

Rick Pazdur’s CDER appointment may steady FDA leadership, but the vague “plausible mechanism pathway” and its apparent conflict with uniQure keep regulatory execution a key risk.Competitive M&A—Lundbeck’s $2.6B Avadel bid versus Alkermes’ $2.1B offer—and Cogent’s PEAK, with 16.5-month mPFS in second-line GIST, create catalysts, while Intellia’s clinical hold keeps gene-editing safety unresolved.

Graig Suvannavejh × Paul Matteis × Brian Skorney × Yaron Werber × Chris Garabedian × Adam Feuerstein

George Tidmarsh’s CBER departure and UniQure’s rejected filing after FDA alignment expose a widening gap between flexible guidance and unpredictable execution.UniQure reported 80% disease slowing at two years and 75% at three years for high dose, while Sarepta’s failed ESSENCE study and December’s Stoke meeting will test evidence standards and early-filing appetite.

Josh Schimmer × Chris Garabedian × Sam Fazeli × Yaron Werber × Adam Feuerstein

Sarepta’s credibility crisis deepened after reporters disclosed a patient death tied to the rAAVrh74 vector, prompting FDA to request halting all Elevidys shipments and a trading halt.Ultragenyx’s CMC-only CRL and GSK’s failed Blenrep ODAC votes signal tighter scrutiny, while large-biopharma M&A and FDA encouragement leave catalysts alongside governance and regulatory risks.

Grace Colón × Josh Schimmer × Sam Fazeli × Tess Cameron × Eric Schmidt × Yaron Werber

Vinay Prasad’s CBER appointment erased 7% from XBI in a day, but his conciliatory debut shifted the key signal from rhetoric to approvals.MRD as a myeloma filing endpoint is the live test: a reversal could lengthen cell-therapy trials, while CDER bispecifics may retain it.Sarepta’s guidance cut to $2.3–2.6B exposed capacity risk, while Novavax and a possible MFN order leave regulatory and pricing catalysts unresolved.

Eric Schmidt × Brad Loncar × Yaron Werber × Paul Matteis × Nina Kjellson

FDA instability now outweighs tariffs as biotech’s central risk, with Peter Marks’s resignation and layoffs leaving its direction unclear.Ultragenyx, REGENXBIO and Denali will test whether prior FDA agreements and CSF heparan sulfate-based accelerated-approval pathways hold, while Lilly’s lepodisiran cut Lp(a) 93.5% at six months.Pelacarsen’s outcomes readout moves to the first half of next year.