Tyvaso's Second Phase 3 Win in IPF; Viridian Crashes 38% on TED Data

United Therapeutics just dropped a second Phase 3 win for Tyvaso in IPF — 130 milliliters of FVC improvement over placebo, 598 patients, 52 weeks. Filing is coming.

And Viridian lost nearly 40 percent of its market cap before breakfast. REVEAL-1 met its endpoints, but the Street is grading elegrobart against Tepezza — and the scorecard wasn't close.

Welcome to The Pharma Closeout for Monday, March 30th, 2026. I'm Alex Mercer.

And I'm Maya Patel. Busy Monday. Let's get into it.

Top story. United Therapeutics may have just laid the foundation for the first new standard of care in IPF in a decade. The TETON-1 trial — 598 patients, multicenter, randomized, double-blind, placebo-controlled, across US and Canadian sites — hit its primary endpoint. Nebulized Tyvaso showed a 130.1-milliliter improvement in absolute forced vital capacity over placebo at 52 weeks. Risk of clinical worsening was reduced. Positive results across all subgroups. United's stock moved higher on the data.

That FVC delta matters more than the headline number suggests. In a disease where pirfenidone and nintedanib slow decline but never reverse it, 130 mLs of separation at a year is clinically meaningful ground. And the concordance with TETON-2 eliminates the fluke question entirely — two independent registrational wins with the same mechanism in the same population.

So the regulatory package is about as clean as it gets. United is already plotting the FDA filing.

Here's what I'm watching. Tyvaso's prostacyclin mechanism is mechanistically orthogonal to the antifibrotic pathway — it's targeting pulmonary vascular remodeling, not fibrosis directly. That means the combination question becomes immediate. If the label supports add-on use with existing antifibrotics, clinicians won't wait for real-world data to start writing those scripts. The unmet need is too deep.

From a commercial standpoint, Tyvaso already generates significant revenue in pulmonary hypertension. An IPF expansion could roughly double the addressable patient population overnight.

Payer dynamics will gate the trajectory. IPF patients are often stacking multiple therapies already, and the add-on cost argument will need health economic evidence to hold up. But the clinical foundation United just built is the strongest any IPF candidate has produced in a generation — and every other company with an IPF program just had their filing calculus disrupted.

Now, the deal that got everyone's attention over the weekend. Eli Lilly put down $115 million upfront to Insilico Medicine in an AI drug discovery collaboration worth more than $2 billion total, per BioPharma Dive and Endpoints News. Let's bring in Marcus Webb for the read on this.

Lilly's been on this acquisition and partnership spree all year — defending the pipeline well beyond its GLP-1 franchise. This fits the pattern but escalates the investment.

The interesting signal is where the deal doesn't specify a single therapeutic area. Lilly isn't buying a program — they're buying a discovery engine. That's a different kind of bet.

Sticking with pipeline news — BridgeBio released long-term data from the ATTRibute-CM open-label extension for acoramidis. Through month 54, they showed a 44.7 percent reduction in all-cause mortality and a 49.3 percent reduction in cardiovascular mortality, both highly significant, per the company's announcement.

At 54 months, that's genuine durability evidence in a disease that's historically been a death sentence once it progresses. Those mortality curves separate further with time, which is exactly the trajectory you want to see in a stabilizer — and it tightens the competitive pressure on tafamidis considerably.

Quick hit — Blackstone closed its sixth life sciences fund at $6.3 billion, oversubscribed at the hard cap. Per the firm's press release, that makes it the largest private fund dedicated to life sciences.

$6.3 billion in fresh capital earmarked for clinical-stage assets at a moment when half the industry is restructuring tells you where long-term conviction lives. It's not in the cost cuts.

Speaking of which — Takeda is eliminating 634 US positions as part of a $1.3 billion restructuring program. And today separately, Viridian Therapeutics had a painful session. REVEAL-1 Phase 3 data for elegrobart in thyroid eye disease met its primary endpoints, but the stock gapped down from $27.39 to a $17 open — roughly 38 percent lost — after the market read a 54 to 63 percent responder rate as materially inferior to Amgen's Tepezza.

Elegrobart's entire differentiation thesis was subcutaneous convenience expanding the treated population beyond what an IV infusion captures. That thesis isn't dead, but the market just dramatically repriced it. The bull case now rests on a narrower claim — that a meaningful cohort of TED patients will choose a less efficacious subQ option over IV Tepezza because of the administration burden. It's plausible. It's just a fraction of the commercial opportunity that was baked into Friday's close.

On the regulatory side, the FDA approved Biogen's high-dose regimen of Spinraza for SMA today. The approval was anchored on the DEVOTE study evaluating both treatment-naïve and previously treated patients, with the new formulation delivering higher drug concentration through loading and maintenance phases. It's already approved in the EU, Switzerland, and Japan — and will be available in the US in the coming weeks.

This is Biogen's lifecycle management answer to the share erosion from Zolgensma and Evrysdi. A higher-dose intrathecal option that leverages Spinraza's decade-plus safety database.

The strategic logic is sound, but the clinical question remains open. SMA treatment selection has become a genuine three-way conversation, and familiarity alone wasn't holding Spinraza's position. Biogen needed a differentiation argument rooted in improved efficacy — and now they have the regulatory stamp. Whether that translates into real-world superiority data is what determines if this recaptures share or simply slows the bleed.

Also today — four companies got dinged by CBER in untitled letters over biologics promotional materials. BMS, Novartis, Gilead, and Iovance, all in one batch.

Four at once from CBER is not routine. That pattern reads like an active enforcement sweep, not isolated actions. Companies with cell therapy or biologics franchises should be pulling their promotional materials for internal review this week — not waiting for their own letter.

Looking ahead. Kailera Therapeutics filed for its IPO to fund a Hengrui-licensed obesity pipeline — a direct market test of whether there's still investor appetite for late-arriving GLP-1 challengers in an increasingly crowded field.

And keep an eye on the White House drug pricing conversation. Reports today indicate pharma gave the administration's latest overtures a frosty reception. If those talks stall, the legislative risk overhang doesn't disappear — it shifts shape heading into Q2, and that changes how the entire sector prices political uncertainty for the rest of the year.

That's your Pharma Closeout for Monday. Tyvaso rewrites the IPF playbook with a second Phase 3 win. Lilly goes all-in on AI discovery with a two-billion-dollar Insilico commitment. BridgeBio posts landmark survival data in ATTR cardiomyopathy. Biogen gets its Spinraza HD approval. And Viridian learns the hard way that meeting endpoints isn't enough when Tepezza sets the curve. If this briefing keeps you sharp, follow us on Spotify and drop a rating — we're back tomorrow.

Enjoy your Monday evening, everyone. See you tomorrow. ## Episode Metadata **Title:** Tyvaso's Second Phase 3 Win in IPF; Viridian Crashes 38% on TED Data; Lilly's $2B AI Deal with Insilico | Mar 30, 2026 **Description:** United Therapeutics' Tyvaso delivers 130.1 mL FVC improvement in TETON-1, its second Phase 3 win in IPF — filing plans now underway. Plus Viridian's 38% stock crash on REVEAL-1 data, Lilly's $115M upfront AI deal with Insilico Medicine, BridgeBio's 54-month ATTR-CM survival data, Biogen's Spinraza HD FDA approval, and CBER untitled letters hitting four major companies. **Tags:** Tyvaso, treprostinil, United Therapeutics, IPF, idiopathic pulmonary fibrosis, TETON-1, Viridian Therapeutics, elegrobart, REVEAL-1, thyroid eye disease, Eli Lilly, Insilico Medicine, AI drug discovery, BridgeBio, acoramidis, ATTR-CM, Biogen, Spinraza, nusinersen, SMA, spinal muscular atrophy, Takeda, restructuring, Blackstone, CBER, untitled letters, BMS, Novartis, Gilead, Iovance, Kailera, obesity, GLP-1, pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals #