After rising 80%, Roivant still has up to 35% upside, according to analysts
Shares of Roivant Sciences $ROIV have risen more than 80% this year, driven by two events within twelve days. First, the U.S. regulator approved its first-ever drug, which went on sale the same day. Then came clinical data for a second candidate, where the primary endpoint beat market expectations roughly twofold. On that second news, the stock added nearly 19% in a single day and closed at a record high. Analysts nevertheless raised their price targets even higher, the highest aiming at $55, or about a third above the current price.
Key points
Within twelve days, Roivant received FDA approval for its first-ever drug and clinical data that beat analyst expectations roughly twofold. The stock added nearly 19% in a single day in response.
The new drug costs $35,000 per month. How many patients would need to take it for a $2 billion revenue estimate to materialize depends on a number that varies tenfold across expert estimates.
The deal with Moderna is worth $2.25 billion. Roivant shareholders will receive roughly a fifth of it, with the rest lost in the ownership structure of subsidiary companies.
The company repurchased $208.7 million of its own shares in the quarter. Yet a retail shareholder today owns a smaller portion of Roivant than a year ago.
Of the $29.5 billion market value, the market can substantiate roughly $9 billion. The remaining $20 billion is attributed to assets, none of which has yet generated profit.
We are still talking about a loss-making company that reported a consolidated loss of $290.6 million in the last quarter. And about a firm that does not develop drugs from scratch itself: it licenses molecules that stalled elsewhere and places each into a separate subsidiary with its own management, its own financing, and often its own external shareholders. It calls those subsidiaries Vants. An investor buying one share is not buying one drug, but a set of stakes of various sizes in several companies, and that structure determines how much of each clinical success ends up with the Roivant shareholder.
Twelve days in which regulatory risk vanished and clinical risk dropped
On the first day of 2026, the stock traded around $22 and Roivant had no drug of its own on the market. The turning point came on August 27, when the FDA approved Lisraya for adult patients with dermatomyositis. It is the first targeted treatment for this disease in tablet form, and prescribing began immediately. It was supported by the Phase 3 VALOR study with 241 patients, in which the 30 mg dose group achieved a mean improvement score of 46.5 after 52 weeks versus 31.2 for placebo and also reduced corticosteroid doses. Approval came earlier than the company itself had expected. Back in August, Priovant planned a commercial launch only for the end of September; ultimately, the drug was available on the day of the regulator's decision.
Twelve days later, the second piece of news arrived and surprised the market far more. The Phase 2 PHocus study tested mosliciguat in pulmonary hypertension associated with interstitial lung disease and reduced pulmonary vascular resistance by 56.3% versus placebo. The company calls it the largest reduction ever shown in a randomized controlled trial of pulmonary hypertension. The six-minute walk improved by 35.2 meters at week 16, and NT-proBNP levels fell by 53.2%.
What mattered was the distance from expectations. TD Cowen had expected around a 32% reduction in resistance and a 20 to 32-meter improvement in walking. The actual primary endpoint nearly doubled expectations, and the improvement arrived in three independent measures simultaneously. The Phase 3 PHrontier study is already enrolling patients.
The stock closed 18.75% higher at $41.48 on September 8, reaching $42.50 intraday, the highest in its history. Analysts immediately rewrote their models. Jefferies raised its target from $42 to $52, saying the Phase 3 is largely de-risked in their view; TD Cowen moved its target from $50 to $55; and Guggenheim raised from $42 to $46.
But this year's rise is not based solely on those two weeks. The stock had been gaining since February, when brepocitinib succeeded in a Phase 2 study for cutaneous sarcoidosis, and again in March after a billion-dollar deal with Moderna in a patent dispute over the lipid nanoparticle technology used to deliver mRNA vaccines into cells. August and September were more a culmination of a series of good news than a solitary jump.
The two events are not as connected as the price reaction might suggest. For Lisraya, regulatory risk has disappeared and been replaced by commercial risk: whether the drug will find patients, physicians, and reimbursement. For mosliciguat, clinical risk has dropped sharply but not vanished: 135 patients in Phase 2 is not the same as the planned 375 in Phase 3, where the effect must be replicated in a different and broader sample.