All 28 Solstice patients completing 96 weeks had undetectable virus.
- Eclipse-1 met all endpoints, with 79% of treated patients reaching undetectable virus and 44% also achieving normal ALT levels after 48 weeks.
- Eclipse 2 and Eclipse 3 results are expected in early 2027, helping an FDA filing around midyear.
- Vir and Astellas plan pivotal prostate-cancer trials in 2027.
Shares of Vir Biotechnology (VIR) surged over nearly 15% overnight heading into Monday after positive hepatitis delta trial results sparked retail buyout speculation and bets on bigger long-term gains.
VIR stock jumped 11% to $12.21 on Friday, bringing its year-to-date gain to about 102%, well above its 56% advance in 2021.
Vir’s Hepatitis Combination Clears Key Trial
Vir said its 124-patient Phase 3 Eclipse-1 trial met all goals for monthly Elebsiran and Tobevibart in chronic hepatitis delta. After 48 weeks, 79% of treated patients had virus levels too low for tests to detect. A smaller group, 44%, also had normal levels of ALT, a liver enzyme used to assess liver injury. Both results were compared with 0% in the delayed-treatment group at Week 12, before those patients began therapy.
No patients paused or discontinued treatment. One severe treatment-related drop in neutrophils, a type of white blood cell, resolved within 15 days.
“We believe the robust viral suppression combined with the flexibility of monthly at-home or healthcare provider administration has the potential to position elebsiran and tobevibart as the best-in-disease treatment for hepatitis delta,” CEO Marianne De Backer said.
Longer-term Solstice results also encouraged hopes that some patients could eventually stop treatment. All 28 patients completing 96 weeks of therapy had undetectable virus.
Separately, 10 selected patients stopped treatment after keeping the virus undetectable for at least 96 weeks. All maintained viral control at 12 weeks after stopping. Seven had reached 24 weeks of follow-up and one reached 48 weeks, with no observed viral rebound or ALT spikes. “These preliminary findings show the potential for a finite treatment approach that goes beyond suppressing HDV to potentially achieving cure,” Chief Medical Officer David Liu said.
Vir Targets Mid-2027 FDA Filing
Vir expects Eclipse 2 and Eclipse 3 results in early 2027, helping an FDA filing around midyear. One trial tests switching patients whose infection is not adequately controlled by bulevirtide. The other compares Vir’s combination directly with bulevirtide in patients who have not previously received that drug.
The monthly treatment, given as two injections, has FDA Breakthrough Therapy and Fast Track designations intended to accelerate development and review. Norgine holds commercialization rights in Europe, Australia and New Zealand, subject to approval.
Beyond Hepatitis: Oncology Adds To Bull Case
On its recent earnings call, Vir said prostate-cancer candidate VIR-5500 had shown early clinical promise and received FDA Fast Track designation. Vir and Astellas plan to begin multiple trials intended to support regulatory approval in 2027.
“Importantly, our plans to pursue first-line mCRPC reflect our belief that VIR-5500 has the potential to become a foundational therapy across the prostate cancer treatment continuum,” De Backer said, referring to advanced, hormone-resistant prostate cancer.
Vir ended September with $901.3 million in cash and investments, excluding $90 million received from Gilead in October. That included $65 million upfront and a $25 million equity investment. Vir could receive up to $1.74 billion in further milestone payments, plus royalties.
The company expects its cash to fund operations into the second half of 2028. Its third-quarter loss of $0.57 per share was smaller than the $0.75 loss analysts expected.
ARCH Funds Trim Holdings Before Data
Two ARCH funds sold a combined 796,175 Vir shares between Nov.3 and Nov.5, according to a Friday regulatory filing. They retained about 11.9 million shares, representing a 6.9% stake in the company.
How Do Retail Traders Feel About VIR?
On Stocktwits, retail sentiment for VIR jumped to ‘extremely bullish’ from ‘bullish’ levels a day ago amid a 1,900% surge in 24-hour message volumes.
One user said, “Phenomenal data! Exceeded all expectations!” The user argued the results increased the likelihood of a Gilead buyout and had also named Astellas in an earlier post.
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Another user said, “I want VIR to be a multi bagger (10X+) rather than a simple double.” In a follow-up, the user argued an early sale could undervalue Vir’s oncology platform and highlighted its cash runway. A separate user asked, “are results already baked in due to recent move or will it pop 2-3 points.”
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