On Monday, Citi maintained a Buy rating on Mirum Pharmaceuticals (NASDAQ:MIRM) with a steady price target of $38.00 following encouraging trial updates. Mirum Pharmaceuticals announced interim results from their Phase 2b VISTAS and VANTAGE trials, which are studying the effects of volixibat in treating primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC).
For the PBC trial, preliminary findings showed a 2.3-point placebo-adjusted reduction in itch using volixibat, a result that surpasses the 1.64-point benefit observed with a competing drug, linerixibat, from GlaxoSmithKline (NYSE:GSK). The VANTAGE trial will continue with a 20mg dose of volixibat based on these early outcomes.
In the case of PSC, the treatment met the predetermined threshold for itch reduction, which supports the potential for success in future pivotal analyses. Patients in the 20mg twice-daily arm of the VISTAS trial will progress to the pivotal stage without the need for an increase in sample size.
Citi anticipates that interest in volixibat will increase significantly among investors, potentially leading to a rise in share value at market opening. This follows a recent forecast by Citi highlighting volixibat as a key upcoming catalyst for the company's stock.
Mirum is scheduled to conduct a conference call today at 8:30 am ET to discuss the trial updates in further detail. The call is expected to provide additional information regarding the safety profile of volixibat, developmental timelines, competitive positioning in the PBC market, and the market size for PSC treatments.
In other recent news, Mirum Pharmaceuticals reported encouraging results from two ongoing Phase 2b clinical trials of volixibat, an oral medication being evaluated for the treatment of primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC). The VANTAGE study, focusing on PBC, reported a significant reduction in itchiness and improvements in fatigue. The VISTAS study on PSC also passed an efficacy threshold necessary for the continuation of the trial.
Citi reaffirmed its Buy rating on Mirum shares, in anticipation of important clinical trial updates for volixibat. Mirum's product, LIVMARLI, received a positive opinion from the European Committee for Medicinal Products for Human Use for the treatment of Progressive Familial Intrahepatic Cholestasis, a rare genetic liver disease.
In financial developments, Mirum reported a significant increase in financial results for the first quarter of 2024, with net product sales reaching $68.9 million. The company forecasts a full-year revenue guidance between $310 million and $320 million.
InvestingPro Insights
As Mirum Pharmaceuticals (NASDAQ:MIRM) garners attention with promising trial results for volixibat, the financial metrics from InvestingPro reveal a nuanced picture. With a market capitalization of $1.22 billion, Mirum shows significant growth potential, underscored by a staggering 133.9% revenue growth over the last twelve months as of Q1 2024. This growth is further reflected in the quarterly figure, with a 119.07% increase in the same period.
InvestingPro Tips highlight that while Mirum is not expected to be profitable this year, and has not been profitable over the last twelve months, the company's liquid assets do exceed its short-term obligations, suggesting a degree of financial resilience. Additionally, the company operates with a moderate level of debt, which may provide some stability in its growth trajectory. It's also worth noting that Mirum does not pay a dividend, indicating that the company is likely reinvesting its earnings back into research and development, which could be promising for the future value of its innovative treatments like volixibat.
For investors intrigued by Mirum's potential, the InvestingPro platform offers additional insights, including a fair value estimate of $28.41, which is below the current analyst target but offers a grounded perspective on the company's valuation. Interested readers can explore further with a special offer: use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, and gain access to the full suite of InvestingPro Tips, with 4 additional tips listed for Mirum Pharmaceuticals.
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