Lastly, MIRM is also working on PBC and PSC treatments. For PBC, trials showed a 3.8-point reduction from baseline in the primary endpoint of pruritus, indicating a significant improvement in reducing this primary symptom of PBC. For PSC, outcomes were also encouraging, preliminary meeting efficacy thresholds that need to be confirmed in further studies with 20mg daily doses. Quality at a Premium: Valuation Analysis According to Seeking Alpha's dashboard on MIRM, the company is projected to generate roughly ...

The Committee for Medicinal Products for Human Use rendered a positive opinion for Livmarli for the treatment of PFIC in patients aged three months and older in May. MIRM has also submitted an additional supplemental new drug application to the FDA seeking label expansion for a higher concentration formulation of Livmarli, which was used in the MARCH study to include treatment of younger patients with PFIC. Feedback from the regulatory body is expected later in 2024. Some better-ranked stocks in the healthc ...

Last month, the company submitted a new drug application (NDA) seeking approval for chenodiol for treating cerebrotendinous xanthomatosis (CTX) patients in the United States. The NDA filing was based on positive data from the phase III RESTORE study. Chenodiol is not currently approved but has received a medical necessity medicine status from the FDA for the treatment of CTX, a rare autosomal genetic disorder. We remind investors that in August 2023, Mirum acquired all assets of Travere Therapeutics' bile a ...

Shares of Mirum Pharmaceuticals, Inc. (MIRM) were up 27.3% on Jun 17 after the company announced positive interim data from two phase IIb studies, which evaluated its oral ileal bile acid transporter inhibitor, volixibat, for treating patients with primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC). The phase IIb VISTAS study investigated volixibat for the treatment of PSC, while the phase IIb VANTAGE study evaluated volixibat for the treatment of PBC. Interim data from the VANTAGE s ...

Earnings and revenue growth expectations certainly give a good sense of the potential strength in a stock, but empirical research shows that trends in earnings estimate revisions are strongly correlated with near-term stock price movements. For Mirum Pharmaceuticals, the consensus EPS estimate for the quarter has remained unchanged over the last 30 days. And a stock's price usually doesn't keep moving higher in the absence of any trend in earnings estimate revisions. So, make sure to keep an eye on MIRM goi ...

Loading... Interim results from the VANTAGE study evaluating volixibat in patients with PBC demonstrated a statistically significant (-3.82, p<0.0001) improvement in pruritus (itch) for volixibat and a placebo-adjusted difference of -2.32 points in the primary endpoint, p=0.0026, as measured by the Adult ItchRO scale. 75% of patients on volixibat achieved a greater than 50% reduction in serum bile acids. No new safety signals were observed, and adverse events were similar between the 20 and 80 mg treatment ...

It has been about a month since the last earnings report for Mirum Pharmaceuticals, Inc. (MIRM) . Shares have lost about 3.4% in that time frame, underperforming the S&P 500. Will the recent negative trend continue leading up to its next earnings release, or is Mirum Pharmaceuticals due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important drivers. Mirum's Q1 Earnings ...

Mirum Pharmaceuticals, Inc.'s (MIRM) lead product, Livmarli (maralixibat), an orally administered ileal bile acid transporter ("IBAT") inhibitor, is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) worldwide. Sales of Livmarli have been rising steadily since its approval and launch in 2021. In March 2024, the FDA approved a label expansion for Livmarli oral solution to include the treatment of cholestatic pruritus in patients aged five years and older with progres ...

Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM) Q1 2024 Earnings Conference Call May 8, 2024 4:30 PM ET Company Participants Andrew McKibben - Vice President, Investor Relations Chris Peetz - Chief Executive Officer Peter Radovich - President & Chief Operating Officer Joanne Quan - Chief Medical Officer Eric Bjerkholt - Chief Financial Officer Conference Call Participants Jessica Fye - JPMorgan Mani Foroohar - Leerink Partners Gavin Clark-Gartner - Evercore ISI Dae Gon Ha - Stifel Steven Seedhouse - Raymond James ...

Mirum Pharmaceuticals, Inc. (MIRM) incurred first-quarter 2024 loss of 54 cents per share, wider than the Zacks Consensus Estimate of a loss of 40 cents. The company had reported a loss of 80 cents per share in the year-ago quarter.Revenues in the first quarter totaled $69.2 million, up almost 118.9% year over year. The figure, however, missed the Zacks Consensus Estimate of $70 million. The top line comprised Livmarli (maralixibat) sales, newly acquired Cholbam and Chenodal sales and minimal license and ot ...