MIRM Mirum Pharmaceuticals Inc

$MIRM Apparently Alfasigma prices Lynavoy at 80K per year net. Lynavoy is the only competitor for volixibat and this is much higher than expected. If payers accept this price for all patients this would mean volixibat is going to be a multibillion product, even if FDA delays it.

$MIRM the good thing is that a share can’t be worth less than 0! 😃 We need pos news around volixibat/FDA talks and the NDA! 💪

$MIRM Mirum (brelo) vs Vir data (tove + eleb combo). Importantly, Mirum placed no limits on the baseline ALT levels and had 17-20% percent of patients with ALT>5x ULN vs 0% in Vir’s trial. • At 24 weeks, Mirum’s P3 vs Vir’s P2 ✓Combined response (Virologic + ALT), registrational endpoint: 56% (weekly dosing), 45% (monthly dosing) vs 47% ✓Virologic response: 86% (weekly dosing), 85% (monthly dosing) vs 100% ✓Safety, flu-like symptoms: 5% (weekly dosing), 11% (weekly dosing) vs 66% • At 48 weeks, Mirum’s P2 vs Vir’s P2 ✓Combined response (Virologic + ALT), registrational endpoint: 55% (weekly dosing), 55% (monthly dosing) vs 56% ✓Virologic response: 95% (weekly dosing), 95% (monthly dosing) vs 97% • Mirum so far has → Same or better efficacy on the registrational endpoint despite about 20% severe patients in the trial. → Comparable efficacy on virologic response considering inclusion of severe patients. → Much better safety

$MIRM this is trading at it’s best in a bio stock. We will be cash pos 2028 latest. Will take some time before we see fruit from these seeds, thats why down together with market today, traders don’t have time, institutions already there. Eventually back to 130 🤩

The FDA approved Mirum Pharmaceuticals’ zilurgisertib, marketed as Atebrioz, to treat fibrodysplasia ossificans progressiva (FOP), a rare genetic disorder in which bone progressively forms in muscles, tendons and ligaments, restricting movement and potentially causing severe disability. Atebrioz is a once-daily oral treatment approved for patients aged 12 and older. The drug works by blocking ALK2, a protein that is abnormally active in most FOP patients and plays a key role in driving the formation of bone outside the normal skeleton. The recommended dose is 100 milligrams. The approval gives Mirum a new treatment option for a rare and debilitating condition for which abnormal bone growth can progressively limit mobility and affect patients’ quality of life. The company’s regulatory milestone also expands its portfolio of therapies targeting uncommon diseases. $MIRM

💊 $MIRM Last trading day before the FDA decision on zilurgisertib, its oral ALK2 inhibitor for FOP. Approval could give Mirum a fourth marketed therapy, with a Q4 launch planned. - Currently sitting on both horizontal + diagonal support 👀 - $138.21 1 year average analyst PT. ~55% upside.

$MIRM i dont get whats going on here. I get that theres a delay on the BLA for Volixibat, but that was known already prior to the recent updates.

$MIRM $INCY Mirum Pharmaceuticals, Incyte announce FDA approval of Atebrioz Mirum Pharmaceuticals (MIRM) and Incyte (INCY) announced that the U.S. FDA has approved Atebrioz tablets to reduce the volume of total new heterotopic ossification in adult and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva. The recommended dose of Atebrioz is 100 mg administered orally, once daily.

Best real binary $MIRM Best retail momentum candidate $IMRX Best balance sheet among the cheap names $CCCC Highest rug risk $BFRI

$MIRM FDA approved Atebrioz (zilurgisertib) Friday, the once-daily FOP pill Mirum licensed from Incyte in April. Launch is set for October; pricing comes at launch. The trial data: 63 patients, 100 mg daily for 24 weeks. New bone growth averaged a decrease of 3.2 cm3 vs an increase of 24.6 cm3 on placebo. It is the third approved FOP therapy after Ipsen's Sohonos (2023) and Regeneron's Pasatru (August). The differentiator is convenience: Pasatru is an IV infusion every 4 weeks limited to adults; Atebrioz is a pill approved down to age 12. The commercial question is the pool: about 900 patients worldwide, 300 in the US. Mirum's CEO told Fierce more patients are on clinical studies than commercial drugs, which he reads as unmet demand rather than saturation. For Incyte the prize is a milestone and royalties on a small base. For Mirum, a 5.8B company trading well below its 52-week high, this is the franchise expanding.

$MIRM label expansion underway(from 2 years) and will surely make it to the european market 😍

$MIRM Atebrioz. Very clean label: no black box, only embryo-fetal toxicity in warnings. 12 years and older.

$MIRM Hopefully we get a positive approval announcement today. Otherwise will start to lean bearish. Also p3 data due anyday for their other trial.

$MIRM Atebrioz is now the third FDA-approved treatment for FOP. Three drugs. Three regulatory histories. How has FDA's evidentiary standard evolved across them?

$MIRM data coming out here tomorrow: Mirum Pharmaceuticals to Host Investor Call to Share Topline Results from the Phase 3 AZURE-1 Study of Brelovitug in Chronic Hepatitis Delta on September 28, 2026 "announced that it will host an investor call on Monday, September 28, 2026 at 8:30 a.m. ET/5:30 a.m. PT to share topline results from the Phase 3 AZURE-1 study of brelovitug in chronic hepatitis delta virus (HDV), along with 48-week data from the Phase 2b portion of the study."

Mirum Pharmaceuticals said the FDA is set to decide on zilurgisertib, an investigational oral ALK2 inhibitor for fibrodysplasia ossificans progressiva (FOP), an ultra-rare genetic disorder that causes abnormal bone formation in soft tissues. The FDA accepted Mirum’s NDA under priority review, with a PDUFA date of September 26, 2026, making the decision a key near-term catalyst for the company. The application is supported by pivotal Phase 2 PROGRESS data, while Mirum holds worldwide development rights to zilurgisertib after acquiring them from Incyte. Mirum has also strengthened its management team with the appointment of hepatologist Rob Myers, M.D., as chief medical officer. Several Wall Street analysts maintain Buy or Outperform ratings, while the company raised its 2026 full-year net product sales guidance to $680 million-$700 million. $MIRM

$MIRM Would sb confirm this, pls? Possibly giving a plausible reason why an insider would sell stock worth a million 2 weeks prior to a pdufa date?

MIRM, INCY Stocks In Focus — Will A September 26 FDA Ruling Reward This Week’s Gains? $MIRM $INCY https://stocktwits.com/news/equity/markets/mirm-incy-stocks-in-focus-will-a-september-26-fda-ruling-reward-this-week-s-gains/cZts245RBdA