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Fly Intel: Wall Street's top stories at midday » 12:2812/1512/15/20
LLY, PRVL, MRNA, WFC, AAPL, OCX, BNR, ARVN, MIRM, MESO
The major averages are…
Fly Intel: Pre-market Movers » 08:5912/1512/15/20
PRVL, LLY, MRNA, OCX, AVXL, ATNX, MIRM, MESO, EAF, OCUL
Check out this morning's…
Mirum Pharmaceuticals 3.75M share Secondary priced at $20.00 » 21:0212/1412/14/20
The deal priced below the…
The deal priced below the last closing price of $24.00. JMP Securities, SVB Leerink and Evercore ISI are acting as joint book running managers for the offering.
Mirum Pharmaceuticals files to sell $75M of common stock » 07:4812/1412/14/20
J.P. Morgan, SVB Leerink…
J.P. Morgan, SVB Leerink and Evercore ISI are acting as joint book-running managers for the proposed offering. H.C. Wainwright & Co. is acting as lead manager for the proposed offering.
Mirum Pharmaceuticals investor day highlights pipeline advances, says Piper » 20:5812/0912/09/20
Piper Sandler analyst…
Piper Sandler analyst Yasmeen Rahimi keeps an Overweight rating and $77 price target on Mirum Pharmaceuticals after its investor day presentation highlighted the company's pipeline advancements with two ASBT inhibitors. The analyst says the company is embarking on "the largest market pediatric cholestatic opportunity in biliary atresia", adding that she walked away "very impressed by the thoughtful design of the randomized, double-blind, placebo-controlled Phase 2 study of 600mg/kg dose of Maralixibat called EMBARK.
Mirum Pharmaceuticals, Oberland announce up to $210M funding arrangement » 09:1112/0912/09/20
Mirum Pharmaceuticals and…
Mirum Pharmaceuticals and Oberland Capital announced a $200M capped, tiered, revenue-based funding agreement based on net revenues of maralixibat, as well as a $10M equity investment agreement. Under the agreements, Mirum will receive: $60M by December 31, including a $10M equity investment; $65M upon announcement of the FDA acceptance of Mirum's new drug application, or NDA, for maralixibat for the treatment of cholestatic pruritus in patients with Alagille syndrome, or ALGS; $35M upon announcement of FDA approval of maralixibat for cholestatic pruritus in patients with ALGS and $50M, at the option of Oberland Capital, which may be funded to support in-licensing or acquisition of assets to further build upon Mirum's development and commercialization pipeline in the pursuit of treatments for rare liver diseases. Mirum is submitting a rolling NDA to the FDA for maralixibat for the treatment of cholestatic pruritus in patients with ALGS, which it expects to complete in the first quarter of 2021, with launch planned in the second half of 2021. Mirum has also submitted a marketing authorization application (MAA) to the European Medicines Agency, or EMA, for maralixibat for the treatment of patients with progressive familial intrahepatic cholestasis type 2, or PFIC2, or bile salt export pump, or BSEP, deficiency. The MAA was recently validated by the EMA and Mirum is preparing for launch in the European Union in the first quarter of 2022.
Mirum Pharmaceuticals to host virtual investor day » 18:1312/0412/04/20
Virtual Investor Day to…
Virtual Investor Day to be held on December 9 at 11 am. Webcast Link
Mirum continues to deliver on milestones, says Piper Sandler » 10:3611/3011/30/20
Piper Sandler analyst…
Piper Sandler analyst Yasmeen Rahimi says Mirum Pharmaceuticals "continues to deliver milestones on time and achieve every goal it sets," with this morning's announcement of Marketing Authorization Application validation for maralixibat in PFIC2. The application validation has a "strong basis" in Mirum's five-year dataset showing transplant-free survival in PFIC2 patients on maralixibat, Rahimi tells investors in a research note. The analyst looks forward to Mirum's investor day on December 9 and keeps an Overweight rating on the shares with a $77 price target.
Mirum Pharmaceuticals announces maralixibat MAA accepted for review by EMA » 08:4011/3011/30/20
Mirum Pharmaceuticals announced that the company's marketing authorization application, or MAA, for its investigational medicine, maralixibat, for the treatment of patients with progressive familial intrahepatic cholestasis type 2, or PFIC2, also known as bile salt export pump, or BSEP, deficiency, was accepted for review by the European Medicines Agency, or EMA. The validation of the application by the EMA confirms all essential regulatory elements are included in the submission such that the EMA can begin its review.
Mirum Pharmaceuticals announces data from ITCH, IMAGINE II studies » 18:3211/1511/15/20
Mirum Pharmaceuticals announced data presented at the Annual Meeting of the American Association for the Study of Liver Diseases - The Liver Meeting Digital Experience. The data were presented in a late-breaking oral presentation titled "Preliminary Analysis of ITCH and IMAGINE II - Outcome of Long-term Administration of Maralixibat in Children with Alagille Syndrome." The objective of the studies was to assess pruritus and other markers of cholestasis in patients with Alagille syndrome with up to 220 weeks of treatment with maralixibat. Maralixibat, an apical sodium bile acid transporter inhibitor, has previously been shown to interrupt the enterohepatic circulation of bile acids, reducing pruritus. Of the children enrolled in the ITCH and IMAGINE II studies, 28 of the 37 patients were on study at 48 weeks with 80% of those experiencing clinically meaningful reductions in pruritus which were durable beyond four years, with 90% of patients who continued on study experiencing a pruritus response at the end of treatment. The mean reduction in ItchRO at week 48 was -1.9 points and deepened to -2.3 points at the end of treatment. Maralixibat treatment improved quality of life and led to improved growth parameters. The long-term data suggest that maralixibat has the potential to be an effective treatment and could serve as an alternative to surgery for ALGS patients, if approved.