-
FDA Approves First Treatment For Alagille Syndrome-Associated Cholestatic Pruritus From Mirum Pharma
Wednesday, September 29, 2021 - 4:45pm | 327Read More...The FDA has approved Mirum Pharmaceuticals Inc (NASDAQ: MIRM) Livmarli (maralixibat) oral solution for cholestatic pruritus in patients with Alagille syndrome (ALGS) one year of age and older. Livmarli, a minimally absorbed ileal bile acid transporter (IBAT) inhibitor, is the...
-
Precision BioSciences, iECURE Ink Licensing Pact For Gene Editing Therapies
Thursday, September 9, 2021 - 11:19am | 275Read More...Precision BioSciences Inc (NASDAQ: DTIL) and iECURE announced a license and collaboration agreement. Under the agreement iECURE plans to advance Precision's PBGENE-PCSK9 candidate into Phase 1 studies and gain access to Precision's PCSK9-directed ARCUS nuclease to develop...
-
Calliditas' Chronic Orphan Liver Disease Candidate Receives FDA Fast Track Tag
Monday, August 9, 2021 - 10:57am | 189Read More...The FDA has granted Fast Track Designation to Calliditas Therapeutics AB's (NASDAQ: CALT) lead NOX inhibitor candidate setanaxib for primary biliary cholangitis (PBC). Setanaxib has previously been granted orphan drug designation for PBC in the US and Europe. In the Phase 2...
-
Dicerna Posts Updated Data From Belcesiran Early-Stage Study For Genetic Liver Disease
Wednesday, July 21, 2021 - 9:17am | 249Read More...Dicerna Pharmaceuticals Inc (NASDAQ: DRNA) has announced interim results from the four completed active-treatment dose cohorts (0.1, 1.0, 3.0, and 6.0 mg/kg) of its Phase 1 trial of belcesiran. The GalXC RNAi therapeutic is in development for alpha-1 antitrypsin deficiency...
-
Albireo's Rare Liver Disease Drug Bylvay Scores Back To Back Approvals In Europe, US
Wednesday, July 21, 2021 - 6:10am | 321Read More...Just a day after European approval, Albireo Pharma Inc (NASDAQ: ALBO) has received FDA approval for Bylvay (odevixibat), the first drug approved to treat pruritus in all subtypes of progressive familial intrahepatic cholestasis (PFIC). PFIC afflicts children with severe,...
-
Albireo's Bylvay Scores European Nod For Rare Pediatric Liver Disease
Monday, July 19, 2021 - 9:35am | 300Read More...The European Commission (EC) has approved Albireo Pharma Inc's (NASDAQ: ALBO) Bylvay (odevixibat) for all subtypes of progressive familial intrahepatic cholestasis (PFIC). Bylvay is a potent, non-systemic ileal bile acid transport inhibitor (IBATi). The approval was based...
-
Albireo's Bylvay Shows Further Evidence Of Sustained, Durable Effect In Pediatric Liver Disease Study
Monday, June 21, 2021 - 11:05am | 275Read More...Albireo Pharma Inc (NASDAQ: ALBO) has announced pooled analysis from Phase 3 PEDFIC studies with Bylvay (odevixibat) and advancement in the characterization of A3907 in adult liver disease. Data will be presented at the EASL International Liver Congress 2021. Results in...
-
Exclusive: Axcella Health Aims To Become The Standard Of Care
Thursday, April 15, 2021 - 5:47pm | 342Read More...Axcella Health Inc (NASDAQ: AXLA) is a clinical-stage biotechnology company focused on endogenous metabolic modulators, or EEMs, said Axcella Health CEO Bill Hinshaw Thursday on Benzinga's YouTube show "Power Hour." Axcella Health has two "rapidly progressing...
-
Immunic's IMU-838 Shows Promising Clinical Effect In Mid-Stage Liver Disease Study
Thursday, February 18, 2021 - 9:26am | 314Read More...Immunic Inc (NASDAQ: IMUX) has announced top-line data from an investigator-sponsored Phase 2 proof-of-concept trial evaluating IMU-838 in primary sclerosing cholangitis (PSC), a rare liver disease characterized by inflamed and narrow bile ducts, thus preventing bile...
-
Mallinkcrodt Is Betting On Ocera Despite Doubts Around Its Liver Disease Drug
Thursday, November 2, 2017 - 2:43pm | 389Read More...Mallinckrodt PLC (NYSE: MNK), a generic specialty pharmaceutical company, said Thursday it has agreed to acquire Ocera Therapeutics Inc (NASDAQ: OCRX), a nano-cap clinical-stage biopharmaceutical company for $1.52 per share plus a contingent value right. Ocera's stock soared higher by 70...
-
FDA Letter On Intercept Pharma Doesn't Include Black Box Warning Label...Yet
Friday, September 22, 2017 - 11:19am | 696Read More...Shares of Intercept Pharmaceuticals Inc (NASDAQ: ICPT) continued to sell off Friday in reaction to the U.S. Food and Drug Administration's letter to physicians warning them against the company's liver disease medicine called Ocaliva. One of the main takeaways from the FDA's letter is the absence of...
-
Will Intercept Stock Potential Be Blindsided By FDA Letter?
Friday, September 22, 2017 - 10:11am | 355Read More...Shares of Intercept Pharmaceuticals Inc (NASDAQ: ICPT) lost around one quarter of their value Thursday and another 7 percent early Friday morning in reaction to a concerning U.S. Food and Drug Administration letter sent to doctors regarding its liver treatment product called Ocaliva for the...
-
FDA Warning Letter Buckles Intercept Pharma Shares; Wells Fargo Downgrades
Friday, September 22, 2017 - 9:13am | 427Read More...The U.S. Food and Drug Administration sent a letter to doctors highlighting potential negative side effects from Intercept Pharmaceuticals Inc (NASDAQ: ICPT)'s liver disease medicine called Ocaliva. The FDA said in its letter that if it is incorrectly dosed in patients with moderate to severe...
-
Here's Why Conatus Pharmaceuticals' Stock Surged 23%
Wednesday, February 3, 2016 - 1:26pm | 249Read More...Shares of Conatus Pharmaceuticals Inc (NASDAQ: CNAT), a nano-cap biotechnology company focused on the development and commercialization of medicines to treat liver disease, surged higher by more than 22 percent on Wednesday. Conatus Pharmaceuticals announced earlier in the day that the U.S....
-
Conatus Pharmaceuticals Surges 25% Following Positive Results In Phase 2 Study
Wednesday, January 6, 2016 - 9:45am | 300Read More...Shares of Conatus Pharmaceuticals Inc (NASDAQ: CNAT), a small-cap biopharmaceutical company focused on developing medicines to treat liver diseases, were trading higher by 25 percent at $3.61 early Wednesday morning. Conatus Pharmaceuticals announced after Tuesday's market close that a three-month...
