| Date | Title | Description |
| 27.07.2024 | Calliditas Therapeutics: A Beacon of Hope in Rare Disease Treatment | In the ever-evolving landscape of biopharmaceuticals, Calliditas Therapeutics is making waves. The company recently announced significant advancements in two of its key treatments, setanaxib and Kinpeygo, which target rare diseases with sub... |
| 26.07.2024 | Calliditas announces positive TRANSFORM Phase 2b topline data in primary biliary cholangitis | Calliditas announces positive TRANSFORM Phase 2b topline data in primary biliary cholangitis
Fri, Jul 26, 2024 08:00 CET Report this content
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced t... |
| 05.03.2024 | Elafibranor for Primary biliary cholangitis (PBC) in 7MM: Market Size, Forecasts, and Emerging Insights, 2019-2023 and 2024-2032 | - |
| 26.09.2023 | Intercept, once a biotech trailblazer, sells itself for less than $1 billion | Intercept Pharmaceuticals, a firm whose treatment for a prevalent liver disease once made it the hottest stock in biotech, said Tuesday it would sell the company for less than $1 billion.
Alfasigma, an Italian pharmaceutical firm, will pay ... |
| 23.06.2023 | Intercept Announces Restructuring to Strengthen Focus on Rare and Serious Liver Diseases and Significantly Reduce Operating Expenses | Measures reinforce Company’s ability to drive growth in PBC business and continue developing innovative new medicines Company to discontinue all NASH-related investment and reduce workforce by approximately one third Company anticipates ach... |
| 28.04.2023 | Current NASH treatment hurdles highlighted, new drugs hailed as game-changers | Michael Betel, President and Founder of the Fatty Liver Alliance testifies at ICER.
Fatty Liver Alliance advocates about the importance of 2 new NASH treatments soon to be approved.
ICER welcomes public comments and discussion about new NAS... |
| 11.11.2022 | Komodo Health & Intercept Partner to Study Rare Liver Disease | What You Should Know:
Intercept initially developed a traditional prospective trial to evaluate patients with advanced PBC using Ocaliva, but terminated it due to feasibility challenges in this rare disease that impacts less than 1% of wome... |
| 09.11.2022 | TES Pharma Congratulates Intercept Pharmaceuticals on their Presentation of Phase 1 INT-787 Data at the AASLD Meeting and the Initiation of the Phase 2a FRESH Study in Patients with Severe Alcohol-Ass... | INT-787 is a selective next generation FXR agonist invented by TES Pharma and licensed to Intercept Pharmaceuticals
INT-787 has shown strong anti-fibrotic and anti-inflammatory effects in animal models
TES Pharma is dedicated to the identif... |
| 05.05.2022 | Sequoia, Andreessen Horowitz, a Saudi prince, and other investors have agreed to pour $7.1B into Elon Musk’s deal for Twitter | This is the web version of Term Sheet, a daily newsletter on the biggest deals and dealmakers. Sign up to get it delivered free to your inbox.
There’s nothing like a good SEC filing to wake a person up in the morning.
Paid Content How does ... |
| 04.11.2021 | Corporate Presentation – November 2021 | Intercept
Pharmaceuticals
November 2021
Debbie,
Living with PBC
Cautionary Note Regarding Forward-Looking Statements and Non-GAAP Financial Measures
This presentation contains forward-looking statements, including, but not limited to, state... |
| 03.11.2021 | Q3 2021 Earnings Call Presentation | Intercept Pharmaceuticals
2021 Third Quarter Financial and Corporate Update
November 3, 2021
Cautionary Note Regarding Forward-Looking Statements and Non-GAAP Financial Measures
This presentation contains forward-looking statements, includi... |
| 03.11.2021 | Intercept Pharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Business Update - Form 8-K | Intercept Pharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Business Update
Worldwide Ocaliva® net sales of $92.8 million, representing 17% growth over the prior year quarter
Company increases 2021 guidance of Ocaliv... |
| 14.09.2021 | Intercept Pharmaceuticals : Baird 2021 Global Healthcare Conference Presentation – September 2021 | Intercept Pharmaceuticals
Baird 2021 Global Healthcare Conference
Jerry Durso, CEO
Cautionary Note Regarding Forward-Looking Statements and Non-GAAP Financial Measures
This presentation contains forward-looking statements, including, but no... |
| 29.07.2021 | Intercept Pharmaceuticals : Q2 2021 Earnings Call Presentation | Intercept Pharmaceuticals
2021 Second Quarter Financial and Corporate Update
July 29, 2021
Cautionary Note Regarding Forward-Looking Statements and Non-GAAP Financial Measures
This presentation contains forward-looking statements, including... |
| 17.06.2021 | INTERCEPT PHARMACEUTICALS, INC.
Intercept Pharmaceuticals : Corporate Presentation – June 2021 | Intercept
Pharmaceuticals
June 2021
Debbie,
Living with PBC
Cautionary Note Regarding Forward-Looking Statements and Non-GAAP Financial Measures
This presentation contains forward-looking statements, including, but not limited to, statement... |
| 17.06.2021 | Intercept Pharmaceuticals : Corporate Presentation – June 2021 | Intercept
Pharmaceuticals
June 2021
Debbie,
Living with PBC
Cautionary Note Regarding Forward-Looking Statements and Non-GAAP Financial Measures
This presentation contains forward-looking statements, including, but not limited to, statement... |
| 05.06.2021 | Intercept Pharmaceuticals : Company narrows 2021 financial guidance; now expects worldwide Ocaliva net sales guidance of $325 million to $340 million and reiterates Non-GAAP adjusted operating expense... | Company narrows2021 financial guidance; now expects worldwide Ocaliva net sales guidance of $325 million to $340 million and reiterates Non-GAAP adjusted operating expense guidance of $380 to $410 million
Process between Intercept and FDA r... |
| 12.05.2021 | INTERCEPT PHARMACEUTICALS, INC.
Intercept Pharmaceuticals : Corporate Presentation – May 2021 | Intercept
Pharmaceuticals
May 2021
Debbie,
Living with PBC
Cautionary Note Regarding Forward-Looking Statements and Non-GAAP Financial Measures
This presentation contains forward-looking statements, including, but not limited to, statements... |
| 12.05.2021 | Intercept Pharmaceuticals : Corporate Presentation – May 2021 | Intercept
Pharmaceuticals
May 2021
Debbie,
Living with PBC
Cautionary Note Regarding Forward-Looking Statements and Non-GAAP Financial Measures
This presentation contains forward-looking statements, including, but not limited to, statements... |
| 06.05.2021 | INTERCEPT PHARMACEUTICALS, INC.
Intercept Pharmaceuticals : Company narrows 2021 financial guidance; now expects worldwide Ocaliva net sales guidance of $325 million to $340 million and reiterates No... | Company narrows2021 financial guidance; now expects worldwide Ocaliva net sales guidance of $325 million to $340 million and reiterates Non-GAAP adjusted operating expense guidance of $380 to $410 million
Process between Intercept and FDA r... |
| 05.04.2021 | Intercept Pharmaceuticals : Company Capability Presentation | Intercept
Pharmaceuticals
March 2021
Debbie,
Living with PBC
Cautionary Note Regarding Forward-Looking Statements and Non-GAAP Financial Measures
This presentation contains forward-looking statements, including, but not limited to, statemen... |
| 05.04.2021 | INTERCEPT PHARMACEUTICALS, INC.
Intercept Pharmaceuticals : Company Capability Presentation | Intercept
Pharmaceuticals
March 2021
Debbie,
Living with PBC
Cautionary Note Regarding Forward-Looking Statements and Non-GAAP Financial Measures
This presentation contains forward-looking statements, including, but not limited to, statemen... |
| 10.03.2021 | Grifols snags the rest of GigaGen in $80M acquisition; Vertex moves cutting-edge diabetes treatment into the clinic | Spain’s Grifols is putting up $80 million to buy out the 56% of equity in GigaGen it doesn’t already own.
Grifols execs touted its acquisition of a pipeline that includes “the world’s first recombinant immunoglobulin and... |
| 10.03.2021 | Covid-19 roundup: US lands another 100M-dose contract from J&J to back Biden's pledge; Pfizer and BioNTech could produce 3B vaccine doses next year | With headlines around the globe focused on various hitches in the global supply chain for Covid vaccines, President Joe Biden is taking out an insurance policy of sorts to help guarantee his promise to rapidly expand acc... |
| 10.03.2021 | Innovation in the clinic is picking up steam. How adaptive designs could pave the road to personalized medicine | Biotech Voices is a collection of exclusive opinion editorials from some of the leading voices in biopharma on the biggest industry questions today. Think you have a voice that should be heard? Reach out to senior editors Kyle Blankenship a... |
| 10.03.2021 | Thermo Fisher will drop a whopping $600M into its manufacturing supply chain as Covid-19 work ramps up | Gene therapy player bluebird bio ran into a big stumbling block last month when they voluntarily placed a hold on their sickle cell program in the wake of two unexpected serious adverse events, a move that was shortly followed by the FDA ma... |
| 10.03.2021 | Another SPAC is gearing up to go public, this time coming from Oleg Nodelman's EcoR1 Capital | Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.
It’s another week in the biotech industry, which these days can only mean one thing: Another SPAC has filed ... |
| 10.03.2021 | Thermo Fisher will drop a whopping $600M into its manufacturing supply chain as Covid-19 work ramps up | A US House of Representatives subcommittee on Tuesday reignited bipartisan angst around the FDA’s drug manufacturing inspection backlog and attempts to improve its inspections process overseas.
The pandemic has forced the FDA to forgo more ... |
| 10.03.2021 | AgomAb Therapeutics looks to take its 'true MET agonist' for broad use into the clinic with $74M round | Years ago, argenx reached out to Paolo Michieli, an Italian professor at the University of Torino. They wanted an expert’s help finding MET antagonists, and Michieli — who has spent more than two decades researching the bi... |
| 10.03.2021 | FDA calls out Kardashian drug promo video for false claims | The FDA is clearly keeping up with the Kardashians as its Office of Prescription Drug Promotion (OPDP) raised concerns that Khloé Kardashian’s promotional video for a Biohaven Pharmaceuticals migraine drug made false cl... |
| 10.03.2021 | Thermo Fisher will drop a whopping $600M into its manufacturing supply chain as Covid-19 work ramps up | Intercept’s leadership has now been almost entirely hollowed out and turned over. On Wednesday, the once highly-valued biotech announced that its CFO, Sandip Kapadia, is leaving the company to “pursue another opportunity.”
Kapadia joins a m... |
| 10.03.2021 | Arctic Vision collects $100M to bring US eye disease candidates overseas | With three eye disease candidates, in-licensed from the US, Shanghai-based Arctic Vision has hooked more than $100 million to see the therapies to the Chinese market — and possibly beyond, if CEO Eddy Wu gets his way.
Wu too... |
| 25.02.2021 | INTERCEPT PHARMACEUTICALS, INC.
Intercept Pharmaceuticals : Q4 2020 Earnings Call Presentation | Intercept Pharmaceuticals
Q4 and Full Year 2020 Earnings Call Presentation
February 25, 2021
Cautionary Note Regarding Forward-Looking Statements and Non-GAAP Financial Measures
This presentation contains forward-looking statements, includi... |
| 25.02.2021 | Intercept Pharmaceuticals : Q4 2020 Earnings Call Presentation | Intercept Pharmaceuticals
Q4 and Full Year 2020 Earnings Call Presentation
February 25, 2021
Cautionary Note Regarding Forward-Looking Statements and Non-GAAP Financial Measures
This presentation contains forward-looking statements, includi... |
| 09.11.2020 | INTERCEPT PHARMACEUTICALS, INC.
Intercept Pharmaceuticals : Reports Third Quarter 2020 Financial Results, Announces Updates to Financial Guidance and Provides Business Update | Worldwide Ocaliva net sales of $79.5 million in the third quarter 2020, representing 29% growth over the prior year quarter
Intercept updates 2020 Ocaliva Net Sales Guidance to narrow the range to $310 million to $320 million
Intercept upda... |
| 09.11.2020 | INTERCEPT PHARMACEUTICALS, INC.
Intercept Pharmaceuticals : Q3 2020 Earnings Call Presentation | Intercept
Pharmaceuticals
Q3 2020 Earnings Call Presentation
November 9, 2020
Cautionary Note Regarding Forward-Looking Statements and Non-GAAP Financial Measures
This presentation contains forward-looking statements, including, but not lim... |
| 11.09.2020 | Intercept Pharmaceuticals : Q3 2020 Earnings Call Presentation | Intercept
Pharmaceuticals
Q3 2020 Earnings Call Presentation
November 9, 2020
Cautionary Note Regarding Forward-Looking Statements and Non-GAAP Financial Measures
This presentation contains forward-looking statements, including, but not lim... |
| 11.09.2020 | Intercept Pharmaceuticals : Reports Third Quarter 2020 Financial Results, Announces Updates to Financial Guidance and Provides Business Update | Worldwide Ocaliva net sales of $79.5 million in the third quarter 2020, representing 29% growth over the prior year quarter
Intercept updates 2020 Ocaliva Net Sales Guidance to narrow the range to $310 million to $320 million
Intercept upda... |
| 10.08.2020 | INTERCEPT PHARMACEUTICALS, INC.
Intercept Pharmaceuticals : Q2 2020 Earnings Call Presentation | Intercept
Pharmaceuticals
Q2 2020 Earnings Call Presentation
August 10, 2020
Cautionary Note Regarding Forward-Looking Statements and Non-GAAP Financial Measures
This presentation contains forward-looking statements, including, but not limi... |
| 29.06.2020 | INTERCEPT PHARMACEUTICALS, INC.
Intercept Receives Complete Response Letter from FDA for Obeticholic Acid for the Treatment of Fibrosis Due to NASH | NEW YORK, June 29, 2020 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, tod... |
| 29.06.2020 | FDA turns down Intercept’s long-anticipated NASH drug | Shares of Intercept were down 39.5% on the Nasdaq in midday trading following the news.
Expressing disappointment at the FDA’s decision, CEO Mark Pruzanski said the company will meet with the FDA to discuss the CRL, but added that the compa... |
| 26.03.2020 | Biopharma companies face regulatory, deal delays due to Covid-19 | Meanwhile, Cambridge, Massachusetts-based bluebird bio said did not anticipate completing its rolling application submission for the gene therapy LentiGlobin as a treatment for the blood disorder beta-thalassemia until the middle of next ye... |
| 17.12.2019 | Intercept hits slight delay in NASH drug approval, but analysts remain upbeat | Indeed, the announcement did not appear to affect Intercept’s stock price, with shares rising 5% on the Nasdaq Monday. The company had also hosted a commercial analyst day Monday.
But while a delay in launch for the drug until the second qu... |
| 13.12.2019 | More questions than answers for biopharma after UK election; Intercept gets FDA advisory date, and a PDUFA delay | → On Thursday, voters in the UK handed Boris Johnson’s Conservative government, and its aggressive Brexit stance, a clear majority. Urte Jakimaviciute, GlobalData‘s senior director of market research, weighed in on... |
| 26.11.2019 | Genfit scores seventh positive data safety monitoring board opinion for Phase III NASH trial | Shares of Genfit were up 8.3% on the Euronext Paris exchange and 3.5% on the Nasdaq following the news.
The company plans to announce top-line interim results for the study in the first quarter of next year and will file for Food and Drug A... |
| 11.11.2019 | 89Bio goes public and the stock price surges | 89Bio company is developing a drug called BIO89-100 that is in Phase I/Phase 2b development for nonalcoholic steatohepatitis or NASH. The drug, originally called TEV-47948, was acquired from Teva Pharmaceutical Industries and is a long-acti... |
| 11.04.2019 | Intercept’s Ocaliva shows continued improvement in NASH fibrosis at European liver conference | Shares of Intercept were down more than 13 percent on the Nasdaq Thursday afternoon.
The data showed that in the intent-to-treat population, once-daily treatment with Ocaliva at 25mg met the primary endpoint of improving fibrosis by one sta... |
| 27.03.2019 | France's NASH contender Genfit leaps onto Nasdaq with $135M IPO | As it gears up for the late-stage readout of its lead experimental NASH drug, France’s Genfit is vaulting onto the Nasdaq on Wednesday with a $135 million IPO under the symbol $GNFT.
The Lille-based company, which is alread... |
| 19.02.2019 | Intercept could score first NASH drug approval on positive Phase III data | Shares of Intercept opened up 18.6 percent on the Nasdaq Tuesday following the news.
The results come a week after another NASH drug, Gilead Sciences’ selonsertib, failed in a Phase III study among patients with Stage 4 fibrosis. The result... |
| 07.12.2017 | Rich Heyman's Metacrine grabs a $22M round in search of a superior NASH drug | A startup founded by biotech A-listers has scored $22 million in a Series B round to help develop its NASH drug. The company, called Metacrine, is pursuing a target its founders think can outperform the field’s fierce compet... |
| 04.05.2017 | Novartis continues its blitz on NASH deals, grabbing an exclusive tie-up in race to develop cocktails | Vasant Narasimhan, Novartis
Five months ago Novartis $NVS rocked Conatus’ world with a collaboration deal for its NASH drug emricasan. The biotech’s stock quadrupled in value. And it got another boost today as the pharma... |
| 10.08.2012 | Intercept Pharmaceuticals Completes $30M Series C Financing | Intercept Pharmaceuticals, Inc., a NYC-based clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic liver diseases, has completed a $30m Series C financing.
The round... |
| 25.01.2010 | Intercept Pharmaceuticals Raises $25M Series B Financing | Intercept Pharmaceuticals, Inc., a New York-based clinical stage biopharmaceutical company developing novel therapeutics for chronic fibrotic and metabolic diseases, completed a $25m Preferred Series B financing by its majority shareholder ... |
| - | FDA turns down Intercept’s long-anticipated NASH drug | A drug that had been expected to become the first to win regulatory approval for the fatty liver disease nonalcoholic steatohepatitis may not be hitting the market anytime soon.
New York-based Intercept Pharmaceuticals said Monday that it h... |
| - | Biopharma companies face regulatory, deal delays due to Covid-19 | Covid-19 is already taking a toll on biopharma, with companies putting off clinical development and canceling meetings and other plans in order to slow the spread of the SARS-CoV-2 virus and free up space at hospitals that are quickly becom... |
| - | Intercept’s Ocaliva shows continued improvement in NASH fibrosis at European liver conference | A company that could become the first to win Food and Drug Administration approval for a drug to treat a form of liver disease rapidly growing worldwide on Thursday added to positive interim data announced two months ago at a liver conferen... |
| - | Genfit scores seventh positive data safety monitoring board opinion for Phase III NASH trial | The committee overseeing Genfit’s registration-directed Phase III trial testing its drug in a fatty-liver disease without any approved treatments has recommended that the trial move forward.
The Lille, France-based company said Tuesday that... |
| - | Intercept hits slight delay in NASH drug approval, but analysts remain upbeat | A company that could become the first to win Food and Drug Administration approval for a drug to treat a form of fatty liver disease has experienced a few months’ delay in the agency reaching its decision. However, analysts sought to assure... |
| - | 89Bio goes public and the stock price surges | A year after announcing that it received a $60 million Series A funding, San Francisco-based 89Bio went public Monday. It priced its share at $16 hoping to bring in $85 million into its coffers. But trading in the early afternoon showed tha... |
| - | Intercept could score first NASH drug approval on positive Phase III data | A drug in development for nonalcoholic steatohepatitis took a step closer to regulatory approval Tuesday with the announcement of positive results from a Phase III clinical trial, which analysts said could make it the first-ever NASH drug t... |
