||5-day change||1st Jan Change|
- Ocaliva® (obeticholic acid or OCA) web gross sales of
$83.7 million, representing 17% progress over the prior yr quarter
- Firm updates full-year 2023 Ocaliva web gross sales steerage to
$320 millionto $340 million; reiterates non-GAAP adjusted working expense steerage of $350 millionto $370 million
- Restructuring plan is on observe to cut back working bills by roughly
- Firm expects to realize significant profitability in 2024
- OCA-bezafibrate mixture making appreciable progress; enrollment of each Section 2 research accomplished; Firm expects to have obligatory information to submit request in 2023 for Finish-of-Section 2 assembly with FDA
- Firm to host convention name at present at
8:30 a.m. ET
“Intercept delivered sturdy double-digit progress of Ocaliva for the fourth consecutive quarter and made appreciable progress with the OCA-bezafibrate mixture program, together with presenting optimistic new information that recommend best-in-class potential,” mentioned
Chosen Second Quarter 2023 Highlights
- Intercept acknowledged
$83.7 millionin web gross sales within the second quarter 2023, representing 17% progress in comparison with $71.8 millionin web gross sales within the prior yr quarter.
- Within the quarter ended
June 30, 2023, Intercept recorded $90.8 millionin complete working bills and $84.5 millionin non-GAAP adjusted working bills, which excludes non-cash stock-based compensation expense of $6.2 millionand depreciation expense of $0.1 million. This compares to the quarter ended on June 30, 2022, the place Intercept recorded $85.1 millionin complete working bills and $79.6 millionin non-GAAP adjusted working bills, which excluded non-cash stock-based compensation expense of $5.4 millionand depreciation expense of $0.1 million.
- Promoting, normal and administrative bills elevated to
$53.3 millionwithin the second quarter of 2023, from $40.0 millionwithin the prior yr quarter. The rise was primarily pushed by funding in NASH launch preparation prices.
- Analysis and growth bills decreased to
$37.3 millionwithin the second quarter of 2023, from $44.8 millionwithin the prior yr quarter. The lower was primarily pushed by the completion of the REVERSE examine and R&D cost-sharing reimbursements.
- References on this press launch to “non-GAAP adjusted working bills” imply our complete working bills, as calculated and offered in accordance with U.S. Typically Accepted Accounting Ideas (“GAAP”), adjusted for the results of two non-cash objects: stock-based compensation and depreciation. See “Non-GAAP Monetary Measures” under. A reconciliation of non-GAAP adjusted working bills to complete working bills for all historic durations offered is included under beneath the heading “Reconciliation of Non-GAAP Adjusted Working Bills to Complete Working Bills.”
- Curiosity expense within the quarters ended June 30, 2023, and 2022 was $2.8 million and $6.7 million, respectively. For the quarters ended
June 30, 2023and 2022, curiosity expense was associated to our Convertible Notes.
- Within the second quarter 2023, Intercept reported a web loss from persevering with operations of
$5.8 million, a lower in comparison with a web loss from persevering with operations of $20.3 millionwithin the second quarter 2022.
- As of
June 30, 2023, Intercept had money, money equivalents, restricted money, and funding debt securities accessible on the market of $415.0 million. As of December 31, 2022, Intercept had money, money equivalents, restricted money, and funding debt securities accessible on the market of roughly $490.9 million.
- The 2023 Convertible Notes matured on
July 1, 2023, upon which the Firm made a money compensation for the full principal quantity due of $109.8 million.
2023 Monetary Steering
- Intercept has up to date its full-year 2023 Ocaliva® web gross sales steerage to
$320-$340 millionfrom $310-$340 million.
June 2023, the Firm lowered 2023 non-GAAP adjusted working expense steerage to $350-$370 million, inclusive of restructuring prices.
- The Firm stays on observe to realize an anticipated web discount in annual non-GAAP adjusted working bills of roughly
$140 million– relative to up to date 2023 non-GAAP adjusted working expense steerage.
June 2023, Intercept introduced an organizational restructuring to considerably cut back working bills, together with discontinuing all nonalcoholic steatohepatitis (NASH)-related funding.
- The Firm has initiated its workforce discount, which impacts most areas of the corporate, and anticipates finishing nearly all of measures by the tip of this yr. The Firm has accomplished the primary wave of notifications, which impacts business and normal & administrative capabilities. Intercept plans to take care of the dimensions of its present subject gross sales group to help the expansion potential of Ocaliva.
- The Firm continues to make progress in closing out the REGENERATE examine. The closeout course of is being actively applied. REGENERATE trial websites have been notified and the method is predicted to be considerably accomplished by the tip of this yr.
Major Biliary Cholangitis (PBC)
- Intercept’s mixture program for OCA, a farnesoid X receptor (FXR) agonist, and bezafibrate, a pan-peroxisome proliferator-activated receptor (pan-PPAR) agonist, has made appreciable progress. The Firm has now accomplished enrollment of each Section 2 research (747-213 / NCT04594694, 747-214 / NCT05239468) which are exploring a variety of therapeutic doses for the mixture of OCA and bezafibrate.
June 23rd, Intercept shared new information on the 2023 European Affiliation for the Examineof the Liver (EASL) Congressfrom a deliberate interim evaluation of Section 2 examine 747-213 assessing enhancements in serum biomarkers of cholestasis in sufferers with PBC after remedy with OCA and bezafibrate. Outcomes confirmed that the mixture of OCA 5-10 mg and bezafibrate 400 mg was efficient in normalizing key biochemical markers related to PBC-induced liver injury.
- The Firm expects to have the required information from the OCA-bezafibrate mixture program to submit a request in 2023 for an Finish-of-Section 2 assembly with the FDA. These information embody analyses from each Section 2 research, along with Section 1 and preclinical information.
- Intercept stays on observe for its sNDA submission to the FDA this yr in help of fulfilling post-marketing necessities for Ocaliva in PBC. This submission will embody information from the Firm’s post-marketing examine, COBALT, and supplementary real-world proof from giant datasets within the
- The Firm continues to progress its FRESH (FXR Impact on Extreme Alcohol-Related Hepatitis) examine, a Section 2a trial evaluating the security, tolerability, efficacy and pharmacokinetics of INT-787 in sufferers with extreme alcohol-associated hepatitis (sAH).
Convention Name on August 2, 2023, at 8:30 a.m. ET
The convention name and webcast discussing the Firm’s second quarter 2023 monetary outcomes will happen on August 2, 2023, at 8:30 a.m. ET. The convention name shall be accessible through a listen-only webcast on the investor web page of our web site at . Individuals who want to ask a query might register right here to obtain dial-in numbers and a novel pin to affix the decision. A replay of the decision shall be accessible on our web site shortly following the completion of the decision and shall be accessible for one yr.
Intercept is a biopharmaceutical firm centered on the event and commercialization of novel therapeutics to deal with uncommon and critical liver ailments, together with main biliary cholangitis (PBC) and extreme alcohol-associated hepatitis (sAH). For extra data, please go to www.interceptpharma.com or join with the Firm on Twitter and LinkedIn.
Non-GAAP Monetary Measures
This press launch presents non-GAAP adjusted working bills on a historic and projected foundation. For the durations offered, non-GAAP adjusted working bills exclude from complete working bills, as calculated and offered in accordance with GAAP, the results of two non-cash objects: stock-based compensation and depreciation. Non-GAAP adjusted working bills is a monetary measure that has not been ready in accordance with GAAP. Accordingly, buyers ought to contemplate non-GAAP adjusted working bills along with, however not as an alternative choice to, complete working bills that we calculate and current in accordance with GAAP. Amongst different issues, our administration makes use of non-GAAP adjusted working bills to determine budgets and operational targets and to handle our enterprise. Different firms might outline or use this measure in several methods. We imagine that the presentation of non-GAAP adjusted working bills gives buyers and administration with useful supplemental data referring to working efficiency and tendencies. A desk reconciling non-GAAP adjusted working bills to complete working bills for all historic durations offered is included under beneath the heading “Reconciliation of Non-GAAP Adjusted Working Bills to Complete Working Bills”. A quantitative reconciliation of projected non-GAAP adjusted working bills to complete working bills will not be accessible with out unreasonable effort primarily because of our incapability to foretell with cheap certainty the quantity of future stock-based compensation expense.
In regards to the Investigational OCA-bezafibrate Mounted-Dose Mixture
Intercept is investigating a fixed-dose mixture of OCA and bezafibrate for the potential remedy of people with PBC. OCA, a farnesoid X receptor (FXR) agonist, is marketed by Intercept as Ocaliva in america for the remedy of PBC (see under for full indication and Essential Security Data). Bezafibrate, a pan-peroxisome proliferator-activated receptor (pan-PPAR) agonist, will not be accepted in the United States for any indication.
FXR and PPAR are distinct pathways that every play a task in PBC. Concurrently concentrating on each pathways might supply the best potential to affect bile acid synthesis, metabolism, and clearance that underly cholestatic liver ailments. Printed research set up a medical proof-of-concept which means that the mixture of OCA and bezafibrate might present additive medical efficacy and tolerability advantages within the remedy of PBC. OCA-bezafibrate mixture remedy is investigational; security and efficacy haven’t been established.
About Major Biliary Cholangitis
Major biliary cholangitis (PBC) is a uncommon, progressive and continual autoimmune illness that impacts the bile ducts within the liver and is most prevalent (roughly 1 in 10,000) in ladies over the age of 40. PBC causes bile acid to construct up within the liver, leading to irritation and scarring (fibrosis), which, if left untreated, can result in cirrhosis, a liver transplant, or dying.
About Ocaliva® (obeticholic acid)
OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the remedy of grownup sufferers with main biliary cholangitis (PBC)
- with out cirrhosis or
- with compensated cirrhosis who shouldn’t have proof of portal hypertension,
both together with ursodeoxycholic acid (UDCA) with an insufficient response to UDCA or as monotherapy in sufferers unable to tolerate UDCA.
This indication is accepted beneath accelerated approval primarily based on a discount in alkaline phosphatase (ALP). An enchancment in survival or disease-related signs has not been established. Continued approval for this indication could also be contingent upon verification and outline of medical profit in confirmatory trials.
IMPORTANT SAFETY INFORMATION
WARNING: HEPATIC DECOMPENSATION AND FAILURE IN PRIMARY BILIARY CHOLANGITIS PATIENTS WITH CIRRHOSIS
- Hepatic decompensation and failure, typically deadly or leading to liver transplant, have been reported with OCALIVA remedy in main biliary cholangitis (PBC) sufferers with both compensated or decompensated cirrhosis.
- OCALIVA is contraindicated in PBC sufferers with decompensated cirrhosis, a previous decompensation occasion, or with compensated cirrhosis who’ve proof of portal hypertension.
- Completely discontinue OCALIVA in sufferers who develop laboratory or medical proof of hepatic decompensation; have compensated cirrhosis and develop proof of portal hypertension, or expertise clinically important hepatic antagonistic reactions whereas on remedy.
OCALIVA is contraindicated in sufferers with:
- decompensated cirrhosis (e.g., Baby-Pugh Class B or C) or a previous decompensation occasion
- compensated cirrhosis who’ve proof of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia)
- full biliary obstruction
Warnings and Precautions
Hepatic Decompensation and Failure in PBC Sufferers with Cirrhosis
Hepatic decompensation and failure, typically deadly or leading to liver transplant, have been reported with OCALIVA remedy in PBC sufferers with cirrhosis, both compensated or decompensated. Amongst post-marketing circumstances reporting it, median time to hepatic decompensation (e.g., new onset ascites) was 4 months for sufferers with compensated cirrhosis; median time to a brand new decompensation occasion (e.g., hepatic encephalopathy) was 2.5 months for sufferers with decompensated cirrhosis.
A few of these circumstances occurred in sufferers with decompensated cirrhosis once they had been handled with greater than the beneficial dosage for that affected person inhabitants; nevertheless, circumstances of hepatic decompensation and failure have continued to be reported in sufferers with decompensated cirrhosis even once they obtained the beneficial dosage.
Hepatotoxicity was noticed within the OCALIVA medical trials. A dose-response relationship was noticed for the prevalence of hepatic antagonistic reactions together with jaundice, worsening ascites, and first biliary cholangitis flare with dosages of OCALIVA of 10 mg as soon as day by day to 50 mg as soon as day by day (as much as 5-times the best beneficial dosage), as early as one month after beginning remedy with OCALIVA in two 3-month, placebo-controlled medical trials in sufferers with primarily early stage PBC.
Routinely monitor sufferers for development of PBC, together with hepatic antagonistic reactions, with laboratory and medical assessments to find out whether or not drug discontinuation is required. Intently monitor sufferers with compensated cirrhosis, concomitant hepatic illness (e.g., autoimmune hepatitis, alcoholic liver illness), and/or with extreme intercurrent sickness for brand spanking new proof of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia), or will increase above the higher restrict of regular in complete bilirubin, direct bilirubin, or prothrombin time to find out whether or not drug discontinuation is required. Completely discontinue OCALIVA in sufferers who develop laboratory or medical proof of hepatic decompensation (e.g., ascites, jaundice, variceal bleeding, hepatic encephalopathy), have compensated cirrhosis and develop proof of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia), expertise clinically important hepatic antagonistic reactions, or develop full biliary obstruction. If extreme intercurrent sickness happens, interrupt remedy with OCALIVA and monitor the affected person’s liver perform. After decision of the intercurrent sickness, contemplate the potential dangers and advantages of restarting OCALIVA remedy.
Extreme pruritus was reported in 23% of sufferers within the OCALIVA 10 mg arm, 19% of sufferers within the OCALIVA titration arm, and seven% of sufferers within the placebo arm in a 12-month double-blind randomized managed medical trial of 216 sufferers. Extreme pruritus was outlined as intense or widespread itching, interfering with actions of day by day dwelling, or inflicting extreme sleep disturbance, or insupportable discomfort, and sometimes requiring medical interventions. Think about medical analysis of sufferers with new onset or worsening extreme pruritus. Administration methods embody the addition of bile acid binding resins or antihistamines, OCALIVA dosage discount, and/or non permanent interruption of OCALIVA dosing.
Discount in HDL-C
Sufferers with PBC typically exhibit hyperlipidemia characterised by a big elevation in complete ldl cholesterol primarily because of elevated ranges of high-density lipoprotein-cholesterol (HDL-C). Dose-dependent reductions from baseline in imply HDL-C ranges had been noticed at 2 weeks in OCALIVA-treated sufferers, 20% and 9% within the 10 mg and titration arms, respectively, in comparison with 2% within the placebo arm. Monitor sufferers for modifications in serum lipid ranges throughout remedy. For sufferers who don’t reply to OCALIVA after 1 yr on the highest beneficial dosage that may be tolerated (most of 10 mg as soon as day by day), and who expertise a discount in HDL-C, weigh the potential dangers in opposition to the advantages of constant remedy.
The commonest antagonistic reactions (≥5%) are: pruritus, fatigue, stomach ache and discomfort, rash, oropharyngeal ache, dizziness, constipation, arthralgia, thyroid perform abnormality, and eczema.
- Bile Acid Binding Resins
Bile acid binding resins comparable to cholestyramine, colestipol, or colesevelam adsorb and cut back bile acid absorption and will cut back the absorption, systemic publicity, and efficacy of OCALIVA. If taking a bile acid binding resin, take OCALIVA no less than 4 hours earlier than or 4 hours after taking the bile acid binding resin, or at as nice an interval as doable.
The Worldwide Normalized Ratio (INR) decreased following coadministration of warfarin and OCALIVA. Monitor INR and alter the dose of warfarin, as wanted, to take care of the goal INR vary when co-administering OCALIVA and warfarin.
- CYP1A2 Substrates with Slim Therapeutic Index
Obeticholic acid might enhance the publicity to concomitant medication which are CYP1A2 substrates. Therapeutic monitoring of CYP1A2 substrates with a slim therapeutic index (e.g., theophylline and tizanidine) is beneficial when co-administered with OCALIVA.
- Inhibitors of Bile Salt Efflux Pump
Keep away from concomitant use of inhibitors of the bile salt efflux pump (BSEP) comparable to cyclosporine. Concomitant medicines that inhibit canalicular membrane bile acid transporters such because the BSEP might exacerbate accumulation of conjugated bile salts together with taurine conjugate of obeticholic acid within the liver and lead to medical signs. If concomitant use is deemed obligatory, monitor serum transaminases and bilirubin.
Please click on right here for
To report SUSPECTED ADVERSE REACTIONS, contact Intercept Prescribed drugs, Inc. at 1-844-782-ICPT or FDA at 1-800-FDA-1088 or .
Cautionary Notice Relating to Ahead-Wanting Statements
This press launch incorporates forward-looking statements, together with, however not restricted to, statements relating to:
- the progress, timing, and outcomes of our medical trials;
- the security and efficacy of our accepted product, Ocaliva (obeticholic acid or “OCA”) for main biliary cholangitis (“PBC”), and our product candidates;
- the timing, acceptance, evaluate, suggestions, and potential approval for our regulatory filings with the
U.S. Meals and Drug Administration(the “FDA”) or different regulators;
- the business prospects of our merchandise or product candidates;
- our deliberate company restructuring; and
- our technique, future operations, future monetary place, future income, projected prices, monetary steerage, prospects, plans, and targets.
These statements represent forward-looking statements throughout the that means of Part 27A of the Securities Act of 1933, as amended, and Part 21E of the Securities Alternate Act of 1934, as amended. The phrases “anticipate,” “imagine,” “estimate,” “anticipate,” “intend,” “might,” “plan,” “predict,” “mission,” “goal,” “potential,” “will,” “would,” “might,” “ought to,” “doable,” “proceed,” and comparable expressions are meant to establish forward-looking statements, though not all forward-looking statements comprise these figuring out phrases. Readers are cautioned to not place undue reliance on these forward-looking statements, which communicate solely as of their dates, and we undertake no obligation to replace any forward-looking assertion besides as required by regulation.
These forward-looking statements are primarily based on estimates and assumptions by our administration that, though believed to be cheap, are inherently unsure and topic to numerous dangers.
The next characterize some, however not essentially all, of the elements that might trigger precise outcomes to vary materially from historic outcomes or these anticipated or predicted by our forward-looking statements:
- the success of our present enterprise and operations, together with Ocaliva for PBC;
- our capability to efficiently commercialize our merchandise and product candidates;
- our capability to take care of our regulatory approval of Ocaliva for PBC;
- our capability to well timed and cost-effectively file for and acquire regulatory approval of our product candidates on an accelerated foundation or in any respect;
- any advisory committee suggestion or dispute decision willpower that any of our merchandise or product candidates shouldn’t be accepted, or must be accepted solely beneath sure circumstances;
- any future willpower that the regulatory purposes and subsequent data that we submit for our merchandise and product candidates don’t comprise enough medical or different information or meet relevant regulatory necessities for approval;
- circumstances which may be imposed by regulatory authorities on our advertising approvals for our merchandise and product candidates, comparable to the necessity for medical outcomes information (and never simply outcomes primarily based on achievement of a surrogate endpoint), any threat mitigation packages comparable to a Threat Analysis and Mitigation Methods (“REMS”) program, and any associated restrictions, limitations, and/or warnings contained within the labels of any of our merchandise or product candidates;
- any potential negative effects related to Ocaliva for PBC or our different merchandise or product candidates that might delay or forestall approval, require that an accepted product be taken off the market, require the inclusion of security warnings or precautions, or in any other case restrict the sale of such product or product candidate;
- the initiation, timing, value, conduct, progress, and outcomes of our analysis and growth actions, preclinical research, and medical trials, together with any points, delays, or failures in figuring out sufferers, enrolling sufferers, treating sufferers, retaining sufferers, assembly particular endpoints, or finishing and well timed reporting the outcomes of our medical trials;
- the outcomes of interactions with regulators, together with the FDA, relating to our medical trials;
- our capability to determine and keep relationships with, and the efficiency of, third-party producers, contract analysis organizations, and different distributors upon whom we’re considerably dependent for, amongst different issues, the manufacture and provide of our merchandise, together with Ocaliva for PBC, and our medical trial actions;
- our capability to establish, develop, and efficiently commercialize our merchandise and product candidates;
- our capability to acquire and keep mental property safety for our merchandise and product candidates, together with our capability to cost-effectively file, prosecute, defend, and implement any patent claims or different mental property rights;
- the scale and progress of the markets for our merchandise and product candidates, and our capability to serve these markets;
- the diploma of market acceptance of Ocaliva for PBC or our different merchandise or product candidates amongst physicians, sufferers, and healthcare payors;
- the supply of enough protection and reimbursement from governmental and personal healthcare payors for our merchandise, together with Ocaliva for PBC, and our capability to acquire enough pricing for such merchandise;
- our capability to determine and keep efficient gross sales, advertising, and distribution capabilities, both straight or by way of collaborations with third events;
- competitors from present medication or new medication that turn into accessible;
- our capability to draw and retain key personnel to handle our enterprise successfully;
- our capability to forestall or defend in opposition to system failures or safety or information breaches because of cyber-attacks, or cyber intrusions, together with ransomware, phishing assaults, and different malicious intrusions;
- our capability to adjust to information safety legal guidelines;
- prices and outcomes referring to any disputes, governmental inquiries or investigations, regulatory proceedings, authorized proceedings, or litigation, together with any securities, mental property, employment, product legal responsibility, or different litigation;
- our collaborators’ election to pursue analysis, growth, and commercialization actions;
- our capability to determine and keep relationships with collaborators with growth, regulatory, and commercialization experience;
- our want for, and skill to generate or receive, further financing;
- our estimates relating to future bills, revenues, and capital necessities, and the accuracy thereof;
- our use of money, money equivalents, and short-term investments;
- our capability to amass, license, and spend money on companies, applied sciences, product candidates, and merchandise;
- our capability to handle our operations, infrastructure, personnel, techniques, and controls, together with our deliberate company restructuring;
- our capability to acquire and keep enough insurance coverage protection;
- the affect of normal financial, trade, market, regulatory, or political circumstances;
- how we use our money available, in addition to money equivalents and funding securities;
- disagreements or authorized, operational, or different enterprise issues arising from our ongoing relationship with Advanz Pharma and its associates (collectively, “Advanz”), the purchaser of our ex-
U.S.enterprise, together with the licensing of the ex- U.S.rights to Ocaliva for PBC, our operational separation from our former ex- U.S.business operations, and our settlement to produce Advanz with OCA;
- sudden tax, regulatory, litigation, or different liabilities;
- whether or not we obtain any future earn-outs beneath the transaction paperwork with Advanz; and
- the opposite dangers and uncertainties recognized in our periodic filings filed with the U.S. Securities and Alternate Fee (the “SEC”), together with our newest Annual Report on Type 10-Okay and/or Quarterly Report on Type 10-Q.
For extra details about Intercept, please contact:
Condensed Consolidated Statements of Operations
(In 1000’s, besides per share information)
|Three Months Ended
||Six Months Ended
|Product income, web||$||83,718||$||71,757||$||151,676||$||130,903|
|Value of gross sales||185||309||407||532|
|Promoting, normal and administrative||53,346||39,985||111,003||77,739|
|Analysis and growth||37,306||44,826||79,017||92,719|
|Complete working bills||90,837||85,120||190,427||170,990|
|Different revenue (expense):|
|Different revenue (expense), web||4,105||(289||)||6,665||(342||)|
|Loss from persevering with operations||$||(5,826||)||$||(20,321||)||$||(37,707||)||$||(53,771||)|
|(Loss)/Earnings from discontinued operations||$||(36||)||$||12,793||$||(290||)||$||28,959|
|Web revenue/(loss) per widespread and potential widespread share:|
|Web loss from persevering with operations||$||(0.14||)||$||(0.68||)||$||(0.90||)||$||(1.81||)|
|Web (loss)/revenue from discontinued operations||$||–||$||0.43||$||(0.01||)||$||0.97|
|Weighted common widespread and potential widespread shares excellent:|
|Primary and diluted||41,731||29,747||41,700||29,721|
Condensed Consolidated Stability Sheet Data
|Money, money equivalents, restricted money and funding debt securities, accessible on the market||$||414,991||$||490,909|
|Complete liabilities (2)||$||417,089||$||460,634|
|Stockholders’ fairness (deficit)||$||67,546||$||93,077|
|(1)||Derived from the monetary statements included in Intercept’s Annual Report on Type 10-Okay for the interval ended
Reconciliation of Non-GAAP Adjusted Working Bills to Complete Working Bills
|Three Months Ended
||Six Months Ended
|Complete working bills||$||90,837||$||85,120||$||190,427||$||170,990|
|Non-GAAP adjusted working bills||$||84,485||$||79,561||$||178,122||$||181,583|
2023 GlobeNewswire, Inc., supply
|Earnings Flash (ICPT) INTERCEPT PHARMACEUTICALS Stories Q2 Income $83.7M, vs. Road Est of $79.6M||
|Intercept Prescribed drugs, Inc. Stories Earnings Outcomes for the Second Quarter and Six Months Ended June 30, 2023||
|Intercept Prescribed drugs Offers Web Gross sales Steering for the Full Yr of 2023||
|North American Morning Briefing: Financial institution Leads to -2-||
|HC Wainwright Double Upgrades Intercept Prescribed drugs to Purchase From Promote, Raises Value Goal to $19 From $8; Shares up 12% Premarket||
|North American Morning Briefing: Inventory Futures -2-||
|Traders aren’t fazed by price hikes anymore|
|Canaccord Genuity Upgrades Intercept Prescribed drugs to Purchase From Maintain||
|ANALYST RECOMMENDATIONS : Ashtead, Beaze Houses, Hibbett, Micron, Viad…|
|RBC Trims PT on Intercept Prescribed drugs to $13 From $14 as Expense Cuts Look ‘Much less Sharp’ Than Agency Anticipated; Sector Carry out Stored||
|Sector Replace: Well being Care Shares Decrease Late Friday||
|Sector Replace: Well being Care Shares Blended in Afternoon Buying and selling||
|Transcript : Intercept Prescribed drugs, Inc. – Particular Name||
|Intercept Prescribed drugs Plans to Minimize Roughly 33% of Workforce||
|Intercept Prescribed drugs, Inc. Presents New Knowledge Displaying Vital Impression of OCA-Bezafibrate Mixture on Normalization of A number of Biomarkers of PBC-Induced Liver Harm||
|Intercept to Minimize Workforce in Q3, Discontinue NASH-Associated Funding; Examine of 747-213 for Biliary Cholangitis Mentioned ‘Efficient’||
|Intercept Pharma Discontinues NASH-Associated Funding, Will Give attention to Liver Ailments||
|US FDA declines to approve Intercept’s fatty liver illness drug||
|Sector Replace: Well being Care Shares Slipping Late Wednesday||
|Sector Replace: Well being Care Shares Falling Wednesday Afternoon||
|Intercept Prescribed drugs Says Investigational Mixture Reveals ‘Therapeutic Potential’ in Major Biliary Cholangitis Trial||
|Intercept Prescribed drugs, Inc. Pronounces New Knowledge Displaying Potential of Mounted-Dose Mixture of OCA and Bezafibrate to Normalize A number of Biomarkers in PBC to be Featured in Podium Presentation at EASL Congress 2023||
|Akero says NASH drug proven to cut back liver fats by 65% in some sufferers||
|Lupin Will get US FDA’s Approval for Generic Major Biliary Cholangitis Drug||
|B. Riley Cuts Intercept Prescribed drugs’ PT to $15 From $30, Updates Mannequin After FDA Advisory Panel Denies NASH Accelerated Approval; Retains Purchase Score||
Intercept Prescribed drugs, Inc. is a biopharmaceutical firm that’s centered on the event and commercialization of therapeutics to deal with progressive non-viral liver ailments with unmet medical want using its bile acid chemistry. Its product candidates embody Ocaliva (obeticholic (OCA)) for liver fibrosis because of nonalcoholic steatohepatitis (NASH), OCA and Bezafibrate, and Different Product Candidates. The Firm’s marketed product, Ocaliva, is a farnesoid X receptor (FXR) agonist for the remedy of main biliary cholangitis (PBC) together with ursodeoxycholic acid (UDCA) in adults with an insufficient response to UDCA or as monotherapy in adults unable to tolerate UDCA. The Firm is evaluating tolerability of OCA together with bezafibrate in sufferers with PBC in a Section II examine outdoors of america. Its different compounds are in early phases of analysis and growth pipeline together with INT-787 compound, an FXR agonist is in a Section IIa medical trial.
Extra in regards to the firm
Unfold / Common Goal