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Intercept Pharmaceuticals Inc (ICPT.OQ)

ICPT.OQ on NASDAQ Stock Exchange Global Select Market

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16 Feb 2018
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Latest Key Developments (Source: Significant Developments)

Intercept Pharma Says Sumitomo Dainippon Pharma Enters Into Amendment To Certain License Agreement
Friday, 16 Feb 2018 05:33pm EST 

Feb 16 (Reuters) - Sumitomo Dainippon Pharma Co Ltd <4506.T>::INTERCEPT PHARMA SAYS ON FEB 13, CO, SUMITOMO DAINIPPON PHARMA ENTERED INTO AMENDMENT TO CERTAIN LICENSE AGREEMENT DATED AS OF MARCH 29, 2011.INTERCEPT PHARMACEUTICALS INC - UNDER AMENDMENT, SUMITOMO DAINIPPON AGREED TO RETURN RIGHTS TO DEVELOP AND COMMERCIALIZE OCA IN JAPAN AND KOREA.INTERCEPT PHARMA - AGREED TO FOREGO ANY FURTHER MILESTONE OR ROYALTY PAYMENTS RELATING TO DEVELOPMENT AND COMMERCIALIZATION OF OCA IN JAPAN AND KOREA.INTERCEPT PHARMA - SUMITOMO DAINIPPON WAIVED RIGHTS TO COUNTRY OPTION, PARTIES ADJUSTED CERTAIN MILESTONE PAYMENT OBLIGATIONS REGARDING OCA.INTERCEPT PHARMA - SUMITOMO MAY CHOOSE TO PAY CO MILESTONE PAYMENT OR TERMINATE DEAL IF CERTAIN CLINICAL MILESTONES IN CHINA NOT MET BY DEC 31, 2020.  Full Article

Intercept Announces Updated U.S. Prescribing Information For Ocaliva
Thursday, 1 Feb 2018 09:46am EST 

Feb 1 (Reuters) - Intercept Pharmaceuticals Inc ::INTERCEPT ANNOUNCES UPDATED U.S. PRESCRIBING INFORMATION FOR OCALIVA® (OBETICHOLIC ACID) TO REINFORCE APPROPRIATE DOSING IN PBC PATIENTS WITH ADVANCED CIRRHOSIS.INTERCEPT PHARMACEUTICALS INC - OCALIVA LABEL HAS BEEN REVISED TO INCLUDE A BOXED WARNING.INTERCEPT PHARMACEUTICALS INC - INTERCEPT WILL BE DISSEMINATING UPDATED PRESCRIBING INFORMATION AND A MEDICATION GUIDE FOR PATIENTS.INTERCEPT PHARMACEUTICALS INC - OCALIVA LABEL HAS BEEN REVISED TO INCLUDE A DOSING TABLE THAT REINFORCE EXISTING DOSING SCHEDULE FOR CERTAIN PATIENTS.INTERCEPT PHARMACEUTICALS INC - U.S. FOOD AND DRUG ADMINISTRATION HAS ISSUED AN UPDATED DRUG SAFETY COMMUNICATION TO ACCOMPANY LABEL.INTERCEPT PHARMACEUTICALS INC - UPDATED LABEL REINFORCES POSITIVE BENEFIT-RISK PROFILE OF OCALIVA WHEN USED AS DIRECTED.INTERCEPT PHARMACEUTICALS - TABLE IS INCLUDED IN UPDATED PRESCRIBING INFORMATION TO INCREASE PROMINENCE OF RECOMMENDED OCALIVA DOSAGE BY DISEASE STAGE.INTERCEPT PHARMA - TABLE INCLUDED UPDATED PRESCRIBING INFORMATION TO INCREASE PROMINENCE OF RECOMMENDED OCALIVA DOSAGE BY CHILD-PUGH CLASSIFICATION.INTERCEPT PHARMACEUTICALS - ALSO WORKING WITH EMA TO UPDATE OCALIVA EUROPEAN SMPC TO REINFORCE APPROPRIATE DOSING IN PATIENTS WITH ADVANCED CIRRHOSIS.INTERCEPT - CO'S RECENT ASSESSMENT OF POSTMARKETING DATA DID NOT ESTABLISH CAUSAL RELATIONSHIP BETWEEN OCALIVA&LIVER DECOMPENSATION &/LIVER FAILURE.  Full Article

Intercept Pharma Says Shifting Guidance For Announcement Of Phase 3 Reverse Trial In Nash Patients With Compensated Cirrhosis To Q1 2018
Thursday, 28 Dec 2017 07:35am EST 

Dec 28 (Reuters) - Intercept Pharmaceuticals Inc ::INTERCEPT PHARMA SAYS SHIFTING GUIDANCE FOR ANNOUNCEMENT OF PHASE 3 REVERSE TRIAL IN NASH PATIENTS WITH COMPENSATED CIRRHOSIS TO Q1 2018 - SEC FILING.  Full Article

Intercept Pharma reports qtrly ‍revenue $41.3 mln vs $5.2 million​
Wednesday, 1 Nov 2017 07:05am EDT 

Nov 1 (Reuters) - Intercept Pharmaceuticals Inc :Intercept Pharmaceuticals reports third quarter 2017 financial results and provides business update.Intercept - ‍non-GAAP adjusted operating expenses for fiscal year ending Dec 31, 2017 will fall in middle of range of $380 million to $420 million​.Intercept Pharmaceuticals - ‍interim analysis in flagship Phase 3 regenerate trial on track to report in H1 2019.Intercept Pharmaceuticals Inc- to streamline operating expenses, decided to deprioritize interest-767 development program for foreseeable future​.Intercept Pharmaceuticals Inc - qtrly ‍rev $41.3 million versus $5.2 million​.Q3 earnings per share view $-3.38, revenue view $37.0 million -- Thomson Reuters I/B/E/S.Intercept Pharmaceuticals inc qtrly net loss per common and potential common share basic and diluted $2.89‍​.  Full Article

Intercept Pharma posts positive results from Phase 2 AESOP trial
Monday, 23 Oct 2017 04:02pm EDT 

Oct 23 (Reuters) - Intercept Pharmaceuticals Inc :Intercept announces positive results from Phase 2 AESOP trial evaluating OCA for the treatment of patients with primary sclerosing cholangitis at The Liver Meeting 2017.Intercept Pharmaceuticals Inc - ‍OCA met primary endpoint of alkaline phosphatase (ALP) reduction at 24 weeks​.  Full Article

Intercept extends strategic partnership with Target PharmaSolutions for Target-Nash
Friday, 13 Oct 2017 09:00am EDT 

Oct 13 (Reuters) - Intercept Pharmaceuticals Inc :Intercept (ICPT) extends strategic partnership with Target PharmaSolutions for Target-Nash.Target PharmaSolutions - Intercept has extended its strategic partnership for Target-Nash to a multi-year agreement​.  Full Article

Intercept Pharmaceuticals comments on Ocaliva safety and dosing in liver disease patients​
Monday, 25 Sep 2017 07:05am EDT 

Sept 25 (Reuters) - Intercept Pharmaceuticals Inc :Intercept Pharmaceuticals Inc comments on Ocaliva (obeticholic acid) safety and dosing in primary biliary cholangitis (PBC) patients​.Intercept Pharmaceuticals - In course of co's post-marketing pharmacovigilance activities, deaths have been reported in pbc patients with moderate or severe hepatic impairment​.Intercept - In analysis performed by co, it concluded that these patients were prescribed once daily doses of Ocaliva, which is seven times higher than recommended weekly dose in such patients.Intercept Pharmaceuticals - Says ‍in addition to DHCP letter, co has taken certain actions to enhance education about appropriate use of ocaliva​.Intercept Pharmaceuticals - Says ‍initiatives include reeducating physicians on label, enhancing monitoring of patients for liver-related adverse reactions​.Intercept Pharmaceuticals - Pursuant to FDA's safety communication, co has begun working with FDA on updates to label to better ensure appropriate and safe use of Ocaliva​.  Full Article

FDA warns about serious liver injury with Ocaliva for rare chronic liver disease
Thursday, 21 Sep 2017 12:20pm EDT 

Sept 21 (Reuters) - U.S. Food and Drug Administration (FDA)::FDA warns about serious liver injury with Ocaliva for rare chronic liver disease.Says Ocaliva (Obeticholic Acid) medicine of Intercept Pharmaceuticals being incorrectly dosed in some patients.  Full Article

Intercept announces positive results from the phase 2 AESOP trial for treatment of patients with primary sclerosing cholangitis
Monday, 31 Jul 2017 07:07am EDT 

July 31 (Reuters) - Intercept Pharmaceuticals Inc :Intercept announces positive results from the phase 2 AESOP trial evaluating OCA for the treatment of patients with primary sclerosing cholangitis.Intercept Pharmaceuticals Inc - ‍OCA met primary endpoint of alkaline phosphatase (ALP) reduction at 24 weeks​.Intercept Pharma - Patients who initiated OCA 5mg with option to titrate to 10mg got statistically significant reduction in alkaline phosphatase versus placebo.  Full Article

Intercept Pharmaceuticals reports qtrly loss per share $3.46
Monday, 31 Jul 2017 07:05am EDT 

July 31 (Reuters) - Intercept Pharmaceuticals Inc :Intercept Pharmaceuticals reports second quarter 2017 financial results and provides business update.Intercept Pharmaceuticals Inc says continues to project non-GAAP adjusted operating expenses of $380 million to $420 million for fiscal year ending December 31, 2017.Intercept Pharmaceuticals Inc says recognized $30.4 million of net sales of Ocaliva for Q2 2017.Qtrly loss per share $3.46.Intercept Pharmaceuticals Inc - Anticipate to initiate phase 2 trial of interest-767 in NASH patients with fibrosis during 2H 2017.Intercept Pharmaceuticals Inc - Anticipate to initiate phase 3 trial in NASH patients with cirrhosis during 2H 2017.  Full Article

BRIEF-Intercept Pharma Says Sumitomo Dainippon Pharma Enters Into Amendment To Certain License Agreement

* INTERCEPT PHARMA SAYS ON FEB 13, CO, SUMITOMO DAINIPPON PHARMA ENTERED INTO AMENDMENT TO CERTAIN LICENSE AGREEMENT DATED AS OF MARCH 29, 2011