Obeticholic acid

Intercept Announces FDA Acceptance of Supplemental New Drug Application for Ocaliva® (obeticholic acid) for the Treatment of PBC

Retrieved on: 
Thursday, February 29, 2024

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2024.

Key Points: 
  • The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2024.
  • In this communication, the agency informed Intercept that they are planning to hold an Advisory Committee meeting to discuss the application.
  • The precedent-setting sNDA for Ocaliva is intended to satisfy the post-marketing requirements to confirm a clinical benefit in patients with PBC.
  • Intercept and Alfasigma remain committed to supporting people living with PBC and look forward to advancing discussions with the agency.

Intercept Announces New Phase 2 Data Showing Significant Impact of OCA-Bezafibrate Combination on Normalization of Multiple Key Biomarkers of PBC-Induced Liver Damage at AASLD The Liver Meeting® 2023

Retrieved on: 
Monday, November 13, 2023

These data will be presented on Monday, November 13, 2023, at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting® in Boston (poster #5019-C).

Key Points: 
  • These data will be presented on Monday, November 13, 2023, at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting® in Boston (poster #5019-C).
  • One severe TEAE (pruritus, OCA5/B100 IR) occurred in Study 214; no TEAEs led to study discontinuation in Study 214.
  • The Company expects to have the necessary data from the OCA-bezafibrate combination program to submit a request in 2023 for an End-of-Phase 2 meeting with the FDA.
  • These data include analyses from both Phase 2 studies, in addition to Phase 1 and preclinical data.

Alfasigma completes acquisition of Intercept Pharmaceuticals, Inc.

Retrieved on: 
Wednesday, November 8, 2023

BOLOGNA, Italy and MORRISTOWN, N.J., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Alfasigma S.p.A. (“Alfasigma”) and Intercept Pharmaceuticals, Inc. (“Intercept”) announced today the completion of the acquisition of Intercept by Alfasigma through its wholly owned subsidiary Interstellar Acquisition Inc.

Key Points: 
  • BOLOGNA, Italy and MORRISTOWN, N.J., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Alfasigma S.p.A. (“Alfasigma”) and Intercept Pharmaceuticals, Inc. (“Intercept”) announced today the completion of the acquisition of Intercept by Alfasigma through its wholly owned subsidiary Interstellar Acquisition Inc.
  • As a result of the transaction, Intercept has become a wholly owned subsidiary of Alfasigma, and the common stock of Intercept has ceased to be traded on the NASDAQ Stock Market.
  • Stefano Golinelli, Chairman of Alfasigma, commented: “At Alfasigma, the passion we have for Pharmaceuticals is in our DNA - and a driver for our ambitious international growth plans.
  • Francesco Balestrieri, CEO of Alfasigma, added: “Today, we complete a transformational acquisition which strongly aligns with our strategy of building a solid presence in gastroenterology and hepatology, Alfasigma’s core business areas.

Alfasigma completes acquisition of Intercept Pharmaceuticals, Inc.

Retrieved on: 
Wednesday, November 8, 2023

Alfasigma S.p.A. (“Alfasigma”) and Intercept Pharmaceuticals, Inc. ( “Intercept”) announced today the completion of the acquisition of Intercept by Alfasigma through its wholly owned subsidiary Interstellar Acquisition Inc.

Key Points: 
  • Alfasigma S.p.A. (“Alfasigma”) and Intercept Pharmaceuticals, Inc. ( “Intercept”) announced today the completion of the acquisition of Intercept by Alfasigma through its wholly owned subsidiary Interstellar Acquisition Inc.
  • As a result of the transaction, Intercept has become a wholly owned subsidiary of Alfasigma, and the common stock of Intercept has ceased to be traded on the NASDAQ Stock Market.
  • Stefano Golinelli, Chairman of Alfasigma, commented: “At Alfasigma, the passion we have for Pharmaceuticals is in our DNA - and a driver for our ambitious international growth plans.
  • Thus, we are delighted to announce the successful outcome of our tender offer for Intercept Pharmaceuticals, Inc.

Gannex Published Phase I Data of ASC42, a Novel Farnesoid X Receptor Agonist on the Journal Drugs in R&D

Retrieved on: 
Monday, November 6, 2023

In-house developed by Gannex, ASC42 is a novel non-steroidal, selective, potent FXR agonist with best-in-class potential and global intellectual property.

Key Points: 
  • In-house developed by Gannex, ASC42 is a novel non-steroidal, selective, potent FXR agonist with best-in-class potential and global intellectual property.
  • On July 20, 2023, Gannex announced the completion of patient enrollment for Phase II clinical trial of ASC42 for PBC.
  • The Phase II clinical trial of Gannex's in-house developed farnesoid X receptor agonist ASC42 will be completed soon.
  • The topline data of the Phase II clinical trial are expected to be released by the end of 2023.

Seladelpar Granted Revised Breakthrough Therapy Designation for the Treatment of Primary Biliary Cholangitis Including Pruritus in Patients Without Cirrhosis or With Compensated Cirrhosis

Retrieved on: 
Monday, October 23, 2023

Seladelpar is the only potent, selective, orally active PPARδ agonist, or delpar, with phase 3 results demonstrating a statistically significant improvement in PBC-related cholestatic pruritus.

Key Points: 
  • Seladelpar is the only potent, selective, orally active PPARδ agonist, or delpar, with phase 3 results demonstrating a statistically significant improvement in PBC-related cholestatic pruritus.
  • This program was designed by the FDA to help ensure patients gain access to important new therapies through FDA approval as soon as possible.
  • The updated Breakthrough Therapy Designation of seladelpar was granted based on additional evidence provided to the Agency, which supports that seladelpar may provide substantial improvement over existing therapy based on a reduction in alkaline phosphatase (ALP) and pruritus in patients without cirrhosis or with compensated cirrhosis.
  • “A Breakthrough Therapy designation is accompanied by the benefit to submit the NDA on a rolling basis.

CymaBay’s RESPONSE Phase 3 Data Evaluating Seladelpar for Primary Biliary Cholangitis to be Featured in an Oral Late-Breaking Presentation at The Liver Meeting® 2023

Retrieved on: 
Wednesday, October 18, 2023

NEWARK, Calif., Oct. 18, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that a late-breaking presentation highlighting results from the RESPONSE Phase 3 study of seladelpar in patients with primary biliary cholangitis (PBC) will be presented at The Liver Meeting® of the American Association for the Study of Liver Diseases (AASLD), in Boston, MA (November 10th – 14th). Seladelpar is a potent, selective, orally active delpar or PPARδ agonist, in development for the treatment of adult patients with primary biliary cholangitis (PBC).

Key Points: 
  • Seladelpar is a potent, selective, orally active delpar or PPARδ agonist, in development for the treatment of adult patients with primary biliary cholangitis (PBC).
  • The oral presentation titled “Efficacy and Safety of Seladelpar in Patients with Primary Biliary Cholangitis in the RESPONSE Trial: A Phase 3 International, Randomized, Placebo-Controlled Study,”1 will be delivered by Professor Gideon Hirschfield, M.D., Lily and Terry Horner Chair in Autoimmune Liver Disease Research, Toronto Centre for Liver Disease.
  • We are extremely grateful to our team, investigators, and especially patients in the participation and collaboration in this endeavor.
  • Presentations at the Liver Meeting® 2023 include:
    1“Efficacy and Safety of Seladelpar in Patients with Primary Biliary Cholangitis in the RESPONSE Trial: A Phase 3 International, Randomized, Placebo-Controlled Study” (Abstract #5002)
    Congress attendees can visit CymaBay throughout the meeting at booth D3034.

Intercept Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Business Updates

Retrieved on: 
Wednesday, August 2, 2023

Selling, general and administrative expenses increased to $53.3 million in the second quarter of 2023, from $40.0 million in the prior year quarter.

Key Points: 
  • Selling, general and administrative expenses increased to $53.3 million in the second quarter of 2023, from $40.0 million in the prior year quarter.
  • Research and development expenses decreased to $37.3 million in the second quarter of 2023, from $44.8 million in the prior year quarter.
  • In the second quarter 2023, Intercept reported a net loss from continuing operations of $5.8 million, a decrease compared to a net loss from continuing operations of $20.3 million in the second quarter 2022.
  • ET
    The conference call and webcast discussing the Company’s second quarter 2023 financial results will take place on August 2, 2023, at 8:30 a.m.

Intercept Announces Restructuring to Strengthen Focus on Rare and Serious Liver Diseases and Significantly Reduce Operating Expenses

Retrieved on: 
Friday, June 23, 2023

ET

Key Points: 
  • ET
    MORRISTOWN, N.J., June 23, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) today announced a restructuring to strengthen the Company’s focus on rare and serious liver diseases and significantly reduce operating expenses, including discontinuing all nonalcoholic steatohepatitis (NASH)-related investment.
  • Actions taken by Intercept to reduce its operating expenses are projected to result in a workforce reduction of approximately one third of the Company.
  • Intercept expects to initiate workforce reductions in the third quarter of 2023, with the vast majority completed by the end of 2023.
  • Intercept is targeting a net reduction in annual non-GAAP adjusted operating expenses of approximately $140 million.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Intercept Pharmaceuticals, Inc. - ICPT

Retrieved on: 
Sunday, June 18, 2023

NEW YORK, June 17, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Intercept Pharmaceuticals, Inc. (“Intercept” or the “Company”) (NASDAQ: ICPT).

Key Points: 
  • NEW YORK, June 17, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Intercept Pharmaceuticals, Inc. (“Intercept” or the “Company”) (NASDAQ: ICPT).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Intercept and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.