| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | November 14, 2023 |
| Accession Number: | 0001104659-23-115755 | ||||||
| Submission Type: | POS AM | ||||||
| |||||||
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| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 7/13/2023 | $8.00 → $19.00 | Sell → Buy | H.C. Wainwright |
| 6/29/2023 | $12.00 → $18.00 | Hold → Buy | Canaccord Genuity |
| 5/23/2023 | Buy → Hold | Needham | |
| 5/22/2023 | $8.00 | Neutral → Sell | H.C. Wainwright |
| 5/17/2023 | Outperform → Mkt Perform | Raymond James | |
| 3/8/2022 | $31.00 → $29.00 | Hold | Canaccord Genuity |
| 3/3/2022 | $22.00 → $16.00 | Sector Perform | RBC Capital |
| 3/3/2022 | $30.00 → $25.00 | Buy | Needham |
H.C. Wainwright upgraded Intercept Pharma from Sell to Buy and set a new price target of $19.00 from $8.00 previously
Canaccord Genuity upgraded Intercept Pharma from Hold to Buy and set a new price target of $18.00 from $12.00 previously
Needham downgraded Intercept Pharma from Buy to Hold
4 - INTERCEPT PHARMACEUTICALS, INC. (0001270073) (Issuer)
4 - INTERCEPT PHARMACEUTICALS, INC. (0001270073) (Issuer)
4 - INTERCEPT PHARMACEUTICALS, INC. (0001270073) (Issuer)
MORRISTOWN, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced five abstracts on primary biliary cholangitis (PBC) will be presented at Digestive Disease Week® (DDW) 2024. The conference will be held from May 18-21 in Washington, D.C. "We are pleased to participate in this year's DDW and share our latest findings, including new data from our Phase 2 trial evaluating a fixed-dose combination of obeticholic acid and bezafibrate in patients with PBC," said Sangeeta Sawh
sNDA intended to satisfy post-marketing requirements to confirm a clinical benefit in patients with PBCPrecedent-setting submission includes data from post-marketing studies COBALT and Study 401 as well as real-world evidence from a claims database and patient registriesFDA has assigned a PDUFA target action date of October 15, 2024 MORRISTOWN, N.J., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supple
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. Following the completion of Alfasigma's successful tender offer to purchase all outstanding shares of common stock of Intercept for USD 19.00 per share, net to the seller thereof in cash, without interest, less any applicable withholding of taxes, Alfasigma acquired all remaining shares of common stock of Intercept through a merger pursuant to Section 251(h) of the General Corporation Law of the St
Submission status for INTERCEPT PHARMS INC's drug OCALIVA (SUPPL-8) with active ingredient OBETICHOLIC ACID has changed to 'Approval' on 02/24/2022. Application Category: NDA, Application Number: 207999, Application Classification: Labeling
Submission status for INTERCEPT PHARMS INC's drug OCALIVA (SUPPL-7) with active ingredient OBETICHOLIC ACID has changed to 'Approval' on 05/26/2021. Application Category: NDA, Application Number: 207999, Application Classification: Labeling
-Mr. Bradbury has over 35 years of experience leading fast-growing life sciences companies- Persephone Biosciences Inc., a biotechnology company reimagining patient health through the development of microbiome-based medicines, today announced that it has appointed Daniel Bradbury as Chair of the Board of Directors. "We are delighted to welcome Dan to our Board. His appointment reflects the recent progress we have made with our MyBabyBiome™ study of infant gut health, and our near-term plans to commercialize our first product based on the findings. Additionally, Persephone has a further two clinical studies underway, namely our ARGONAUT study of gut microbiome-linked immune modulation in
NEW YORK, June 09, 2021 (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, today announced the appointment of M. Michelle Berrey, M.D., M.P.H., as President of Research & Development and Chief Medical Officer. “Dr. Berrey brings a wealth of leadership experience in drug development and executive management to Intercept, and I am very pleased to welcome her to the team,” said Jerry Durso, President and Chief Executive Officer of Intercept. “She joins us at a pivotal time for the company as we continue to drive our foundational PB
NEW YORK, Feb. 23, 2021 (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, today announced the appointment of Dagmar Rosa-Bjorkeson to its Board of Directors as of April 1, 2021. Ms. Rosa-Bjorkeson has more than 25 years of global experience in the pharmaceutical industry, including executive leadership positions in corporate and product strategy, market development and operational execution. She is currently the Chief Operating Officer of Mesoblast Limited. Ms. Rosa-Bjorkeson has led multiple successful product launches, inclu
SC 13G/A - INTERCEPT PHARMACEUTICALS, INC. (0001270073) (Subject)
SC 13G/A - INTERCEPT PHARMACEUTICALS, INC. (0001270073) (Subject)
SC 13G/A - INTERCEPT PHARMACEUTICALS, INC. (0001270073) (Subject)
15-12G - INTERCEPT PHARMACEUTICALS, INC. (0001270073) (Filer)
EFFECT - INTERCEPT PHARMACEUTICALS, INC. (0001270073) (Filer)
EFFECT - INTERCEPT PHARMACEUTICALS, INC. (0001270073) (Filer)
MORRISTOWN, N.J., July 26, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, will announce its second quarter 2023 financial results on Wednesday, August 2, 2023. The announcement will be followed by a conference call and audio webcast at 8:30 a.m. ET. Participants can access the conference call live via webcast which will be available on the investor page of the company's website at http://ir.interceptpharma.com. Participants who wish to ask a question may register here to receive dial-in numbers and a unique pin to join the
Company to discontinue all NASH-related investment and restructure the Company's operations to strengthen its focus on rare and serious liver diseasesCompany anticipates achieving profitability in 2024 as a result of planned actionsConference call scheduled for Friday, June 23, 2023, at 8:30 a.m. ET MORRISTOWN, N.J., June 22, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the Company's New Drug Applicat
12 of 16 voting-eligible advisors vote "no" (with two abstentions) on question, "given the available efficacy and safety data, do the benefits of OCA 25 mg outweigh the risks in NASH patients with stage 2 or 3 fibrosis?" 15 of 16 voting-eligible advisors vote to "defer approval until clinical outcome data from trial 747-303 are submitted and reviewed, at which time the traditional approval pathway could be considered" PDUFA Target Action Date set for June 22, 2023 Company to host conference call on Monday, May 22, 2023, at 8:30 a.m. ET MORRISTOWN, N.J., May 19, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development
Monday, Gilead Sciences Inc (NASDAQ:GILD) agreed to acquire CymaBay Therapeutics Inc (NASDAQ:CBAY) for $32.50 per share in cash or a total equity value of $4.3 billion. The addition of CymaBay’s investigational lead product candidate, seladelpar for primary biliary cholangitis (PBC), including pruritus, complements Gilead’s existing liver portfolio. Baird writes that Gilead’s investment in seladelpar for liver disease appears to be a strategically sound move, especially compared to potential investments in oncology. The company’s focus on a space where it has demonstrated commercial success is seen as a positive step to restore confidence in its growth prospects. Despite the m
Data from two Phase 2 studies in PBC show combination of OCA + bezafibrate achieved biochemical remission (normalization of ALP, total bilirubin, GGT, ALT and AST) in 40-44% of patients in the first 12 weeks OCA 5 or 5-10 mg + bezafibrate 400 mg cohorts in both studies showed a >60% reduction from baseline in serum ALP (primary endpoint)Treatment-emergent adverse events were generally balanced across all cohorts in both studiesData support progression to Phase 3 trials of sustained release formulation of bezafibrate with low doses of OCAResults featured in late-breaking poster presentation on Monday, November 13, during The Liver Meeting® 2023MORRISTOWN, N.J., Nov. 13, 2023 (GLOBE NEWSWIRE)
New analysis demonstrates the impact of OCA on achievement of GGT <3.2×ULN and ALP <1.5×ULNFindings suggest that OCA has the potential to reduce the liver biomarker GGT, in addition to well-known effects on ALP, below thresholds that predict improved outcomes, including survival, in PBCData to be featured in poster presentation on Monday, November 13MORRISTOWN, N.J., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly-owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced new data from a sub-analysis of the landmark Phase 3 POISE