Tag Archives: Intercept Pharmaceuticals

Rockley Photonics Progresses Non-Invasive, Optical Blood Glucose Monitoring; Intercept to be Acquired by Alfasigma; EMA to Discuss GLP-1RA-Associated Aspiration Risks; Kallyope Initiates Ph2 trial of Oral Obesity and T2DM Treatment

Four cardiometabolic-related news items have been observed: Rockley Photonics announced it is continuing to make progress on non-invasive glucose sensing with its wearable silicon photonics-based sensor (view press release); Intercept announced it has entered a definitive agreement to be acquired by Alfasigma (view press release); EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will reportedly be discussing aspiration-related risks associated with GLP-1RAs in its September 2023 meeting (view article); and Kallyope announced it initiated a Ph2 trial evaluating K-757 and K-833, oral nutrient receptor agonists, for the treatment of obesity and T2DM (view press release). Below, FENIX provides highlights and insights into the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Lilly Initiates Additional Ph3 Orforglipron Trial; Mounjaro Label Update; Vertex, Amarin, and Intercept Q2 ‘23 Earnings; Glenmark Receives ANDA Approval for 2.5mg and 5mg Saxagliptin; Dario Introduces GLP-1RA Obesity Program; Tandem Initiates Sigi Patch Pump Trial

A series of cardiometabolic-related news items have been observed from Lilly, Vertex, Amarin, Intercept, Glenmark, Dario, and Tandem. Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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ADA 2023 Key Press Releases (June 23)

On the first day of ADA 2023, two cardiometabolic-related news items were observed from BI/Lilly and Intercept. Below, FENIX provides context and analysis for the announcements.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Intercept to Discontinue OCA NASH Development Following Second CRL

Intercept Pharmaceuticals announced it received a CRL from FDA regarding the obeticholic acid (OCA) NDA for the treatment of pre-cirrhotic liver fibrosis due to NASH. According to the press release, FDA indicated in the CRL that any resubmission of an NDA for OCA in NASH would require, at minimum, successful completion of the long-term outcomes phase of the REGENERATE study (view CT.gov record). As a result of the CRL, Intercept has decided to discontinue all NASH-related investment and restructure the company’s operations to strengthen its focus on rare and serious liver diseases. Below, FENIX provides brief thoughts on the CRL and Intercept’s decision.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Novo OASIS 1 Topline Results; Intercept Hosts Post-adcom Update; Lilly Initiates Oral Obesity GLP-1RA Program; May CHMP Agenda

A series of cardiometabolic-related news have been observed: Novo Nordisk announced topline results from its Ph3 oral GLP-1RA obesity trial (OASIS-1), demonstrating 15% weight loss at 68 weeks (view press release); Intercept hosted a company update to discuss the results of the OCA in NASH adcom (webcast); Lilly has initiated the orforglipron pivotal obesity program (view CT.gov record); and the CHMP agenda (view here) for this month’s meeting (May 22-25) has been released. Below FENIX provides highlights and insights into the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

FDA Adcom Strongly Votes Against OCA NASH Approval (2-12-2)

Today, FDA held a Gastrointestinal Drugs Advisory Committee (GIDAC) meeting to discuss the use of Intercept’s obeticholic acid (OCA) for the treatment of pre-cirrhotic liver fibrosis due to NASH, and panelists voted overwhelmingly against (2-12) the OCA benefit/risk profile with two abstentions. The second voting question was consistent whereby the panel voted (15-1) to defer an approval decision until the full REGENERATE (view CT.gov record) data are available. For context, in January 2023, FDA accepted the NDA resubmission for OCA seeking accelerated approval as a Class 2 resubmission and assigned a PDUFA date of June 22, 2023 (previous FENIX insight). Of note, Intercept has halted stock trading today due to the adcom (view press release). Below, FENIX provides key commentary from the adcom panel as well as insight on the future of the asset.

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Intercept Faces Uphill Battle for Impending FDA Adcom; Briefing Documents Released

Briefing documents have been posted (view here) for FDA’s Gastrointestinal Drugs Advisory Committee (GIDAC) meeting to discuss the use of Intercept’s obeticholic acid (OCA) for the treatment of pre-cirrhotic liver fibrosis due to NASH. For context, the OCA adcom is on Friday, May 19, 2023 (previous FENIX insight). Recall, in January 2023, FDA accepted the NDA for OCA seeking accelerated approval as a Class 2 resubmission and assigned a PDUFA date of June 22, 2023 (previous FENIX insight). Of note, Intercept’s stock price decreased as much as -22% in intraday trading following the release of the briefing documents. Below, FENIX provides insight into the potential outcome of the OCA FDA adcom.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Intercept, AZ, and Sanofi Q1 ’23 Earnings; Sanofi Completes Provention Acquisition; DRI Sells Tzield Royalties to Sanofi

Five cardiometabolic-related news items have been observed: Intercept (press release; slides), AstraZeneca (press release; slides), and Sanofi (press release; slides) hosted their respective Q1 ’23 earnings calls; Sanofi announced it has completed its acquisition of Provention Bio (view press release); and DRI Healthcare Trust announced that it has sold its Tzield royalty interests and milestone payment obligations to Sanofi for $210M (view press release). Below, FENIX provides highlights and insights from the call.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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FDA Accepts OCA NASH NDA; Palatin Initiates Ph2b DKD Trial

Two cardiometabolic-related news items have been observed: Intercept announced FDA has accepted the NDA for obeticholic acid (OCA) seeking accelerated approval for the treatment of patients with pre-cirrhotic liver fibrosis due to NASH (view press release); and Palatin Technologies announced that its Ph2b BREAKOUT study (CT.gov record not observed), evaluating melanocortin agonist bremelanotide in DKD, initiated enrollment in December 2022 (view press release). Below, FENIX provides highlights and insights for the respective news items, including commentary on the future of OCA’s NASH indication.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

JPM 2023 Day 4: TNDM, ICPT, LXRX, MNKD, and XERS; Oramed Discontinues Ph3 Development ORMD-0801 in T2DM; Versanis Initiates Ph2b Obesity Trial Enrollment

On the fourth and final day of JPM 2023, FENIX has provided coverage of presentations by other CVRM companies including Tandem, Intercept, Lexicon, MannKind, and Xeris. Separately, two CVRM-related news items have been observed: Oramed announced its oral insulin (ORMD-0801) failed to meet primary and secondary endpoints in the first Ph3 T2DM study, and the company is discontinuing development in T2DM (view press release); and Versanis Bio announced that the BELIEVE Ph2b study evaluating bimagrumab alone and in combination with semaglutide for the treatment of obesity has begun enrolling patients (view press release).

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.