Associated tags: Liver disease, Therapy, Liver, NASH, THR, Medication, Fatty liver disease, Patient, Pharmaceutical industry, Madrigal
Locations: RARE, AST, BONE, WEST CONSHOHOCKEN, PA, US
FDA,
CFO,
EDT,
Liver disease,
Portola Pharmaceuticals,
Safety,
Food,
Security (finance),
Abstract (summary),
Marketing,
MAA,
CHMP,
Fatty liver disease,
Webcast,
Prescription,
NASH,
Therapy,
THR,
F2,
Oral medicine,
Cirrhosis,
Patient,
EMA,
Fibrosis,
Committee,
Diagnosis,
Health,
Standard of care,
Marketing Authorisation Application,
Biotechnology,
Food and Drug Administration,
Pharmaceutical industry Madrigal estimates that approximately 1.5 million patients have been diagnosed with NASH in the U.S., of which approximately 525,000 have NASH with moderate to advanced liver fibrosis.
Key Points:
- Madrigal estimates that approximately 1.5 million patients have been diagnosed with NASH in the U.S., of which approximately 525,000 have NASH with moderate to advanced liver fibrosis.
- Madrigal is focused on the approximately 315,000 diagnosed patients with NASH with moderate to advanced liver fibrosis under the care of specialist physicians.
- The accelerated approval of Rezdiffra was based on results from the Phase 3 MAESTRO-NASH trial, which was published in The New England Journal of Medicine in February 2024.
- At 8 a.m. EDT today, May 7, 2024, the Company will host a webcast to review its financial and operating results and provide a general business update.
Retrieved on:
Wednesday, April 24, 2024
CONSHOHOCKEN, Pa., April 24, 2024 (GLOBE NEWSWIRE) -- The Madrigal team is shocked and saddened to learn of the passing of Dr. Stephen Harrison.
Key Points:
- CONSHOHOCKEN, Pa., April 24, 2024 (GLOBE NEWSWIRE) -- The Madrigal team is shocked and saddened to learn of the passing of Dr. Stephen Harrison.
- We offer our deepest condolences to Stephen’s family for their loss.
- Stephen was a colleague and friend to so many of us at Madrigal.
- Stephen was much more than a brilliant investigator and physician; he was a true leader who inspired all of us with his commitment to patients.
CONSHOHOCKEN, Pa., April 23, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) announced today that it will release its first-quarter 2024 financial results on Tuesday, May 7, 2024, prior to the open of the U.S. financial markets.
Key Points:
- CONSHOHOCKEN, Pa., April 23, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) announced today that it will release its first-quarter 2024 financial results on Tuesday, May 7, 2024, prior to the open of the U.S. financial markets.
- Following the announcement, Madrigal’s management will host a live webcast at 8 a.m. Eastern Time to review the Company’s financial and operating results.
- The live webcast may be accessed at the Investor Relations section of the Madrigal Pharmaceuticals website .
- The webcast will be available approximately two hours after the live webcast.
The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).
Key Points:
- The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).
- The equity awards were granted as inducement material to employees’ acceptance of employment with the company.
- All restricted stock units granted vest in a 25% increment on each of the first through fourth anniversaries of the grant date.
- The vesting of all awards described above shall be subject to each such employee’s continued employment as of the vesting date.
Diagnosis,
Biopsy,
Fatty liver disease,
Cirrhosis,
Exercise,
F2,
Patient,
Prescription,
MD,
Diet,
Fibrosis,
Pharmacy,
NASH,
Therapy,
FDA,
THR,
JD I can finally tell my appropriate patients with moderate to advanced fibrosis that we have an approved treatment to help improve fibrosis and resolve NASH.
Key Points:
- I can finally tell my appropriate patients with moderate to advanced fibrosis that we have an approved treatment to help improve fibrosis and resolve NASH.
- Madrigal is committed to helping appropriate patients who may benefit from Rezdiffra access the medication through the Madrigal Patient Support program.
- This program is designed to help patients navigate insurance and affordability challenges and provide co-pay support for eligible patients.
- Madrigal has also established a patient assistance program (PAP) to help patients with no insurance access Rezdiffra.
The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).
Key Points:
- The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).
- The equity awards were granted as inducement material to employees’ acceptance of employment with the company.
- All restricted stock units granted vest in a 25% increment on each of the first through fourth anniversaries of the grant date.
- The vesting of all awards described above shall be subject to each such employee’s continued employment as of the vesting date.
Montgomery Street,
Fatty liver disease,
UBS,
ECM,
Madison Avenue,
Goldman Sachs,
Form,
Telephone,
Citizenship,
Research,
Sale,
Public expenditure,
Attention,
Security (finance),
Lexington Avenue,
Prospectus,
Suite,
Jefferies,
NASH,
Therapy,
Nicollet Mall,
Equity capital markets,
Jefferies Group,
ATTN:,
Evercore The size of the offering was increased by $100 million subsequent to the initial announcement of the offering.
Key Points:
- The size of the offering was increased by $100 million subsequent to the initial announcement of the offering.
- The gross proceeds to Madrigal from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $600 million.
- Madrigal has granted the underwriters of the offering a 30-day option to purchase up to an additional 346,153 shares of common stock from the company at the public offering price, less underwriting discounts and commissions.
- The offering is expected to close on or about March 21, 2024, subject to the satisfaction of customary closing conditions.
Montgomery Street,
Fatty liver disease,
UBS,
ECM,
Madison Avenue,
Goldman Sachs,
Form,
Telephone,
Citizenship,
Research,
Sale,
Public expenditure,
Attention,
Security (finance),
Lexington Avenue,
Prospectus,
Suite,
Jefferies,
NASH,
Therapy,
Nicollet Mall,
Equity capital markets,
Jefferies Group,
ATTN:,
Evercore Madrigal also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock offered in the public offering at the public offering price, less underwriting discounts and commissions.
Key Points:
- Madrigal also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock offered in the public offering at the public offering price, less underwriting discounts and commissions.
- All of the shares in the proposed offering are to be sold by Madrigal.
- Goldman Sachs & Co. LLC, Jefferies, TD Cowen, Evercore ISI, Piper Sandler, UBS Investment Bank and Citizens JMP are acting as joint bookrunning managers of the proposed offering.
- The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
Diagnosis,
Fatty liver disease,
Cirrhosis,
Exercise,
Entrepreneurship,
Liver disease,
Physician,
F2,
Patient,
Research,
Diet,
Fibrosis,
Drug development,
NASH,
Therapy,
NAFLD,
FDA,
THR,
Food,
Pharmaceutical industry Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.
Key Points:
- Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.
- Bill Sibold, Chief Executive Officer of Madrigal, stated, “NASH with moderate to advanced liver fibrosis is a serious and progressive liver disease that, until now, has not had an FDA-approved therapy.
- Fibrosis improvement and NASH resolution were consistent regardless of age, gender, type 2 diabetes status, or fibrosis stage.
- Madrigal is committed to helping appropriate patients who may benefit from Rezdiffra access the medication through the Madrigal Patient Support program.
The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).
Key Points:
- The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).
- The equity awards were granted as inducement material to Ms. Dier’s and the other employees’ acceptance of employment with the company.
- Ms. Dier received options to purchase 13,353 shares of Madrigal’s common stock, 8,875 time-based restricted stock units and 8,875 market-based performance stock units (“MSUs”).
- All restricted stock units granted vest in a 25% increment on each of the first through fourth anniversaries of the grant date.
