Esperion Therapeutics Azioni (NASDAQ: ESPR)

Ultime notizie per Esperion Therapeutics (NASDAQ:ESPR) Azioni

ESPERION THERAPEUTICS INC

Esperion Therapeutics

Esperion Therapeutics Inc is a pharmaceutical company. It specializes in developing and commercializing accessible, oral, once-daily, non-statin medicines for patients struggling with elevated low-density lipoprotein cholesterol. The firm has the business of researching, developing and commercializing therapies for the treatment of patients with the elevated low-density lipoprotein cholesterol operating segment. Its products include NEXLETOL, NEXLIZET, NILEMDO and NUSTENDI. The company manages its business in one operating segment, which is the business of researching, developing and commercializing therapies for the treatment of patients with elevated LDL-C.

Esperion Therapeutics, Inc. - Common Stock

Esperion Therapeutics Inc

ESPRE TECHNOLOGIES INC B by ESPRE TECHNOLOGIES INC

Espre Technologies Inc

ESPRIT HOLDINS LTD by Esprit Holdings Ltd.

Esprit Holdings Ltd

ESPRIT HLDGS S/ADR by Esprit Holdings Ltd.

Esperion (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ESPR#NASDAQ">ESPR</a>) today announced that it has entered into a settlement agreement with Accord Healthcare Inc. This agreement resolves the patent litigation brought by Esperion against Accord Healthcare Inc. in response to Accord Healthcare Inc's Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of NEXLETOL prior to the expiration of the applicable patents. Pursuant to the agreement, Accord Healthcare Inc. has agreed not to market a generic version of NEXLETOL in the United States prior to April 19, 2040, unless certain limited circumstances customarily included in these types of agreements occur.
The pending patent litigation against the remaining defendants (Alkem Laboratories Ltd.; Aurobindo Pharma Limited (along with an affiliate); Dr. Reddy's Laboratories Inc. (along with an affiliate); MSN Pharmaceuticals Inc. (along with an affiliate); Renata Limited; and Sandoz Inc.) is ongoing, and there can be no assurance whether such ongoing patent litigation will allow a generic version of NEXLETOL and/or NEXLIZET, as applicable, to be marketed in the U.S. prior to April 19, 2040.

Biotech

News

General

ESPR

Esperion Reaches Settlement With Accord Healthcare To Delay U.S. Launch Of Generic NEXLETOL Until At Least April 2040

HC Wainwright &amp; Co. analyst Joseph Pantginis reiterates Esperion Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ESPR#NASDAQ">ESPR</a>) with a Buy and maintains $16 price target.

Price Target

Reiteration

Analyst Ratings

HC Wainwright & Co. Reiterates Buy on Esperion Therapeutics, Maintains $16 Price Target

Esperion (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ESPR#NASDAQ">ESPR</a>) today announced that it has entered into a settlement agreement with Hetero USA, Inc. and its affiliates Hetero Labs Limited, Hetero Labs Limited Unit-V, and Honour Lab Limited (together, Hetero USA). This agreement resolves the patent litigation brought by Esperion against Hetero USA in response to Hetero USA' s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of NEXLETOL prior to the expiration of the applicable patents. Pursuant to the agreement, Hetero USA has agreed not to market a generic version of NEXLETOL in the United States prior to April 19, 2040, unless certain limited circumstances customarily included in these types of agreements occur.
The pending patent litigation against the remaining defendants (Accord Healthcare Inc; Alkem Laboratories Ltd.; Aurobindo Pharma Limited (along with an affiliate); Dr. Reddy's Laboratories Inc. (along with an affiliate); MSN Pharmaceuticals Inc. (along with an affiliate); Renata Limited; and Sandoz Inc.) is ongoing, and there can be no assurance whether such ongoing patent litigation will allow a generic version of NEXLETOL and/or NEXLIZET, as applicable, to be marketed in the U.S. prior to April 19, 2040.

Legal

Esperion Reaches Settlement With Hetero USA To Delay Generic NEXLETOL Launch Until 2040, While Patent Litigation Against Additional Generic Challengers Remains Ongoing

Esperion (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ESPR#NASDAQ">ESPR</a>) today announced that it has entered into a settlement agreement with Micro Labs USA, Inc. and its affiliate Micro Labs Limited (together, Micro Labs). This agreement resolves the patent litigation brought by Esperion against Micro Labs in response to Micro Labs' Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of NEXLETOL prior to the expiration of the applicable patents. Pursuant to the agreement, Micro Labs has agreed not to market a generic version of NEXLETOL in the United States prior to April 19, 2040, unless certain limited circumstances customarily included in these types of agreements occur.
The pending patent litigation against the remaining defendants (Accord Healthcare Inc; Alkem Laboratories Ltd.; Aurobindo Pharma Limited (along with an affiliate); Dr. Reddy's Laboratories Inc. (along with an affiliate); Hetero USA Inc. (along with affiliates); MSN Pharmaceuticals Inc. (along with an affiliate); Renata Limited; and Sandoz Inc.) is ongoing, and there can be no assurance whether such ongoing patent litigation will allow a generic version of NEXLETOL and/or NEXLIZET, as applicable, to be marketed in the U.S. prior to April 19, 2040.

Esperion Settles Patent Litigation with Micro Labs, Preventing Generic NEXLETOL Launch Before 2040

– These cardiovascular medicines have the potential to address a significant unmet medical need for over half a million Canadians
– HLS will leverage existing organizational capabilities and commercial infrastructure
– Already approved and commercially available in the U.S. and Europe,&nbsp;NEXLETOL/NEXLIZET are under regulatory review in Canada with a decision expected later this year
– Deal terms include $1 million paid upfront and additional milestone payments tied to achievement of regulatory, pricing, reimbursement and commercial sales objectives
TORONTO, May 8, 2025 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX:<a class="ticker" href="https://www.benzinga.com/stock/HLS#TSX">HLS</a>), a pharmaceutical company focused on addressing unmet needs in the treatment of psychiatric disorders and cardiovascular disease, announces that it has entered into an agreement with Esperion Therapeutics Inc. ("Esperion") (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ESPR#NASDAQ">ESPR</a>) to in-license and commercialize NEXLETOL&#xAE; (bempedoic acid) and NEXLIZET&#xAE; (bempedoic acid and ezetimibe) in Canada. All financial figures are in U.S. dollars unless otherwise stated.
In Q4 2024, Esperion submitted New Drug Submissions to Health Canada for both NEXLETOL and NEXLIZET1. Under this agreement, HLS will be responsible for obtaining Health Canada approval, which is expected by the end of 2025. NEXLETOL and NEXLIZET are oral medications currently available in the U.S. and several European countries. Initially approved by the U.S. Food and Drug Administration in 2020 to help reduce low-density lipoprotein cholesterol ("LDL-C") levels, their labels were expanded in 2024 to include broader indications for cardiovascular risk reduction in patients who are unable to take recommended statin therapy, supported by data from the CLEAR Outcomes trial.
Current estimates suggest there are over half a million Canadians who could potentially benefit from NEXLETOL or NEXLIZET. This includes patients with elevated LDL-C levels and who are either statin intolerant or who are not at their LDL-C goal despite being on combination therapy with statins and ezetimibe. &nbsp;&nbsp;

TSX:HLS

HLS Therapeutics Agrees With Esperion Therapeutics To In-License And Commercialize NEXLETOL And NEXLIZET In Canada

Needham analyst Serge Belanger maintains Esperion Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ESPR#NASDAQ">ESPR</a>) with a Buy and lowers the price target from $5 to $4.

Needham Maintains Buy on Esperion Therapeutics, Lowers Price Target to $4

Esperion Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ESPR#NASDAQ">ESPR</a>) reported quarterly losses of $(0.21) per share which missed the analyst consensus estimate of $(0.15) by 40 percent. This is a 161.76 percent decrease over earnings of $0.34 per share from the same period last year. The company reported quarterly sales of $65.00 million which beat the analyst consensus estimate of $54.34 million by 19.61 percent. This is a 52.81 percent decrease over sales of $137.74 million the same period last year.

Earnings

Earnings Beats

Earnings Misses

Esperion Therapeutics Q1 EPS $(0.21) Misses $(0.15) Estimate, Sales $65.00M Beat $54.34M Estimate

ACLS

AHCO

ALAB

ALGS

ALGT

AMTM

ANDE

ANET

ANGI

ARDT

ARIS

ARMK

ARQT

ARRY

ATKR

ATOM

ATRO

AUDC

AVNS

AVNT

AVNW

AZEK

BALL

BBNX

BCAB

BLDP

BRLT

BWIN

BWMN

CCCS

CCLD

CDRE

CELH

CGAU

CGBD

CHMI

CHRD

CIFR

CIGI

CLDT

CLOV

COTY

CPAY

CPIX

CPNG

CRCT

CRIS

CRMD

CRSR

CRUS

CURI

CVGI

CXDO

CYTK

DASH

DAWN

DDOG

DOCN

DRCT

DRVN

DVAX

ENLT

EOSE

Embraer-Empresa Brasileira De Aeronautica

EVGO

Earnings Scheduled For May 6, 2025

Needham analyst Serge Belanger reiterates Esperion Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ESPR#NASDAQ">ESPR</a>) with a Buy and maintains $5 price target.

Needham Reiterates Buy on Esperion Therapeutics, Maintains $5 Price Target

– Expands Development Portfolio with Introduction of a Novel Program Targeting PSC –
– Confirms Highly Specific Allosteric ACLY Inhibitor Shown to Reduce Liver Injury, Inflammation and Fibrosis Across Multiple PSC-Relevant Pre-Clinical Models –
– Demonstrates Internal R&amp;D Capabilities with Wholly Owned, Next-Generation Candidates Targeting Liver and Kidney Disease –
– Esperion to Webcast R&amp;D Day Event Today at 9:00 a.m. ET –
Esperion (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ESPR#NASDAQ">ESPR</a>) today announced that the Company plans to highlight new research supporting its lead development candidates for the treatment of primary sclerosing cholangitis (PSC), a rare and progressive liver disease, today at 9:00 a.m. ET in New York City. A live webcast of the event will also be available. These candidates are novel allosteric inhibitors of ATP citrate lyase (ACLY), a key metabolic enzyme with emerging relevance in hepatic inflammation and fibrosis.
"We are leveraging our deep expertise in ACLY biology to expand our portfolio beyond NEXLETOL&#xAE; (bempedoic acid)/NEXLIZET&#xAE; (bempedoic acid and ezetimibe) and to address the urgent needs of patients living with PSC," said Sheldon Koenig, Chief Executive Officer at Esperion. "Our lead candidates, including ESP-1336, are promising, potential first-in-class allosteric ACLY inhibitors, well-characterized with significant preclinical data, and represent a natural extension of our metabolic franchise. PSC is a rare and progressive liver disease with no approved therapies proven to slow or halt its progression. Our next-generation ACLY inhibitor discovery program was purpose-built to improve potency, selectivity, and guide indication and patient population selection through data-driven innovation."
"ACLY is a promising target in hepatic disease, given its central role in metabolic regulation," said David E. Cohen MD, PhD, Chief, Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital. "By modulating acetyl-coenzyme A (acetyl-CoA) levels in multiple hepatobiliary cell types, these inhibitors may disrupt key disease-driving pathways in PSC, offering a potentially transformative approach to treatment."

Esperion Announces The Company Plans To Highlight New Research Supporting Its Lead Development Candidates For The Treatment Of Primary Sclerosing Cholangitis April 24, 2025 Today At 9:00 AM ET In New York City. Also Expands Portfolio With Introduction Of A Novel Program Targeting PSC

Goldman Sachs analyst Paul Choi maintains Esperion Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ESPR#NASDAQ">ESPR</a>) with a Neutral and lowers the price target from $4 to $3.

Goldman Sachs Maintains Neutral on Esperion Therapeutics, Lowers Price Target to $3

Esperion Announces Alignment With FDA On Path To Initiate Phase 3 Clinical Trials Of Bempedoic Acid Alone And In Combination With Ezetimibe

Citizens Capital Markets analyst Jason Butler reiterates Esperion Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ESPR#NASDAQ">ESPR</a>) with a Market Outperform and maintains $4 price target.

Citizens Capital Markets Reiterates Market Outperform on Esperion Therapeutics, Maintains $4 Price Target

WIIM

Esperion Therapeutics shares are trading higher after the company reported better than expected Q4 FY24 earnings.

Guidance

Health Care

Esperion Expects Full Year 2025 Operating Expenses Of $215M-$235M, Including Approximately $15M In Non-cash Expenses Related To Stock Compensation

Esperion Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ESPR#NASDAQ">ESPR</a>) reported quarterly losses of $(0.11) per share which beat the analyst consensus estimate of $(0.16) by 31.25 percent. This is a 78 percent increase over losses of $(0.50) per share from the same period last year. The company reported quarterly sales of $69.11 million which beat the analyst consensus estimate of $61.58 million by 12.22 percent. This is a 114.30 percent increase over sales of $32.25 million the same period last year.

Esperion Therapeutics Q4 2024 GAAP EPS $(0.11) Beats $(0.16) Estimate, Sales $69.11M Beat $61.58M Estimate

Press Releases

Esperion Partners with HLS Therapeutics to Commercialize NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) in Canada

HLS Therapeutics partners with Esperion Therapeutics to commercialize NEXLETOL® and NEXLIZET® in Canada

HLS Therapeutics Announces Q1 2025 Financial Results

Esperion Announces Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

Esperion to Participate in H.C. Wainwright's 3rd Annual BioConnect Investor Conference

Contracts

Esperion Reaches Settlement Agreement with ANDA Filer Not to Market Generic Version of NEXLETOL® (bempedoic acid) Prior to April 19, 2040

Esperion to Participate in Upcoming June Investor Conferences

Esperion Reaches Settlement Agreement with Second ANDA Filer Not to Market Generic Version of NEXLETOL® (bempedoic acid) Prior to April 19, 2040

Management

Esperion Appoints Craig Thompson to Board of Directors

Esperion Reaches Settlement Agreement with Third ANDA Filer Not to Market Generic Version of NEXLETOL® (bempedoic acid) Prior to April 19, 2040

Comments

Esperion Therapeutics

Notizie

Ultime notizie per Esperion Therapeutics (NASDAQ:ESPR) Azioni

Le persone guardano anche

Notizie

PARTNER/COLLABORATORE

BENZINGA NEL MONDO