Ultime notizie per Arrowhead Pharma (NASDAQ:ARWR) Azioni

Arrowhead Pharma

Arrowhead Pharmaceuticals Inc is an American biotechnology company. Its main target is the development of medicine to treat diseases with a genetic origin, characterized by the overproduction of one or more proteins. Its medical solutions are aimed at the genes that trigger the diseases. Its portfolio includes drugs targeting hepatitis B, Alpha-1 Antitrypsin Deficiency, thrombosis and angioedema, clear-cell and renal cell carcinoma, and cardiovascular disease.

Arrowhead Pharmaceuticals, Inc. - Common Stock

Arrowhead Pharmaceuticals Inc

News

ARWR

Arrowhead Pharmaceuticals Submits New Drug Application To The US FDA For Plozasiran In Treatment Of Familial Chylomicronemia Syndrome

HC Wainwright &amp; Co. analyst Patrick Trucchio reiterates Arrowhead Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARWR#NASDAQ">ARWR</a>) with a Buy and maintains $60 price target.

Price Target

Reiteration

Analyst Ratings

HC Wainwright & Co. Reiterates Buy on Arrowhead Pharma, Maintains $60 Price Target

Piper Sandler analyst Edward Tenthoff reiterates Arrowhead Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARWR#NASDAQ">ARWR</a>) with a Overweight and maintains $62 price target.

Piper Sandler Reiterates Overweight on Arrowhead Pharma, Maintains $62 Price Target

RBC Capital analyst Luca Issi reiterates Arrowhead Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARWR#NASDAQ">ARWR</a>) with a Outperform and maintains $42 price target.

RBC Capital Reiterates Outperform on Arrowhead Pharma, Maintains $42 Price Target

Arrowhead Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARWR#NASDAQ">ARWR</a>) today announced that it has filed for regulatory clearance to initiate a Phase 1/2a clinical trial of ARO-INHBE, the company's investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for obesity. Arrowhead also plans to file for regulatory clearance before the end of 2024 to initiate a clinical trial for its second obesity candidate, ARO-ALK7.
"Arrowhead's two investigational RNAi therapies for the treatment of obesity, ARO-INHBE and ARO-ALK7, are both designed to intervene in the same pathway that signals the body to store fat in adipose tissue. We have generated very promising preclinical data that suggests inhibition of these targets reduces body mass and fat mass but spares lean muscle mass resulting in improved body composition," said James Hamilton, M.D., Chief of Discovery and Translational Medicine at Arrowhead. "We have designed the initial Phase 1/2 study to evaluate single and multiple doses of ARO-INHBE monotherapy in Part 1 which will enroll patients with obesity, and to evaluate multiple doses of ARO-INHBE in combination with tirzepatide in Part 2 which will enroll diabetic and non-diabetic patients with obesity. We believe new therapeutic strategies with novel mechanisms of action, like ARO-INHBE and ARO-ALK7, have the potential to make a significant impact on the way obesity is treated and we are eager to initiate clinical studies of these important new programs."
ARO-INHBE is designed to reduce the hepatic expression of the INHBE gene and its secreted gene product, Activin E. INHBE is a promising genetically validated target in which loss-of-function INHBE variants in humans are associated with lower risk of obesity and metabolic diseases, such as type 2 diabetes. Activin E acts as a ligand in a pathway that regulates energy homeostasis in adipose tissue​. Intervening in this pathway with investigational ARO-INHBE treatment has the potential to increase lipolysis, and reduce adipose hypertrophy and dysfunction, visceral adiposity, and insulin resistance.
An application for approval to initiate the clinical trial was submitted to the New Zealand Medicines and Medical Devices Safety Authority for review by the Standing Committee on Therapeutic Trials. Pending clearance, Arrowhead intends to proceed with AROINHBE-1001, A Phase 1/2a dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-INHBE in up to 78 adult volunteers with obesity. Part 1 of the study is designed to assess single and multiple doses of ARO-INHBE monotherapy, and Part 2 of the study is designed to assess ARO-INHBE in combination with tirzepatide, a subcutaneously administered GLP-1/GIP receptor co-agonist that has been approved in the United States and the European Union for management type 2 diabetes mellitus since 2022 and weight management since 2023/2024 respectively.

Arrowhead Pharmaceuticals Files for Phase 1/2a Trial of New Obesity Treatment, ARO-INHBE

Biotech

Health Care

General

The FDA Granted Breakthrough Therapy Designation To Arrowhead Pharmaceuticals' Investigational Plozasiran As An Adjunct To Diet To Reduce Triglycerides In Adults With Familial Chylomicronemia Syndrome

Cantor Fitzgerald analyst Josh Schimmer reiterates Arrowhead Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARWR#NASDAQ">ARWR</a>) with a Overweight.

Cantor Fitzgerald Reiterates Overweight on Arrowhead Pharma

Arrowhead Pharmaceuticals shares are trading higher after the company announced results from the Phase 3 PALISADE study of investigational plozasiran in patients with familial chylomicronemia syndrome.

Arrowhead Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARWR#NASDAQ">ARWR</a>) today announced results from the Phase 3 PALISADE study of investigational plozasiran in patients with familial chylomicronemia syndrome (FCS), a severe and rare genetic disease which currently has no approved treatments in the U.S. PALISADE successfully met its primary endpoint and all multiplicity-controlled key secondary endpoints, including statistically significant reductions in triglycerides (TGs), apolipoprotein C-III (APOC3), and the incidence of acute pancreatitis (AP). These data were presented today in a late-breaking oral presentation at the European Society of Cardiology (ESC) Congress 2024 and simultaneously published in <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.nejm.org%2Fstoken%2Fdefault%2Bdomain%2FREPRINTS_36489%2Ffull%3FredirectUri%3D%2Fdoi%2Ffull%2F10.1056%2FNEJMoa2409368&amp;esheet=54115926&amp;newsitemid=20240902885250&amp;lan=en-US&amp;anchor=The+New+England+Journal+of+Medicine&amp;index=1&amp;md5=f4ec0ad245234d2880dc83cdf9ea3473">The New England Journal of Medicine</a>.
Based on these positive findings from the PALISADE study, Arrowhead intends to file a New Drug Application with the United States Food and Drug Administration (FDA) by year-end 2024 and plans to seek regulatory approval with additional global regulatory authorities thereafter.

Government

Regulations

Arrowhead's Plozasiran Meets All Primary and Secondary Endpoints in Phase 3 Study, To Seek FDA Approval

Arrowhead Pharmaceuticals Announced That It Will Present New Phase 3 Clinical Data From The Palisade Study Of Plozasiran At The European Society Of Cardiology Congress 2024

- Company hosting an obesity/metabolic R&amp;D webinar today, August 14, 2024, at 2:00 pm ET as Part IV of the 2024 Summer Series of R&amp;D Webinars
Arrowhead Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARWR#NASDAQ">ARWR</a>) today presented preclinical data and detailed its plans to advance two next generation RNAi-based candidates, ARO-INHBE and ARO-ALK7, into upcoming clinical studies for the treatment of obesity and metabolic diseases. In preclinical studies to date, these candidates demonstrated the potential to reduce body weight and fat mass with a novel mechanism of action that may lead to improved preservation of lean muscle mass compared to currently approved obesity therapies. Arrowhead plans to submit clinical trial applications with regulatory authorities for both programs by the end of 2024 with the goal of initiating clinical studies in volunteers with obesity in early 2025.

Arrowhead Pharmaceuticals To Advance Two New RNAi-Based Obesity Candidates, ARO-INHBE And ARO-ALK7, Into Clinical Studies After They Demonstrated The Potential To Reduce Body Weight And Fat Mass With A Novel Mechanism Of Action That May Lead To Improved Preservation Of Lean Muscle Mass Compared To Currently Approved Obesity Therapies

B. Riley Securities analyst Mayank Mamtani reiterates Arrowhead Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARWR#NASDAQ">ARWR</a>) with a Buy and maintains $55 price target.

B. Riley Securities Reiterates Buy on Arrowhead Pharma, Maintains $55 Price Target

WIIM

Arrowhead Pharmaceuticals shares are trading lower after the company reported worse-than-expected Q3 EPS results and a year-over-year Q3 revenue decrease.

- Balance sheet strengthened with long-term, non-dilutive capital - $400 million funded at close with the potential to draw an additional $100 million - Immediately enhances Arrowhead's ability to advance plozasiran towards a 2025 launch - Expands possibilities to fund innovation and growth across Arrowhead's robust and diverse pipeline of RNAi therapeutics
Arrowhead Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARWR#NASDAQ">ARWR</a>) today announced that it has entered into a strategic financing agreement with Sixth Street for significant, long-term, non-dilutive capital to fund innovation and growth opportunities across Arrowhead's robust and diverse pipeline of RNAi therapeutics. The $500 million senior secured credit facility includes $400 million funded at close with an additional $100 million available at Arrowhead's option, subject to mutual agreement between Sixth Street and Arrowhead, during the seven-year term of the agreement.

Financing

Arrowhead Pharmaceuticals Announces $500M Strategic Financing Facility

Earnings

Arrowhead Pharma Q3 2024 Revenue $0 Down From $15.825M YoY

Arrowhead Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARWR#NASDAQ">ARWR</a>) reported quarterly losses of $(1.38) per share which missed the analyst consensus estimate of $(0.53) by 160.38 percent.

Earnings Misses

Arrowhead Pharma Q3 2024 GAAP EPS $(1.38) Misses $(0.53) Estimate

Chardan Capital analyst Keay Nakae maintains Arrowhead Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARWR#NASDAQ">ARWR</a>) with a Buy and maintains $60 price target.

Chardan Capital Maintains Buy on Arrowhead Pharma, Maintains $60 Price Target

In a report released today, Luca Issi from RBC Capital reiterated a Buy rating on Arrowhead Pharmaceuticals (ARWR – Research Report), with a price ...

Arrowhead Pharmaceuticals (ARWR) Receives a Buy from RBC Capital

Arrowhead: A First Approval Likely - Jury Still Out On Investment Opportunity

In a report released today, Michael Ulz from Morgan Stanley maintained a Hold rating on Arrowhead Pharmaceuticals (ARWR – Research Report), with a ...

Maintaining Hold on Arrowhead Pharmaceuticals Amid Promising CNS Portfolio Developments

Piper Sandler analyst Edward Tenthoff reiterated a Buy rating on Arrowhead Pharmaceuticals (ARWR – Research Report) today and set a price target of...

Piper Sandler Keeps Their Buy Rating on Arrowhead Pharmaceuticals (ARWR)

TD Cowen analyst Brendan Smith maintained a Buy rating on Arrowhead Pharmaceuticals (ARWR – Research Report) today. The company's shares closed yes...

TD Cowen Reaffirms Their Buy Rating on Arrowhead Pharmaceuticals (ARWR)

Arrowhead Pharmaceuticals (ARWR – Research Report), the Healthcare sector company, was revisited by a Wall Street analyst today. Analyst Patrick Tr...

Buy Rating Justified by Arrowhead Pharmaceuticals' Advancements in CNS-Targeted RNAi Therapeutics

Arrowhead (ARWR) announced that it submitted a new drug application, or NDA, to the FDA for investigational plozasiran for the treatment of familia...

Arrowhead submits plozasiran NDA to FDA

In a report released today, Edward Tenthoff from Piper Sandler reiterated a Buy rating on Arrowhead Pharmaceuticals (ARWR – Research Report), with ...

Piper Sandler Sticks to Its Buy Rating for Arrowhead Pharmaceuticals (ARWR)

Analyst Patrick Trucchio of H.C. Wainwright reiterated a Buy rating on Arrowhead Pharmaceuticals (ARWR – Research Report), retaining the price targ...

Arrowhead Pharmaceuticals' Potential Approval of Clozasiran Drives Buy Rating and $60 Price Target

Earnings week ahead: CRWD, DELL, ZM, WDAY, HPQ, M, BBY and more

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Press Releases

Arrowhead Pharmaceuticals to Present New Phase 3 Data at ESC 2024 from PALISADE Study of Plozasiran in Patients with Familial Chylomicronemia Syndrome

Arrowhead Pharmaceuticals Presents New Pivotal Phase 3 Data at ESC 2024 from PALISADE Study of Plozasiran in Patients with Familial Chylomicronemia Syndrome

Arrowhead Pharmaceuticals Receives FDA Breakthrough Therapy Designation for Plozasiran

Arrowhead Pharmaceuticals Files for Regulatory Clearance to Initiate Phase 1/2a Study of ARO-INHBE for the Treatment of Obesity

Arrowhead Pharmaceuticals Reports Inducement Grants under NASDAQ Listing Rule 5635(c)(4)

Arrowhead Pharmaceuticals Launches New Disease Awareness Campaign, 'We'll Get There Soon,' to Inspire Hope for the Rare Disease Community Affected by Familial Chylomicronemia Syndrome

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