Latest news with #Arrowhead
Yahoo
11 hours ago
- Business
- Yahoo
Sarepta shares rebound after shipments of gene therapy Elevidys resume in US
(Reuters) -Sarepta Therapeutics shares surged more than 30% before the bell on Tuesday, as analysts said the resumption of U.S. shipments for its muscular gene therapy partially removes financial headwinds and decreases the risk of market withdrawal. The company said on Monday it would resume shipments of Elevidys — approved in the U.S. to treat a rare condition called Duchenne muscular dystrophy — to patients who can walk. U.S. shipments to patients who cannot walk independently are still halted, following the death of two teenage boys earlier this year. These incidents brought heightened regulatory scrutiny to Sarepta in recent weeks, while the pause of shipments raised concerns about the future of Elevidys — the company's largest revenue generator. Sarepta's announcement followed the U.S. Food and Drug Administration's recommendation that the voluntary hold on shipments be removed after a probe showed the death of an 8-year-old boy in Brazil was not related to Elevidys. Wall Street analysts said the resumption of shipments would allow Sarepta to fulfill its near-term payments to partner Arrowhead and maintain access to its debt facilities. "The FDA's recommendation and the resumption of commercial treatment in the U.S. virtually eliminate the risk of Elevidys being formally withdrawn from the market," said William Blair analyst Sami Corwin. While the decision allows some patients to regain access to the treatment, analysts warned that patients and doctors could show hesitancy in light of the recent hit to reputation. "It remains to be seen how the news headlines regarding the patient deaths will affect commercial interest in the near term," Corwin said. Sarepta's partner Roche had also stopped Elevidys shipments in certain countries outside the U.S. Shares of Sarepta surged 36% to $18.85 in premarket trading. They have fallen more than 80% since the first Elevidys-related death was reported in March. Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Reuters
12 hours ago
- Business
- Reuters
Sarepta shares rebound after shipments of gene therapy Elevidys resume in US
July 29 (Reuters) - Sarepta Therapeutics (SRPT.O), opens new tab shares surged more than 30% before the bell on Tuesday, as analysts said the resumption of U.S. shipments for its muscular gene therapy partially removes financial headwinds and decreases the risk of market withdrawal. The company said on Monday it would resume shipments of Elevidys — approved in the U.S. to treat a rare condition called Duchenne muscular dystrophy — to patients who can walk. U.S. shipments to patients who cannot walk independently are still halted, following the death of two teenage boys earlier this year. These incidents brought heightened regulatory scrutiny to Sarepta in recent weeks, while the pause of shipments raised concerns about the future of Elevidys — the company's largest revenue generator. Sarepta's announcement followed the U.S. Food and Drug Administration's recommendation that the voluntary hold on shipments be removed after a probe showed the death of an 8-year-old boy in Brazil was not related to Elevidys. Wall Street analysts said the resumption of shipments would allow Sarepta to fulfill its near-term payments to partner Arrowhead (ARWR.O), opens new tab and maintain access to its debt facilities. "The FDA's recommendation and the resumption of commercial treatment in the U.S. virtually eliminate the risk of Elevidys being formally withdrawn from the market," said William Blair analyst Sami Corwin. While the decision allows some patients to regain access to the treatment, analysts warned that patients and doctors could show hesitancy in light of the recent hit to reputation. "It remains to be seen how the news headlines regarding the patient deaths will affect commercial interest in the near term," Corwin said. Sarepta's partner Roche (ROG.S), opens new tab had also stopped Elevidys shipments in certain countries outside the U.S. Shares of Sarepta surged 36% to $18.85 in premarket trading. They have fallen more than 80% since the first Elevidys-related death was reported in March.
Boston Globe
a day ago
- Business
- Boston Globe
Brown University borrows $500 million more amid ‘deep financial challenges'
Get Starting Point A guide through the most important stories of the morning, delivered Monday through Friday. Enter Email Sign Up BIOTECH Advertisement Beleaguered Sarepta says it will 'honor' $100 million payment to Arrowstone Advertisement Arrowhead Pharmaceuticals Inc. said Monday that it's owed a $100 million milestone payment from Sarepta Therapeutics Inc. within the next two months, pressuring the beleaguered Cambridge-based biotech company just days after it stopped selling its biggest drug due to safety concerns. Arrowhead has stepped up public pressure on Sarepta over the past week, saying it could take back the rights to its drug if Sarepta fails to make payments. Sarepta has staked much of its future pipeline on RNA-targeting drugs, including those developed by Arrowhead. 'We intend to honor our commitments' to Arrowhead, Sarepta said in an emailed statement. Arrowhead investors have questioned whether Sarepta can make the payments, said TD Cowen analyst Joseph Thome. Monday's announcement, he said, was likely aimed at assuaging investors 'who were nervous that something might go sideways.' Earlier this month, Sarepa said it was cutting more than a third of its workforce and pausing several drugs in its pipeline to reduce costs. Sarepta is staring down $1.2 billion of debt and warned in filings earlier this year that its cash flow may not be enough to pay that obligation, which is due in 2027. — BLOOMBERG NEWS. INTERNATIONAL Trade court denies request to restore tariff exemption for small shipments A US trade court has for now denied an effort to restore a tariff exemption for small-value packages from China that President Trump ended earlier this year. The decision from the Court of International Trade on Monday in the fight over what's known as the 'de minimis' tariff exemption is the latest favorable order for the Trump administration in its defense against multiple lawsuits over his move to raise global tariffs. The three-judge panel said it wouldn't act in a case brought by a US-based auto parts distributor while a set of separate legal challenges to Trump's tariff actions are pending before a federal appeals court. The president's contested policies remain in effect for now. The US Court of Appeals for the Federal Circuit is set to hear arguments at the end of this month in the earlier cases, and in Monday's order, the three-judge panel wrote that it 'will not grant redundant, contingent relief' while the other fight works its way through the US legal system. Packages coming into the United States have qualified for the exemption if they have a retail value of $800 or less. Trump's move to end it for China and Hong Kong hurt discount Chinese marketplaces such as Temu and Shein Group Ltd. that ship low-cost clothing, household goods, and other items directly to US consumers. The administration has accused Chinese chemical companies of abusing the policy to ship illegal synthetic opioids to the United States. Small businesses in the United States have also said they're feeling the pinch. — BLOOMBERG NEWS Advertisement DEMOGRAPHICS In bid to boost birthrate, China will offer subsidies of $502 per child China announced that it will start handing out childcare subsidies across the nation, in its latest push to boost birthrates after a worrying drop in recent years. The government will spend $502 a year per child under age 3, according to the official Xinhua News Agency. The assistance, effective retrospectively from Jan. 1 this year and available regardless of the first, second, or third child, is meant as an incentive for young couples wary of rising costs of child-rearing. The policy is expected to benefit more than 20 million families each year, Xinuha reported. China has previously offered tax breaks and has been working to offer more affordable daycare services, it said. The latest measure follows China's population shrinking for a third straight year in 2024. New births at 9.54 million last year was only half of the 18.8 million registered in 2016 when China lifted its one-child policy. Diminishing birthrate is a worry for the world's second-largest economy, where the working-age population has been declining in a threat to labor supply and productivity. The country, which lost its title as the most-populous nation to India in 2023, may see its population drop further to 1.3 billion by 2050 and below 800 million by 2100, according to the UN's demographic modeling. — BLOOMBERG NEWS Advertisement HIGHER EDUCATION Amid federal probe, UVA business school ends diversity partnerships The University of Virginia's Darden School of Business suspended its partnerships with several organizations dedicated to increasing opportunities for underrepresented groups in business schools amid persistent calls from the White House to dismantle diversity, equity, and inclusion initiatives in order to maintain federal funding. The decision was 'part of a broader review of policies, programs and practices across the University of Virginia,' UVA Darden spokesperson McGregor McCance wrote in a statement. UVA Darden suspended a three-decade long partnership with the Consortium for Graduate Study in Management, which aims to increase Black, Native American, and Hispanic representation in business schools, and a two-decade long connection to the Forté Foundation, which advocates for more women in business education. The school also suspended its ties with Reaching Out MBA, which offers scholarships and networking opportunities for LGBTQ+ students, and Management Leadership for Tomorrow, which focuses on expanding economic mobility and building better workplaces. The Trump administration has been targeting DEI programs at educational institutions, alleging they constitute a form of racial discrimination. In a letter sent to schools in February, the Department of Education threatened institutions that failed to comply with the loss of federal funding. And recently, the administration has followed through on those threats. UVA is being investigated by the Department of Justice over its DEI policies, which may result in the termination of federal funds, according to a June 16 letter sent to the head of UVA's board. The probe prompted University of Virginia president James Ryan to resign last month. — BLOOMBERG NEWS Advertisement
Business Wire
a day ago
- Business
- Business Wire
Arrowhead Pharmaceuticals Earns $100 Million Milestone from Sarepta Therapeutics
PASADENA, Calif.--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has earned a $100 million milestone payment from Sarepta Therapeutics (NASDAQ: SRPT). The milestone was triggered when Arrowhead reached the first of two prespecified enrollment targets and subsequent authorization to dose escalate in a Phase 1/2 clinical study of ARO-DM1, an investigational RNA interference (RNAi) therapeutic for the treatment of type 1 myotonic dystrophy (DM1), the most common adult-onset muscular dystrophy. Arrowhead currently expects to achieve the second enrollment target by the end of 2025, which would trigger an additional $200 million milestone payment from Sarepta. Arrowhead currently expects to achieve the second enrollment target by the end of 2025, which would trigger an additional $200 million milestone payment from Sarepta. Share In accordance with the license and collaboration agreement, Arrowhead expects to receive this payment within 60 days. About the Arrowhead-Sarepta Agreement Arrowhead and Sarepta signed a global licensing and collaboration agreement in November 2024, which closed in February 2025, whereby Sarepta received rights to multiple investigational treatments that leverage Arrowhead's leading Targeted RNAi Molecule (TRiM TM) platform. The agreement covers multiple clinical and preclinical programs in rare, genetic diseases of the muscle, central nervous system, and the lungs, and also allows Sarepta to select up to six new targets for Arrowhead to conduct discovery and preclinical development activities in areas complementary to Sarepta's leadership in precision genetic medicine for rare diseases. Summary Financial Terms Upon closing, Arrowhead received a $500 million upfront payment and $325 million through the purchase by Sarepta of Arrowhead common stock priced at $27.25 per share, representing a 35% premium to the 30-day volume weighted average price (VWAP) when the agreement was signed. Arrowhead will also receive $250 million to be paid in annual installments of $50 million over five years, and has the potential to receive an additional $300 million in near-term milestone payments associated with the continued enrollment of certain cohorts of a Phase 1/2 study of ARO-DM1, $100 million of which has now been earned. Arrowhead is also eligible to receive further development milestone payments of between $110 million and $180 million per program, sales milestone payments of between $500 million and $700 million per program, and tiered royalties on commercial sales up to the low double digits. Summary of Programs Under the License and Collaboration Agreement Clinical Stage ARO-DUX4, which is designed to target the gene that encodes the DUX4 protein as a potential treatment for patients with facioscapulohumeral muscular dystrophy type 1, currently dosing patients in a Phase 1/2 clinical study. ARO-DM1, which is designed to reduce expression of the dystrophia myotonica protein kinase (DMPK), gene in skeletal muscle as a potential treatment for patients with type 1 myotonic dystrophy, currently dosing patients in a Phase 1/2 clinical study. ARO-MMP7, which is designed to reduce expression of matrix metalloproteinase 7 (MMP7) in the lung as a potential treatment for idiopathic pulmonary fibrosis, currently dosing patients in a Phase 1/2 clinical study. ARO-ATXN2, which is designed to silence expression of the toxic ATXN2 protein in the CNS as a potential treatment for spinocerebellar ataxia 2 (SCA2), currently in a Phase 1/2 study that is open for enrollment. Preclinical Stage ARO-HTT for patients with Huntington's disease, expected to be CTA-ready in 2025 ARO-ATXN1 for patients with spinocerebellar ataxia 1 (SCA1) expected to be CTA-ready in 2026 ARO-ATXN3 for patients with spinocerebellar ataxia 3 (SCA3) expected to be CTA-ready in 2026 Discovery During the five-year term, Sarepta can propose up to six new CNS or muscle targets for which Arrowhead will perform discovery and preclinical development. Sarepta would then receive an exclusive license to those programs and would be responsible for subsequent clinical development and commercialization. Drug Manufacturing Under the terms of the agreement, Arrowhead will manufacture clinical drug supply for all programs arising out of the license and collaboration, and commercial drug product for the four programs currently in clinical trials. About Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. For more information, please visit or follow us on X (formerly Twitter) at @ArrowheadPharma, LinkedIn, Facebook, and Instagram. To be added to the Company's email list and receive news directly, please visit Safe Harbor Statement under the Private Securities Litigation Reform Act: This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as 'may,' 'will,' 'expect,' 'believe,' 'anticipate,' 'hope,' 'intend,' 'plan,' 'project,' 'could,' 'estimate,' 'continue,' 'target,' 'forecast' or 'continue' or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; our expectations regarding the potential benefits of the partnership, licensing and/or collaboration arrangements and other strategic arrangements and transactions we have entered into or may enter into in the future; our beliefs and expectations regarding milestone, royalty or other payments that could be due to or from third parties under existing agreements; and our estimates regarding future revenues, research and development expenses, capital requirements and payments to third parties. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the impact of the ongoing COVID-19 pandemic on our business, the safety and efficacy of our product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances. Source: Arrowhead Pharmaceuticals, Inc.
Yahoo
22-07-2025
- Sport
- Yahoo
FIFA World Cup 26 CEO discusses how Kansas City is preparing
KANSAS CITY, Mo. — The World Cup comes to Kansas City in less than a year. Perhaps the largest sporting event in the world, spread out over five weeks. Kansas City is one of 16 North American host cities, with Arrowhead set to host six matches. See the latest headlines in Kansas City and across Kansas, Missouri The region will also be a base camp for up to three teams. As the weeks fly by, how prepared is the city when it comes to transportation, security, volunteers, and more? This week, FOX4 sits down with FIFA World Cup 26 CEO Pam Kramer to get some answers. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
