Latest news with #Arvinas
Yahoo
6 days ago
- Business
- Yahoo
Arvinas, Inc. (ARVN): A Bull Case Theory
This stock is one of several featured in our latest research. For more small-cap opportunities with asymmetric return potential, read our free article: 10 Promising SmallCap Stocks Under $1 Billion Market Cap. We came across a bullish thesis on Arvinas, Inc. on by Ray Palmer. In this article, we will summarize the bulls' thesis on ARVN. Arvinas, Inc.'s share was trading at $7.59 as of July 16th. Photo by Myriam Zilles on Unsplash Arvinas (ARVN) presents a compelling deep value investment, trading at $6.50 despite holding $954M in cash ($13/share), significantly exceeding its market cap. Beyond cash, Arvinas owns a Novartis-partnered asset that brought in $150M upfront, with a risk-adjusted NPV estimated at $300M ($4/share). Its breast cancer drug, vepdegestrant (vepdeg), though no longer a blockbuster candidate, retains meaningful value as a second-line treatment for mutant patients—a smaller but high-value market. The company estimates a sum-of-the-parts valuation north of $20/share, though corporate overhead currently drags on that value. The opportunity exists due to a combination of investor disillusionment and strategic missteps. Vepdeg's Phase 3 data, announced in March, showed no efficacy in wild-type patients, capping its commercial scope. Pfizer, Arvinas's partner, subsequently cancelled combo trials, but notably retained involvement through a Phase 1 combo study it fully funds and prominently featured vepdeg in its ASCO plans—suggesting continued interest. A near-term catalyst is ASCO's full data reveal, where Arvinas has teased best-in-class potential in mutant breast cancer. A second catalyst could be Pfizer assuming full commercialization duties under existing partnership terms, avoiding Arvinas's inefficient standalone approach. If Pfizer declines, selling the asset becomes the most viable path. Activism remains a third catalyst. Insider ownership is minimal, executive compensation is excessive, and the cost structure hasn't adapted to the company's diminished scope. An activist could drive governance reforms, prevent value-destructive commercialization attempts, and push for a return of excess cash to shareholders. With a large margin of safety and multiple catalysts, Arvinas offers an attractive asymmetric risk/reward setup. Previously we covered a on Relay Therapeutics, Inc. by Steve Wagner in May 2025, which highlighted the company's strategic pivot to focus solely on RLY-2608, supported by deep cost cuts and a strong cash runway through 2029. The company's stock price has appreciated approximately by 15% since our coverage. This is because early clinical data validated RLY-2608's potential. The thesis still stands as the lead program advances into pivotal trials. Ray Palmer shares a similar view on the breast cancer space but emphasizes Arvinas's undervaluation, cash-rich balance sheet, and activist-driven upside. Arvinas, Inc. is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 37 hedge fund portfolios held ARVN at the end of the first quarter which was 32 in the previous quarter. While we acknowledge the potential of ARVN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None.
Yahoo
09-07-2025
- Business
- Yahoo
Gilead signs lenacapavir access deal; Arvinas CEO to step down
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Today, a brief rundown of news involving Gilead Sciences and Arvinas, as well as updates from Chugai Pharmaceutical, Recursion Pharmaceuticals and Dizal Pharma that you may have missed. Gilead Sciences on Wednesday said it would supply its HIV prevention drug lenacapavir 'at no profit' to low and lower-middle-income countries through a three-year agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria. The Global Fund will prioritize country access based on HIV epidemiology and available resources. The move builds on previous steps taken by Gilead, including its agreement in October to license rights to manufacture and supply lenacapavir in many of these countries. The new deal will provide enough doses for up to 2 million people to access the drug until those licensed generic versions are available. The twice-yearly injection was approved by the Food and Drug Administration for HIV pre-exposure prophylaxis last month, which one analyst said could 'redefine the PrEP market.' — Delilah Alvarado Arvinas CEO John Houston will step down following the search and appointment of a new CEO, the company said Wednesday. Houston joined in 2017 as head of R&D and chief scientific officer, but was promoted months later to CEO. Two years ago, he became chairman of the board, a position he'll continue in after departing the CEO post. According to Arvinas, Houston played a pivotal role in advancing its 'PROTAC' drugmaking technology, including the drug vepdegestrant, for which it recently unveiled mixed Phase 3 data. — Delilah Alvarado Chugai Pharmaceutical said Monday it will pay up to $250 million to Singapore-based Gero as part of a collaboration to develop antibody drugs to treat aging-related diseases. Under the deal, Gero will identify biological targets active in aging-related diseases using its discovery technology, while Chugai will have exclusive rights to create, research, develop, manufacture and commercialize drugs emerging from Gero's work. Payments to Gero will be based on development and sales milestones, and Chugai would additionally owe royalties to Gero on sales of any launched drugs. Chugai is majority owned by Roche. — Jonathan Gardner Recursion Pharmaceuticals is paying $7.5 million upfront for shares in partner RallyBio and up to $25 million in total to purchase rights to jointly developed treatments for the genetic disorder hypophosphatasia. RallyBio began working with Exscientia in 2019 to research drugs targeting ENPP enzymes, a collaboration which Recursion inherited when it acquired Exscientia in 2024. Recursion has been retrenching, halting development of two drugs and pausing a third in May, followed by job cuts in June. With the agreement, Recursion gains control of a drug called REV102, and a backup molecule. RallyBio said the upfront payment will help fund operations through mid-2027, extending its runway by around a year. — Jonathan Gardner The Food and Drug Administration granted accelerated approval to an oral lung cancer drug developed by China-based Dizal Pharma that could compete with Johnson & Johnson's antibody drug Rybrevant. The drug, called Zegfrovy, is approved to treat people with non-small cell lung cancer that has an epidermal growth factor receptor exon 20 insertion mutation and whose disease has progressed following chemotherapy. It will be the only oral drug on the market to treat those patients following withdrawal of Takeda's Exkivity, which failed confirmatory trials. People with the EGFR exon 20 insertion mutation, which represent a small percentage of NSCLC patients, often are resistant to other EGFR targeting drugs like Tarceva or Iressa. — Jonathan Gardner
Yahoo
06-06-2025
- Business
- Yahoo
Otsuka tops Vera with kidney drug data; Regenxbio sinks on Duchenne update
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Today, a brief rundown of news involving Otsuka Pharmaceutical and Arvinas, as well as updates from Regenxbio, Vigil Neuroscience and Sagimet Biosciences that you may have missed. Vera Therapeutics lost nearly a third of its market value Friday after Otsuka Pharmaceutical presented late-stage study data on a rival drug it's developing for the kidney disease IgA nephropathy. At a medical meeting, Otsuka said its therapy, sibeprenlimab, led to a 51% reduction in proteinuria, a key marker of kidney health, after nine months of treatment. Though cross-trial comparisons can be misleading, Vera's therapy led to a 42% reduction in proteinuria compared to placebo at a similar timepoint in its own Phase 3 study, causing investors to sell off company shares. Still, some analysts defended Vera. Jefferies' Farzin Haque cautioned not to 'overinterpret the data' and argued the two datasets 'are not clinically or statistically different for commercial uptake.' The Food and Drug Administration could approve Otsuka's drug by Nov. 28. On Monday, Vera said it intends to file an accelerated approval application in the fourth quarter. — Ben Fidler Arvinas and partner Pfizer have filed for a U.S. approval of their experimental protein-degrading drug for breast cancer, Arvinas said Friday. The two submitted the therapy, vepdegestrant, for use in people with estrogen-receptor positive, HER2 negative breast cancer and a mutation in the ESR1 gene. The application is based on Phase 3 data presented at the American Society of Clinical Oncology meeting this week showing the drug held tumors in check longer than a standard treatment. That benefit was modest, however, and wasn't observed in the overall study population. — Delilah Alvarado Regenxbio released new data Thursday showing a potential impact on muscle function among Duchenne muscular dystrophy patients who received its experimental gene therapy in an early-stage clinical trial. Regenxbio said those given the dose it's using in pivotal testing outperformed how historical data suggests they might on multiple widely used assessments of functional benefits. Still, shares fell by double digits, as some key information was missing from the update, the treatment's effects appear to be 'plateauing' and there is concern the data may not be strong enough to support an accelerated approval, wrote Jefferies analyst Maury Raycroft. Regenxbio expects to report pivotal data next year and has said it intends to seek a speedy approval afterwards, based on the therapy's ability to produce a tiny version of a muscle-protecting protein. — Ben Fidler Vigil Neuroscience reported Wednesday the failure of a mid-stage trial meant to prove its most advanced drug works as intended. The study enrolled 20 people with 'ALSP,' a rare disorder hallmarked by the erosion of white matter in the brain. All participants received Vigil's drug, VGL101, which is designed to boost the TREM2 proteins that help control inflammation in the brain. The company said that while showing favorable safety and tolerability, its treatment had no beneficial effects on important markers of effectiveness or biological activity. As such, a separate, so-called long-term extension study is being discontinued. Sanofi is in the process of acquiring Vigil for access to a different TREM2-targeting medicine. Per terms of that deal, rights to VGL101 will be returned to its original licensor, Amgen. — Jacob Bell Shares of Sagimet Biosciences have climbed nearly 40% since partner Ascletis Bioscience on Wednesday reported the company's drug denifanstat succeeded in a Phase 3 trial in China in people with moderate-to-severe acne. The drug produced 'compelling efficacy' in the trial with only mild-to-moderate side effects, which could have positive implications for its ability to treat metabolic dysfunction-associated steatohepatitis, Leerink Partners analyst Thomas Smith wrote in a research note. A 2019 partnership handed Ascletis rights in greater China to denifanstat. Sagimet could receive up to $122 million in future payments, as well as sales royalties, if the drug is approved. — Ben Fidler
Associated Press
06-06-2025
- Business
- Associated Press
Arvinas Announces Submission of New Drug Application to U.S. FDA for Vepdegestrant for Patients with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer
– This submission is supported by the pivotal Phase 3 VERITAC-2 clinical trial, results of which were recently presented at the 2025 American Society for Clinical Oncology Annual Meeting and published in The New England Journal of Medicine – – VERITAC-2 data support vepdegestrant as a potential treatment option in patients with ESR1m ER+/HER2- advanced or metastatic breast cancer – NEW HAVEN, Conn., June 06, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) with its partner Pfizer Inc. (NYSE: PFE), for vepdegestrant for the treatment of patients with ER-positive (ER+)/human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. This submission is based on results from VERITAC-2 (NCT05654623), a global, randomized Phase 3 trial evaluating vepdegestrant versus fulvestrant. 'This milestone comes after an exciting presentation at the American Society of Clinical Oncology's annual meeting,' said John Houston, Ph.D., Chairperson, Chief Executive Officer and President at Arvinas. 'We look forward to the NDA review and to the first ever FDA-approved PROTAC ER degrader potentially being available to patients who could benefit from a much needed, new treatment option.' Vepdegestrant is being jointly developed by Arvinas and Pfizer for the treatment of patients with advanced or metastatic ER+/HER2- breast cancer and was granted fast track designation as a monotherapy by the FDA. Results from the VERITAC-2 study were recently presented in a late-breaking oral presentation at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting and were selected for the ASCO press briefing and for Best of ASCO. Detailed results were also simultaneously published in the New England Journal of Medicine. About the VERITAC-2 Clinical Trial The Phase 3 VERITAC-2 clinical trial ( NCT05654623 ) is a global, randomized trial evaluating the efficacy and safety of vepdegestrant (ARV-471) as a monotherapy compared to fulvestrant in patients with ER+/HER2- advanced or metastatic breast cancer. The trial enrolled 624 patients at sites in 25 countries who had previously received treatment with a CDK4/6 inhibitor plus endocrine therapy. Patients were randomized 1:1 to receive either vepdegestrant once daily, orally on a 28-day continuous dosing schedule, or fulvestrant, administered intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each 28-day cycle starting from Day 1 of Cycle 2. In the trial, 43% of patients (n=270) had ESR1 mutations detected. The primary endpoint was progression-free survival (PFS) in the ESR1-mutation and intent-to-treat populations as determined by blinded independent central review. Overall survival is the key secondary endpoint. About Vepdegestrant Vepdegestrant is an investigational, orally bioavailable PROTAC (PROteolysis TArgeting Chimera) protein degrader designed to specifically target and degrade the estrogen receptor (ER). Vepdegestrant is being developed as a potential monotherapy for ER+/HER2- advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second line-plus setting. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits. The U.S. Food and Drug Administration (FDA) has granted vepdegestrant Fast Track designation as a monotherapy in the treatment of adults with ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy. About Arvinas Arvinas (Nasdaq: ARVN) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROTAC (PROteolysis TArgeting Chimera) protein degrader platform, the Company is pioneering the development of protein degradation therapies designed to harness the body's natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Arvinas is currently progressing multiple investigational drugs through clinical development programs, including vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; and ARV-102, targeting LRRK2 for neurodegenerative disorders. Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit and connect on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding: the NDA review and to the first ever FDA-approved PROTAC ER degrader potentially being available to patients who could benefit from a much needed, new treatment option; and vepdegestrant's development as a potential monotherapy for ER+/HER2- advanced or metastatic breast cancer with ESR1 mutations in the second line-plus setting. All statements, other than statements of historical fact, contained in this press release, including statements regarding Arvinas' strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words 'anticipate,' 'believe,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'target,' 'goal,' 'potential,' 'will,' 'would,' 'could,' 'should,' 'look forward,' 'continue,' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Arvinas may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Arvinas makes as a result of various risks and uncertainties, including but not limited to: whether Arvinas and Pfizer will successfully perform their respective obligations under the collaboration between Arvinas and Pfizer; whether Arvinas and Pfizer will be able to successfully conduct and complete clinical development for vepdegestrant as a monotherapy; whether the VERITAC-2 clinical trial will meet the secondary endpoint for overall survival; risks related to our expectations regarding the potential clinical benefit of vepdegestrant to patients; uncertainties relating to regulatory applications and related filing and approval timelines, including the New Drug Application seeking FDA approval of vepdegestrant and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; whether FDA or other regulatory authorities will require additional information or further studies, or may fail or refuse to approve or may delay approval of vepdegestrant; whether Arvinas and Pfizer, as appropriate, will be able to obtain marketing approval for and commercialize vepdegestrant and other product candidates on current timelines or at all; Arvinas' ability to protect its intellectual property portfolio; Arvinas' reliance on third parties; whether Arvinas will be able to raise capital when needed; whether Arvinas' cash and cash equivalent resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other important factors discussed in the 'Risk Factors' section of Arvinas' Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent other reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Arvinas' current views with respect to future events, and Arvinas assumes no obligation to update any forward-looking statements, except as required by applicable law. These forward-looking statements should not be relied upon as representing Arvinas' views as of any date subsequent to the date of this release. Contacts Investors: Jeff Boyle +1 (347) 247-5089 [email protected] Media: Kirsten Owens +1 (203) 584-0307 [email protected]
Business Insider
02-06-2025
- Business
- Business Insider
Arvinas downgraded to Market Perform from Outperform at Leerink
Leerink analyst Andrew Berens downgraded Arvinas (ARVN) to Market Perform from Outperform with a price target of $9, down from $10, after the company presented full results from the Phase 3 VERITAC-2 trial evaluating vepdegestrant in second-line HR+/HER2- metastatic breast cancer patients. The firm says that while the full presentation demonstrates the drug is active in patients with ESR1 mutations and likely approvable, it is not convinced vepdeg is best-in-class. Further, a number of key uncertainties in the rapidly evolving treatment paradigm for ESR1m breast cancer landscape have emerged, the analyst tells investors in a research note. Leerink 'gradually tempered the ESR1m rate in second-line from 30% to 15% to reflect potential impact from the SERENA-6 data, as well as ongoing first-line oral SERD trials, lowering its assumed worldwide peak vepdeg sales to $416M from $576M.
