Latest news with #BioMarin
Yahoo
23-05-2025
- Business
- Yahoo
Biotech Stock Roundup: BMRN to Acquire INZY, NVAX Gains on Vaccine Approval & More
Mergers and acquisitions grabbed the spotlight in the biotech sector once again this week after BioMarin BMRN agreed to acquire Inozyme Pharma INZY. Meanwhile, other pipeline and regulatory updates were in focus. BioMarin Pharmaceutical announced that it has entered into a definitive agreement to acquire all outstanding shares of the clinical-stage company Inozyme Pharma for $4.00 per share in cash, totaling nearly $270 million. Shares of INZY soared on the news. The deal, approved by the board of directors of both companies, is expected to be closed in the third quarter of 2025. BioMarin will add Inozyme's lead asset, INZ-701, to its pipeline, following the completion of this acquisition. This investigational enzyme replacement therapy (ERT) is currently being evaluated in a pivotal late-stage study for the treatment of a rare genetic disorder, ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) deficiency, in children. The deal is a strategic fit for BioMarin, which already markets five first-in-disease enzyme therapies, namely Aldurazyme, Brineura, Naglazyme, Palynziq and Vimizim. The addition of Inozyme's lead candidate will expand BioMarin's Enzyme Therapies portfolio and further diversify its revenue stream. Novavax NVAX announced that the FDA approved its protein-based COVID-19 vaccine, Nuvaxovid. Shares of the company surged on this long-awaited approval from the FDA, albeit with a narrower label than initially expected. While the agency granted full approval to Nuvaxovid for use in older adults aged 65 and above, it restricted the vaccine's use in individuals aged 12-64 with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. Additionally, the agency requires Novavax to conduct a new Phase IV post-marketing study in individuals aged 50 to 64 without high-risk conditions for severe COVID-19. The full approval is based on data from a pivotal late-stage study, which showed that Nuvaxovid was safe and effective for the prevention of COVID-19. Until now, the vaccine had been available for use under the FDA's emergency use the full approval, Nuvaxovid is the only non-mRNA-based COVID-19 vaccine available in the country. Moderna MRNA announced that it has voluntarily withdrawn a regulatory filing seeking the FDA's approval for mRNA-1083, its investigational mRNA-based combination vaccine against influenza and COVID-19. Per the company, the decision was taken in consultation with the agency. The stock was down on the announcement. This setback derailed the company's initial plans to secure a potential FDA approval for the vaccine before this year's end. Moderna plans to resubmit this filing later this year after vaccine efficacy data from the ongoing phase III study on its investigational seasonal influenza vaccine, mRNA-1010, is available. Interim data from this study is expected this summer. The initial FDA filing, which sought approval for use in older adults aged 50 years and above, was supported by data from a phase III study announced last year. Data from this study showed that mRNA-1083 elicited higher immune responses against influenza and COVID-19 compared with licensed standalone influenza and COVID-19 vaccines. Moderna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Prime Medicine, Inc. PRME announced a strategic restructuring of its business. Shares of the company declined on the news. The restructuring includes the deprioritization of its Chronic Granulomatous Disease ('CGD') programs, as well as a cost and workforce reduction to focus on its liver franchise and programs funded through external partnerships. Prime Medicine is currently advancing in vivo programs to cure two of the largest genetic liver diseases, Wilson's Disease and Alpha-1 Antitrypsin Deficiency ('AATD'). Initial clinical data from both programs are expected in 2027. An investigational new drug (IND) and/or clinical trial application (CTA) is expected to be filed for its Wilson's Disease program in the first half of 2026 and for its AATD program in mid-2026. Initial data from both programs are expected in 2027. Prime Medicine is exploring options for the continued clinical development of PM359 and ceasing further efforts in X-linked CGD. In addition, PRME is reducing its headcount by approximately 25%. The headcount reduction, along with its cost reduction measures and other restructuring efforts, is expected to reduce operating expenses and cash burn, lowering anticipated cash needs by almost half through 2027. Prime Medicine announced that it has recently engaged in binding arbitration proceedings with Beam Therapeutics, Inc. regarding its collaboration agreement. Prime Medicine continues to expect that its cash, cash equivalents and investments, as of March 31, 2025, will be sufficient to fund its operations and capital expenditure requirements into the first half of 2026. The Nasdaq Biotechnology Index has gained 4.56% in the past five trading sessions and GILD's shares have gained 9.49%. In the past six months, shares of MRNA have plunged 32.55%. (See the last biotech stock roundup here: Biotech Stock Roundup: BMY Down on Study Data, Updates From REGN & More) Image Source: Zacks Investment Research Stay tuned for more pipeline updates. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report BioMarin Pharmaceutical Inc. (BMRN) : Free Stock Analysis Report Moderna, Inc. (MRNA) : Free Stock Analysis Report Novavax, Inc. (NVAX) : Free Stock Analysis Report Prime Medicine, Inc. (PRME) : Free Stock Analysis Report Inozyme Pharma, Inc. (INZY) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Yahoo
20-05-2025
- Business
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BioMarin Offers to Buy Inozyme for $270M to Boost Enzyme Therapy Biz
BioMarin Pharmaceutical BMRN announced that it has entered into a definitive agreement to acquire all outstanding shares of the clinical-stage company Inozyme Pharma INZY for $4.00 per share in cash, totaling nearly $270 million. The deal, approved by the board of directors of both companies, is expected to be closed in the third quarter of 2025. Following the completion of this acquisition, BioMarin will add Inozyme's lead asset, INZ-701, to its pipeline. This investigational enzyme replacement therapy (ERT) is currently being evaluated in a pivotal late-stage study for the treatment of a rare genetic disorder, ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) deficiency, in children. This condition affects blood vessels, soft tissues and bones, and is associated with increased cardiovascular mortality risk. Interim results from this late-stage study are expected in early 2026. If this data is positive, a regulatory approval for INZ-701 is expected in 2027, making it the first-in-disease treatment for this indication. Inozyme is also evaluating the ERT in a pivotal study for infants with ENPP1 and plans to initiate a supportive study for adolescents and adults with the disease. Inozyme is also exploring the potential of INZ-701 in separate clinical studies for two more rare disorders, namely ABCC6 Deficiency and calciphylaxis. Like ENPP1, there are currently no approved therapies for either of these disorders. Following this news on Friday, shares of Inozyme surged 178% and those of BioMarin gained about 2%. Year to date, shares of BMRN have lost 10%, while those of INZY have risen 43%. During the same timeframe, the industry has declined 7%. Image Source: Zacks Investment Research In our opinion, the deal is a strategic fit for BioMarin, which already markets five first-in-disease enzyme therapies, namely Aldurazyme, Brineura, Naglazyme, Palynziq and Vimizim. The addition of Inozyme's lead candidate will expand BioMarin's Enzyme Therapies portfolio and further diversify its revenue stream. The deal also benefits INZY as it lacks the commercial infrastructure and expertise needed to bring a drug to market, areas where BioMarin is already well established. BioMarin has reaffirmed its full-year 2025 guidance of $3.1-$3.2 billion for sales and $4.20-$4.40 for adjusted EPS. BioMarin currently carries a Zacks Rank #3 (Hold). BioMarin Pharmaceutical Inc. price | BioMarin Pharmaceutical Inc. Quote A couple of better-ranked stocks from the industry are Adaptive Biotechnologies ADPT and Agenus AGEN, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. In the past 60 days, estimates for Adaptive Biotechnologies' 2025 loss per share have improved from 92 to 87 cents. During the same timeframe, estimates for 2026 loss per share have narrowed from 69 to 65 cents. Adaptive Biotechnologies' earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.38%. Shares of ADPT have surged 51% year to date. Estimates for Agenus' 2025 loss per share have narrowed from $7.05 to $2.78 over the past 60 days, and the same for 2026 loss has improved from $7.14 to $5.26. Agenus' earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 22.71%. Year to date, its shares have gained 27%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report BioMarin Pharmaceutical Inc. (BMRN) : Free Stock Analysis Report Agenus Inc. (AGEN) : Free Stock Analysis Report Adaptive Biotechnologies Corporation (ADPT) : Free Stock Analysis Report Inozyme Pharma, Inc. (INZY) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
19-05-2025
- Business
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BioMarin agrees to acquire Inozyme for $270m
BioMarin Pharmaceutical has agreed to acquire Inozyme Pharma for $4.00 per share in a $270m all-cash transaction. This will enhance BioMarin's enzyme therapy portfolio by adding a late-stage enzyme replacement therapy, INZ-701. Unanimously approved by both companies' boards, the transaction will close in the third quarter of 2025, subject to regulatory clearance, tender offer completion and other customary closing conditions. INZ-701 is being evaluated to treat ectonucleotide pyrophosphatase/ phosphodiesterase 1 (ENPP1) deficiency, a rare genetic condition that impacts blood vessels, bones and soft tissues. This leads to increased cardiovascular mortality risk, particularly in infants, and severe rickets and osteomalacia in the paediatric and adult population. The first Phase III pivotal trial data for the therapy in children is anticipated in early 2026. Regulatory approval is expected in 2027. BioMarin will commence a cash tender offer to purchase all outstanding shares of Inozyme common stock. The board of directors of Inozyme has unanimously recommended that its stockholders tender their shares. The tender offer's completion is contingent upon standard closing conditions, including a majority of the outstanding Inozyme shares being tendered, the Hart-Scott-Rodino Antitrust Improvements Act waiting period expiry or termination, and other customary conditions. After the tender offer, a subsidiary of BioMarin will merge with Inozyme, and the remaining shares not tendered will be converted into the right to obtain the same $4.00 per share in cash. The acquisition is not dependent on financing. Goldman Sachs & Co is the exclusive financial advisor to BioMarin, with Cooley as legal counsel. Centerview Partners is Inozyme's exclusive financial advisor, and Goodwin Procter provides legal counsel. BioMarin Pharmaceutical CEO and president Alexander Hardy stated: "This acquisition brings to BioMarin an important medicine that has the potential to be the first treatment for children and adults with ENPP1 deficiency, improving care for people living with this serious condition. 'As BioMarin continues our transformation and delivers on our corporate strategy, we will continue to evaluate external innovation alongside internal innovation.' In 2024, the US Food and Drug Administration expanded the approval of BioMarin's supplemental biologics licence application (sBLA) for Brineura, an enzyme replacement therapy, to include children under three years of age with neuronal ceroid lipofuscinosis type 2 (CLN2) disease. "BioMarin agrees to acquire Inozyme for $270m" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
19-05-2025
- Business
- Yahoo
BioMarin Expands Rare Disease Portfolio with $270M Inozyme Acquisition
On May 16, BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) announced a $270 million acquisition of Inozyme Pharma, aiming to expand its rare disease research. The all-cash deal, backed by both companies' boards, is expected to close between July and September, giving BioMarin control of INZ-701, an enzyme replacement therapy targeting ENPP1 and ABCC6 deficiencies, life-threatening disorders caused by mineral buildup in soft tissues. A close-up of a hand holding a vial of biopharmaceutical drugs ready to be administered. With no FDA-approved treatments, INZ-701 aims to restore inorganic pyrophosphate levels, preventing tissue calcification. Late-stage trial results for ENPP1 deficiency are expected next year, with potential FDA approval by 2027. Analysts view the deal as a strategic expansion, complementing BioMarin Pharmaceutical Inc.'s (NASDAQ:BMRN) existing enzyme replacement therapies, including Vimizim, Naglazyme, and Palynziq. Despite a rare patient pool of around 10,000 globally, experts see commercial potential, expecting the acquisition to strengthen BioMarin's pipeline development. While some analysts praise its strong strategic fit, others believe it won't significantly impact BioMarin's overall market position. While we acknowledge the potential of BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than BMRN and that has 100x upside potential, check out our report about the . READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
18-05-2025
- Business
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BioMarin Expands Rare Disease Portfolio with $270M Inozyme Acquisition
On May 16, BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) announced a $270 million acquisition of Inozyme Pharma, aiming to expand its rare disease research. The all-cash deal, backed by both companies' boards, is expected to close between July and September, giving BioMarin control of INZ-701, an enzyme replacement therapy targeting ENPP1 and ABCC6 deficiencies, life-threatening disorders caused by mineral buildup in soft tissues. A close-up of a hand holding a vial of biopharmaceutical drugs ready to be administered. With no FDA-approved treatments, INZ-701 aims to restore inorganic pyrophosphate levels, preventing tissue calcification. Late-stage trial results for ENPP1 deficiency are expected next year, with potential FDA approval by 2027. Analysts view the deal as a strategic expansion, complementing BioMarin Pharmaceutical Inc.'s (NASDAQ:BMRN) existing enzyme replacement therapies, including Vimizim, Naglazyme, and Palynziq. Despite a rare patient pool of around 10,000 globally, experts see commercial potential, expecting the acquisition to strengthen BioMarin's pipeline development. While some analysts praise its strong strategic fit, others believe it won't significantly impact BioMarin's overall market position. While we acknowledge the potential of BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than BMRN and that has 100x upside potential, check out our report about the . READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. Sign in to access your portfolio
