Latest news with #Camzyos
Yahoo
14-05-2025
- Business
- Yahoo
Bluebird extends deal deadline; Affimed files for insolvency
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 Bluebird bio and Affimed, as well as updates from Cytokinetics, BridgeBio Pharma and Acelyrin that you may have missed. Carlyle and SK Capital Partners, two investment firms attempting to buy Bluebird bio, have amended their offer to give Bluebird shareholders a choice of payouts. Holders of Bluebird stock can either receive $3 per share plus rights to $6.84 more if a certain sales milestone is achieved — Carlyle and SK Capital's original bid — or $5 per share. Shareholders previously had a deadline of May 12 to tender their stock to the original deal, but now have until May 29 to do so. Bluebird's board is in favor of accepting Carlyle and SK Capital's offer, warning investors in a statement Wednesday that, absent a deal, the company is at 'significant risk' of default. — Ned Pagliarulo Cancer drug developer Affimed has filed for 'insolvency,' warning investors Tuesday that there is 'substantial doubt' the company can sustain itself. As a result of the filing, Affimed shares will be suspended from trading on the Nasdaq stock exchange beginning May 20. The company has been talking with 'potential investors and partners' about deals or other ways in which it might raise capital, but has so far been unsuccessful. Affimed, which has three drugs in clinical testing, last reported cash holdings of 24 million euros as of Sept. 30, 2024. — Ned Pagliarulo Cytokinetics on Tuesday said its experimental drug aficamten outperformed beta blockers in a Phase 3 study of people with obstructive hypertrophic cardiomyopathy. U.S. regulators are already reviewing aficamten's use in the inherited heart condition, with an approval decision now expected by late December after a recent delay. The latest results, though generally expected by investors, could help boost its case with physicians and insurers, wrote RBC Capital Markets analyst Brian Abrahams. If approved, aficamten would compete for market share with Bristol Myers Squibb's Camzyos, which booked $602 million in sales last year. — Ben Fidler BridgeBio Pharma has begun dosing patients in a first-of-its-kind Phase 3 trial testing whether its drug, Attruby, can prevent or delay the onset of transthyretin amyloidosis in people more likely to inherit it. The trial, ACT-EARLY, will evaluate Attruby as a prophylactic treatment in carriers of a disease-causing variant of the TTR gene that's implicated in the hereditary form of the condition. Attruby is one of three marketed drugs that can slow progression of a type of transthyretin amyloidosis that affects the heart. No medicines have been proven to prevent the disease, however. — Ben Fidler Shareholders in Acelyrin and Alumis voted Tuesday to combine the two biotechnology companies, ending a twisting merger saga that featured an unsolicited bid from an entity controlled by and a push from to force Acelyrin to liquidate its assets and return cash to its stockholders. Since announcing the planned combination, Alumis has tweaked the terms of the deal, saying its shareholders would own 52% of the new company, while Acelyrin's would hold 48%. The merger is now set to close in the second quarter of 2025. — Gwendolyn Wu 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
08-05-2025
- Health
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Haya banks $65M to scour the ‘dark genome' for new drugs
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Scientists long believed the human genome consisted mostly of useless DNA. These sequences, after all, aren't translated into proteins, making them appear as bits of genetic material with no biological purpose. They were often referred to as 'junk.' Accumulating academic research over the last decade or so has proven otherwise. That 'junk' is transcribed into so-called long non-coding RNAs, which are key cogs of the molecular machinery that switches genes on or off. Mining them for drug targets might yield a way to control those switches and, in the process, help treat an array of diseases. The promise has tantalized venture capitalists for awhile now, leading to the formation of several companies startups — among them Rome Therapeutics and NextRNA Therapeutics — to sift through this 'dark genome' for different types of drugs. While research remains early and hasn't led to an approved medicine, investment has continued, with a fresh financing serving as the latest example. Biotechnology startup Haya Therapeutics disclosed Thursday that it raised $65 million in Series A funding to probe for drug targets in this large portion of the genome. The financing will propel Haya's lead program, for an inherited heart condition called non-obstructive hypertrophic cardiomyopathy, into clinical testing. It will also support earlier programs in development for other conditions, including pulmonary fibrosis and obesity, as well as an expansion of the company's research efforts. Sofinnova Partners and Earlybird Venture Capital led the round, which involved Eli Lilly, Alexandria Venture Investments and eight other investment firms. The funding follows a $25 million seed round raised by the firm in 2021 and an obesity-focused partnership with Lilly last September. Haya is using computing tools to build an internal 'atlas' of the dark genome that can help it identify drug targets as well as 'RNA-guided therapeutics' that can impact them. In a statement, co-founder and CEO Samir Ounzain claimed Haya's treatments should 'reprogram disease-driving cell states into healthy ones.' Haya's first test of that theory is a drug aimed at a long non-coding RNA dubbed 'Wisper' that's overexpressed in certain cardiovascular conditions — among them hypertrophic cardiomyopathy. In 2022, Bristol Myers Squibb brought to market the first drug for the 'obstructive' and most common form of this condition, which causes a potentially deadly stiffening of the heart muscles. But the pharmaceutical giant recently failed to prove its drug could effectively treat people with the 'non-obstructive' form, giving others, such as Cytokinetics, Edgewise Therapeutics and Haya a chance to compete. Bristol Myers;, Cytokinetics' and Edgewise's medicines are all designed to make the heart's contractions less forceful. The failure of Bristol Myers' Camzyos, though, raised questions as to whether that approach is helpful in non-obstructive disease. Haya's drug, named HTX-100, works differently, as it's supposed to reduce the dangerous heart tissue thickening by suppressing Wisper. In an email to BioPharma Dive, Ounzain noted how non-obstructive hypertrophic cardiomyopathy is primarily driven by mechanisms, such as progressive buildup of scar tissue, that current therapies 'do not adequately target.' Haya's drug is 'designed specifically to address these underlying drivers,' he wrote, noting Wisper plays a 'central role' in the fibrosis that occurs. A paper outlining the approach was co-authored by Ounzain and published in Science Translational Medicine in 2017, the year Haya was founded, but the company hasn't proven it works in humans yet. Ounzain said Haya's first clinical trial in non-obstructive hypertrophic cardiomyopathy will start 'in the near future.' Cytokinetics and Edgewise's medicines are in or nearing Phase 3 testing. 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
22-04-2025
- Business
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Patent Cliff Looms Large for Bristol-Myers Squibb Stock (BMY)
Bristol-Myers Squibb (BMY) stock is down 11% year-to-date as the company navigates several looming patent cliffs. After a $13 billion acquisition of MyoKardia for its obstructive hypertrophic myopathy (HCM) drug, Camzyos, in 2020, the pharmaceutical giant has had difficulty achieving a return on investment. Discover outperforming stocks and invest smarter with Top Smart Score Stocks. Filter, analyze, and streamline your search for investment opportunities using Tipranks' Stock Screener. Bristol once believed Camzyos, FDA-approved for obstructive HCM (oHCM), could generate $4 billion in peak annual sales, but this has taken a hit on many fronts. Last week, Bristol revealed that Camyzos failed a critical Phase 3 trial assessing the drug in patients with non-obstructive HCM (nHCM), negating one-third of the HCM market. The company's struggles to 'fill the shoes' of blockbusters like Eliquis and Revlimid concern its future prospects, meriting a bearish outlook on its stock. After a slower-than-expected launch, Camzyos generated $223 million in revenue in the fourth quarter of 2024. Although the drug is the first of its kind for this genetic heart disease, it also competes with traditional treatments such as beta blockers. Moreover, many HCM patients go undiagnosed, further limiting the total addressable market. After a failure in nHCM, the company may have to temper its expectations of Camzyos. Moreover, Bristol may soon face competition from Cytokinetics (CYTK), whose me-too cardiac myosin inhibitor, aficamten, awaits a September FDA approval decision in oHCM. Aficamten could split the market for oHCM, especially should the drug generate a different outcome in nHCM. While the nHCM failure definitely limits Camzyos' market, the drug is still anticipated to generate upwards of $2 billion in peak annual revenue. Prospects like Camzyos are crucial because BMY wants to see a return on investment after dishing out $13 billion and because BMY has several blockbuster drugs nearing a 'patent cliff.' To review, after drugs are approved, their intellectual property is protected for a limited time before others can sell generic versions. After this exclusivity period, generics can flood the market, effectively decreasing the branded drug's pricing power and market share. This is also why large pharmaceutical companies invest so much in research and development and are willing to spend billions on promising drugs. Unfortunately for Bristol, its top two drugs, Eliquis and Opdivo, are expected to succumb to generic competition within the next three years. Together, they make up approximately 45% of Bristol's total revenues. Its third-largest drug, Revlimid, lost exclusivity in 2022. In Q4 2024, Revlimid revenues dropped 8% worldwide to reach $1.4 billion, with further expected declines en route. On the positive front, BMY has a few promising growth prospects brewing. For instance, Cobenfy is a highly anticipated schizophrenia drug that recently received FDA approval. The drug represents the first novel treatment for the condition in over seven decades. Analysts believe Cobenfy could generate anywhere between $2 billion and $10 billion at its peak. However, the drug wasn't cheap. BMY spent $14 billion to acquire its developer, Karuna Therapeutics. While a strategy of simply acquiring promising drugs can pay off, it's not as cost-effective as developing them in-house. Drugs like Cobenfy and Camzyos could have been developed for much less than $1 billion had Bristol developed them itself. Of course, Bristol does have its own growth engine. It hopes that its subcutaneous version of Opdivo, branded as Opdivo Qvantig, can help extend the impact of its immuno-oncology franchise. Interestingly, the company is engaging in strategic cost-cutting and reinvestment. It aims to cut $2 billion in costs by the end of 2027. Notably, this timeline perfectly aligns with Opdivo's loss of exclusivity in 2028. Lastly, the company is looking for additional 'bolt-on opportunities' via acquisitions and continues to advance several pipeline assets through clinical trials. On Wall Street, BMY has a Hold consensus rating based on four Buy, 12 Hold, and one Sell rating over the past three months. BMY's average price target of $57.77 implies a 17% upside potential over the next twelve months. Last week, Tim Anderson of Bank of America Securities reiterated a Hold rating on BMY with a price target lowered from $63 to $58. The analyst expressed concerns about Camzyos' clinical setback. He also noted 'broader pharmaceutical sector' problems, like tariffs and drug pricing regulations, that lower overall price-to-earnings (P/E) multiples. Lastly, he believes Bristol will 'face several years of earnings pressure due to generic competition.' The recent Camzyos nHCM trial failure highlights the challenges in developing new blockbusters to offset impending revenue losses. However, this is just one problem. The more pressing concern remains the looming patent expirations for Eliquis and Opdivo, which make up nearly half the company's revenue base. BMY's strategy of large-scale acquisitions has been a mixed bag and comes at a price. While newly approved drugs like Cobenfy offer promising growth prospects, building a portfolio to replace the revenue from established blockbusters is an uphill battle for any pharmaceutical company. And as some on Wall Street have pointed out, BMY's valuation is no longer relatively cheap. As evidenced by its consensus Hold recommendation, investors may benefit from siding cautiously as the company continues its search for the next generation of blockbuster medicines. Disclaimer & DisclosureReport an Issue
Yahoo
19-04-2025
- Business
- Yahoo
GSK prepares to relaunch Blenrep; Activists challenge another ‘zombie' biotech
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 GSK and Bristol Myers Squibb, as well as updates from Elevation Oncology, Bayer and Airna that you may have missed. GSK's Blenrep has been approved in the U.K. to treat people whose multiple myeloma has progressed after one line of therapy, the company said Thursday. The clearance is Blenrep's first since it was withdrawn from the market three years ago following the failure of a confirmatory trial, and comes after the company succeeded in additional studies that have since positioned it for a relaunch. The Food and Drug Administration is set to decide on a new approval in the U.S. by July 23. — Jonathan Gardner Investment firm BML Capital Management has called for cancer drug developer Elevation Oncology to liquidate and return all of its cash to shareholders, according to a regulatory filing. Elevation dropped its lead drug, laid off a majority of its staff, and began a strategic review after reporting disappointing study data last month. That process often ends in a 'reverse merger' with a privately held company that then continues on in the public markets. However, BML, which owns 9.9% of Elevation stock, argued in a letter to management that winding down is the company's 'best course of action' given the state of the equity markets and the 'abysmal performance' of many recent reverse mergers. Multiple other struggling biotechs, including fellow cancer drug developer , have recently faced activist pressure as well. — Ben Fidler The FDA updated the prescribing information for Bristol Myers Squibb's hypertrophic cardiomyopathy drug Camzyos to ease risk monitoring requirements and lower the number of therapies it's contraindicated with, the company said Thursday. The updated prescribing information lowers the frequency of echocardiogram monitoring for some patients and removes two kinds of inhibitor drugs as contraindicated therapies. The move suggests 'greater comfort' with so-called cardiac myosin inhibitors like Camzyos and should help 'build out the still nascent' market for them, wrote Stifel analyst James Condulis. Camzyos generated $602 million in sales last year, and could soon face competition from Cytokinetics' aficamten, which is currently being reviewed by U.S. regulators. — Ben Fidler Ligand Pharmaceuticals and Channel Therapeutics will combine a trio of subsidiaries in a deal that will create a new company, Pelthos Therapeutics, focused on selling an already-approved prescription gel for molluscum infections. Pelthos will also own a portfolio of pain drugs aimed at Nav1.7, a target of interest to other developers as well, including Vertex Pharmaceuticals and SiteOne will invest $18 million in the combined company, with a group led by investment firm Murchinson kicking in another $32 million. — Ben Fidler Bayer on Wednesday debuted a 70,000-square-foot expansion to a Myerstown, Pennsylvania, facility that now represents the largest manufacturing site for its consumer health division. The expansion follows a $44 million investment in 2022 and will help the company more efficiently manufacture products like Aspirin, Claritin and Midol. The facility employs more than 585 full-time workers, according to a published report.— Ben Fidler RNA editing startup Airna has named former Sarepta Therapeutics executive Jacob Elkins as its chief medical officer. Elkins was most recently Sarepta's CMO and head of development sciences, and in that role helped support the development of the company's 'exon skipping' RNA therapies and the Duchenne muscular dystrophy gene therapy Elevidys. At Airna, he'll oversee development of an experimental treatment for alpha-1 antitrypsin deficiency that's nearing human testing, and help expand the company's pipeline into more common conditions as well. — Ben Fidler Recommended Reading JPM25: The FDA's future, AbbVie's second thoughts and Lilly's lesson Sign in to access your portfolio
Yahoo
19-04-2025
- Business
- Yahoo
Bristol Myers says FDA updates Camzyos label to simplify treatment
Bristol Myers (BMY) Squibb announced that the U.S. Food and Drug Administration has updated the U.S. Prescribing Information for Camzyos, simplifying treatment for patients and physicians by reducing the required echo monitoring for eligible patients in the maintenance phase and expanding patient eligibility by reducing contraindications. 'In addition to the established efficacy of Camzyos, these meaningful updates to the label reinforce the strong safety profile of the therapy. With robust clinical and real-world data and more than 15,000 patients prescribed Camzyos in the U.S., this medicine has redefined the treatment landscape for symptomatic obstructive HCM and can have a significant impact for patients living with the condition. Simplifying treatment by reducing the frequency of echo monitoring not only improves the patient experience, but will also save time for cardiologists, allowing them to treat more patients,' said Al Reba, senior vice president, Cardiovascular & Immunology Commercialization at Bristol Myers Squibb. Discover outperforming stocks and invest smarter with Top Smart Score Stocks. Filter, analyze, and streamline your search for investment opportunities using Tipranks' Stock Screener. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See today's best-performing stocks on TipRanks >> Read More on BMY: Disclaimer & DisclosureReport an Issue Bristol Myers price target lowered to $58 from $63 at BofA Hold Rating on Bristol-Myers Squibb Amid Revenue Challenges and Sector-Wide Valuation Pressures Cytokinetics price target lowered to $54 from $62 at BofA Bristol-Myers Squibb: Hold Rating Amidst Trial Setbacks and Pipeline Challenges Sell Rating for Bristol-Myers Squibb Due to Camzyos Trial Failure and Revenue Pressures
