Edgewise Therapeutics, Inc.

Novo Holdings CEO Kasim Kutay asked, \"who’s going to IPO an asset in this environment?\"\n The CEO of Novo Holdings has warned that his $160 billion fund will slow down investment activity until the dust settles after the Trump administration’s tariff blitz.Trump’s attack on global trade—and fast retreat from his initial tariffs—has left investors uncertain about where the economy is heading. That could make life hard for investors such as Novo Holdings. The fund, which is best known as the controlling shareholder of Novo Nordisk, deployed (PDF) 34 billion Danish kroner ($5.2 billion) in life sciences last year. Now, Novo Holdings CEO Kasim Kutay is pumping the brakes.“Until there is more clarity on the prospects for economic growth, we will slow down our investment activities,” Kutay told Bloomberg. “We’re in the midst of uncharted waters.”The shift in Novo Holdings’ approach could have implications for biotechs that are seeking to raise cash. Last year was one of the most active years in the 25-year history of Novo Holdings’ venture investments group, which has pumped money into biotechs including Alentis Therapeutics, Amolyt, Edgewise, Numab and Vaxcyte. Novo Holdings’ venture portfolio was valued at 16 billion Danish krone ($2.4 billion) at the end of 2024. Around two-thirds of the 60 companies in the venture portfolio are private. Novo Holdings had planned to exit some of the assets this year but those actions could now be pushed to 2026.“I mean, who’s going to IPO an asset in this environment? Unless you have to, it’s probably not advisable,” Kutay said. “The view on interest rates, which is a key barometer and a driver of how and when to invest, is all over the place.”Kutay’s comments come shortly after Roche’s CEO Thomas Schinecker said tariffs could make it “more difficult to make financial sense of any M&A deals.” Merck & Co. CEO Rob Davis also said that \"clearly what’s happening does make it more complex to get things done because [of] the uncertainty everyone is wrestling with.”

Dive Brief:Bristol Myers Squibb on Monday said its drug Camzyos failed a Phase 3 trial in people with a progressive heart condition, closing off an opportunity to expand use of a medicine it sees as a future blockbuster.According to Bristol Myers, Camzyos missed the dual main goals of a study focused on the non-obstructive form of HCM, or hypertrophic cardiomyopathy. It failed to meaningfully improve peak oxygen consumption as well as scores on an assessment of heart health. The company didnt provide study details, but said more information will be shared with the scientific community in the future.Camzyos was acquired through the $13 billion buyout of MyoKardia in 2020 and two years later became the first drug cleared for use in the obstructive and more common form of the disease. Biotechnology companies Cytokinetics and Edgewise Therapeutics are developing similar medicines that are both in the advanced stages of clinical testing. Cytokinetics drug, aficamten, could be approved in the U.S. later this year.Dive Insight:Camzyos setback carries implications for Bristol Myers as well as the companies trying to develop better medicines for HCM, a chronic condition characterized by a potentially deadly stiffening of the heart muscle.Bristol Myers is bracing for the losses of billions of dollars in yearly revenue when the patents expire for its cancer immunotherapy Opdivo and blood thinner Eliquis. The company already announced a cost-cutting plan under CEO Chris Boerner, and is looking to a handful of medicines, Camzyos among them, to grow sales in the years ahead.Camzyos generated $602 million in sales in 2024. But Bristol Myers has said that number could reach $4 billion in 2029, and one way to get there was a clearance in the non-obstructive setting, which is estimated to account for about a third of the people with the condition. The setback is a disappointment, wrote Leerink Partners analyst David Risinger, though Bristol Myers could rebound if a series of coming Phase 3 readouts are successful.The study failure also stirred debate among analysts as to whether drugs like Camzyos, known as cardiac myosin inhibitors, can help all people with HCM. Camzyos has proven beneficial for the obstructive form that impedes blood flow and can lead to heart failure as well as other potentially serious complications. The non-obstructive type doesnt, but can still put people at risk of poor health outcomes. The new study tested whether Camzyos might be similarly helpful for those people as well.The fact that Camzyos wasnt suggests obstructive and non-obstructive HCM are two unique diseases, said Milind Desai, the director of the Cleveland Clinics HCM Center, in a statement provided by Bristol Myers.Analysts were mixed on whether the cardiac myosin inhibitors Cytokinetics and Edgewise are developing might similarly struggle in non-obstructive HCM. Cytokinetics drug, aficamten, is under Food and Drug Administration review in obstructive HCM and in a Phase 3 trial in non-obstructive disease. Edgewises EDG-7500 could join it in late-stage testing next year.Matt Phipps, of the investment bank William Blair, wrote that Camzyos shaky performance in the latest study as well as Phase 2 testing in non-obstructive HCM patients may be more attributed to disease biology, which has negative implications for the whole drug class.That form of the disease is also more heterogeneous, making it tougher for a drug to succeed in testing, added RBC Capital Markets Leonid Timashev.Still, there are key differences between the drugs and their development plans that leave some analysts optimistic about Cytokinetics and Edgewises chances. Aficamten appeared to perform better in earlier testing in non-obstructive patients, and Cytokinetics Phase 3 study is designed differently, wrote Mizuho Securities Salim Syed. RBCs Timashev added that EDG-7500s unique mechanism could overcome the limitations of other medicines in non-obstructive HCM.We now see a 2-handed market split between Cytokinetics and Edgewise, Timashev wrote. '

Across Edgewise Therapeutics\' study, two patients experienced “serious adverse events of atrial fibrillation (AF) requiring cardioversion,” the company said.\n Edgewise Therapeutics\' hypertrophic cardiomyopathy (HCM) asset has resulted in “rapid and clinically meaningful” reductions of a measure of obstruction of the heart’s valves.The biotech has been evaluating 50-mg and 100-mg daily doses of its cardiac sarcomere modulator, dubbed EDG-7500, in a four-week, open-label phase 2 Cirrus-HCM trial of patients with obstructive or nonobstructive HCM, a disease in which the heart muscle becomes thickened.Should EDG-7500 eventually make it to market, the drug will find itself competing with Bristol Myers Squibb’s established Camzyos and Cytokinetics’ candidate aficamten, which has been submitted to the FDA for approval and has a PDUFA date of Sept. 26. The latest slice of data shows that among patients with obstructive HCM—where the thickening affects the amount of blood pumped out of the heart—a 100-mg dose resulted in a mean reduction from baseline of 71% of left ventricular outflow tract gradient (LVOT-G) when resting and 58% after forced exhalation. LVOT-G measures the difference in pressure between the heart’s left ventricle and aorta. This reduction in pressure was achieved without a meaningful change in left ventricular ejection fraction (LVEF), Edgewise noted, meaning that the left ventricle of the heart was still pumping a normal amount of blood.In addition, the 100-mg cohort also saw a 62% mean reduction from baseline in NT-proBNP, a biomarker of heart failure.In participants with nonobstructive HCM, 100 mg of EDG-7500 administration resulted in a 42% reduction in NT-proBNP. Across the study, two patients experienced “serious adverse events of atrial fibrillation (AF) requiring cardioversion,” Edgewise said. The rates of AF—a term for irregular heart rhythm—were in the range of those seen in phase 2 trials of cardiac myosin inhibitors, according to the biotech.Overall, the most frequently reported adverse events in the trial were dizziness, upper respiratory tract infection and AF, with “nearly all” of these events “considered mild to moderate in severity.” Camzyos comes with an FDA black box warning of heart failure. “Building on the strength of clinical data to date, we are optimizing our dosing strategy in part D of CIRRUS-HCM in participants with obstructive and nonobstructive HCM, which will inform our plans for phase 3,” Edgewise’s CEO Kevin Koch, Ph.D., said in the April 2 release.“We believe EDG-7500, which delivered clinically meaningful results without causing systolic dysfunction, has the potential to be a significant advancement for patients with HCM and the clinicians who care for them,” Koch added.The latest data drop follows an earlier readout from the study last September that hit key biomarkers.Initial data from the final part of the study are expected in the second half of the year, with Edgeiwse penciling in a phase 3 trial launch in the first half of 2026.Edgewise aligned this morning’s news with a $200 million underwritten offering of common stock. The biotech has earmarked the funds to support the hoped-for launch of its Becker muscular dystrophy drug sevasemten, as well as the phase 3 trial of EDG-7500.The biotech was down 28% in premarket trading Wednesday morning after announcing its offering.