Apitegromab

This is the latest installment in a new series where BioPharma Dive uses data visualization to recap whats going on across the industry. Today, were looking at a spurt of China licensing deals from GSK, Electra Therapeutics big IPO and how investors responded to Scholar Rocks long-awaited drug approval.Over the last couple years, the pharmaceutical industry has rushed to scoop up drugs discovered in China. More than 100 deals have been struck, according to BioPharma Dive data, a trend thats sparked concern among U.S. lawmakers as well as debate among biotech executives and investors.Since the start of 2025, GSK has looked to China more than most of its peers. Data show that the company has struck five such deals over that span with China-based drug developers, trailing only Roche. Two of those pacts have come this month, and both involve next-generation cancer medicines involving different kinds of antibody technology. An alliance with Hutchmed gave GSK rights to an antibody-targeted therapy conjugate, a twist on the antibody-drug conjugates that are now commonly used in cancer care. A pact with Chimagen Biosciences handed the company a three-pronged myeloma drug.GSKs China dealmaking could soon pay dividends, too. A drug prominently featured at the World Conference on Lung Cancer last weekend came to GSK via a 2023 partnership with Hansoh Pharma. Jefferies analyst Michael Leuchten recently referred to that drug as an underappreciated, potentially major oncology asset.GSK is investing heavily in drugs from ChinaLicensing deals between GSK and China-based drugmakers since the start of 2025.(function(){function e(){window.addEventListener(`message`,function(e){if(e.data[`datawrapper-height`]!==void 0){var t=document.querySelectorAll(`iframe`);for(var n in e.data[`datawrapper-height`])for(var r=0,i;i=t[r];r++)if(i.contentWindow===e.source){var a=e.data[`datawrapper-height`][n]+`px`;i.style.height=a}}})}e()})();Its no secret now that biotech initial public offerings have rebounded in 2026. More than 20 companies have priced new stock sales this year, almost doubling 2025s anemic total, BioPharma Dive data show. Most trade well above their debut price.But the pace of offerings this year is merely approaching, rather than blowing past, historical norms. Whats different is the size of these IPOs, which approaches what was last seen during the sectors bubbly pandemic peak.Electra Therapeutics stock offering Thursday night was the latest example. In pricing its IPO, Electra became the 11th drugmaker to raise at least $300 million in proceeds. That figure matches 2021s total a record year for biotech IPOs and surpasses the previous four years combined.Biotech IPOs have regularly topped $300M in 2026The top drugmaker IPOs, by total proceeds, since Jan. 1.(function(){function e(){window.addEventListener(`message`,function(e){if(e.data[`datawrapper-height`]!==void 0){var t=document.querySelectorAll(`iframe`);for(var n in e.data[`datawrapper-height`])for(var r=0,i;i=t[r];r++)if(i.contentWindow===e.source){var a=e.data[`datawrapper-height`][n]+`px`;i.style.height=a}}})}e()})();Scholar Rock hit a milestone a week ago. The 14-year-old biotechnology company last Friday won its first regulatory approval with the U.S. clearance of Isembyld, a first-of-its-kind muscle-targeted treatment for the rare disease spinal muscular atrophy. In the process, Scholar Rock overcame a manufacturing issue that led to an earlier rejection of Isembyld and a year-long delay.Wall Street analysts have long viewed Isembyld as a possible blockbuster, and the broad prescribing information endorsing use in all patients at least two years of age and on existing treatments supported those projections. TD Cowen analyst Ritu Baral, for instance, wrote in a Monday client note that she expects sales to peak at $2.3 billion in 2035.Yet Scholar Rock stock price has swung wildly in both directions since the approval. Shares initially surged to as high as $62 in after-hours trading, fell to around $47, and closed on Thursday at just over $49. One possible reason for the volatility was a disclosure that surprised analysts: a safety warning linking Isembyld to a risk of fractures. That news generated investor [questions], wrote Evercore ISI analyst Cory Kasimov, though he and others waved off any meaningful impact on drug sales.Instead, Kasimov attributed the stock slide to a sell the news dynamic, when a companys market value falls just after a positive development such as a regulatory approval.Scholar Rock shares tumbled after the company's first drug approvalThe biotech's stock price has fallen more than 12% since Isembyld's Sept. 11 clearance.(function(){function e(){window.addEventListener(`message`,function(e){if(e.data[`datawrapper-height`]!==void 0){var t=document.querySelectorAll(`iframe`);for(var n in e.data[`datawrapper-height`])for(var r=0,i;i=t[r];r++)if(i.contentWindow===e.source){var a=e.data[`datawrapper-height`][n]+`px`;i.style.height=a}}})}e()})(); '

After manufacturing woes sank Scholar Rock's initial bid for approval of its spinal muscular atrophy (SMA) treatment, Isembyld (apitegromab-mstn) has finally been greenlit by the FDA — about a year behind its original PDUFA date. Isembyld was cleared Friday for individuals two and older taking a survival motor neuron 2 (SMN2)-targeted treatment. The mAb, which selectively binds pro- and latent forms of myostatin in skeletal muscle to restrict muscle growth, is the first muscle-targeted treatment to demonstrate motor function improvements in SMA. The therapy's approval will see Scholar Rock pocket a rare paediatric disease priority review voucherTribulations and triumphs Scholar Rock's application for Isemblyd was rebuffed last September after the FDA flagged issues at a fill-finish site formerly owned by Catalent, now run by Novo Nordisk. While the biotech had hoped to resolve the issues quickly for a speedy resubmission, the US regulator's inspection of the Indiana facility was then classified as official action indicated (OAI), the most severe of the agency's grades. Reports suggested repeated quality control failures at the site, including foreign particle contamination, bacterial risks and inadequate corrective actions.The year-long regulatory delay for Isemblyd was disappointing, particularly after the mAb impressed in late-stage testing.  In the Phase III SAPPHIRE trial, which enrolled 156 participants aged 2 to 12 years old, patients taking Isemblyd achieved a statistically significant and clinically meaningful improvement versus placebo in motor function as measured by the Hammersmith Functional Motor Scale Expanded (HFMSE). Following the study's top-line readout in 2024, Alexander Fay — a paediatric neurologist and assistant professor of neurology at UCSF Benioff Children's Hospital — told FirstWord that the time was right for an add-on therapy like Isemblyd to join the SMA treatment landscape. "I think where the myostatin inhibitors fit in is cases where we need to do more to help muscles grow and catch up after a lifetime of not having normal neurons," he said. For more from that interview, see KOL Views Q&A: Leading neurologist says time is right for Scholar Rock’s myostatin movement in SMA. While Jefferies analysts previously modelled $1.8-billion in peak SMA sales for Isemblyd, reimbursement may make or break adoption (see – Spotlight On: How will newcomers reshape the SMA market?)."My fear as a clinician is that they are going to add a significant burden when it comes to testing, monitoring and paperwork that we have to submit to insurance before we can get it authorised," Fay added.