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iStock, Nuthawut Somsuk Dozens of biotechs reported earnings this week. BioSpace recaps key highlights from Capricor Therapeutics, Legend Biotech, Inovio and Allogene. Myriad biotechs reported earnings this week, with stories ranging from Legend Biotech’s near-term goal of hitting profitability this year to Capricor Therapeutics’ regulatory comeback. 2025 was a rollercoaster year for biotech as regulatory uncertainty and a policy focus on drug pricing sent the markets into tumult. While a comeback had been predicted at the beginning of the year, in reality, the first half of 2025 was what law firm Ropes & Grey dubbed a bear market in a report this week. But things looked up in the second half as the industry started to rebound. The M&A stalemate finally broke and many large deals—primarily Pfizer’s contested but ultimately successful bid for Metsera —revived interest. That set the stage for a promising fourth quarter, which the industry is now getting more detail on as these smaller, science-forward companies report earnings for the period and the full year. Below, BioSpace recaps the top news from across the industry’s small innovators. Capricor Preps for Post-Prasad FDA One biotech that had a particularly tough year was Capricor Therapeutics, with the FDA rejecting the Duchenne muscular dystrophy cardiomyopathy cell therapy in July 2025. The therapy reportedly got caught up in FDA infighting, as Nicole Verdun, the agency’s then-top regulator of cell and gene therapies, wanted to hold an advisory committee meeting while her boss, Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad, did not. Last week, Prasad’s departure was announced , potentially clearing the way for Capricor and other biotechs. Indeed, days later, the FDA announced a plan to review the Duchenne cardiomyopathy therapy, called deramiocel, again by August 22. With things back on track, Capricor CEO Linda Marbán told analysts on a Thursday fourth quarter earnings call that no decision has been made on an adcomm—but the biotech is preparing no matter what. FDA ‘Unprecedented’ FDA Leaks Sow Confusion for Patients, Sarepta and Capricor Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy families have turned to the news for answers. Meanwhile, the FDA insists it remains committed to notifying companies of any regulatory action before sharing information with the media or public. August 4, 2025 · 7 min read · Heather McKenzie Read more “I think with the departure of Vinay Prasad, it’s a little bit up in the air as to what’s happening within CBER and what their manifest will be,” Marbán said. “Either way, we’ll be prepared.” The CEO is emboldened by data from the Phase 3 HOPE-3 trial, which was added to the resubmission package for deramiocel in December 2025. The study showed that patients given the cell therapy saw significant improvements in upper-limb and cardiac function compared with those on placebo. The data are “so very strong that I really would be delighted, whether I present it in an AdComm or we proceed directly to PDUFA without it,” Marbán said. A Legend-ary Plan To Make Money in 2026 Legend Biotech is heading toward company-wide profitability this year, thanks to the Johnson & Johnson–partnered CAR T cell therapy Carvykti. The New Jersey– and China-based company reported revenue of $555 million for Carvykti in the fourth quarter , a 5.9% increase compared to the third quarter. This still meant a net loss of $30.9 million for the quarter—but with the cell therapy growing, executives are confident in a goal to reach profitability this year. The drug itself reached profitability in 2025; Legend has $949 million in cash on hand, CEO Ying Huang explained on Legend’s Tuesday earnings call. Cell Therapy 6 Companies Hanging On in Cell Therapy As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go. December 1, 2025 · 9 min read · Tristan Manalac Read more Truist Securities predicts that sales of Carvykti will continue to grow in all quarters of 2026, according to a Thursday note. The firm estimates total revenue of $1.46 billion for 2026. Now or Never for Allogene Elsewhere in cell therapy, Allogene is expecting a make-or-break moment in the second quarter of 2026 with the futility analysis for the Phase 2 ALPHA3 study of CD19 CAR T cema-cel. The trial is testing the therapy in first-line consolidation for large B cell lymphoma, meaning it would be given as an initial treatment to prevent remission. The study is expected to detail minimum residual disease (MRD) clearance, which is a key measure of remission in the disease. The company is hoping to see 30% MRD conversion as compared to the control arm to be clinically meaningful. “We remain bullish on the overall success of ALPHA3 and continue to believe cema-cel has the potential to leapfrog other autologous and allogeneic CD19 CAR-T therapies, remain competitive for longer, and expand the total addressable market,” William Blair wrote in a Friday morning note. Results for ALPHA3 are due in April. Otherwise, Allogene reported a net loss of $38.8 million but $258.3 million in cash on hand, which should provide runway into the first quarter of 2028. A Rocky Regulatory Run for Inovio Inovio’s 2026 could be the biggest in company history, with a drug application finally in front of the FDA after almost 30 years of toiling away in the clinic. The biologics license application for INO-3107, under development for adults with recurrent respiratory papillomatosis, is expected to receive a decision by October 30. While this was a major step forward, executives provided more context on the unique circumstances of this asset’s regulatory review during a fourth quarter earnings call on Thursday . Specifically, the application was granted accelerated review, allowing for marketing without a study showing clinical benefit until a confirmatory one can be conducted. However, the FDA issued a preliminary conclusion that the company has not justified eligibility for the program. Business Inovio Taps New CEO, Drops COVID-19 Vaccine Candidate Jacqueline Shea will take over as the new CEO and announced plans to discontinue its Phase III Innovate trial to prioritize its heterologous booster strategy for COVID-19. May 11, 2022 · 3 min read · Alex Keown Read more Inovio CEO Jacqueline Shea said this was the first time the company had heard of any such issues. “We strongly believe that INO-3107 does fulfill the criteria for review under the accelerated approval program, by meeting an unmet medical need and providing a meaningful therapeutic benefit over existing treatment.” The FDA has agreed to meet with the Inovio team and the company has provided more details, the CEO explained. Meanwhile, commercial plans are continuing ahead of the FDA’s October deadline. That has meant some tough decisions to conserve resources, including eliminating some roles unrelated to advancing INO-3107 to the market. The cuts will help extend Inovio’s cash runway into the fourth quarter of this year, Shea said. The DNA medicine company reported cash on hand of $58.5 million. Analysts from Stephens wrote on Friday that Inovio will need to raise capital to launch INO-3107 if it receives approval. .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to BioPharm Executive! Market insights, trending business and policy stories for biopharma leaders hbspt.forms.create({ region: "na1", portalId: "4413123", formId: "7c139b3c-ff0b-44e0-bffe-f449801dca59", onFormSubmitted: function($form, data) { window.dataLayer = window.dataLayer || []; window.dataLayer.push({ 'event': 'GTMevent', 'event_name': 'newsletter_sign_up' }); } });