Fianlimab

iStock, panom73 Biopharma is entering its second-quarter earnings season riding high on a wave of massive deals and venture capital flow, plus a clearing of regulatory and policy overhangs. What can industry watchers expect to hear on the upcoming investor calls? Pharma is entering the second-quarter earnings season riding high on a surge of deals—and now largely unencumbered by previous policy headwinds. The XBI—a fund that tracks the performance of the biotech sector—is back to “pandemic peak levels,” Truist Securities told investors in a July 7 note, pointing to the metric as evidence not only of the industry’s recovery from the post-COVID crash but also of the momentum building as the calendar flips to the back half of the year. Truist expects to see revenue start picking up across the board, “a rebound from a traditionally softer start to the year.” Analysts will also be on the lookout for updates on the completion of major acquisitions and on upcoming data readouts. “We continue to sense easing concern toward regulatory and policy factors, previously top of mind, into the midterms,” Truist added. No doubt contributing to this ease is the exit of former FDA Commissioner Marty Makary, who stepped down from his post in May, closing out what Capital Alpha called “ the most damaging period in FDA history .” FDA After ‘most damaging period in FDA history,’ Makary will be hard to replace With Commissioner Marty Makary’s exit, the FDA will enter a period of “unprecedented” and “prolonged” leadership vacuum, analysts at Capital Alpha predicted, noting that the government will have trouble finding someone who will want to take the FDA’s reins. May 13, 2026 · 3 min read · Tristan Manalac Read more Alongside the clearing regulatory skies, biopharma in recent months has also ridden high on a swelling wave of deals. M&A, for instance, has hit a total cumulative value of around $80 billion, per Truist’s estimate. This sum includes the year’s four of largest takeovers so far, all inked in Q2: Sun Pharma’s $11.75 billion pickup of Organon, AbbVie’s $10.9 billion gambit for Apogee, GSK’s $10.6 billion purchase of Nuvalent Bio and Vertex’s $10 billion Crinetics play. There has also been an encouraging influx of money into the industry, with Truist documenting “healthy financing activity and robust appetite for new paper.” Indeed, Isomorphic Labs in May closed its eye-watering $2.1 billion series B round—the second-largest in the sector’s history. But even as headwinds ebb for biopharma overall, some companies, such as Amgen and Gilead, continue to face challenges brought about by certain market factors—and analysts expect to see some weakness in their prints here. Venture capital 5 largest VC rounds of H1 2026 Early-stage financing rounds are on track to hit their lowest dollar value in years as funders continue to eschew risky investments, experts told BioSpace . July 8, 2026 · 9 min read · Tristan Manalac Read more What to watch for With the obesity market projected to hit up to $200 billion next year , this therapeutic space is top of mind for most analysts and investors—and here, Eli Lilly continues to be the most closely watched company. The pharma could deliver a “beat and raise quarter,” Truist wrote in a Lilly-focused note sent on July 8, pointing to “strong US script growth” in the company’s tirzepatide profile. Both the obesity brand Zepbound and the diabetes drug Mounjaro are poised to grow quarter-on-quarter, as per the firm’s projections. Q2 will also be the first full commercial quarter for Lilly’s weight-loss pill Foundayo, which won the FDA’s go-ahead on April 1. Figures for the oral drug don’t point to a blowout victory for Lilly, however, with Truist noting that Foundayo’s U.S. launch has been “off to a slower than expected start.” Here, Novo Nordisk seems to have eked out an edge, with its oral Wegovy reaching 1 million patients in May after just 16 weeks on the market, exceeding all expectations and marking what CEO Maziar Mike Doustdar called a “record-breaking start” in the U.S. Still, Truist remains optimistic about Foundayo, writing on July 8 that “we see substantial potential” for the pill, “particularly in the international market.” Editorial With oral obesity race underway, all eyes are on Lilly’s Foundayo launch Novo Nordisk’s oral Wegovy has a few months’ head start on Eli Lilly’s newly approved pill. While the Indianapolis pharma has come from behind the Danish rival in the weight loss space before, last time it clearly had the better drug. April 10, 2026 · 3 min read · Jef Akst Read more Aside from Lilly, analysts are also keeping an eye on Pfizer, from which Guggenheim Partners expects to hear obesity updates, according to a July 10 note. The pharma has been aggressively building out its weight loss portfolio, winning a bidding war against Novo Nordisk last November to bag Metsera for close to $10 billion . A readout from berobenatide—the acquisition’s centerpiece, which is being trialed with an amylin analog—is expected later this year . Outside of obesity, Guggenheim also wants to hear about Pfizer’s “latest capital allocation and business development priorities,” given the impending departure of the pharma’s CFO Dave Denton on Aug. 16. Also on Guggenheim’s docket is AbbVie, which analysts expect to report $16.65 billion in revenue in Q2—largely in line with, if not slightly below, the $16.77 billion consensus forecast. Top-of-mind for the analysts, according to a separate note sent July 8, is the pharma’s progress toward closing its Apogee acquisition. Guggenheim is also looking forward to hearing from AbbVie how competitive dynamics have changed in the immunology space since the entry of Johnson & Johnson’s plaque psoriasis pill Icotyde after its March approval . Aesthetics is also an area to watch, the group continued, especially following the FDA’s April rejection of trenibotulinumtoxinE, AbbVie’s successor to Botox. In cancer, Guggenheim is watching for updates from Merck on the market uptake for Keytruda Qlex, the subcutaneous formulation of the blockbuster PD-1 inhibitor, analysts wrote in a July 10 note focused on the pharma. Looking ahead, the firm awaits additional data for Merck’s Kelun Biotech–partnered antibody-drug conjugate sac-TMT. Antibody-drug conjugate (ADC) ASCO: Merck overshadowed by upstart biotechs but TROP2 plans begin to pay off Merck may not have had the splashiest presentation at the American Society of Clinical Oncology meeting, but the data show why the Big Pharma remains king of oncology, analysts say. June 2, 2026 · 4 min read · Annalee Armstrong Read more Merck is also set to provide updated sales figures for its respiratory drug Ohtuvayre and hypertension medicine Winrevair—both of which are also on Guggenheim’s radar. Moderna, meanwhile, is a rapidly emerging player in oncology with stock that has performed strongly in 2026 so far, surging 121% year-to-date. Much of this is “due to growing excitement toward mRNA-4157,” Jefferies analysts wrote in a July 12 note focused on the company. The personalized cancer vaccine is being developed along with Keytruda for melanoma. A late-stage readout is on track for later this year—and Jefferies is anticipating details on that during the company’s call. Otherwise, the firm expects Moderna’s earnings call to be “straightforward,” noting that the company has already projected a dip in income due to seasonality in demand for its COVID-19 products. Dark clouds still hang overhead While many key headwinds for pharma have petered out, some companies continue to face challenges. Amgen, for instance, has been contending with calls from the FDA to withdraw its rare disease drug Tavneos. While the pharma has come out in defense of Tavneos— requesting a hearing with the FDA and enlisting an independent analysis from the Duke Clinical Research Institute—Truist has nevertheless lowered its projections for the drug this year “in light of recent safety and data integrity concerns.” Tavneos made $119 million in the first quarter, a 32% year-on-year increase. Regulatory Amgen continues to defend Tavneos as global regulatory pressure mounts Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx. July 10, 2026 · 4 min read · Nick Paul Taylor Read more Another company dealing with difficulties is Regeneron, which in May revealed that its LAG-3 inhibitor fianlimab, when used with the PD-1 blocker Libtayo, failed to significantly outperform Keytruda in a Phase 3 melanoma study.BMO Capital Markets at the time took the failure hard: “Confidence shaken; frustration mounting around R&D execution.” Truist, in its July 7 note, suggested that investors have started moving on. “We note fading LAG-3 (fianlimab) frustration, with focus turning back to commercial execution.” On this front, the firm expects Regeneron to surpass the consensus earnings estimate, driven heavily by a strong projected performance of its Sanofi-partnered Dupixent. The firm also noted that investors could start clamoring for Regeneron to join the M&A frenzy sweeping across pharma, asking the company to “strike on more fulsome and de-risked portfolios,” though the analysts didn’t identify any potential acquisition targets. Cancer Regeneron misses again as melanoma combo bows to Merck’s Keytruda in Phase 3 The late-stage miss shakes analyst confidence in Regeneron’s clinical execution, according to BMO Capital Markets, also noting last year’s Phase 3 failure in chronic obstructive pulmonary disease. May 18, 2026 · 2 min read · Tristan Manalac Read more Truist also expects to see some slowness on Gilead’s end, with the firm forecasting that Q2 revenues could come slightly under the consensus estimate. Looking at drug script trends, the analysts anticipate sales of the daily HIV pill Biktarvy and the CAR T therapy Yescarta to also fall behind Wall Street projections. Gilead’s twice-yearly HIV pre-exposure prophylactic Yeztugo is likewise on track to miss the consensus forecast, according to Truist’s projections. On the company call, the firm wants to hear how Gilead is preparing for the launch of its next CAR T therapy, anito-cel, ahead of a potential approval later this year. The pharma is proposing anito-cel for multiple myeloma, with an FDA target action date of Dec. 23 . Mergers & acquisitions Gilead Doubles Down on CAR T With $7.8B Arcellx Acquisition The centerpiece of the takeover is anito-cel, a CAR T therapy under development for relapsed or refractory multiple myeloma. An FDA decision on the therapy is expected by December 2026. February 23, 2026 · 2 min read · Tristan Manalac Read more Looking ahead to the back half of the year, Truist anticipates a “robust catalyst calendar, supported by sector optimism and deal activity” across biopharma.