Lanadelumab

The Japanese pharma is targeting 2026 revenues of 4.64 trillion Japanese yen ($29.4 billion). With a new CEO prepared to take the reins next month and three key launches on deck for 2026 and 2027, Takeda is ready to shake off the generic-related declines that have plagued revenues in recent years as it eyes a “new era” to be marked by growth acceleration, according to the Japanese pharma.However, several thousand employees won’t be entering the new chapter with the company. In its full-year earnings presentation (PDF) on May 13, Takeda filled in details on its 2026 “transformation program,” which looks to centralize corporate functions, reduce management layers and target process simplification.  The multiyear slim-down is expected to hit about 4,500 roles during the 2026 fiscal year, resulting in about 170 billion Japanese yen ($1.07 billion) in restructuring costs and some 100 billion yen ($633 million) in gross savings for 2026, the company said. More than 200 billion yen ($1.26 billion) in annualized savings is projected by 2028. Takeda recently telegraphed a round of job reductions in the U.S, affecting 634 roles assigned to the company’s U.S. headquarters in Cambridge, Massachusetts, as part of the $1.26 billion efficiency drive. The latest restructuring comes on the heels of 2024-2025’s “enterprise-wide efficiency program,” which saw over 4,000 positions impacted over the two years, Takeda noted. Takeda’s cost-savings push began in 2024, as revenues for its blockbuster attention-deficit/hyperactivity disorder med Vyvanse rapidly declined in the face of generics swarming the market upon its patent expiration, a struggle that has haunted the organization since. With the company predicting last year that 2025 would be the last year of major generic headwinds to Vyvanse, Takeda is hoping that its three upcoming new launches will help put its Vyvanse-related sales woes in the rearview. In fiscal 2026, which ends in March 2027, the company anticipates full-year revenues of 4.64 trillion Japanese yen ($29.4 billion), reflecting “mature portfolio headwinds in a year that we pivot to new launches,” it explained in its presentation. The new launches include potential regulatory approvals for Takeda’s three leading late-stage assets in narcolepsy treatment oveporexton, polycythemia vera candidate rusfertide and psoriasis medicine zasocitinib. Oveporexton and rusfertide are both under priority review with the FDA and could see a U.S. commercial launch during the second half of 2026, while the company is making “decisive investments” to support a zasocitnib regulatory filing later this year. “We are very, very excited about these three launches, and we’re laser-focused on the execution,” CEO-Elect Julie Kim said on the company’s earnings conference call with investors. As the company zeroes in on transitioning to a “new cohort of blockbuster brands” that positions it for “long-term profitable growth and patient impact,” Kim said in a release, Takeda is outlining its metamorphosis in two phases. The first step, dubbed “Horizon One,” will see the company establish a trio of new growth drivers while ensuring the “resilience and competitiveness” of its core in-line brands. After that, “Horizon Two” will launch another wave of late-stage pipeline assets and maximize revenue from the first launches.Takeda enters its 2026 fiscal year with 684.5 billion yen ($4.3 billion) in free cash flow after collecting full-year 2025 revenues of 4.5 trillion yen ($28.3 billion) in a 1.7% year-over-year decline. Over half (51%) of the company’s yearly revenue came from its collection of growth and launch products, which includes blockbuster inflammatory bowel disease (IBD) drug Entyvio and hereditary angioedema (HAE) drug Takhzyro, among others.  Put together, the selection of growth products spread across the company’s six key business areas together earned 2.3 trillion Japanese yen ($14.5 billion) over the year, which “partially mitigated” the continued impacts of Vyvanse’s generic erosion. Vyvanse and other products impacted by patent expirations saw a pooled sales decline of 43% over the year, the company noted in its presentation. Takeda’s full-year 2025 earnings conference call was the last under longtime CEO Christophe Weber, who took over the pharma in 2015 after a 20-year career at GSK. Weber was the first non-Japanese CEO in the company’s over 200-year history and was credited with “building Takeda into the company it is today,” Kim said on the call. Kim, who joined Takeda in 2019, had headed up the company’s U.S. operations since 2022 and was selected as CEO as part of a “thoughtful and intentional” succession process, Weber noted.

Shares in Intellia rose 4% to $14.20 in premarket trading. \n A phase 3 trial of Intellia Therapeutics’ in vivo gene-editing therapy lonvoguran ziclumeran (lonvo-z) has hit its primary endpoint, leading the biotech to start a rolling submission for FDA approval. The study randomized 80 people with hereditary angioedema (HAE) to receive lonvo-z or placebo. HAE is a rare genetic condition characterized by recurrent and potentially life-threatening swelling. Noting that overproduction of bradykinin drives the disease, Intellia bet it could improve outcomes by using CRISPR to inactivate a gene needed to produce the peptide. Intellia’s phase 3 Haelo data validate the hypothesis, while leaving the question of whether the bet will pay off commercially unanswered. One infusion of lonvo-z reduced swelling attacks by 87% compared to placebo during the six-month efficacy evaluation period, hitting the trial’s primary endpoint.The investor bull case was for about a 90% placebo-normalized reduction in attack rates, William Blair analysts said in a note to investors Monday. However, hitting that target depended on a very low placebo response, which the analysts said: “can be tricky to navigate for more mild attacks.” Intellia beat William Blair’s 80% base case, leading the analysts to call lonvo-z a “compelling one-time option.” The trial met all key secondary endpoints. Intellia said 62% of patients were attack- and therapy-free in the lonvo-z arm during the six-month efficacy evaluation period, compared with 11% of patients in the placebo cohort.The data suggest lonvo-z is at least as effective as existing treatments for HAE. Ionis Pharmaceuticals won FDA approval for Dawnzera last year after linking the antisense oligonucleotide to an 81% reduction in attacks versus placebo. Other treatments include Takeda’s blockbuster standard of care, Takhzyro, and BioCryst Pharmaceuticals’ Orladeyo.While the existing HAE arsenal contains a mix of injectable and oral drugs, all of the treatments require people to keep taking medicines to prevent attacks. Lonvo-z could permanently reduce HAE attacks after a single dose. “Lonvo-z appears highly differentiated given its ability to free most patients from both attacks and ongoing treatment with just one dose,” Marc Riedl, M.D., clinical director of a HAE center at UC San Diego, said on Intellia’s call with analysts to discuss the phase 3 lonvo-z data. “The efficacy observed in Haelo appears highly competitive and attractive.” Intellia aims to complete its rolling submission in the second half of the year, putting it on track to launch the therapy in the first half of 2027. If the FDA approves lonvo-z, Intellia will face the challenge of reassuring patients that a treatment that permanently edits their DNA is safe and a better option than existing therapies.The most common treatment-emergent adverse events (TEAEs) during the phase 3 primary observation period were infusion-related reactions, headache and fatigue. All TEAEs were mild or moderate and no serious adverse events were observed in the lonvo-z arm.The safety of gene editing was thrust into the spotlight last year when a patient suffered liver injury and died from septic shock following rupture in the intestine after receiving Intellia’s nex-z. Lonvo-z was unaffected by the resulting clinical hold. Yet Guggenheim Securities analysts said in a note to investors at the time that the safety concerns mean lonvo-z may face commercial headwinds, especially as in their view the phase 3 trial was too small to allay the worries. Intellia CEO John Leonard, M.D., said on the Monday analyst call that one grade 2 case of elevated liver enzymes was observed. The event happened a couple of weeks after dosing, was asymptomatic and resolved spontaneously within one week. Other patients had grade 1 cases. Some companies have struggled to get patients to switch from ongoing treatments to one-time genetic medicines. BioMarin recently pulled its hemophilia gene therapy Roctavian from the market after failing to capture a significant share of a market served by drugs such as Roche’s bispecific antibody Hemlibra. Even those closest to HAE patients are unsure how widely lonvo-z will be adopted. Burden of treatment is a real thing for HAE patients, Riedl said. Yet while the doctor expects patients burdened by existing drugs to “look long and hard” at lonvo-z, he said he lacks “a good sense” of what percentage will elect to have the treatment.Shares in Intellia rose 4% to $14.20 in premarket trading.