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AbbVie to Acquire Apogee Therapeutics for $10.9B

SAN DIEGO — AbbVie has agreed to acquire Apogee Therapeutics for $10.9 billion, the companies said today, in a deal designed to bolster the buyer’s pipeline with an atopic dermatitis (AD) candidate set to advance to Phase III trials during the second half of this year, and being positioned as a potential challenger to a top-selling drug.

Apogee’s lead candidate zumilokibart, an IL-13 inhibitor also called APG777, is a long-acting treatment that according to the company holds “pipeline-in-a-product potential” because of the opportunity it has for treating a variety of immunology and inflammation (I&I) diseases for which the drug is under study.

“We continue to believe that Apogee’s zumilokibart is one of the more attractive assets in the I&I space, and its current valuation proves this out,” Edward Nash, a managing director and senior biotechnology analyst with Canaccord Genuity, wrote this morning in a research note. “The company, since its 2022 inception, has continued to deliver strong clinical results for zumilokibart in atopic dermatitis. The BIG [emphasis in original] differentiator for the drug is its potential to be dosed once every three or six months, which was just demonstrated in recently announced updates from the Phase II trial.”

Last month, Apogee announced positive 16-week data from Part B of its Phase II APEX trial (NCT06395948) assessing zumilokibart in moderate-to-severe AD. The trial met its primary and secondary endpoints with high statistical significance, as 65.9% of patients treated with mid-dose zumilokibart achieved EASI-75 (41.9% placebo adjusted).

Based on these results and subject to positive regulatory feedback, Apogee said it planned to move forward in its Phase III trials with the mid-dose, which achieved the best clinical activity of the three doses tested and was well-tolerated.

To support those Phase III trials and continued late phase development and potential commercialization of zumilokibart, Apogee last month entered into a strategic financing for up to $1.3 billion in flexible, non-dilutive total capital.

The capital includes up to $800 million of synthetic royalty funding and access of up to $500 million in senior corporate debt available by mutual consent of Blackstone and Apogee. Blackstone agreed to provide the synthetic royalty funding in exchange for low-to-mid single digit tiered royalties for 15 years on worldwide annual sales of zumilokibart. The royalties decrease with increasing sales, with zero royalties paid out on global annual sales exceeding $8 billion.

Third-largest deal, so far

The $10.9 billion Apogee acquisition is the new third largest biopharma merger-and-acquisition (M&A) deal announced so far this year, behind the €10.7 billion ($12.268 billion) cash buyout offer for Italian-based Recordati being pursued by CVC Capital Partners and Groupe Bruxelles Lambert, which aim to take the company private; and Sun Pharmaceutical Industries’ planned $11.75 billion purchase of Organon, the women’s health drug developer spun out of Merck & Co., in a deal expected to close in early 2027.

The previous third-largest M&A deal this year, now fourth-largest, is GlaxoSmithKline (GSK)’s planned $10.6 billion buyout of Nuvalent,  announced June 9 and expected to close in the third quarter.

For AbbVie, the deal for Apogee adds to its pipeline in I&I, a category the biopharma giant dominated when its multi-indication blockbuster Humira® (adalimumab) was the world’s best-selling drug, before it lost patent exclusivity in the European Union in 2018 and the U.S. in 2023—after which it slipped from the top of GEN’s annual A-Lists of Top 10 Best-Selling Drugs.

However, AbbVie has developed two successful I&I drugs in recent years, Skyrizi® (risankizumab)  and Rinvoq® (upadacitinib)—with Skyrizi ranking No. 6 on GEN’s latest best-selling drugs A-List, generating $17.562 billion in sales last year (up 49.9% from 2024) and $4.483 billion in Q1 2026, up 30.9% from Q1 2025.

“For more than two decades, AbbVie has led and shaped the field of immunology bringing the science, scale and expertise needed to address some of the most complex diseases,” Robert A. Michael, AbbVie’s chairman and CEO, said in a statement. “The acquisition of Apogee further builds on our existing leadership, strengthening our ability to deliver innovative medicines to patients who need better options while also creating significant long-term value for shareholders.”

Apogee investors signaled support for the buyout with a surge of stock buying that sent the company’s shares soaring 47% in early day trading from $90.38 to $132.65 as of 10:21 am ET. AbbVie shares rose 4.5% from $216.49 to $226.24.

Potential Dupixent® challenger

Apogee is positioning zumilokibart as a potential challenger to Dupixent® (dupilumab), the blockbuster drug for AD and other indications that is co-marketed by Sanofi, which records global net sales, and Regeneron Pharmaceuticals.

Dupixent ranked No. 5 among “Top 10 Best-Selling Drugs” as ranked by GEN in a recent A-List, with $18.124 billion (€15.714 billion) in 2025 sales, up 20.2% from the $15.077 billion (€13.072 billion) that the drug racked up in 2024. Dupixent carried that momentum into the first quarter of this year, garnering $4.9 billion (€4.2 billion) in sales as recorded by Sanofi, up 33% from a year earlier. 

However, Dupixent is set to lose key U.S. patent exclusivity in 2031, giving Apogee and other AD drug developers time, they hope, to bring new treatments to market that can successfully compete when Dupixent loses its IP protection.

In addition to AD, zumilokibart is also being developed to treat asthma and eosinophilic esophagitis (EoE). The EoE program is set to advance into mid-stage clinical study as Apogee plans to launch the Phase IIb ELEVATE trial in the second half of this year.

Apogee has generated positive Phase Ib data for zumilokibart in asthma, and is on course to advance that program into the Phase IIb ASPIRE trial, set to launch in the first half of 2027.

Two other programs, both of them combination therapies that include zumilokibart, round out Apogee’s pipeline. APG279, a combination of zumilokibart and APG990, an OX40L inhibitor, is an AD candidate now in a Phase I trial (NCT07027527) comparing the the safety, tolerability, and pharmacokinetic (PK) parameters of the combination vs. Dupixent in adults with moderate-to-severe atopic dermatitis (AD).

Apogee cites preclinical studies showing that APG279 has driven closer to JAK-like inhibition of Type 1, 2, and 3 signaling compared to approved or in-development biologics, with the potential for best-in-class dosing and better tolerability in AD and a variety of other I&I diseases.

One-two punch

Apogee reasons that its chances of treating AD are enhanced by a proverbial one-two punch combining deep and sustained inhibition of Type 2 inflammation through zumilokibart’s inhibition of IL-13 with broader inhibition of Type 1-3 inflammation through APG990’s inhibition of OX40L.

The other combination program, APG273, is a preclinical combination of zumilokibart with APG333, a TSLP (thymic stromal lymphopoietin) that is being developed to treat asthma and COPD. Apogee has said it plans to announce additional plans for clinical studies later this year.

“Apogee’s pipeline adds highly differentiated clinical-stage assets, further expanding our robust immunology portfolio in areas of significant patient need, including atopic dermatitis and asthma,” Michael added. With our deep scientific expertise and proven capabilities, we are uniquely positioned to rapidly advance these programs and continue to transform the standard of care in inflammatory diseases.”

AbbVie has agreed to acquire all outstanding shares of Apogee for $135.11 per share cash, a 49.5% premium from the stock’s closing price on Friday.

The boards of AbbVie and Apogee have unanimously approved the transaction, which is expected to close in the third quarter subject to customary closing conditions, including Apogee shareholder approval and receipt of regulatory approvals.

“This transaction reflects the strength of Apogee’s vision, our team’s dedication and the significant progress we’ve made advancing zumilokibart and our differentiated pipeline,” stated Apogee CEO Michael Henderson, MD. “Since our founding, we’ve focused on developing transformative therapies for patients with inflammatory diseases while creating value for shareholders. This transaction delivers substantial shareholder value and positions our programs to reach their full potential.”

“We believe AbbVie can advance zumilokibart and our portfolio while expanding their impact for patients worldwide,”  Henderson added.

The post AbbVie to Acquire Apogee Therapeutics for $10.9B appeared first on GEN – Genetic Engineering and Biotechnology News.

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STAT+: FDA to launch pilot program to speed up early-stage clinical trials

WASHINGTON — Federal health officials announced a pilot program Monday to speed up early-stage clinical trials, which they say will reduce development timelines by six to 12 months, in hopes of encouraging U.S.-based trials and combating Chinese dominance in the field.

The pilot comes as the Food and Drug Administration, through the president’s 2027 fiscal budget, asks Congress to establish a permanent, faster process for the existing Investigational New Drug pathway. That proposal was championed by former FDA Commissioner Marty Makary before he resigned last month, though officials said on a Monday morning call that this program had been in the works since the start of the administration.

In a Fox News op-ed, health secretary Robert F. Kennedy Jr. wrote that the U.S. is “losing ground” against China in clinical research and touted the actions as a way to reverse that trend.

Continue to STAT+ to read the full story…

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Paradoxical reflex bradycardia in paroxysmal sympathetic hyperactivity following traumatic brain injury: a case report

BackgroundParoxysmal sympathetic hyperactivity (PSH) is a devastating complication of traumatic brain injury (TBI), characterized by the simultaneous onset of various manifestations due to sympathetic overactivity. Paradoxical bradycardia, an uncommon manifestation of PSH, is poorly characterized, and there is limited evidence regarding its clinical features, pathophysiological mechanisms and targeted management.Case presentationA 25-years-old male sustained severe traumatic brain injury in a nighttime motorcycle collision with a parked vehicle and underwent multiple neurosurgical procedures. He developed typical PSH on day 48 post injury, with a Paroxysmal Sympathetic Hyperactivity Assessment Measure (PSH-AM) score of 27. On the 92nd day post-injury, the patient developed persistent resting bradycardia (40–66 beats/min) after cranioplasty, while a reduced maximum heart rate (140–159 beats/min) was noted during PSH episodes. He subsequently experienced an acute PSH episode with severe bradycardia (38–43 beats/min, PSH-AM score of 20). After excluding common predisposing factors, intravenous isoproterenol (initial dose 4 μg/min, titrated to 2 μg/min) was administered in combination with anti-PSH medication regimen, and the patient’s clinical symptoms were relieved. The patient was discharged in a stable condition and had no further episodes of bradycardia at the 3-months follow-up.ConclusionParadoxical bradycardia represents an atypical clinical phenotype of post-TBI PSH, likely mediated by an atypical Cushing reflex secondary to fluctuating intracranial pressure elevations during PSH exacerbations. Clinically, for TBI patients with unexplained bradycardia, potential primary causes should be actively explored, with particular attention to monitoring dynamic changes in intracranial pressure.
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Bridging the gap from mechanism to clinic: a translational perspective on taVNS for gastrointestinal disorders

In recent years, multiple clinical and translational studies have investigated the application and mechanisms of transcutaneous auricular vagus nerve stimulation (taVNS) in gastrointestinal disorders (GIDs), with consideration given to pathophysiology, stimulation parameters, and patient-specific factors. In this review, we systematically synthesize recent evidence from clinical trials and preclinical models published in leading gastroenterology and neurology journals. Our focus is on taVNS-mediated modulation of the brain–gut axis, particularly its role in improving autonomic balance, reducing visceral sensitivity, and attenuating inflammatory responses, with the aim of enhancing therapeutic outcomes in functional and inflammatory GIDs. There is a need to optimize stimulation protocols through mechanistic insights and to promote the use of this non-invasive, well-tolerated neuromodulation approach. These advances are essential for expanding taVNS accessibility in clinical practice, especially for patients with refractory symptoms, comorbid psychological conditions, and in settings where conventional treatments are limited or contraindicated. Personalized taVNS strategies and biomarker-guided dosing represent emerging trends in neuromodulation therapy. However, standardized protocols and predictive models have yet to be established for widespread clinical implementation.
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Enhancing adult neurogenesis attenuates hippocampal-related behavioral deficits in an Alzheimer’s mouse model

Alzheimer’s disease (AD) is the most prevalent form of dementia, characterized by progressive memory loss, cognitive decline, and emotional dysregulation. Adult hippocampal neurogenesis (AHN) critically contributes to cognition and mood but undergoes precipitous decline during AD progression. Here, we investigated whether enhancing AHN through genetic expansion of endogenous neural stem cells (NSC) ameliorates AD-related phenotypes. Using lentiviral overexpression of the cell cycle regulators Cdk4 and CyclinD1 in the dentate gyrus of 3xTg-AD mice, we show that enhancing AHN is accompanied by partial improvements in selected behavioral measures associated with hippocampal function, including in the open-field test and Morris water maze. These findings indicate that the AD-compromised neurogenic niche remains responsive to NSC-targeted stimulation and support the use of AHN as a potential additional avenue for multi-modal therapeutic strategies for AD.
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Body mass index affects EEG microstate dynamics through blood viscosity in high-altitude environments

High-altitude hypoxia imposes substantial challenges on cerebral oxygen delivery and brain functional regulation. Body mass index (BMI) may influence neurophysiological adaptation to such environments through metabolic and hemorheological pathways, yet its relationship with resting-state Electroencephalography (EEG) microstate dynamics remains unclear. This study examined whether blood viscosity (BV) mediates the association between BMI and EEG microstate characteristics in a high-altitude population. A total of 123 permanent residents from Lhasa, Tibet, were initially included. Because only five participants met the obesity criterion, the main statistical analyses were conducted in 118 participants after excluding the obese subgroup. Resting-state eyes-closed EEG data were recorded using a 64-channel system, and standardized 180-s artifact-free segments were used for microstate analysis. Four canonical microstates were identified, and temporal parameters, including coverage, duration, global explained variance, global field power, occurrence, and transition probabilities, were extracted. BMI was calculated from measured height and weight, and BV was estimated using hematological indicators based on a validated high-altitude prediction model. The four identified microstate maps showed topographic patterns broadly consistent with previous EEG microstate studies. Microstate C showed the highest values across several temporal parameters, suggesting a potentially dominant resting-state pattern under high-altitude conditions. BMI was positively correlated with BV, while BV was negatively correlated with the occurrence of microstate B. The mediation model suggested an indirect statistical pathway from BMI to microstate B occurrence through estimated BV: higher BMI was associated with higher estimated BV, which in turn was associated with reduced microstate B occurrence. These findings suggest that BMI-related alterations in resting-state brain dynamics at high altitude may be linked to hemorheological changes. Overall, this study provides preliminary evidence for a BMI–blood viscosity–brain microstate pathway in high-altitude residents. The results highlight BV as a potential physiological bridge between body composition and spontaneous brain activity under chronic hypoxic exposure.
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Acoustic stimulation in pain management: neurobiological mechanisms and clinical applications—a narrative review

Pain affects over 30% of the global population, with an underlying pathogenesis involving a complex interplay of biopsychosocial factors. Despite the availability of conventional pharmacological and interventional therapies, their clinical utility is frequently constrained by concerns regarding substance misuse, surgical complications, and other adverse sequelae. Acoustic stimulation (AS) has emerged as a promising alternative in pain management, characterized by its non-invasive nature, favorable safety profile, and high cost-effectiveness. However, current literature lacks a comprehensive evaluation of cutting-edge AS technologies and a profound decryption of its pleiotropic analgesic mechanisms, which has hindered the integration of AS into multimodal analgesic strategies. This review provides the first comprehensive synthesis of the neurobiological mechanisms and clinical applications of AS. We comprehensively evaluate the analgesic efficacy of diverse modalities, ranging from established interventions—such as music therapy (MT), natural sounds (NS)/noise, and auditory beat stimulation (ABS)—to emerging approaches, including vibroacoustic therapy (VAT) and immersive interactive technologies that integrate multisensory acoustic information. Emerging evidence suggests that AS exerts its therapeutic effects via a multidimensional neurobiological framework, notably through the modulation of corticothalamic circuits, the activation of descending pain-inhibitory systems, and the dynamic regulation of neurochemical mediators. Clinical data consistently highlight the adjunctive value of MT, NS/noise, and VAT in the management of both acute and chronic pain. Furthermore, the convergence of AS with immersive interactive technologies is pioneering a novel digital intervention paradigm, facilitating the seamless integration of AS into multimodal analgesic frameworks. Collectively, these findings suggest that AS represents a robust, non-pharmacological strategy that warrants further exploration as a cornerstone of future personalized, multimodal pain management.
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Network analysis of spousal support and fear of childbirth in pregnant women of advanced maternal age

BackgroundFear of childbirth is an important perinatal mental health concern, particularly among women of advanced maternal age. However, the specific interrelations between spousal support and fear of childbirth remain unclear.MethodsThis cross-sectional study recruited 279 pregnant women of advanced maternal age from a tertiary hospital in Henan, China, using convenience sampling. Spousal support and fear of childbirth were assessed using the Spouse Support Inventory and the Childbirth Attitude Questionnaire. A regularized partial-correlation network was estimated using EBICglasso, and central and bridge nodes were identified. Network stability was examined using bootstrap procedures.ResultsThe prevalence of any fear of childbirth, defined as a CAQ score ≥28 and including mild, moderate, and severe categories, was 86.4% (n = 241). Negative associations predominated between the spousal support and fear of childbirth communities. The strongest cross-community association was observed between “teaching you how to do things you do not know how to do” and “concern about fetal health.” The most central nodes were “participating in activities together to reduce your stress” and “providing you with helpful information,” whereas the strongest bridge nodes were “helping you understand why things did not go well” and “giving you encouragement.ConclusionSpecific supportive behaviors, especially informational and cognitive-appraisal support, occupied central positions in the network linking spousal support and fear of childbirth among pregnant women of advanced maternal age. Strengthening these forms of spousal support may inform the development of couple-based interventions to reduce childbirth fear and promote perinatal mental health.