Pharma Phriday (April 10, 2026)

Written by Duncan Emerton, Pharma Phriday is a comprehensive weekly update on the pharmaceutical industry, covering clinical trial results, regulatory approvals, corporate development activity, and other significant developments.

In this week’s note:

Clinical

• Amgen’s subQ Tepezza hits mark in Phase III TED study

• Ascendis reports Wk52 data for its TransCon CNP/hGH combo in achondroplasia

• Boehringer Ingelheim/BioNTech to study obrixtamig/pumitamig combo in ES-SCLC

• Insmed terminates development of brensocatib in HS

• Merck & Co. initiates Phase IIb/III trial for MK-8748 in nvAMD

• Sanofi’s lunsekimig posts mixed bag of Phase II results

Regulatory

• China’s NMPA approves GSK’s Exdensur for CRSwNP

• FDA accepts Ultragenyx’s acceptance of BLA Resubmission for UX111

Commercial

• Biocon announces US launch of denosumab biosimilars

• Biogen and Alloy collaborate on ASO development

• Gilead to acquire Tubulis GmbH for $3.1 billion

• Neurocrine to acquire Soleno Therapeutics for $2.9 billion

• Roche extends collaboration with C4T to include degrader-antibody conjugates

In Brief

• Anthropic buys biotech startup Coefficient Bio for $400 million

• BMS teams up with Faro Health to use AI for trial protocol design

• Pfizer, BioNTech halt US COVID vaccine study after recruitment struggles

• Promising study links coffee consumption to reduced dementia risk

• Regeneron and TriNetX forge RWD collaboration

• Vertex partners with Halozyme on drug formulation R&D

Clinical

Amgen’s subQ Tepezza hits mark in Phase III TED study

What happened. Amgen has announced positive topline results from a Phase III trial of Tepezza (teprotumumab) administered by subQ injection via an on-body injector (OBI) in participants with moderate-to-severe active Thyroid Eye Disease (TED, also known as Graves’ orbitopathy). Tepezza OBI provides comparable efficacy to the IV formulation of Tepezza which was approved by the FDA in January 2020 and remains the only medicine approved for the treatment of TED in the US. The Phase III Tepezza OBI trial met its primary endpoint in moderate-to-severe active TED, showing a statistically significant and clinically meaningful 77% proptosis response rate during the 24-week placebo-controlled period (76.7% Tepezza OBI vs. 19.6% placebo [p<0.0001]). Importantly, the mean proptosis reduction, a key secondary endpoint, was -3.17 mm at week 24 (-3.17 mm Tepezza OBI vs. -0.80 mm placebo; p<0.0001).

Why this matters. Lots to digest here as it relates to teprotumumab’s comparative efficacy to Viridian’s elegrobart which posted positive topline Phase III data from the REVEAL-1 trial last month. Recall, the Phase III REVEAL-1 study assessed the efficacy/safety of subQ elegrobart in patients with active TED. Data suggests similar efficacy between teprotumumab OBI and elegrobart subQ (based on placebo-adjusted proptosis rates), but questions are being asked about dosing format and schedule (i.e., is the OBI that much more convenient than subQ dosing), safety (e.g., hearing impairment) and diplopia (i.e., double vision). A full data set for teprotumumab OBI is expected at a medical conference this year, and data from REVEAL-2 which is evaluating elegrobart subQ in patients with chronic TED, is on track for topline readout in Q2 2026.

Ascendis reports Wk52 data for its TransCon CNP/hGH combo in achondroplasia

What happened. Ascendis Pharma has announced new data demonstrating TransCon hGH (lonapegsomatropin) accelerated TransCon CNP’s (navepegritide) benefits beyond linear growth with substantial improvements in arm span, spinal canal dimensions, and lower limb alignment. The new data are from Week 52 of the ongoing Phase II COACH Trial of combination therapy with once-weekly TransCon CNP and once-weekly TransCon hGH in children with achondroplasia. Ascendis previously reported Week 52 COACH results that demonstrated mean annualized growth velocity exceeding the 97th-percentile of average stature children, without compromising safety or tolerability and with no acceleration of bone age. TransCon CNP and TransCon hGH have both been approved by the FDA as Yuviwel and Skytrofa, respectively.

Why this matters. These week 52 COACH data arrive at a commercially important moment, just days after the US launch of Yuviwel (navepegritide). Showing meaningful improvements in arm span, spinal canal dimensions, and leg alignment beyond linear growth strengthens the case for a combination therapy approach and broadens the clinical story well beyond height alone, which is a significant differentiator. Approved in November 2021, BioMarin’s Voxzogo (vosoritide) remains the only approved treatment for children with achondroplasia starting from birth. One practical difference that may favour Yuviwel (and its combination with Skytrofa) is its once weekly dosing versus Voxzogo’s daily injection, a meaningful burden reduction for families. BridgeBio's infigratinib, which delivered positive Phase III results in February 2026, is also heading towards regulatory discussions in H2 2026. Combination therapy data of this kind could sharpen Ascendis' differentiation in an increasingly crowded field. On balance, data from COACH are promising, but due to the studies size and design, larger confirmatory trials will be needed to complete the story.

Boehringer Ingelheim/BioNTech to study obrixtamig/pumitamig combo in ES-SCLC

What happened. Boehringer Ingelheim has announced a clinical trial collaboration with BioNTech to evaluate a novel immuno‑oncology combination in extensive‑stage small cell lung cancer (ES-SCLC). Under the agreement, BioNTech will supply pumitamig (BNT327/BMS‑986545), a PD‑L1/VEGF‑A bsAb being jointly developed by BioNTech and BMS. Boehringer Ingelheim will be the regulatory sponsor of the Phase Ib/II study. The aim is to assess safety, tolerability and early clinical activity of obrixtamig (BI 764532), Boehringer Ingelheim’s investigational DLL3/CD3 T‑cell engager, in combination with pumitamig. Under the terms of the agreement, both companies retain full rights to their respective assets, and the agreement is mutually non-exclusive. The trial will begin dosing patients in the second half of 2026.

Why this matters. The combination of a DLL3 targeting TCE with a PD-L1/VEGF-A bsAb is one of the most mechanistically compelling approaches in SCLC oncology. The biological rationale is sound as each component addresses specific limitations of the others, and early data from tarlatamab (DLL3 TCE; Amgen) plus durvalumab (PD-L1 inhibitor; AstraZeneca) already suggests survival outcomes that exceed any prior therapy in extensive-stage SCLC. Adding VEGF-A inhibition via pumitamig offers a further layer of modulation that could deepen and extend responses. But as with all combo regimens that hit multiple targets, there is a significant risk of additive immune-mediated toxicity (e.g., CRS) and the inherent complexity of managing multi-agent immunotherapy in a patient population often characterised by poor performance status and prior treatment burden.

Insmed terminates development of brensocatib in HS

What happened. Insmed has announced that the Phase IIb CEDAR study, which evaluated brensocatib (a DPP1 inhibitor) in adult patients with moderate to severe hidradenitis suppurativa (HS), did not meet its primary or secondary efficacy endpoints in either the 10mg or 40mg treatment arms. Brensocatib was well tolerated, with no new safety signals identified, including in the 40mg arm, which is the highest dose Insmed has studied to date. Insmed will discontinue its development program of brensocatib in HS and intends to present these data at a future congress.

Why this matters. By all accounts this result was expected and is unlikely to dent Insmed’s growth aspirations for Brinsupri. The DPP1 inhibitor has already been approved as a treatment for non-cystic fibrosis bronchiectasis, and Insmed expects to generate full-year 2026 revenues of at least $1 billion from that indication alone. The data themselves are interesting. The placebo arm reduced abscess and inflammatory nodule count by 57.1% at Week 16, numerically outperforming both the 10mg (45.5%) and 40mg (40.3%) active arms. This pattern of placebo outperforming treatment has now occurred twice for brensocatib, following a similar outcome in chronic rhinosinusitis without nasal polyps in December 2025. The high placebo response rate is a recognised feature of HS trials, driven by the disease's fluctuating natural course and the absence of validated preclinical models. Insmed’s exit from HS clears space in a growing field. Incyte's povorcitinib has positive Phase III data in hand, UCB's bimekizumab has three-year real-world durability data, and several other agents are in late-stage development. The broader concern is that two consecutive placebo-outperformance results across different inflammatory indications raises questions about the rationale for DPP1 inhibition beyond bronchiectasis, even if safety remains clean.

Merck & Co. initiates Phase IIb/III trial for MK-8748 in nvAMD

What happened. Merck & Co. has announced the initiation of a pivotal Phase IIb/III trial evaluating MK-8748 (also known as Tiespectus, EYE201), a novel investigational bispecific antibody that directly activates Tie2 signalling and inhibits vascular endothelial growth factor (VEGF), for the treatment of neovascular (wet) age-related macular degeneration (nvAMD). The study, known as MALBEC (NCT07440225), is the first trial of a broader late-phase development program for MK-8748, with a second study in nvAMD scheduled to begin this year (NCT07496567). The decision to advance into pivotal studies is based on results from the Phase I/IIa RIOJA trial (NCT06664502), a two-part study evaluating MK-8748 in patients with either NVAMD, macular oedema secondary to branch retinal vein occlusion (BRVO) or diabetic macular oedema (DME).

Why this matters. The potential efficacy benefit of this approach over current anti-VEGF monotherapy lies in addressing two complementary drivers of retinal damage simultaneously: vessel overgrowth and vascular leakage via VEGF inhibition, and endothelial instability via direct Tie2 activation. If this translates clinically, the combination could offer more complete fluid resolution, better visual acuity outcomes, and extended treatment durability, reducing the injection burden that currently limits real-world effectiveness. Whether MK-8748 or similar agents deliver on this potential will depend on the pivotal trial results now beginning to read out. Recall, Merck & Co. gained access to MK-8748 (formerly EYE201) via its $3 billion acquisition of Eyebiotech in May 2024.  

Sanofi’s lunsekimig posts mixed bag of Phase II results

What happened. Sanofi has reported results from three Phase II trials for lunsekimig, its anti-TLSP/IL13 bsAb. Two studies (the Phase IIb AIRCULES study in moderate-to-severe asthma, and the Phase IIa DUET study in chronic rhinosinusitis with nasal polyps) met primary and key secondary endpoints, but a third (the Phase IIb VELVET study) did not meet its primary endpoint in moderate-to-severe atopic dermatitis. Lunsekimig is also being assessed in the Phase II AIRLYMPUS study (high-risk asthma) and in the Phase III PERSEPHONE and THESEUS studies (both COPD).

Why this matters. Lunsekimig is one of a trio of pipeline assets being developed as potential successors to dupilumab (Dupixent). The others are amlitelimab (anti-OX40L) and itepekimab (anti-IL-33). Positive Phase II data for lunsekimig in both asthma and CRSwNP, across biomarker-unselected patients, supports the case for lunsekimig as a broad respiratory asset. Moreover, lunsekimig's biomarker-agnostic profile in asthma is a meaningful signal. The ability to reduce exacerbations regardless of eosinophil or FeNO status directly challenges the patient stratification logic that currently shapes biologic prescribing in severe asthma. The key caveat is the absence of head-to-head comparative data against approved biologics. Whether lunsekimig delivers genuinely synergistic clinical benefit over tezepelumab or dupilumab alone remains an open question that Phase III data will need to answer. The atopic dermatitis miss in VELVET, though exploratory, also suggests the dual mechanism does not automatically translate across all type 2 inflammatory conditions.

Regulatory

China’s NMPA approves GSK’s Exdensur for CRSwNP

What happened. GSK has announced that China’s National Medical Products Administration (NMPA) has approved Exdensur (depemokimab) as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. This follows the NMPA’s recent approval for Exdensur as an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and paediatric patients aged 12 years and older. The approval of Exdensur in CRSwNP is based on data from the Phase III ANCHOR-1 and ANCHOR-2 trials, which showed an improvement (reduction) from baseline in nasal polyp score (scale: 0-8) at 52 weeks. Across these trials, depemokimab was well-tolerated, with patients experiencing a similar rate and severity of side effects as those receiving placebo plus standard of care.

Why this matters. This approval for CRSwNP comes only a week after Exdensur was approved in China for severe asthma. The approval will continue to strengthen GSK’s position in the respiratory disease market by giving it a clear differentiator against established competitors such as AstraZeneca/Amgen’s tezepelumab and other IL-5 or type 2 inflammation-targeted biologics that require more frequent dosing. Safety and long-term data will need ongoing monitoring as more patients use the drug outside clinical trials, but this is nothing that GSK isn’t able to achieve considering its heritage in respiratory medicine.

FDA accepts Ultragenyx’s acceptance of BLA Resubmission for UX111

What happened. Ultragenyx Pharmaceuticals has announced the FDA has accepted for review the resubmitted Biologics License Application (BLA) seeking accelerated approval for UX111 (rebisufligene etisparvovec) AAV9 gene therapy as a treatment for patients with Sanfilippo syndrome Type A (MPS IIIA). The FDA set a PDUFA action date of September 19, 2026. Recall, in July 2025, Ultragenyx received a CRL from the FDA, in which the FDA requested that the company provide additional information and improvements related to specific aspects of CMC and observations from the recently completed manufacturing facility inspections.

Why this matters. After a torrid regulatory journey, Ultragenyx seems to have satisfied the FDA’s requirements and barring any last minute hiccups, UX111 looks set to be approved later this year. Patients now have some genuine hope that they will be able to get access to the first disease-altering treatment for Sanfilippo syndrome Type A, though uncertainties around real-world effectiveness will remain.

Commercial

Biocon announces US launch of denosumab biosimilars

What happened. Biocon has announced the commercial launch of Bosaya (denosumab) and Aukelso (denosumab) in the US. Bosaya (biosimilar to Prolia) and Aukelso (biosimilar to Xgeva) are now available by prescription nationwide through specialty pharmacies and healthcare providers. Both products have been previously approved and granted interchangeable designation by the FDA in September 2025, allowing substitution at the pharmacy level in accordance with state laws.

Why this matters. Biocon launches into a highly competitive market as several other denosumab biosimilars are already available on the US market, including Conexxence/ Bomyntra (Fresenius Kabi), Stoboclo/Osenvelt (Celltrion), Jubbonti/Wyost (Sandoz) and Ospomyv/Xbryk (Samsung Bioepis). Like Bosaya/Aukelso from Biocon, the denosumab biosimilars from Sandoz and Samsung Bioepis are interchangeable, but the ones from Fresenius Kabi and Celltrion are not. It remains to be seen if interchangeability status can drive rapid uptake, seeing as the commercial performance of other interchangeable biosimilars has been lower than expected. Moves are afoot in the US to remove the distinction between biosimilars and interchangeable biosimilars as it’s believed to have kept biosimilar adoption at bay.

Biogen and Alloy collaborate on ASO development

What happened. Alloy Therapeutics has announced a collaboration and license agreement with Biogen for the use of Alloy’s novel and proprietary AntiClastic ASO (anti-sense oligonucleotide) Platform. Through this collaboration, Biogen will apply the platform to advance antisense therapeutics against multiple undisclosed targets. Alloy will receive an upfront payment and is eligible for additional milestone payments and tiered royalties on any products resulting from the collaboration. Alloy’s platform is specifically designed to address potency and therapeutic index challenges that have historically held back the promise of antisense drugs due to limited biodistribution, and therefore, efficacy.

Why this matters. This is a logical extension of Biogen’s growing ASO strategy. The company has active ASO programmes in Alzheimer's disease, spinal muscular atrophy, and Dravet syndrome, and has been investing in both next-generation ASO chemistry and intrathecal delivery infrastructure. Accessing Alloy’s technology across multiple undisclosed targets could meaningfully expand the addressable range of Biogen's genetic medicines pipeline, particularly in CNS disease where biodistribution and tissue penetration remain challenging. Companies such as Ionis Pharmaceuticals, Alnylam, and Wave Life Sciences will be monitoring developments closely due to overlapping clinical and commercial interests. However, the claimed improvements in potency are based on in vitro data, and the platform has not yet produced approved medicines or published pivotal clinical trial results. Financial terms are undisclosed and the undisclosed target list both make any assessment of commercial importance and clinical relevance speculative at this stage.

Gilead to acquire Tubulis GmbH for $3.1 billion

What happened. Gilead Sciences has announced it has entered into a definitive agreement to acquire Tubulis GmbH, a private Germany-based, clinical-stage biotechnology company developing next-generation ADCs. The acquisition expands Gilead’s ADC capabilities by adding next-generation assets and platforms designed to more selectively deliver diverse payloads to tumours and maximise patient benefit. Tubulis’ lead asset, TUB-040, a NaPi2b-directed topoisomerase-I inhibitor (TOPO1i) ADC, is currently in Phase Ib/II development for platinum-resistant ovarian cancer and non-small cell lung cancer (NSCLC). Gilead will also acquire TUB-030, a 5T4 targeted ADC, which has demonstrated promising initial clinical data across various solid tumour types. Tubulis’ programs and platforms have broad potential across multiple tumour types, complementing Gilead’s existing development and commercialization expertise in oncology. Following the close of the transaction, Tubulis will operate as a dedicated ADC research organization within Gilead, with the Munich site serving as a hub for ADC innovation, building on its integrated discovery, manufacturing and clinical capabilities to advance next generation ADCs.

Why this matters. The acquisition of Tubulis brings complimentary expertise in ADCs and, assuming clinical success, gives Gilead the opportunity to gain further ground on other leading ADC players including AstraZeneca/Daiichi Sankyo (Enhertu, Datroway), Pfizer (Adcetris, Padcev, Tivdak), Roche (Kadcyla, Polivy) and AbbVie (Elahere, Emrelis). Recall, Gilead already has Trodelvy in triple-negative breast cancer and urothelial cancer, which it gained via its October 2020 acquisition of Immunomedics. My take is that Gilead will take a breather from M&A for a while. Along with Tubulis, it also has to digest Arcellx and Ouro Medicines, along with a number of smaller deals (e.g., Sprint Bioscience’s pre-clinical TREX1-targeting oncology program, Genhouse Bio’s synthetic lethal cancer candidate, GH31).

Neurocrine to acquire Soleno Therapeutics for $2.9 billion

What happened. Neurocrine Biosciences and Soleno Therapeutics have announced that Neurocrine has entered into a definitive agreement to acquire Soleno for $2.9 billion. The acquisition of Soleno adds Vykat XR (diazoxide choline), a first-in-class therapy to treat hyperphagia, the defining feature of Prader-Willi syndrome (PWS), to Neurocrine’s portfolio. Launched in Q2’25, Vykat XR generated $190 million in 2025. Soon after the announcement, Soleno said that it would voluntarily withdraw its EU marketing application (made in May 2025) for Vykat XR following Neurocrine's ‌plans to sharpen focus on the US market.

Why this matters. This deal adds a third marketed, first-in-class medicine to Neurocrine’s portfolio alongside Ingrezza (valbenazine; Huntington’s disease) and Crenessity (crinecerfont; congenital adrenal hyperplasia), deepening its rare disease and endocrinology franchise. Vykat XR’s patent protection extending into the mid-2040s also provides the long revenue runway that rare disease acquirers prize. Aardvark Therapeutics' ARD-101 remains in Phase III for hyperphagia in PWS, representing the most credible pipeline challenge, though it is some years from approval. Neurocrine's first-mover advantage will make it harder for any future competitor to displace Vykat XR once it becomes standard of care. The only potential wrinkle is the side effect profile of Vykat XR, which includes hyperglycaemia, oedema, and hypertrichosis, and requires ongoing monitoring.

Roche extends collaboration with C4T to include degrader-antibody conjugates

What happened. C4 Therapeutics (C4T) has announced that it has entered into a new collaboration agreement with Roche to advance research in the emerging degrader-antibody conjugate (DAC) modality. Working together, C4T and Roche will combine antibody-drug conjugation (ADC) and targeted protein degradation (TPD) to develop a new way to treat cancers that leverages both the specificity and catalytic efficiency of degraders with the delivery capabilities of ADCs. Under the joint research plan, C4T and Roche will collaborate on two programmes to develop DACs against undisclosed oncology targets exclusive to the collaboration. For this, C4T will receive a $20 million upfront payment. C4T is also eligible to receive over $1 billion in discovery, regulatory and commercial milestone payments. In addition, C4T is entitled to tiered royalties on future sales, subject to reductions under certain circumstances as described in the collaboration agreement.

Why this matters. DACs combine the tumour-targeting precision of monoclonal antibodies with the intracellular protein degradation power of either PROTACs or molecular glue degraders as the payload, rather than the cytotoxic small molecules used in conventional ADCs. By delivering a degrader directly to cancer cells via antibody-mediated internalisation, DACs aim to eliminate oncoproteins that are otherwise undruggable by occupancy-based inhibitors, including transcription factors and scaffolding proteins. Key challenges include the size and physicochemical complexity of PROTAC payloads, linker instability, and limited lysosomal release. Several early-phase trials are now underway. Today's deal extends Roche’s relationship with C4T, which goes back to January 2016 when they first announced an alliance. While this DAC collaboration is early on its journey, other big pharmas have also expressed interest in the field, including Merck & Co., BMS and Pfizer.

In Brief

Anthropic buys biotech startup Coefficient Bio for $400 million

Anthropic has purchased the stealth biotech AI startup Coefficient Bio in a $400 million stock deal. Sources close to the deal confirmed to TechCrunch that it closed, though declined to comment on the amount. The deal comes as Anthropic continues its push into healthcare and life sciences, following its October announcement of Claude for Life Sciences, a tool that aims to help scientific researchers make discoveries.

BMS teams up with Faro Health to use AI for trial protocol design

BMS will use artificial intelligence (AI) to develop clinical trial protocols in partnership with tech firm Faro Health. This marks in the US drug maker’s second AI-focused deal in as many months, following its February 2026 collaboration with Evinova. The multiyear collaboration will use AI agents in study design, drafting, validation, and optimization. Faro’s technology converts narrative protocol design elements, such as objectives and endpoints, into structured digital assets. It also ensures protocols are in line with industry standards, including the Tufts Center for the Study of Drug Development framework. In addition, the technology can simulate scheduling activities and research site assessments.

Pfizer, BioNTech halt US COVID vaccine study after recruitment struggles

Vaccine makers Pfizer and BioNTech halted a large US trial of their updated COVID-19 vaccine in healthy adults aged 50-64, saying enrollment in the trials had been too low to generate the needed data. In a letter to trial investigators dated March ‌30, seen by Reuters and previously unreported, Pfizer said it would stop surveillance for signs of COVID illness of all participants in the study after April ‌3. Enrollment was closed on March 6, following a review of current epidemiological trends, it said.

Promising study links coffee consumption to reduced dementia risk

Daily coffee consumption, if caffeinated, may be linked to lower risks of dementia in older adults. A study published in the February 2026 issue of the Journal of the American Medical Association reviewed data from over 100,000 adults over a period of four decades. The investigators, based at Harvard Medical School and the T.H. Chan School of Public Health at Harvard, looked at females enrolled in the Nurses Health Study between 1980 and 2023 (over 86,000 individuals) and men enrolled in the Health Professionals Follow-Up Study from 1986-2023 (over 45,000 individuals).

Regeneron and TriNetX forge RWD collaboration

Regeneron and TriNetX have announced a strategic collaboration to support Regeneron’s capabilities in drug discovery and development, as well as new initiatives to deliver digital health solutions of the future for consumers, patients and providers. Regeneron gains the exclusive opportunity to connect large-scale genomic and proteomic data cohorts to TriNetX’s industry-leading phenotypic data network of approximately 300 million de-identified and anonymized patients. This collaboration will enable expansion of Regeneron’s world-leading genomic and proteomic Electronic Health Record (EHR)-linked database, a key driver of the company’s industry-leading therapeutics pipeline.

Vertex partners with Halozyme on drug formulation R&D

Halozyme Therapeutics and Vertex Pharmaceuticals have announced a collaboration where Vertex gains access to Halozyme's Hypercon technology for use in up to three drug targets. Hypercon is an innovative microparticle technology that allows for hyperconcentration of drugs and biologics, thus reducing injection volume for the same dosage and enabling convenient, at-home administration. Under the terms of the exclusive agreement, Vertex will make a $15 million upfront payment to Halozyme and potential future milestone payments. Halozyme will also be entitled to royalties on net sales of products developed using the Hypercon technology.