THOUSAND OAKS (dpa-AFX) - This week's biotech landscape witnessed regulatory approvals across the U.S., Canada, and China, alongside the lifting of a clinical trial hold by the FDA, collaborations, acquisitions, discontinuations, and positive data readouts spanning multiple therapeutic areas.
Let's dive into the details.
FDA and EU Approvals & Rejections
MacroGenics Resumes LINNET Study After FDA Lifts Partial Hold on Lorigerlimab?Study
MacroGenics, Inc. (MGNX), announced that the FDA has lifted the partial hold on its Phase 2 LINNET study of Lorigerlimab in ovarian cancer and clear cell gynaecologic cancer. Enrollment will resume under a revised protocol with added safety measures, and the company expects a program update by mid-2026.
MGNX closed Thursday's trading (April 9, 2026) at $3.44, down 0.29%.
Adagio Medical Gains IDE Approval to Expand FULCRUM-VT Trial
Adagio Medical Holdings, Inc. (ADGM) received FDA Investigational Device Exemption approval to expand its FULCRUM-VT trial enabling evaluation of the next-generation cCLAS Ultra-Low Temperature Ablation System for sustained monomorphic ventricular tachycardia. The sub-study will enroll upto 55 patients and assess the system's ability to deliver ultra-cold temperatures around -170 °C, aiming to improve lesion durability, reduce ablation time, and enhance workflow efficiency.
ADGM closed Thursday's trading at $1.41.
Waters Gains FDA Clearance for Onclarity HPV Self-Collection Kit
Waters (WAT) announced FDA clearance of the Onclarity HPV Self-Collection Kit and approval of the BD Onclarity HPV Assay with extended genotyping for at-home use. The kit, processed on the BD COR System, enables prescription-based self-sampling and is the only FDA-approved HPV assay to identify six individual types and three pooled groups. Nationwide access is expected in the coming months.
WATclosed Thursday's trading at $317.65, down 0.28%.
GSK Wins China Approval for Exdensur?in CRSwNP
GSK plc (GSK, GSK.L) announced that China's National Medical Products Administration has approved Exdensur or depemokimab as an add-on therapy with intranasal corticosteroids for adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who are not adequately controlled with systemic corticosteroids or surgery. The approval, supported by ANCHOR-1 and ANCHOR-2 Phase III trial, adds to Exdensur's global approvals in severe asthma and CRSwNP across the US, EU, UK, and Japan.
GSK closed Thursday's trading at $58.36, up 1.73%.
Artivion Secures FDA Approval for NEXUS
Artivion, Inc. (AORT) announced FDA premarket approval for the NEXUS Aortic Arch System, the first branched endovascular stent graft cleared in the U.S. to treat complex aortic arch disease. Supported by TRIOMPHE?trial data showing strong survival and stroke-free outcomes, NEXUS offers a minimally invasive alternative to open-chest surgery. The approval also enables Artivion to exercise its option to acquire Endospan Ltd., further expanding its cardiovascular portfolio.
AORT closed Thursday's trading at $36.51, up 1.25%.
Stereotaxis?Gains FDA Clearance for Synchrony System
Stereotaxis Inc. (STXS) announced FDA 510(k) clearance for its Synchrony system, a digital platform designed to modernize interventional catheter labs. Featuring a 55-inch 4K display and paired with the SynX cloud app, Synchrony consolidates disparate systems, streamlines workflows, and enables secure remote collaboration. The company expects the platform to enhance efficiency, support future AI-driven innovations, and expand adoption across busy cath labs.
STXS closed Thursday's trading at $1.95, up 1.04%.
Regeneron Wins FDA Approval to Extend EYLEA HD Dosing
Regeneron Pharmaceuticals, Inc. (REGN) announced FDA approval to extend EYLEA HD (Aflibercept 8mg) dosing intervals up to every 20 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). Supported by 96-week data from the pivotal PULSAR and PHOTON trials, the update allows individualized treatment schedules ranging from every 4 weeks to every 20 weeks, reducing injection frequency while maintaining efficacy.
REGN closed Thursday's trading at $767.85, down 0.99%.
Glemark Wins FDA Approval for Progesterone Vaginal Inserts
Glenmark Pharmaceuticals Limited (532296, GLENMARK) received final FDA approval for its Progesterone Vaginal Inserts, 100 mg, deemed bioequivalent to Endometrin. Distributed through its U.S. subsidiary, the product supports embryo implantation and early pregnancy in women undergoing assisted reproductive technology (ART). The approval strengthens Glenmark's women's health portfolio and expands its U.S. presence.
Glenmark closed Friday's trading at INR2,163, down 0.27%.
Sobi Gains Health Canada Approval for EMPAVELI?in Rare Kidney Diseases
Swedish Orphan Biovitrum AB (SWOBYI, BIOVF, SOBI.ST) announced Health Canada approval of EMPAVELI?(pegcetacoplan) for patients aged 12 and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN). Supported by Phase 3 VALIANT trial data, EMPAVELI?showed significant reductions in proteinuria, stabilisation of kidney function, and clearance of C3 deposits. The approval marks a key milestone for patients, who number about 700 in Canada.
SOBI.ST closed Thursday's trading at $404.00, up 0.50%.
Deals
C4 Therapeutics Enters Collaboration Agreement with Roche
C4 Therapeutics (CCCC) has entered into a new collaboration agreement with Roche (RHHBY, RO.SW, ROG.SW) to advance research in the degrader-antibody conjugates or DAC.
C4 Therapeutics will use its TORPEDO platform to design degrader payload candidates, and Roche will select and design the antibody, as well as conjugate it to the degrader payload.
C4 Therapeutics will receive a $20 million upfront payment for the two programs, as well as discovery, development, and commercial milestones, in addition to future royalties.
CCCC closed Thursday's trade at $2.83, down 2.41%.
Advance Biomed Signs Agreement to Acquire Acellent Technologies
Advanced Biomed Inc. (ADVB) unveiled that it has entered into a share purchase agreement to acquire Acellent Technologies (Hong Kong) Co. Limited.
As per the agreement, Advanced Biomed will acquire Acellent by issuing 0.27 million shares, with an aggregate estimated value of $1.08 million. Meanwhile, the transaction closure date is undisclosed.
ADVB closed Thursday's trade at $6.69, up 3.88%
Akari Therapeutics Announces Strategic Partnership with WuXi XDC
Akari Therapeutics, Plc (AKTX), an oncology biotechnology company, announced a strategic partnership with WuXi XDC to accelerate the development of its proprietary PH1 payload.
The collaboration is expected to support Akari's IND filing by late 2026 and advance its lead program, AKTX-101, which is initially targeting metastatic urothelial cancer. Based on regulatory?clearance, a Phase 1 clinical trial?is anticipated in late 2026 or early 2027.
AKTX closed Thursday's trade at $3.92, up 1.03%.
Neurocrine To Acquire Soleno Therapeutics
Neurocrine Biosciences. (NBIX), has entered into a definitive agreement to acquire Soleno Therapeutics (SLNO) for $53.00 per share in cash, representing a total equity value of approximately $2.9 billion.
The acquisition brings Soleno's lead product, VYKAT XR (diazoxide choline), into Neurocrine's portfolio. VYKAT XR is the first and only FDA-approved treatment for hyperphagia, the defining feature of Prader-Willi syndrome (PWS), a rare genetic disorder characterised by insatiable hunger.?
The deal is expected to close within 90 days following customary regulatory approvals.
SLNO closed Thursday's trade at $52.51, down 0.17%.
Profusa Unveils LOI To Acquire PanOmics Diagnostics Platform For $30 Mln
Profusa, Inc. (PFSA), a commercial-stage digital health company, announced a Letter of Intent to acquire PanOmics, a multi-omics diagnostics platform from BioInsights LLC, for a total consideration of $30 million, to support strategic expansion into molecular diagnostics.
Under the terms of the agreement, Profusa would acquire exclusive rights to the PanOmics platform for total consideration of approximately $30 million, payable in equity securities. In return, BioInsights will provide access to a specified number of samples for validation and will receive a 3% royalty on net revenue.
PFSA closed Thursday's trade at $1.05, down 13.93%.
Clinical Trials - Breakthroughs & Setbacks
Zentalis Advances Azenosertib With 400mg Dose
Zentalis Pharmaceuticals, Inc. (ZNTL) announced that 400mg once daily on a 5-day-on, 2-day-off schedule has been selected as the pivotal monotherapy dose of Azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC).
The decision follows a prespecified interim analysis from the ongoing DENALI Part 2a trial, which showed a clearly differentiated response rate at 400mg compared to 300mg, with comparable safety profiles.
ZNTL closed Thursday's trade at $4.42, up 60.14%
AtaiBeckley's BPL-003 Shows Rapid, Durable Antidepressant Response in Treatment-Resistant Depression
AtaiBeckley Inc. (ATAI) has reported new Phase 2a data showing that a single intranasal dose of its investigational therapy BPL-003, a Mebufotenin Benzoate (5-MeO-DMT) formulation, produced a rapid and durable antidepressant response in adults with treatment-resistant depression who remained on stable SSRI therapy.
In the open-label Phase 2a study, 66.7% of participants (8 out of 12) achieved an antidepressant response, defined as at least a 50% reduction in MADRS score, by Day 2 after receiving a single intranasal dose of BPL-003.
The company prepares to begin Phase 3 trials in the second quarter of 2026.
ATAI closed Thursday's trade at $3.70, down 1.60%.
Insmed Discontinues Brensocatib in Hidradenitis Suppurativa After Phase 2b Results
Insmed Inc. (INSM) announced that the Phase 2b CEDAR study evaluating Brensocatib in adult patients with moderate to severe hidradenitis suppurativa (HS) did not meet its primary or secondary efficacy endpoints in either the 10 mg or 40 mg treatment arms.
As a result, the company will discontinue its development program of Brensocatib in hidradenitis suppurativa.
INSM closed Thursday's trade at $159.59, down 0.37%.
Sanofi's Lunsekimig Shows Promise in Respiratory Diseases
Sanofi (SNY) announced that its investigational therapy Lunsekimig, a pentavalent Nanobody VHH,?met both primary and key secondary endpoints in two Phase 2 studies targeting chronic respiratory conditions.
The AIRCULES Phase 2b study evaluated Lunsekimig in adults with moderate-to-severe asthma. Results showed a statistically significant reduction in asthma exacerbations and meaningful improvements in lung function compared to placebo.
The DUET Phase 2a study tested Lunsekimig in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).?The therapy achieved its primary endpoint, including improvements in nasal congestion score, nasal polyp score, and Lund-Mackay Computed Tomography (LMK-CT) score at Week 24, all compared to placebo.?
SNY closed Thursday's trade at $47.08, down 0.13%.
Organogenesis Advances PuraPly AM in?non-healing diabetic foot ulcers
Organogenesis Holdings Inc. (ORGO) announced it has completed a randomised controlled trial evaluating PuraPly AM, a collagen-based wound dressing with Polyhexamethylene Biguanide (PHMB) antimicrobial protection in the management of non-healing diabetic foot ulcers.
The randomised controlled trial (RCT) of PuraPly AM plus standard of care (SOC) versus SOC alone in the management of non-healing diabetic foot ulcers (DFUs) met its primary endpoint, demonstrating a statistically significant improvement in wound healing compared with SOC alone.
ORGO closed Thursday's trade at $2.29, down 4.18%.
AMGEN Reports Positive Phase 3 Results for Subcutaneous Tepezza in Thyroid Eye Disease
Amgen Inc. (AMGN), a commercial-stage biotechnology firm,?announced positive topline results from a Phase 3 trial of TEPEZZA (teprotumumab-trbw) administered by subcutaneous injection via an on-body injector (OBI in participants with moderate-to-severe active Thyroid Eye Disease (TED).
The Phase 3 TEPEZZA OBI trial met its primary endpoint in moderate-to-severe active TED, demonstrating a statistically significant and clinically meaningful 77% proptosis response rate during the 24-week placebo-controlled period, compared with 19.6% with placebo.
The mean proptosis reduction, a key secondary endpoint, was -3.17 mm, compared with -0.80 mm in the placebo group at week 24.
AMGN closed Thursday's trade at $356.60, up 1.66%.
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