INDIANAPOLIS (dpa-AFX) - This week's biotech landscape witnessed regulatory approvals across the U.S., Taiwan, and Europe, alongside FDA rejections, collaborations, acquisitions, and positive data readouts spanning multiple therapeutic areas, including Colorectal Cancer, Obesity and Fatty Liver Disease.
Let's unpack the specifics.
FDA and EU Approvals & Rejections
Phillips Secures FDA Clearance for AI-Powered Verida Spectral CT
Royal Philips (PHG) received FDA 510(k) clearance for its new Spectral CT Verida system, an AI-powered, detector-based spectral CT system designed to deliver always-on spectral imaging and faster diagnostic reconstruction. The platform integrates dual-layer detectors with deep-learning image processing to enhance clarity, reduce noise, and support high-volume clinical workflows across radiology, cardiology, oncology, and lung cancer screening.
PHG closed Thursday's trading (April 16, 2026) at $28.63, down 1.58%.
Nxera Pharma's QUVIVIQ Wins Taiwan Approval for Insomnia Treatment
Nxera Pharma Co., Ltd. (SOLTF, 4565.T) announced that its partner, Holling Bio-Pharma, received Taiwan Food and Drug Administration (TFDA) approval to market QUVIVIQ (daridorexant) 25 mg and 50 mg for the treatment of adult insomnia, expanding the drug's Asia-Pacific footprint. The approval, granted under Taiwan's Streamlined Review Designation (SRD), leveraged Japan's regulatory dossier and included milestone payments, royalties, and product-supply revenue for Nxera ahead of a planned 2026 launch.
4565.T closed Friday's trading at JPY 1,013, down 3.06%.
Travere Wins Full FDA Approval For FILSPARI In FSGS
Travere Therapeutics, Inc. (TVTX) secured full FDA approval for FILSPARI to reduce proteinuria in adults and children aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome- the first and only FDA-approved therapy for this rare kidney disorder. The decision, backed by the Phase 3 DUPLEX study, expands FILSPARI's reach to an estimated 30,000 U.S. patients, strengthening its commercial momentum following $322 million in U.S. sales in 2025.
TVTX closed Thursday's trading at $39.54, down 3.44%.
Dupixent Wins EC Approval for Treating CSU in Children Aged 2-11
Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi received European Commission approval for Dupixent to treat moderate-to-severe chronic spontaneous urticaria (CSU) in children aged 2 to 11 years who remain symptomatic despite antihistamines. The decision, supported by the LIBERTY-CUPID clinical program, expands Dupixent's CSU indication in the EU and builds on its broad global footprint across multiple inflammatory conditions.
REGN closed Thursday's trading at $746.00, down 1.05%.
Replimune Receives Second FDA CRL for RP1 in Melanoma
Replimune Group, Inc. (REPL) received a second complete response letter from the FDA for RP1 in advanced melanoma, stating that the pivotal RPL-001-16 trial does not provide adequate, well-controlled evidence of efficacy. The FDA noted no safety or manufacturing issues, but the company said the decision means continued development of RP1 is not feasible.
REPL closed Thursday's trading at $2.19, down 3.95%.
DealsStereotaxis To Acquire Robocath
Stereotaxis Inc. (STXS), a U.S.-based company specialising in surgical robotics for minimally invasive heart and vascular procedures, has signed a definitive agreement to acquire Robocath, a French developer of robotic technologies for interventional cardiology and neurointerventions.
Stereotaxis will pay $20 million upfront, with up to $25 million in contingent payments tied to regulatory and commercial milestones, including FDA clearance. Stereotaxis estimates that Robocath will contribute about $2 million in revenue in its first year post-acquisition, with breakeven expected by the third year, supported by commercial collaborations.
STXS closed Thursday's trade at $2.01.
Mesoblast Acquires CAR Technology From Mayo Clinic
Mesoblast Limited (MESO) announced the acquisition of worldwide licensing rights to a patented chimeric antigen receptor (CAR) technology platform from the Mayo Clinic.
The firm plans to improve target specificity and augment immunomodulation and tissue regeneration to treat inflammatory and autoimmune diseases. Mayo Clinic will provide in-kind support to advance CAR-MSC technology, including the development of good manufacturing practice (GMP) activities. Mesoblast completed the acquisition by issuance of ASX ordinary shares.
MESO closed Thursday's trade at $16.09, up 2.16%.
American Industrial Partners To Acquire Avanos Medical in $1.27 Bln deal
Avanos Medical (AVNS) has entered into a definitive agreement to be acquired by affiliates of American Industrial Partners or AIP, an operationally-oriented industrial investor, in an all-cash transaction that values Avanos at approximately $1.272 billion in enterprise value. Closing is expected in the second half of 2026, pending approval. Avanos shareholders will receive $25.00 per share in cash for their shares.
Upon completion, Avanos will become private and will no longer be listed on the NYSE.
AVNS closed Thursday's trade at $24.66, down 0.24%.
Sana Announces Strategic Collaboration With Mayo Clinic For Developing SC451
Sana Biotechnology Inc. (SANA), a company developing engineered cell therapies, announced a strategic collaboration with Mayo Clinic to develop SC451, an investigational pancreatic islet cell therapy for the treatment of Type-1 diabetes.
As part of the collaboration, the Mayo Clinic will provide end-to-end clinical and operational insights, workflow optimisation, surgical expertise, handling, delivery, and post-treatment management. Additionally, Mayo Clinic will provide an equity investment to Sana, with an option for future equity investments.
SANA closed Thursday's trade at $3.47, up 0.87%.
Clinical Trials - Breakthroughs & SetbacksPDS Biotech Reports Strong Interim Data With PDS01ADC In Colorectal Cancer
PDS Biotechnology Corporation (PDSB) announced positive interim Phase 2 results from Stage 1 of an NCI-led trial evaluating its tumour-targeted IL-12 immunocytokine, PDS01ADC, in patients with metastatic colorectal cancer, the second leading cause of cancer-related deaths in the U.S.
The key findings include an objective response rate (ORR) of 77.8% at six months, compared with 35% in a parallel trial without PDS01ADC. The median progression-free survival was not reached at 13.1 months of follow-up, compared with 8.1 months in the parallel trial.
PDSB closed Thursday's trade at $1.28, down 5.88%.
Hoth Therapeutics Unveils Positive HT-VA Study Data Of GDNF In Obesity And Fatty Liver Disease
Hoth Therapeutics, Inc. (HOTH), a clinical-stage biopharmaceutical company, announced positive data from its HT-VA study evaluating the effects of parenteral GDNF (Glial Cell-Derived Neurotrophic Factor) in diet-induced obesity and metabolic-associated fatty liver disease.
The study demonstrated parenteral GDNF directly reprograms liver fat metabolism at the genetic level in a preclinical model of metabolic-associated fatty liver disease.
The results include a notable decrease in Srebf1, a crucial gene regulating fat synthesis in the liver and increased expression of Ppara, a central regulator of fat metabolism and fat burning.
HOTH closed Thursday's trade at $0.74, up 6.61%.
Revolution Medicines' Daraxonrasib Shows Positive Results in Phase 3 RASolute 302 Trial
Revolution Medicines (RVMD), a late-stage oncology company, announced positive topline results from the Phase 3 RASolute 302 clinical trial evaluating Daraxonrasib in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who had been previously treated. The trial met all primary and key secondary endpoints.
In the overall study population, Daraxonrasib demonstrated a median OS of 13.2 months versus 6.7 months with chemotherapy, and a hazard ratio of 0.40. Daraxonrasib was generally well tolerated, with a manageable safety profile and with no new safety signals according to the firm.
RVMD closed Thursday's trade at $149.27, down 2.14%.
Spyre Therapeutics Meets Key Goal In Phase 2 SKYLINE Trial For Ulcerative Colitis
Spyre Therapeutics, Inc. (SYRE), a clinical-stage biotechnology company, announced positive 12-week induction data from Part A of the Phase 2 SKYLINE trial of SPY001, an extended half-life investigational antibody. The trial met the primary endpoint for the treatment of moderate-to-severe ulcerative colitis.
SPY001 met its primary endpoint, with a well-tolerated safety profile consistent with the a4ß7 class, and a statistically significant reduction of 9.2 points from baseline at Week 12 in the Robarts Histopathology Index (RHI) score. The rates of the key secondary endpoints, clinical remission and endoscopic improvement, were clinically meaningful.
SYRE closed Thursday's trade at $69.70, up 1.03%.
Allogene's Reports Positive Interim Findings Of Cema-Cel In Large B-cell Lymphoma
Allogene Therapeutics, Inc. (ALLO), a clinical-stage biotechnology company, reported positive data from the planned interim futility analysis of its pivotal, randomised Phase 2 ALPHA3 trial of Cemacabtagene ansegedleucel (Cema-Cel) in first-line consolidation of large B-cell lymphoma (LBCL).
At the data cut, when the 24th patient completed the day 45 minimal residual disease (MRD) assessment, 58.3% (7/12) of patients in the Cema-cel arm achieved MRD negativity, compared to 16.7% (2/12) in the observation arm.
ALLO closed Thursday's trade at $2.37, up 9.22%.
Lilly's Jaypirca Added To Venetoclax And Rituximab Improves PFS In CLL/SLL Study
Eli Lilly and Co. (LLY) reported positive results from a phase 3 trial of Jaypirca in patients with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL), dubbed BRUIN CLL-322.
The study met its primary endpoint, demonstrating that the addition of Jaypirca to venetoclax plus rituximab led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS).
Overall survival (OS), an important secondary endpoint, although not fully established, shows early results suggesting a positive trend for the Jaypirca combination regimen.
LLY closed Thursday's study at $903.99, down 0.11%.
IDEAYA's Darovasertib Shows Positive Results in OptimUM-02 Trial Of MUM
IDEAYA Biosciences, Inc. (IDYA), an oncology company, and Servier announced positive topline results from the Phase 2/3 registrational trial named OptimUM-02, evaluating Darovasertib in combination with Crizotinib in patients with first-line HLA-A*A2:01-negative metastatic uveal melanoma.
OptimUM-02 is a global, randomised Phase 2/3 trial evaluating the Darovasertib and Crizotinib combination arm in 210 patients versus the ICT arm, consisting of 103 patients.
The study met the primary goal of a statistically significant improvement in median progression-free survival (PFS) relative to the investigator's choice of therapy (ICT) arm, as assessed by blinded independent central review (BICR).
IDYA closed Thursday's trade at $32.51, up 1.03%
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