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PharmaDeviceNews Features & Analysis
Electra Therapeutics raised $350 million in its Nasdaq IPO to advance ipsoprubart through a registrational programme in secondary hemophagocytic lymphohistiocytosis. Representative image.
Features & Analysis

Electra’s $350m IPO fell 11.7% on debut. Does ipsoprubart justify the immunology bet?

Electra Therapeutics has raised $350 million in one of 2026’s larger biotechnology IPOs, giving the clinical-stage company enough projected capital to reach pivotal results for ipsoprubart in secondary hemophagocytic lymphohistiocytosis. The stock’s 11.7% first-day decline shows that investors remain cautious, however, because the company’s most striking efficacy evidence still comes from a small uncontrolled Phase

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Teva Pharmaceutical Industries’ once-monthly TEV-’749 could make long-acting olanzapine more practical if FDA review supports use without the three-hour post-injection monitoring required for existing olanzapine depot therapy. Representative image.
Features & Analysis

Teva saw no PDSS across 3,470 injections. Could TEV-’749 finally make long-acting olanzapine practical?

Teva Pharmaceutical Industries has reported new long-term data for once-monthly subcutaneous TEV-’749 ahead of an expected fourth-quarter FDA decision. Its competitive proposition is not a new antipsychotic mechanism, but an attempt to combine established olanzapine efficacy with long-acting dosing without the post-injection monitoring burden that has constrained the existing olanzapine depot.

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IntraBio’s AQNEURSA has become the first FDA-approved treatment for ataxia in patients with ataxia-telangiectasia after significant neurological improvement in Phase 3 testing. Representative image.
Features & Analysis

AQNEURSA is the first ataxia-telangiectasia treatment. Can a 12-week improvement change a lifelong disease?

IntraBio’s AQNEURSA has become the first approved treatment for ataxia in people with ataxia-telangiectasia after a randomized Phase 3 trial showed a significant improvement in neurological function. The approval ends decades without a specific therapy for the disorder’s ataxia, but it does not resolve whether levacetylleucine can slow long-term neurodegeneration or alter the immune, pulmonary

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Gilead Sciences is preparing generic manufacturing for investigational once-yearly lenacapavir across 120 countries before the Phase 3 PURPOSE 365 HIV prevention study reports. Representative image.
Features & Analysis

Gilead is licensing once-yearly lenacapavir before Phase 3 results. Why take the manufacturing risk now?

Gilead Sciences has expanded royalty-free licensing agreements with six generic manufacturers to cover investigational once-yearly lenacapavir for HIV prevention while the Phase 3 PURPOSE 365 study is still underway. The decision deliberately moves manufacturing and access planning ahead of regulatory certainty, potentially shortening the years-long delay that has historically separated pharmaceutical innovation from broad availability

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Johnson & Johnson’s PAPILLON trial reported 34.3-month median survival with first-line RYBREVANT plus chemotherapy, while extensive treatment crossover complicated the final overall-survival analysis. Representative image.
Features & Analysis

Johnson & Johnson says RYBREVANT delivered the longest reported survival in EGFR exon 20 lung cancer. Why was p=0.307?

Johnson & Johnson’s final PAPILLON analysis found median overall survival of 34.3 months with first-line RYBREVANT plus chemotherapy versus 27.9 months with chemotherapy, but the protocol-specified comparison was not statistically significant. With 76% of eligible chemotherapy patients later receiving amivantamab, the trial has become a case study in how effective crossover can obscure overall-survival differences.

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Aptitude’s FDA-cleared next-generation Metrix COVID Test represents a shift from pandemic emergency authorization toward permanent decentralized molecular diagnostics. Representative image.
Features & Analysis

Aptitude’s Metrix is three times more analytically sensitive. Is COVID testing really just the first application?

Aptitude Medical Systems has secured traditional FDA 510(k) clearance for its next-generation Metrix COVID Test as pandemic-era emergency authorizations approach their scheduled end. The deeper opportunity is not COVID testing itself, but whether a compact RT-LAMP platform can make laboratory-quality molecular diagnostics economically practical across urgent care, physician offices and other decentralized settings.

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GE HealthCare’s StarGuide GX 4D SPECT/CT is designed for expanding theranostics workflows and emerging radionuclides including investigational alpha emitters. Representative image.
Features & Analysis

GE HealthCare designed StarGuide GX for the radiopharma boom. Is SPECT/CT becoming treatment infrastructure?

GE HealthCare has moved StarGuide GX toward the U.S. market as radiopharmaceutical therapy expands beyond conventional nuclear medicine. The 4D CZT SPECT/CT system is designed to image across a wide energy range, including investigational alpha emitters, highlighting how the theranostics boom is creating demand not just for drugs but for quantitation, dosimetry and workflow infrastructure.

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Medtronic’s FDA-cleared LigaSure RAS Maryland instrument expands the Hugo robotic-assisted surgery ecosystem with vessel-sealing technology used in more than 45 million procedures. Representative image.
Features & Analysis

Hugo has U.S. clearance, but Medtronic is still building its toolset. Why does LigaSure matter so much?

The FDA has cleared Medtronic’s LigaSure RAS Maryland instrument for the Hugo robotic-assisted surgery platform, bringing vessel-sealing technology used in more than 45 million procedures into U.S. robotic workflows. The milestone illustrates a less glamorous but commercially crucial reality of surgical robotics: hospitals buy ecosystems, not merely robots.

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Xenon Pharmaceuticals has submitted azetukalner for FDA approval in focal seizures while separately evaluating neuropsychiatric adverse events in its depression programmes. Representative image.
Features & Analysis

Azetukalner’s epilepsy NDA is backed by 1,500 patient-years. Do psychiatric adverse events change the regulatory equation?

Xenon Pharmaceuticals has submitted azetukalner for FDA approval in focal seizures after strong Phase 3 efficacy and more than 1,500 patient-years of epilepsy exposure. On the same day, the company paused new enrollment in psychiatry studies after neuropsychiatric adverse events emerged, creating a difficult question over how regulators and investors should interpret safety signals that

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Ultragenyx Pharmaceutical’s $3.95 million FAYUVI gene therapy is the first FDA-approved disease-modifying treatment for children with Sanfilippo syndrome type A. Representative image.
Features & Analysis

FAYUVI costs $3.95m for one infusion. Can Ultragenyx make the first Sanfilippo therapy accessible?

Ultragenyx Pharmaceutical has won FDA approval for FAYUVI, the first treatment designed to alter the course of Sanfilippo syndrome type A. The one-time AAV9 gene therapy carries a $3.95 million U.S. list price and will initially flow through specialist treatment centres, putting early diagnosis, payer access and preservation of neurodevelopmental function at the centre of

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