Merck achieved its primary endpoint in a phase 2b/3 trial for its diabetic macular edema drug, while Telix Pharmaceuticals announced a $1.65 billion acquisition of ITM to expand radiopharmaceutical manufacturing. Additionally, Eli Lilly entered a research deal worth up to $3.35 billion with InnoCare, and an FDA panel favored approval for Grail's multicancer blood test. In policy, CDC opened state COVID-19 vaccine ordering, and Dr. Heidi Overton faced a confirmation hearing for FDA commissioner.
01Company specific
Merck Achieves Clinical Success in Pivotal Eye Disease Trial
Merck achieved its primary endpoint in the phase 2b/3 Brunello trial for remigromig, a trispecific diabetic macular edema drug acquired through its takeover of EyeBio. Both doses of remigromig demonstrated noninferiority to ranibizumab at Week 52 on the best-corrected visual acuity vision test. The trial evaluated remigromig against ranibizumab, a VEGF inhibitor sold as Lucentis by Roche subsidiary Genentech. Merck reported higher rates of proliferative diabetic retinopathy, vitreous hemorrhage, and treatment discontinuations due to adverse events on remigromig compared to the comparator. Merck plans to present the trial data at the American Academy of Ophthalmology Annual Meeting next month and discuss the findings with regulatory authorities. An ongoing second phase 2b/3 trial comparing remigromig to ranibizumab is scheduled to reach primary completion in March. Merck acquired remigromig and the Tie2xVEGF bispecific MK-8748 in a $1.3 billion upfront transaction in 2024, with up to $1.7 billion in potential milestone payments. The ophthalmology assets are part of Merck's expansion following the future loss of exclusivity for Keytrudaus.
Telix Acquires ITM for $1.6 Billion to Expand Radiopharmaceutical Reach
Telix Pharmaceuticals is acquiring Isotope Technologies Munich for $1.65 billion upfront in a deal that expands its reach in radiopharmaceuticals. The transaction includes an additional $700 million in milestone payments tied to regulatory approvals and sales targets for ITM's lead candidate, ITM-11. Telix will also assume more than $300 million of ITM's at closing. ITM generated $273 million in in 2025, supported by strong growth in recent years. The combined company projects 2026 revenue to exceed $1.3 billion. ITM brings manufacturing infrastructure and a distribution network spanning more than 65 countries. The gives Telix control over supplies of radioisotopes including lutetium-177, actinium-225, and terbium-161. ITM-11 is a peptide receptor radionuclide therapy designed to treat gastroenteropancreatic neuroendocrine tumors. The U.S. Food and Drug Administration issued a complete response letter for ITM-11 last month, citing manufacturing issues at a third-party facility rather than clinical safety or data. ITM plans to resubmit its application following remediation talks. Post-acquisition, Telix shareholders will own approximately 76.3% of the combined company, with ITM backers holding the remaining 23.7%. The transaction has secured approval from Telix's board and investors representing more than 90% of ITM's shares, with closure expected by the end of 2026.
Eli Lilly Partners With InnoCare in Licensing Deal Worth Up to $3.35 Billion
Eli Lilly has entered into a research collaboration and licensing agreement with InnoCare Pharma worth up to $3.35 billion. Under the terms of the accord, InnoCare will receive up to $100 million in upfront and near-term payments alongside about $3.25 billion in development and commercial milestone payments. The Beijing-based drugmaker will also collect tiered, single-digit royalties on future annual net product sales. InnoCare will its drug discovery platform to develop new medicines targeting up to five compounds. The company specialises in treatments for cancer and autoimmune diseases.
FDA Releases Comments Ahead of Advisory Committee Panel Vote on Grail Cancer Test
An advisory panel voted 7-2 with one abstention on Wednesday to find that the probable benefits of Grail's Galleri multicancer blood test outweigh its risks. The molecular and clinical genetics panel also voted unanimously that the test is safe and backed its effectiveness in a 6-4 vote. Galleri screens a single blood draw for methylation patterns in cell-free DNA to detect multiple cancer types in adults aged 50 and older. Grail has submitted a premarket approval application for the test, which has been sold as a laboratory developed test since 2021 with a list price of $949. Panelists stressed that the test should not replace standard guideline-recommended screenings for breast, cervical, colorectal, and lung cancer. The test previously missed its primary endpoint in the NHS-Galleri trial earlier this year by failing to show a statistically significant reduction in later-stage combined cancers. Grail shares surged 33% on Monday ahead of the advisory committee meeting. The FDA is expected to make a final decision on the premarket approval application in the coming months.
CDC Opens State Ordering for COVID-19 Vaccines After Delay
According to arstechnica.com, the Centers for Disease Control and Prevention has opened state ordering for COVID-19 vaccines following an unexplained delay. The Department of Health and Human Services confirmed the ordering system is active but declined to explain the cause or resolution of the hold. The disruption follows years of public opposition to COVID-19 vaccines from Health Secretary Robert F. Kennedy, who previously petitioned the Food and Drug Administration to withdraw approval for the shots. Last year, the health secretary unilaterally revoked universal CDC recommendations for the vaccines, though a federal judge halted several related policy changes in March. Those legal interventions leave current federal recommendations aligned with the July 2025 schedule, which advises shots for moderately to severely immunocompromised children aged six months to 17 years. Healthy children in that same age bracket are directed to obtain the vaccines through shared clinical decision-making with a doctor or pharmacist. A update added to the CDC platform attributes the reliance on the July 2025 framework to ongoing legal uncertainties for the 2026-2027 respiratory illness season. Those federal standards diverge from guidelines issued by leading medical groups, which recommend vaccinations for all infants between six months and 23 months old.
FDA Commissioner Nominee Outlines Strategy to Accelerate Drug Approvals
Dr. Heidi Overton faces a Senate confirmation hearing today as the Trump administration nominee to lead the Food and Drug Administration. At 37 years old, she would become the youngest commissioner in the agency's history if confirmed. Overton enters the role following an 18-month period marked by staff departures and a reduction-in-force in 2025 that cut agency numbers by nearly 20 percent. In her prepared opening statement, Overton emphasized the need to accelerate drug approvals to counter China's expanding biotechnology sector. She pointed to Operation Trialblazer, an administration initiative launched earlier this year to streamline the process.
Rezolute filed its operational and financial results on September 24, 2026. The Redwood City-based pharmaceutical company reported its condition in an 8-K filing with the Securities and Exchange Commission. The filing covers the period ending September 24, 2026. Operations are directed from its headquarters at 275 Shoreline Drive.
Major pipeline deals and positive regulatory votes point to strong commercial momentum in biopharma. However, federal vaccine distribution delays and shifting FDA leadership leave future regulatory timing and public health guidance unresolved for investors.
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