Aleth LifeSci Brief: 4-8 August 2025
Lilly's obesity pill misses, Novo rebounds
ALETH / LIFESCI-BRIEF / 2025-08-08 / LILLY'S OBESITY PILL MISSES, NOVO REBOUNDSIn this edition
Monday: US obesity-drug pilot; US CDC funding block; Regeneron FDA rejection
Tuesday: Alcon-STAAR deal; UK clinical trials; Vertex pain-drug miss
Wednesday: Trump pharma tariff; Novo Nordisk slowdown; SERB-Y-mAbs deal; US mRNA funding cut
Monday 4 August
The Trump administration is planning a pilot to let Medicare and Medicaid pay for weight-loss drugs, The Washington Post reported.
Medicare has been barred by statute from covering medicines prescribed for weight loss alone, so a pilot extending coverage of GLP-1 obesity treatments to low-income people and retirees would open the largest payer market still closed to Novo Nordisk and Eli Lilly. The report, citing people familiar and internal documents, said the model would run through the Center for Medicare and Medicaid Innovation and was cast as a response to chronic obesity in the US. A formal design came later; on 1 August the plan existed as reporting.
Sources:
Medicare, Medicaid may cover weight-loss drugs under Trump plan - The Washington Post
The White House is withholding money Congress approved for a range of CDC public-health programs, The Wall Street Journal reported.
The blocked work spans youth-violence prevention, firearm-injury research, and programmes on diabetes, chronic kidney disease and tobacco. The Office of Management and Budget used a footnote on a July appropriations memo to tell CDC centre directors they could not move funding into the affected programmes, and the White House began releasing CDC money month by month, citing external reviews. The sum could not be pinned down but was put as high as about $200 million. It extends the administration’s running impoundment fight into disease-control work. Some funds were released days later.
Sources:
Trump administration blocks funding for CDC health programs - The Wall Street Journal
Regeneron drew a second FDA rejection for odronextamab, its CD20xCD3 bispecific antibody for lymphoma.
Disclosed in the company’s second-quarter results on 1 August, the Complete Response Letter for relapsed or refractory follicular lymphoma turned on deficiencies found during an FDA inspection of a third-party fill-finish plant, Catalent Indiana, and did not raise concerns about the drug’s safety or efficacy or about Regeneron’s own trials. The agency had first declined odronextamab in March 2024. The antibody has been approved in the European Union since August 2024, so the setback is specific to the US route, and Regeneron said the manufacturing issue was being resolved.
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Tuesday 5 August
Alcon agreed to buy STAAR Surgical for about $1.5 billion, moving the Swiss eye-care group into lens-based vision correction.
Under the deal announced on 5 August, Alcon will pay $28.00 a share in cash, roughly a 51% premium to STAAR’s 4 August close and about 59% over its 90-day average price. STAAR makes the EVO family of implantable collamer lenses for correcting moderate to high myopia, a surgical alternative to laser refractive procedures, which sits alongside Alcon’s cataract and refractive portfolio. The purchase adds an implant business to a company built on cataract surgery and contact lenses.
Sources:
The UK government set out plans to cut the time needed to set up a clinical trial to 150 days or less.
The Department of Health and Social Care published an update on 4 August restating the 150-day target, measured from regulatory approval to sites opening for recruitment and then to first participant recruited, as part of reforms under its clinical research programme and the 10-Year Health Plan. The aim is to draw more commercial trial work to Britain after years of complaints about slow study start-up. The document frames the target as an ambition the regulators and the NHS are working toward, and reports set-up times already falling for commercial studies.
Sources:
Transforming the UK clinical research system: August 2025 update - Department of Health and Social Care
Vertex will not take VX-993 forward as a standalone acute-pain drug after it missed in Phase 2.
The oral NaV1.8 inhibitor did not beat placebo on the primary endpoint, the time-weighted sum of pain-intensity difference over 48 hours, in a dose-ranging study in patients recovering from bunionectomy surgery. Vertex said on 4 August the candidate was not expected to be superior to its existing NaV1.8 inhibitors, so it would not enter pivotal development as a monotherapy in acute pain. The company already sells Journavx, its approved non-opioid pain medicine, and is still testing VX-993 in diabetic nerve pain.
Sources:
Vertex announces results from Phase 2 study of VX-993 for the treatment of acute pain - Vertex Pharmaceuticals
Wednesday 6 August
President Trump said pharmaceutical tariffs would start small and climb to 150% and then as high as 250%.
Speaking to CNBC on 5 August, he said he would first impose a “small tariff” on drug imports, without naming the rate, then raise it to 150% and ultimately up to 250% within “one year, one and a half maximum.” The path runs well beyond the sector-specific duties the industry had been bracing for and puts a timetable on shifting production into the US, which he stated as the goal: “We want pharmaceuticals made in our country.” The escalation would land on every large exporter shipping medicines into the US market, UK and European manufacturers included.
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Novo Nordisk reported a sharp slowdown in its diabetes and obesity franchise as competition and copycats bit.
In its half-year report on 6 August, total sales rose 18% at CER, but growth in diabetes and obesity care fell to 16% from 26% a year earlier. Novo reaffirmed its lowered full-year outlook it set on 29 July, of 8 to 14% sales growth, blaming continued unlawful compounding of GLP-1 medicines in the US, slower market expansion, and share loss to Eli Lilly’s tirzepatide, which hit Ozempic in US diabetes and Wegovy in US obesity.
Novo has dropped the GLP-1/GIP co-agonist NNC0519-0130 for weight management, even though its Phase 2 study met the primary goal of significant weight loss, citing “portfolio considerations” for a molecule that looked close to Eli Lilly’s tirzepatide. It also abandoned INV-347, a next-generation CB1 receptor blocker from its 2023 Inversago buyout, and terminated the FGF-21 analogue zalfermin in the liver disease MASH. It advanced subcutaneous and oral amycretin into Phase 3 in weight management, a signal that the cuts free room for more differentiated bets.
Sources:
SERB Pharmaceuticals agreed to buy cancer biotech Y-mAbs Therapeutics for about $412 million in cash.
The specialty drugmaker will pay $8.60 a share, roughly a 105% premium to Y-mAbs’s 4 August close. The prize is Danyelza, the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma, which broadens SERB’s specialty and rare-disease range. The deal was struck on 5 August and structured to complete through a statutory merger, taking Y-mAbs off Nasdaq.
Sources:
SERB Pharmaceuticals agrees to acquire Y-mAbs Therapeutics - Y-mAbs Therapeutics
HHS is winding down the mRNA vaccine work it funds through BARDA.
On 5 August the department said it was terminating and de-scoping about 22 investments worth nearly $500 million and would start no new mRNA-based projects, pulling federal money from the platform behind the COVID-19 shots. Secretary Robert F. Kennedy Jr. said the vaccines failed to protect well against upper-respiratory infections such as COVID and flu, and that funding would move to “safer, broader” platforms. Affected work included a Moderna H5N1 award and contracts with Emory University and Tiba Biotech, while some late-stage contracts were left to run their course. The move leaves developers without a US government backer for the work.
Sources:
HHS winds down mRNA development under BARDA - Department of Health and Human Services
Thursday 7 August
Novartis is weighing a bid of about $4.3 billion for Avidity Biosciences, the Financial Times reported.
The San Diego biotech has three medicines in clinical trials, including a candidate for Duchenne muscular dystrophy, built on antibody oligonucleotide conjugates that link an antibody to an RNA payload to reach muscle tissue. The report set the talks against a busy year for deals, with Oppenheimer counting more than $78 billion of pharma transactions agreed in 2025 to date against $45 billion across all of 2024, as large-cap companies buy to replace revenue facing near-term patent cliffs. On 7 August the approach existed as reporting, with no confirmation from either company.
Sources:
Novartis weighs $4.3bn bid for Avidity Biosciences - Financial Times
The Government Accountability Office found the White House broke the law by withholding NIH money Congress had approved.
In a decision on 5 August, the congressional watchdog said HHS and the NIH violated the Impoundment Control Act of 1974 by cancelling grants and pausing new awards, acting on executive orders that directed agencies to cut funding for equity-related activities. NIH obligated almost $8 billion less between February and June 2025 than in the same months a year earlier, and terminated more than 1,800 grants. GAO decisions carry no penalty, but they can arm Congress and plaintiffs already challenging the freezes in court.
Sources:
Department of Health and Human Services - National Institutes of Health - Application of Impoundment Control Act - Government Accountability Office
Friday 8 August
The Trump administration has been pressing drugmakers to raise prices in Europe as a way to bring US costs down, Reuters reported.
The discussions follow the administration’s most-favoured-nation demand that US prices match the lowest paid in other wealthy countries. Lifting prices abroad is the industry’s preferred route to close that gap, which turns the question toward European payers, the NHS among them, being asked to pay more. On 7 August the talks were reported rather than settled, and put a transatlantic price of the US pricing push onto European health systems.
Sources:
Eli Lilly’s oral obesity pill orforglipron delivered less weight loss than investors wanted, and the market handed Novo Nordisk a reprieve.
In ATTAIN-1, the first of two pivotal Phase 3 trials, the 36 mg once-daily dose cut weight by an average of 12.4%, or 27.3 lbs, over 72 weeks against 0.9% on placebo, with all doses meeting the primary and key secondary endpoints and gastrointestinal side effects the most common. Lilly said on 7 August it would submit for regulatory review by year-end. The pill was meant to widen Lilly’s lead in oral obesity treatment; the size of the effect fell short of expectations, so Lilly shares fell and Novo Nordisk’s rose, easing pressure on the Danish company in a contest worth tens of billions of dollars a year.
Sources:
Lilly’s oral GLP-1 orforglipron delivers weight loss of up to an average of 27.3 lbs - Eli Lilly
Eli Lilly’s weight-loss pill disappoints investors - Financial Times
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