Summary of pharmaceutical actions: Death of a patient in the PFE DMD study, FDA panel meeting for LLY Donanemab – May 10, 2024

This week, Pfizer (PFE – Free Report) reported the death of a young boy who participated in an interim study of its Duchenne muscular dystrophy (“DMD”) drug, fordadistrogen movaparvovec. An FDA advisory committee meeting to discuss Elie Lilly(THERE IS – Free report) The candidate against Alzheimer’s disease, donanemab, will be conducted on June 10. Merck(MRK – Free Report) a phase III study evaluating a Keytruda-based regimen for an endometrial cancer indication failed to meet the primary endpoint.

Roundup of the week’s most important stories

Patient Death in Pfizer DMD Phase II Study: Pfizer has released a community letter notifying the death of a patient who participated in its ongoing Phase II study, called DAYLIGHT, evaluating the fordadistrogen movaparvovec gene therapy to treat DMD in boys aged 2 to 3 years. The boy received the gene therapy a year ago, in early 2023.

Pfizer said it did not have complete information on whether the death was due to the drug and was working to get more details. It also reviews the data with the data monitoring committee. Pfizer suspended treatment in the crossover arm of another ongoing Phase III study called CIFFREO that is studying the fordadistrogen movaparvovec in patients aged 4 to 8 years with DMD. The pause does not apply to other ongoing studies in the DMD program, as dosing has already ended.

FDA panel meeting to discuss Lilly’s Donanemab BLA in June: The FDA announced that an in-person meeting of the Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee will be convened on June 10 to discuss Lilly’s Alzheimer’s disease drug, donanemab.

Donanemab’s Biologics License Application (BLA) was based on data from the Phase III TRAILBLAZER-ALZ 2 study, which evaluated the candidate in participants aged 60 to 85 with Alzheimer’s disease early symptomatic. Lilly had filed the BLA around mid-2023 and the FDA’s decision on donanemab was initially expected in the first quarter of 2024. However, in March 2024, the FDA said an advisory committee meeting would be convened to discuss TRAILBLAZER data. -ALZ 2 study to obtain more information on the safety and effectiveness of donanemab.

Data published last year from the TRAILBLAZER-ALZ 2 study showed that donanemab significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer’s disease.

Merck’s Keytruda Endometrial Cancer Study Fails: Merck’s Phase III first-line endometrial cancer study of Keytruda failed to meet its primary endpoint of disease-free survival (DFS) in an interim analysis led by a independent data monitoring committee. The study called KEYNOTE-B21 evaluated Keytruda in combination with chemotherapy as adjuvant therapy, with or without radiotherapy, for the treatment of patients with newly diagnosed high-risk endometrial cancer following curative-intent surgery. . As the study failed to achieve superiority for the DFS endpoint, the study’s other primary endpoint, overall survival, was not formally tested. Keytruda is currently approved for two approved indications in advanced endometrial cancer.

The NYSE ARCA Pharmaceutical Index is up 1.7% over the past five trading sessions.

Here is how the top eight stocks performed over the past five trading sessions.

Over the past five trading sessions, Novo Nordisk rose the most (3.7%), while AbbVie fell the most (0.3%).

Over the past six months, Novo Nordisk saw the biggest increase (27.7%), while Pfizer saw the biggest drop (2.7%).

(See the latest pharma stock roundup here: LLY, NVO, PFE Q1 results, JNJ’s new plan to resolve talc complaints)

What’s next in the pharmaceutical world?

Watch this space for regular pipeline and regulatory updates next week.

Lilly, Pfizer, and Merck each have a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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