This week, Eli Lilly LLY announced plans to acquire SiteOne Therapeutics to expand its pain pipeline. Moderna MRNA announced that the U.S. Department of Health and Human Services (“HHS”) has terminated the award for the late-stage development of its H5 avian flu vaccine. GSKplc GSK and Sanofi SNY announced pipeline data. Merck MRK and Japan’s Daiichi Sankyo voluntarily withdrew their regulatory application seeking approval for their HER3-directed antibody-drug conjugate, patritumab deruxtecan, in the United States.
Here's a recap of the week’s most important stories.
Lilly to Acquire SiteOne Therapeutics in $1B Deal
Lilly announced a definitive agreement to acquire private biotech, SiteOne Therapeutics, which will add novel non-opioid medicines for pain management to its pipeline portfolio. SiteOne Therapeutics makes small-molecule inhibitors of sodium channels to treat pain and other neuronal hyperexcitability disorders. Its lead pipeline candidate is STC-004, a phase II ready Nav1.8 inhibitor being studied for the treatment of pain. For the deal, Lilly will make a payment of up to $1.0 billion in cash, which includes an upfront payment and subsequent milestone payments.
Phase III Study on GSK/SPRO’s Oral Antibiotic Stopped Early for Efficacy
GSK and partner Spero Therapeutics announced that a phase III study on their oral antibiotic candidate, tebipenem HBr for the potential treatment of complicated urinary tract infections (cUTIs), was stopped early for efficacy. The decision followed a review by an Independent Data Monitoring Committee, based on a planned interim analysis of data from the phase III PIVOT-PO study on tebipenem HBr. The study met the primary endpoint of non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin in hospitalized adult patients with cUTI.
If approved by the FDA, tebipenem HBr will become the first oral carbapenem antibiotic treatment for cUTI, providing patients a novel alternative to hospital-based intravenous treatment. Carbapenem antibiotics are the standard of care treatments for cUTI, which can at present only be administered via IV administration.
The companies plan to file a regulatory application to the FDA in the second half of 2025, which will include the latest data from the PIVOT-PO study.
The European Medicines Agency’s Committee for Medicinal Products for Human Use gave a positive opinion recommending approval for the Blenrep (belantamab mafodotin) combination therapy to treat relapsed or refractory multiple myeloma. European Commission’s decision on the regulatory application is expected in the third quarter of 2025.
HHS Ends $766M Funding Contract for MRNA’s Bird Flu Vaccine
Moderna announced that HHS will terminate the $766M funding for the late-stage development of its mRNA-based H5 avian flu vaccine, mRNA-1018, and also the right to purchase this pre-pandemic influenza vaccine.
Moderna also announced robust immune response data from an interim analysis of a phase I/II study of mRNA-1018. In the study, mRNA-1018 demonstrated rapid, potent and durable immune response and was generally well-tolerated, with no dose-limiting tolerability concerns.
MRK & Daichi Withdraw Patritumab Deruxtecan BLA
Merck and partner Daiichi Sankyo have voluntarily withdrawn their biologics license application (BLA) seeking approval for their jointly developed ADC, patritumab deruxtecan, for previously treated EGFR-mutated non-small cell lung cancer. The decision was taken as the HERTHENA-Lung02 phase III study showed that the drug did not achieve a statistically significant overall survival benefit. The decision was made after discussions with the FDA and is not related to the complete response letter received in June last year regarding manufacturing issues.
Merck and Daiichi are also co-developing two other DXd ADCs — ifinatamab deruxtecan/MK-2400 and raludotatug deruxtecan/MK-5909 for several cancers as part of their 2023 collaboration deal.
Mixed Data From SNY/REGN’s COPD Study on Itepekimab
Sanofi and partner Regeneron announced mixed results from two phase III studies on their pipeline candidate, Itepekimab, for treating chronic obstructive pulmonary disease (COPD). The AERIFY-1 study met its primary endpoint of a statistically significant reduction in moderate or severe exacerbations compared to placebo in former smokers with inadequately controlled COPD. The study achieved this milestone regardless of eosinophilic phenotype and provided a clinically meaningful benefit. However, the second study, AERIFY-2, failed to meet the same primary endpoint, despite a benefit seen earlier in the study.
Sanofi and Regeneron will discuss the data with regulatory authorities to evaluate next steps. Itepekimab is also being evaluated in other indications like chronic rhinosinusitis with nasal polyps or CRSwNP and bronchiectasis.
GSK has a Zacks Rank #2 (Buy), while Lilly, Moderna, Sanofi and Merck carry a Zacks Rank of 3 (Hold) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The NYSE ARCA Pharmaceutical Index has declined 5.2% in the past five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the previous five trading sessions.
Zacks Investment Research
Image Source: Zacks Investment Research
In the last five trading sessions, AbbVie rose the most (4.1%), while Merck declined the most (0.8%).
In the past six months, Novartis rose the most (9.9%), while Novo Nordisk declined the most (35.3%).
(See the last pharma stock roundup here: NVO CEO Resigns, SNY to Buy VIGL & More)
What's Next in the Pharma World?
Watch this space for regular pipeline and regulatory updates next week.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
