Lee Landenberger

Strong interim safety and efficacy data from Hoth Therapeutics Inc.’s phase IIa study of HT-001 helped boost the company’s stock (NASDAQ:HOTH) on Jan. 7 as shares rose 178% to close at $2.28 each.

The 2025 edition of Clarivate’s Drugs to Watch features 11 candidates or approved therapeutics that may well revolutionize treatments or become blockbusters. The 12 th annual report has a strong track record. Twelve of the 13 drugs from the 2024 Drugs to Watch report have been approved and launched.

Despite positive preliminary data from its early stage study of treating hives, Jasper Therapeutics Inc. saw its stock drop dramatically on Jan. 8. Results were from the ongoing phase Ib/IIa study of the monoclonal antibody and lead candidate briquilimab in treating chronic spontaneous urticaria, often referred to as hives. The results showed clinical responses across several of the dosing cohorts. The treatment also displayed a favorable safety profile.

Top-line data from Maat Pharma SA’s phase III study of MaaT-013, an enema microbiome ecosystem therapy for acute graft-vs.-host disease, hit its primary endpoint. The milestone has prompted the company to think about filing an MAA submission for the treatment in Europe sometime in the middle of 2025, which is earlier than it had anticipated.

Dyne Therapeutics Inc. is eyeing accelerated approval for its myotonic dystrophy type 1 treatment after reviewing new results from a phase I/II study. DYNE-101, an oligonucleotide antisense and DMPK gene modulator, produced results on disease biomarkers that included DMPK and splicing correction, disease progression reversal on several functional endpoints and a favorable safety profile. The accelerated approval submission could come in the first half of 2026.

Abbvie Inc. and Simcere Zaiming Pharmaceutical Co. Ltd. are part of the volley of large deals accompanying the opening of the 43rd annual J.P. Morgan Healthcare Conference in San Francisco. The two have agreed to develop SIM-0500, a humanized GPRC5D-BCMA-CD3 trispecific antibody, which is in phase I studies in the U.S. and China to treat refractory multiple myeloma.

Day two of the J.P Morgan Healthcare Conference rolled on with positive data from Sling Therapeutics Inc. that is leading the company to a phase III study in treating thyroid eye disease. The privately held company posted top-line efficacy and safety results from a phase IIb/III study of its lead candidate, linsitinib, which hits its primary endpoint with statistical significance at the twice-daily, 150-mg oral dose.

Can the market justify the hundreds of GLP-1 developers that are working to eventually reach the market? When the dust settles, Minji Kim, CEO of Cross Border Partners and Advisory Service, told attendees at the Biotech Showcase in San Francisco, only a few leading companies will end up dominating the field.

While Moderna Inc. plans to cut its expenses by $1 billion in 2025, the company has received a little breathing room by a hefty U.S. Department of Health and Human Services (HHS) grant. The Biomedical Advanced Research and Development Authority awarded Moderna roughly $590 million to support late-stage development of its mRNA-based avian-variant vaccines and to increase the number of clinical trials for another five additional subtypes of pre-pandemic influenza.

Tris Pharma Inc.’s positive top-line data from a pivotal phase III study of cebranopadol in pain relief has the company thinking about an NDA submission later in the year. The company’s goal is to avoid the problems opioids have brought to treating pain.