Shares of Jazz Pharmaceuticals JAZZ rose nearly 6% on Tuesday after it reported positive top-line results from the phase III IMforte study, which evaluated Zepzelca (lurbinectedin), combined with Roche’s RHHBY Tecentriq (atezolizumab), in patients with extensive-stage small cell lung cancer (ES-SCLC).
The Roche-sponsored IMforte study achieved statistically significant improvement in the primary endpoints of overall survival and progression-free survival. Treatment with the Zepzelca-Tecentriq combination outpaced Tecentriq alone when used as a first-line maintenance treatment for adults with ES-SCLC, following induction therapy with chemotherapy, Tecentriq and etoposide. The combination therapy was also well-tolerated in study participants, with no new safety signal.
Based on the above results, Jazz intends to submit a regulatory filing in first-half 2025 seeking approval for Zepzelca plus Roche’s Tecentriq as a first-line maintenance treatment for ES-SCLC. It also plans to present the IMforte results at a future medical meeting.
Year to date, shares of Jazz have lost 4.6% compared with the industry’s 2.9% decline.
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Jazz’s Zepzelca has been approved by the FDA under the accelerated pathway since 2020 to treat adult patients with metastatic small-cell lung cancer (SCLC) who have already been treated with platinum-based chemotherapy. The company is currently evaluating Zepzelca in the confirmatory phase III LAGOON study, which is evaluating Zepzelca for the treatment of patients with relapsed SCLC. If data from this study is positive, management intends to use the results to convert the accelerated approval to a full one.
Jazz licensed Zepzelca from Spain-based PharmaMar in 2019. JAZZ holds commercial rights to the drug in North America.
Based on the IMforte study results, PharmaMar also intends to submit a regulatory filing with the EMA for the Zepzelca-Tecentriq combination in the first half of 2025.
Jazz Pharmaceuticals PLC price | Jazz Pharmaceuticals PLC Quote
JAZZ currently carries a Zacks Rank #1 (Strong Buy). Some other top-ranked stocks in the healthcare sector are ANI Pharmaceuticals, Inc. ANIP and Alnylam Pharmaceuticals, Inc. ALNY, each presently sporting a Zacks Rank #1. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.69 to $4.81. Earnings per share estimates for 2025 have improved from $5.37 to $5.86. Year to date, shares of ANIP have risen 6.2%.
ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 31.32%.
In the past 60 days, estimates for Alnylam’s 2024 loss per share have narrowed from $1.20 to 63 cents. Loss per share estimates for 2025 have narrowed from 34 to 26 cents. Year to date, shares of ALNY have rallied 50.2%.
ALNY’s earnings beat estimates in each of the trailing four quarters, the average surprise being 108.53%.
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