Lisata's (LSTA) Lead Cancer Drug Gets EC's Orphan Tag, Stock Up
Lisata Therapeutics, Inc. LSTA announced that that European Commission has granted orphan drug designation to its lead investigational candidate, LSTA1, for the treatment of pancreatic cancer. Shares of the company were up 6.6% on Oct 17 in response to the news.
The EC grants Orphan Drug designation in the European Union (EU) to a drug or biologic based on the positive opinion rendered by the European Medicines Agency’s (EMA) Committee for Orphan Medical Products (COMP). The Orphan tag is granted to a product candidate intended to treat, prevent or diagnose a rare disease or condition that does not affect more than five in 10,000 people across the EU.
The designation also includes incentives, including protocol assistance from the EMA, financial aid depending on the sponsor status as well as marketing exclusivity for 10 years upon potential regulatory approval in the EU.
LSTA1 is an investigational drug that allows co-administered or tethered anti-cancer drugs to better penetrate solid tumors by activating a novel uptake pathway. The candidate has exhibited the potential to improve the tumor environment, thereby making tumors more responsive to immunotherapy.
LSTA1 is currently being evaluated as a combination therapy with various anti-cancer regimens in multiple early-to-mid-stage studies targeting various cancer indications, including pancreatic cancer.
Shares of Lisata have declined 10.7% so far this year compared with the industry’s decrease of 18.4%.
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We remind investors that the FDA had granted an Orphan Drug designation to LSTA1 for the treatment of malignant glioma in August 2023. The designation provides Lisata with an expedited regulatory pathway and an additional seven-year market exclusivity in the event of a marketing approval in the United States.
Last month, Lisata announced a positive outcome from the interim futility analysis of the phase IIb ASCEND study, which evaluated LSTA1, in combination with standard-of-care gemcitabine/nab-p+aclitaxel for treating patients with first-line, metastatic pancreatic ductal adenocarcinoma.
LSTA aims to complete enrollment in the ASCEND study by the first half of 2024.
Lisata Therapeutics, Inc. Price
Lisata Therapeutics, Inc. price | Lisata Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Lisata currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Neurocrine Biosciences, Inc. NBIX, Sarepta Therapeutics, Inc. SRPT and MEI Pharma, Inc. MEIP, sporting a Zacks Rank #1 (Strong Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
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In the past 60 days, estimates for Sarepta’s 2023 loss per share have improved from $9.21 to $9.19. During the same period, loss per share estimates for 2024 have narrowed from $1.46 to $1.00. Year to date, shares of SRPT have declined 8.4%.
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In the past 60 days, estimates for MEI Pharma’s 2023 loss per share have improved from $6.54 to $4.89. During the same period, loss per share estimates for 2024 have narrowed from $5.14 to $4.02. Year to date, shares of MEIP have rallied 40%.
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Lisata Therapeutics, Inc. (LSTA) : Free Stock Analysis Report
