Lisata's (LSTA) LSTA1 Gets FDA's RPDD Tag for Osteosarcoma
Lisata Therapeutics, Inc. LSTA announced that the FDA has granted a Rare Pediatric Disease Designation (“RPDD”) to its lead pipeline candidate, LSTA1, for the treatment of osteosarcoma, a rare type of bone cancer that affects children, adolescents and young adults. Shares of the company were up 8.4% on Mar 21, following the announcement of the news.
The RPDD designation is granted by the FDA to medicines that treat serious or life-threatening diseases, usually affecting less than 200,000 children in the United States of all ages. Upon potential approval for LSTA1 by the FDA, the company may become eligible to receive a priority review voucher (“PRV”). This PRV can be used either by LSTA in a subsequent marketing application filed with the FDA for a different product or may even be sold to any other third party to boost cash reserves.
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.
Shares of Lisata have rallied 8.8% in the past year against the industry’s decline of 7.5%.
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We remind investors that LSTA1 is currently being evaluated as a combination therapy with various anti-cancer regimens in several early-to-mid-stage studies for treating multiple cancer indications, including metastatic pancreatic ductal adenocarcinoma (“mPDAC”) and other forms of pancreatic cancer, cholangiocarcinoma, esophageal cancer, head and neck cancer, appendiceal cancer, colon cancer and glioblastoma multiforme (“GBM”).
The FDA has granted orphan drug designation to LSTA1 for the treatment of pancreatic cancer and GBM.
In January 2024, Lisata treated the first patient in a phase IIa study evaluating LSTA1 in combination with temozolomide — the standard of care (“SoC”) — versus SoC and placebo in subjects with newly diagnosed GBM.
In December 2023, Lisata completed patient enrollment in the phase IIb ASCEND study, which is evaluating LSTA1 with SoC gemcitabine/nab-p+aclitaxel for patients with first-line mPDAC.
Top-line data from cohort A (98 patients assigned) of the ASCEND study are now expected in the fourth quarter of 2024, while complete data for all 158 patients in the study are now anticipated by mid-2025.
The European Commission granted orphan drug designation to LSTA1 for the treatment of pancreatic cancer in October 2023.
Zacks Rank & Stocks to Consider
Lisata currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are ADMA Biologics, Inc. ADMA, Vanda Pharmaceuticals Inc. VNDA and ANI Pharmaceuticals, Inc. ANIP, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. In the past year, shares of ADMA have risen 99.4%.
ADMA’s earnings beat estimates in three of the trailing four quarters and met the same once, the average surprise being 85.00%.
In the past 60 days, the Zacks Consensus Estimate for Vanda Pharmaceuticals’ 2024 bottom line has improved from a loss of 46 cents per share to earnings of 1 cent. In the past year, shares of VNDA have plunged 41.1%.
VNDA’s earnings beat estimates in each of the trailing three quarters, the average surprise being 92.88%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.43. In the past year, shares of ANIP have increased 81.7%.
Earnings of ANIP beat estimates in each of the trailing four quarters, the average surprise being 109.06%.
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