Century (IPSC) Up 36% on FDA Nod to Begin Phase I Lupus Study
Century Therapeutics IPSC announced FDA clearance of its investigational new drug (IND) application for CNTY-101 for an autoimmune and inflammatory disease indication. This IND clearance allows IPSC to initiate an early-stage study to assess the drug in patients with moderate to severe systemic lupus erythematosus (SLE), who have failed at least two standard immunosuppressive therapies.
Century expects to initiate the early-stage study of CNTY-101 in SLE in the first half of 2024. Initial data readout from the phase I study is anticipated by 2024-end.
The planned phase I study will evaluate safety, tolerability, pharmacokinetics, and clinical response of CNTY-101 in. The study will administer one to two cycles of three weekly doses of CNTY-101 in the enrolled patient population.
The stock rallied 36.1% in the last trading session as investors cheered the regulatory update for CNTY-101. Year to date, shares of Century have plunged 58.1% compared with the industry’s 9.1% decline.
Image Source: Zacks Investment Research
Century’s lead drug, CNTY-101, is anallogeneic, off-the-shelf iPSC-derived CD19-targeted CAR NK cell therapy product candidate. It is developed using IPSC’s proprietary gene-editing technology, Allo-Evasion. CNTY-101 is the first cell therapy product candidate engineered with six precision gene edits.
IND clearance for treatment of SLE marks the second IND clearance for CNTY-101 and the first in an autoimmune and inflammatory disease indication.
Century had previously received IND clearance for CNTY-101 for treatment of relapsed/refractory B-cell malignancies. A phase I ELiPSE-1 study is currently evaluating CNTY-101 in patients with relapsed or refractory CD19-positive B-cell lymphomas.
Per Century, currently available SLE therapies lack efficacy. New B-cell-directed autologous CAR T cell treatment options have demonstrated efficacy inducing durable remissions.
IPSC looks to quench the unmet medical need with CNTY-101 which has a novel mechanism of action that could provide multiple potential treatment advantages.
Century Therapeutics, Inc. Price and Consensus
Century Therapeutics, Inc. price-consensus-chart | Century Therapeutics, Inc. Quote
Zacks Rank and Stocks to Consider
Century currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks worth mentioning are Puma Biotechnology, Inc. PBYI, ADMA Biologics ADMA and Agenus AGEN. While PBYI sports a Zacks Rank #1 (Strong Buy), ADMA and AGEN carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share has remained constant at 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 earnings per share has increased from 62 cents to 64 cents. Year to date, shares of PBYI have lost 7.8%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 6 cents to 3 cents. The consensus estimate for ADMA Biologics’ 2024 earnings per share is pegged at 16 cents. Year to date, shares of ADMA have lost 1.5%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 loss per share has narrowed from 77 cents to 63 cents. During the same time frame, the consensus estimate for Agenus’ 2024 loss per share has narrowed from 70 cents to 45 cents. Year to date, shares of AGEN have plunged 67.4%.
AGEN beat estimates in one of the trailing four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.
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
Agenus Inc. (AGEN) : Free Stock Analysis Report
Puma Biotechnology, Inc. (PBYI) : Free Stock Analysis Report
ADMA Biologics Inc (ADMA) : Free Stock Analysis Report
Century Therapeutics, Inc. (IPSC) : Free Stock Analysis Report
