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Pliant (PLRX) Receives Positive Review of IPF Study at Top Dose
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Pliant Therapeutics (PLRX - Free Report) received a positive safety review of the ongoing INTGERIS-IPF phase IIa study evaluating PLN-74809 at 320 mg for the treatment of idiopathic pulmonary fibrosis (IPF) from the independent Data Safety Monitoring Board (DSMB).
The DSMB meeting was held per regular schedule after the completion of the enrollment of the study in its 320 mg cohort.
The DSMB examined the safety data from all the subjects enrolled in the study and recommended that the company continue with the study without any modification. The positive review further confirms PLN-74809's safety profile to date.
The results from the INTEGRIS-IPF 320 mg dose cohort study are expected in early 2023.
Post the announcement of the news, the stock moved up 5.29% on Sep 1. Shares of Pliant have returned 50.3% in the year-to-date period against the industry’s decline of 23.9%
Image Source: Zacks Investment Research
Investors must note that Pliant had announced positive results for the phase IIa study of PLN-74809 at once-daily doses of 40 mg, 80 mg, 160 mg or placebo for 12 weeks in 90 patients with IPF. The trial met both its primary and secondary endpoint. It demonstrated well tolerability and positive treatment effect on forced vital capacity (FVC) and Quantitative Lung Fibrosis (QLF) of PLN-74809 in the IPF patients over a 12-week treatment period. It also exhibited a favorable pharmacokinetic profile.
Apart from IPF, the lead candidate, PLN-74809 is being developed for the treatment of primary sclerosing cholangitis (PSC). In July, the company received Fast Track status from the FDA for PLN-74809, for the potential treatment of PSC.
PLN-74809 is currently being evaluated for PSC as a part of the INTEGRIS-PSC phase II study. Pliant expects top-line results from the aforementioned study in the first half of 2023.
Immuncore’s loss per share estimates for 2022 have narrowed from $2.62 to $1.34 in the past 30 days. The same for 2023 has narrowed from $2.90 to $1.78 in the same time frame.
Earnings of Immunocore missed estimates in two of the trailing four quarters and beat the same on the remaining two occasions. The average earnings surprise for IMCR is 33.28%.
Sutro’s loss per share estimates for 2022 have improved from $3.33 to $2.23 in the past 30 days. The same for 2023 has narrowed from $3.43 to $2.81 in the same time frame.
Earnings of Sutro beat estimates in two of the trailing four quarters, were in line in one and missed the same on the remaining occasion. The average negative earnings surprise for STRO is 1.13%.
Vascular Biogenics’ loss per share estimates for 2022 improved from 51 cents to 49 cents in the past 30 days. The same for 2023 has widened from 46 cents to 47 cents in the same time frame.
Earnings of VBLT beat estimates in two of the trailing four quarters and missed the same on the remaining two occasions. The average negative earnings surprise for VBLT is 10.16%.
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Pliant (PLRX) Receives Positive Review of IPF Study at Top Dose
Pliant Therapeutics (PLRX - Free Report) received a positive safety review of the ongoing INTGERIS-IPF phase IIa study evaluating PLN-74809 at 320 mg for the treatment of idiopathic pulmonary fibrosis (IPF) from the independent Data Safety Monitoring Board (DSMB).
The DSMB meeting was held per regular schedule after the completion of the enrollment of the study in its 320 mg cohort.
The DSMB examined the safety data from all the subjects enrolled in the study and recommended that the company continue with the study without any modification. The positive review further confirms PLN-74809's safety profile to date.
The results from the INTEGRIS-IPF 320 mg dose cohort study are expected in early 2023.
Post the announcement of the news, the stock moved up 5.29% on Sep 1. Shares of Pliant have returned 50.3% in the year-to-date period against the industry’s decline of 23.9%
Image Source: Zacks Investment Research
Investors must note that Pliant had announced positive results for the phase IIa study of PLN-74809 at once-daily doses of 40 mg, 80 mg, 160 mg or placebo for 12 weeks in 90 patients with IPF. The trial met both its primary and secondary endpoint. It demonstrated well tolerability and positive treatment effect on forced vital capacity (FVC) and Quantitative Lung Fibrosis (QLF) of PLN-74809 in the IPF patients over a 12-week treatment period. It also exhibited a favorable pharmacokinetic profile.
Apart from IPF, the lead candidate, PLN-74809 is being developed for the treatment of primary sclerosing cholangitis (PSC). In July, the company received Fast Track status from the FDA for PLN-74809, for the potential treatment of PSC.
PLN-74809 is currently being evaluated for PSC as a part of the INTEGRIS-PSC phase II study. Pliant expects top-line results from the aforementioned study in the first half of 2023.
Pliant Therapeutics, Inc. Price
Pliant Therapeutics, Inc. price | Pliant Therapeutics, Inc. Quote
Zacks Rank and Stocks to Consider
Pliant Therapeutics currently has a Zacks Rank #3 (Hold).
Some better stocks in the same sector are Immunocore (IMCR - Free Report) , Sutro Biopharma (STRO - Free Report) and Vascular Biogenics , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Immuncore’s loss per share estimates for 2022 have narrowed from $2.62 to $1.34 in the past 30 days. The same for 2023 has narrowed from $2.90 to $1.78 in the same time frame.
Earnings of Immunocore missed estimates in two of the trailing four quarters and beat the same on the remaining two occasions. The average earnings surprise for IMCR is 33.28%.
Sutro’s loss per share estimates for 2022 have improved from $3.33 to $2.23 in the past 30 days. The same for 2023 has narrowed from $3.43 to $2.81 in the same time frame.
Earnings of Sutro beat estimates in two of the trailing four quarters, were in line in one and missed the same on the remaining occasion. The average negative earnings surprise for STRO is 1.13%.
Vascular Biogenics’ loss per share estimates for 2022 improved from 51 cents to 49 cents in the past 30 days. The same for 2023 has widened from 46 cents to 47 cents in the same time frame.
Earnings of VBLT beat estimates in two of the trailing four quarters and missed the same on the remaining two occasions. The average negative earnings surprise for VBLT is 10.16%.