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Oncolytics (ONCY) Up on Lead Drug Securing 2nd FDA Fast Track Tag

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Shares of Oncolytics Biotech (ONCY - Free Report) surged 20.5% on Dec 1 after management announced that the FDA granted a second fast-track designation to its lead pipeline drug, pelareorep, in pancreatic cancer indication.

The FDA granted the designation to pelareorep combined with Roche’s (RHHBY - Free Report) PD-L1 inhibitor Tecentriq (atezolizumab) and chemotherapeutic agents gemcitabine and nab-paclitaxel to treat advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). The drug has already been granted a fast track designation by the FDA for treatment of metastatic breast cancer in 2017. 

Fast Track is designed to facilitate the development and acceleration of the review of drugs to treat serious conditions and fill an unmet medical need or offer a potential advantage over the existing treatments. A candidate granted Fast Track designation is also eligible for rolling review.

This year so far, shares of Oncolytics have surged 52.5% against the industry’s 18.3% fall.

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FDA granted the fast-track designation based on data from the phase I/II GOBLET study, which is evaluating pelareorep plus Roche’s Tecentriq in multiple gastro-intestinal cancer indications. Last month, Oncolytics announced interim clinical data from a cohort of the GOBLET study that evaluated the combination of pelareorep, Roche’s Tecentriq, gemcitabine and nab-paclitaxel in first-line advanced/metastatic PDAC patients. Data from this cohort showed that this combination achieved a 69% objective response rate (ORR), which is nearly thrice the average ORR of 25% reported in PDAC patients treated with the combination of gemcitabine and nab-paclitaxel.

The GOBLET study is part of a new master clinical supply agreement entered between Oncolytics Biotech and Roche in 2020. Per the agreement, Roche will supply Tecentriq for use in Oncolytics' clinical development plan. Both companies will have access to clinical data.

Apart from gastrointestinal cancers, pelareorep is also being evaluated in clinical studies for breast cancer and multiple myeloma indications. The drug is being studied in combination studies with popular drugs like Amgen’s Kyprolis, Bristol Myers’ Opdivo and Pfizer/Merck’s Bavencio.


Zacks Rank & Stocks to Consider

Oncolytics Biotech currently carries a Zacks Rank #2 (Buy). A couple of better-ranked stocks in the overall healthcare sector include Kamada and Repare Therapeutics (RPTX - Free Report) , 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 30 days, estimates for Kamada’s 2022 loss per share have narrowed from 14 cents to 7 cents. During the same period, the earnings estimates per share for 2023 have risen from 26 cents to 42 cents. Shares of Kamada have declined 28.6% in the year-to-date period.

Earnings of Kamada beat estimates in two of the last four quarters and missed the mark twice, witnessing a negative earnings surprise of 62.50%, on average. In the last reported quarter, Kamada’s earnings beat estimates by 433.33%.

Repare Therapeutics’ stock has declined 23.1% this year so far. While Repare Therapeutics’ loss estimates for 2022 have narrowed from $2.89 to $0.69 per share in the past 30 days, estimates for 2023 have narrowed from $3.22 to $3.21 per share during the same period.

Repare Therapeutics beat earnings estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 240.65%. In the last reported quarter, RPTX reported an earnings surprise of 955.00%.

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