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Olema (OLMA) Up on FDA Fast Track Tag for Breast Cancer Drug
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Olema Pharmaceuticals, Inc. (OLMA - Free Report) announced that the FDA has granted Fast Track designation to its lead product candidate, OP-1250, for the treatment of ER+/HER2- metastatic breast cancer where the disease has progressed after one or more lines of endocrine therapy with at least one line given in combination with a CDK 4/6 inhibitor.
The Fast Track designation from the regulatory body facilitates the development and expedites the review of new drugs and vaccines intended to treat or prevent serious conditions and address unmet medical need.
Shares of Olema were up 20.6% following the announcement of the news on Thursday. The stock has plunged 39.3% so far this year compared with the industry’s decline 20.4%.
Image Source: Zacks Investment Research
OP-1250 is being developed as a novel oral small molecule with combined activity as both a complete ER antagonist, CERAN, and a selective ER degrader, SERD.
A phase Ib study is evaluating OP-1250 in combination with Pfizer’s (PFE - Free Report) Ibrance (palbociclib) for the treatment of patients with recurrent, locally advanced, or metastatic ER+/HER2- breast cancer.
Breast cancer drug, Ibrance, has been a key revenue driver for PFE over the years. Pfizer is exploring the possibility of expanding Ibrance into recurrent and subsequent early breast cancer indications.
OP-1250 is also being evaluated in a phase I/II study as a monotherapy for the treatment of patients with recurrent, locally advanced or metastatic ER+/HER2- breast cancer.
In July 2020, the company entered into a collaboration and supply agreement with Novartis (NVS - Free Report) .
Under the collaboration, the companies are looking to evaluate OP-1250 in combination with Novartis’ proprietary CDK4/6 inhibitor, Kisqali (ribociclib), and/or proprietary phosphatidylinositol 3-kinase inhibitor, Piqray (alpelisib), as part of OLMA’s planned phase Ib study of OP-1250 in patients with metastatic ER+ breast cancer.
Olema plans to initiate a phase Ib study evaluating OP-1250 in patients with ER+/HER2+ breast cancer and central nervous system metastases in the second half of 2022.
OLMA has no approved product in its portfolio at the moment. Therefore, the successful development of its pipeline candidates remains a key focus for the company.
Beam Therapeutics’ loss per share estimates narrowed 0.7% for 2022 and 0.8% for 2023 in the past 60 days.
Earnings of Beam Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. BEAM delivered an earnings surprise of 1.80%, on average.
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Olema (OLMA) Up on FDA Fast Track Tag for Breast Cancer Drug
Olema Pharmaceuticals, Inc. (OLMA - Free Report) announced that the FDA has granted Fast Track designation to its lead product candidate, OP-1250, for the treatment of ER+/HER2- metastatic breast cancer where the disease has progressed after one or more lines of endocrine therapy with at least one line given in combination with a CDK 4/6 inhibitor.
The Fast Track designation from the regulatory body facilitates the development and expedites the review of new drugs and vaccines intended to treat or prevent serious conditions and address unmet medical need.
Shares of Olema were up 20.6% following the announcement of the news on Thursday. The stock has plunged 39.3% so far this year compared with the industry’s decline 20.4%.
Image Source: Zacks Investment Research
OP-1250 is being developed as a novel oral small molecule with combined activity as both a complete ER antagonist, CERAN, and a selective ER degrader, SERD.
A phase Ib study is evaluating OP-1250 in combination with Pfizer’s (PFE - Free Report) Ibrance (palbociclib) for the treatment of patients with recurrent, locally advanced, or metastatic ER+/HER2- breast cancer.
Breast cancer drug, Ibrance, has been a key revenue driver for PFE over the years. Pfizer is exploring the possibility of expanding Ibrance into recurrent and subsequent early breast cancer indications.
OP-1250 is also being evaluated in a phase I/II study as a monotherapy for the treatment of patients with recurrent, locally advanced or metastatic ER+/HER2- breast cancer.
In July 2020, the company entered into a collaboration and supply agreement with Novartis (NVS - Free Report) .
Under the collaboration, the companies are looking to evaluate OP-1250 in combination with Novartis’ proprietary CDK4/6 inhibitor, Kisqali (ribociclib), and/or proprietary phosphatidylinositol 3-kinase inhibitor, Piqray (alpelisib), as part of OLMA’s planned phase Ib study of OP-1250 in patients with metastatic ER+ breast cancer.
Olema plans to initiate a phase Ib study evaluating OP-1250 in patients with ER+/HER2+ breast cancer and central nervous system metastases in the second half of 2022.
OLMA has no approved product in its portfolio at the moment. Therefore, the successful development of its pipeline candidates remains a key focus for the company.
Zacks Rank & Stock to Consider
Olema currently carries a Zacks Rank #4 (Sell).
A better-ranked stock in the biotech sector is Beam Therapeutics Inc. (BEAM - Free Report) , which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Beam Therapeutics’ loss per share estimates narrowed 0.7% for 2022 and 0.8% for 2023 in the past 60 days.
Earnings of Beam Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. BEAM delivered an earnings surprise of 1.80%, on average.