Olema Pharmaceuticals OLMA is a clinical-stage biopharmaceutical company focusing on crafting game-changing therapies for women’s cancers.
The star product of the company is palazestrant (OP-1250), an exclusive, orally accessible small molecule boasting double-barreled potential as a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD).
Presently, palazestrant is undergoing multiple studies, both as a standalone option and in conjunction with other remedies, for treating certain patients with metastatic breast cancer.
In the current year, Olema has witnessed a staggering 471.4% rise in its shares, whereas the industry has seen a significant drop of 22.7%.
Image Source: Zacks Investment Research
The surge came after the management unveiled encouraging data from a phase Ib/II study in May that assessed palazestrant in conjunction with Pfizer’s PFE CDK4/6 inhibitor Ibrance (palbociclib) in patients with ER+/HER2- metastatic breast cancer.
These results lured the attention of Wall Street, which lauded the news. Several analysts highlighted that the palazestrant-Ibrance combination exhibited superior efficacy compared to standalone CDK4/6 inhibitors designed to halt the growth of cancer cells.
Data from the phase Ib/II study indicated that the palazestrant-Ibrance combo was safe and well tolerated, with no dose-limiting toxicities or observed drug-drug interactions. In fact, the treatment exhibited anti-tumor activity and prolonged disease stabilization, even in patients previously administered CDK4/6 inhibitors (including Pfizer’s Ibrance).
Olema plans to disclose updated data from the phase Ib/II study on palazestrant-Ibrance combination at the 2023 San Antonio Breast Cancer Symposium (SABCS) next month. The updated results are likely to determine whether the combination could be advanced to late-stage development.
In addition to Pfizer’s Ibrance, Olema is scrutinizing palazestrant in conjunction with Kisqali (ribociclib), another CDK4/6 inhibitor marketed by Novartis NVS, in a phase Ib/II study. The management also intends to reveal data from the phase Ib portion of the study at the SABCS.
In 2020, the company entered into separate clinical collaboration and supply pacts with Pfizer and Novartis for their respective CDK4/6 inhibitors. Recently, Olema broadened its partnership with Novartis, nearly doubling the size of the phase Ib/II study evaluating the palazestrant-Kisqali combination to around 60 patients.
Besides the combination studies, palazestrant exhibited potential as a standalone agent in treating metastatic ER+/HER2- breast cancer. Last month, Olema reported data from a phase II study demonstrating that the drug accomplished a median progression-free survival (PFS) of 4.6 months with a confirmed benefit rate of 40% across all 86 heavily pre-treated patients, with 42% of patients being fourth-line or later at study entry.
Based on these results, the management recently launched a pivotal phase III study (OPERA-01) to assess palazestrant as a monotherapy in second- and third-line metastatic breast cancer. The enrollment of the first patient is anticipated before the year’s end.
Currently, palazestrant is the only pipeline candidate of Olema undergoing clinical development. Apart from palazestrant, the company is planning to push a new pipeline candidate, a novel KAT6 inhibitor, into clinical development. This new candidate, developed in collaboration with Aurigene Oncology, has shown promising anti-tumor activity in preclinical ER+ breast cancer studies. Management aims to submit an investigational new drug (IND) application to the FDA next year to begin clinical studies on the KAT6 inhibitor.
Olema Pharmaceuticals, Inc. Price
Olema Pharmaceuticals, Inc. price | Olema Pharmaceuticals, Inc. Quote
Zacks Rank & A Key Pick
Olema currently holds a Zacks Rank #3 (Hold). A better-placed stock in the broader healthcare sector is Acadia Pharmaceuticals ACAD, which has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The loss estimates for Acadia Pharmaceuticals in 2023 have been revised from 41 cents to 33 cents per share in the past 60 days. During the same period, the estimates for 2024 earnings per share have increased from 52 cents to 94 cents. Year to date, Acadia Pharmaceuticals’ shares have advanced by 40.0%.
Acadia Pharmaceuticals surpassed earnings estimates in two of the last four quarters while falling short on the other two occasions, resulting in an average earnings surprise of 20.69%. In the last reported quarter, ACAD reported an earnings surprise of 6.98%.
Zacks Names #1 Semiconductor Stock
It’s only 1/9,000th the size of NVIDIA which surged more than +800% since being recommended. NVIDIA is still formidable, but our new top chip stock has much more potential to soar.
With robust earnings growth and an expanding customer base, it’s positioned to cater to the skyrocketing demand for Artificial Intelligence, Machine Learning, and Internet of Things. The global semiconductor manufacturing industry is anticipated to swell from $452 billion in 2021 to $803 billion by 2028.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.