Olema Pharmaceuticals announces FDA clearance for Phase 1 trial of OP-3136, targeting breast cancer treatment.
Quiver AI Summary
Olema Pharmaceuticals announced that the U.S. FDA has approved its Investigational New Drug application for OP-3136, a novel small molecule targeting KAT6, which is implicated in breast cancer and other malignancies. The company plans to initiate a Phase 1 clinical trial for OP-3136 in early 2025, having observed promising preclinical results both as a standalone treatment and in combination with palazestrant. David C. Myles, Olema's Chief Discovery and Non-Clinical Development Officer, expressed enthusiasm for the drug's potential to improve outcomes for breast cancer patients. Olema, headquartered in San Francisco, is focused on developing innovative therapies to transform breast cancer treatment.
Potential Positives
- FDA clearance of IND application for OP-3136 allows Olema to initiate Phase 1 clinical trials, marking a significant step in drug development.
- OP-3136 demonstrated compelling activity in preclinical models, generating strong investigator interest, which may enhance Olema's reputation in cancer research.
- Olema's commitment to transforming care for breast cancer and beyond is reinforced by the advancement of OP-3136, indicating a focus on innovative therapies.
Potential Negatives
- Initiating a Phase 1 clinical trial for OP-3136 suggests the drug is still in very early development stages, which may imply a long timeline before potential commercialization or revenue generation.
- The significant emphasis on forward-looking statements indicates a high level of uncertainty regarding the clinical development and potential market success of OP-3136, which may concern investors.
- The mention of various risks and uncertainties associated with the forward-looking statements highlights potential volatility and challenges that could affect the company's future performance.
FAQ
What is OP-3136 and its significance?
OP-3136 is a novel small molecule developed by Olema Pharmaceuticals that selectively inhibits KAT6, a target relevant to breast cancer treatments.
When will the Phase 1 clinical trial for OP-3136 begin?
The Phase 1 clinical trial for OP-3136 is expected to initiate in early 2025.
What FDA action was taken regarding OP-3136?
The FDA has cleared Olema's Investigational New Drug (IND) application for OP-3136, allowing it to proceed into clinical trials.
What prior results supported the development of OP-3136?
OP-3136 demonstrated compelling preclinical activity as a single agent and in combination with palazestrant, generating significant investigator interest.
What is Olema Pharmaceuticals' focus?
Olema Pharmaceuticals is focused on developing targeted therapies for breast cancer and other related conditions, aiming to improve patient outcomes.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$OLMA Insider Trading Activity
$OLMA insiders have traded $OLMA stock on the open market 6 times in the past 6 months. Of those trades, 0 have been purchases and 6 have been sales.
Here's a breakdown of recent trading of $OLMA stock by insiders over the last 6 months:
- BIOCAPITAL ADVISORS LP PARADIGM has traded it 2 times. They made 0 purchases and 2 sales, selling 2,400,000 shares.
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$OLMA Hedge Fund Activity
We have seen 66 institutional investors add shares of $OLMA stock to their portfolio, and 80 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- PARADIGM BIOCAPITAL ADVISORS LP removed 2,400,000 shares (-30.4%) from their portfolio in Q3 2024
- PICTET ASSET MANAGEMENT HOLDING SA added 1,667,459 shares (+inf%) to their portfolio in Q3 2024
- CITADEL ADVISORS LLC added 1,120,492 shares (+847.2%) to their portfolio in Q3 2024
- POLAR CAPITAL HOLDINGS PLC removed 1,000,000 shares (-100.0%) from their portfolio in Q3 2024
- BALYASNY ASSET MANAGEMENT L.P. added 709,097 shares (+inf%) to their portfolio in Q3 2024
- BRAIDWELL LP removed 704,344 shares (-100.0%) from their portfolio in Q2 2024
- ALTIUM CAPITAL MANAGEMENT LP removed 605,000 shares (-100.0%) from their portfolio in Q2 2024
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Full Release
Phase 1 clinical trial for OP-3136 to initiate in early 2025
SAN FRANCISCO, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for OP-3136, a novel small molecule that potently and selectively inhibits KAT6, a validated epigenetic target that is dysregulated in breast and other cancers.
"We are very pleased to have received notification from the FDA that OP-3136 may proceed into the clinic," said David C. Myles, Ph.D., Chief Discovery and Non-Clinical Development Officer of Olema Oncology. "The compelling activity demonstrated by OP-3136 in preclinical models both as a single agent and in combination with palazestrant has generated strong investigator interest in OP-3136. We expect to initiate the Phase 1 clinical trial early next year and are excited by OP-3136's potential in breast cancer and beyond."
About Olema Oncology
Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Our lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD), currently in a Phase 3 clinical trial called OPERA-01. In addition, Olema is developing a potent KAT6 inhibitor (OP-3136). Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at
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Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as "anticipate," "believe," "could," "expect," "goal," "may," "potential," "upcoming," "will" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the advancement of OP-3136 into clinical development, including timelines for initiation and enrollment, the combinability of OP-3136 with other drugs and potential beneficial characteristics of OP-3136 as a monotherapy and in combination with other drugs. Because such statements deal with future events and are based on Olema's current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled "Risk Factors" in Olema's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, and other filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements.
Media and Investor Relations Contact
Courtney O'Konek
Vice President, Corporate Communications
Olema Oncology
media@olema.com
