SAN FRANCISCO, Jan. 30, 2026 (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 Shane Kovacs, Chief Operating and Financial Officer, is departing the Company effective January 30, 2026 to pursue new opportunities. Mr. Kovacs will continue in a consulting capacity with Olema through August 1, ...

​Olema Pharmaceuticals, Inc. (NASDAQ:OLMA) is one of the Best Small Cap Stocks Ready to Explode in 2026. On January 26, Sam Slutsky from LifeSci Capital reiterated a Buy rating on the stock and raised the price target from $39 to $45. Earlier, on January 14, Kelsey Goodwin from Piper Sandler reiterated a Buy rating on Olema Pharmaceuticals, Inc. (NASDAQ:OLMA) with a price target of $40. ​Analysts at Piper Sandler noted that the bullish rating is based on the company’s Palazestrant. Palazestrant is a pote ...

Company Overview - Olema aims to improve treatments for patients with ER-positive HER2-negative breast cancer, addressing significant unmet needs in this common cancer indication [1] Clinical Programs - Olema has two programs in the clinic: one in Phase III trials and one in Phase I/Phase Ib [2] - The lead asset, palazestrant, is a complete estrogen receptor antagonist, which is believed to be the best endocrine therapy for ER-positive HER2-negative breast cancer [2] Treatment Approach - Endocrine therapy is the backbone of treatment for ER-positive HER2-negative breast cancer, as the estrogen receptor is a primary driver of tumor growth and proliferation [3] - Palazestrant is currently in a first-line trial in combination with ribociclib, marking it as the only first-line trial of a CERAN/SERD in the endocrine-sensitive wild-type ESR1 setting [3] - Additionally, palazestrant is involved in a second third-line trial, OPERA-01, as a monotherapy [3]

Group 1 - U.S. stock futures are lower, with Dow futures down approximately 100 points [1] - Glaukos Corp reported preliminary FY25 sales of $507 million, leading to a 12.1% drop in shares to $96.97 in pre-market trading [1] Group 2 - Briacell Therapeutics Corp experienced a significant decline of 53.1% to $5.12 after announcing a $30 million public offering [2] - Trip.com Group Ltd shares fell 9.3% to $68.55 amid an investigation by China's SAMR for potential anti-monopoly violations [2] - Pearson PLC shares decreased by 7.2% to $13.36 following a trading update for 2025 [2] - Olema Pharmaceuticals Inc shares declined 5.5% to $26.37 after a previous drop of 3% [2] - Fresenius Medical Care AG shares fell 4.8% to $21.79 [2] - Ambitions Enterprise Management Co LLC shares dropped 4.3% to $11.81 after a significant increase of 134% the previous day [2] - NovaBay Pharmaceuticals Inc shares decreased by 3.8% to $12.55 following a 3% drop on Tuesday [2] - SmartRent Inc shares fell 2.3% to $1.74 in pre-market trading [2]

Olema Pharmaceuticals FY Conference Summary Company Overview - **Company**: Olema Pharmaceuticals (NasdaqGS:OLMA) - **Focus**: Improving treatments for patients with ER-positive, HER2-negative breast cancer, addressing significant unmet needs in this common cancer indication [1][2] Key Programs and Trials - **Lead Asset**: Palazestrant, a complete estrogen receptor antagonist, currently in two phase III trials and one phase I trial [1][2] - **Trial Details**: - **OPERA-02**: First-line trial in combination with ribociclib, targeting a market opportunity of over $10 billion [3] - **OPERA-01**: Second/third-line trial as a monotherapy, with a potential market opportunity of $5 billion [3][9] - **OP3136**: KAT6 inhibitor in phase I, exploring combination studies with endocrine agents [2][14] Market Opportunity - **Adjuvant Setting**: Potential market opportunity approaching $20 billion globally [3] - **First-Line Treatment**: OPERA-02 targeting a $10 billion market opportunity [3] - **Later Lines of Treatment**: OPERA-01 targeting a $5 billion market opportunity [3] - **Overall Market Potential for Palazestrant**: Estimated at $3 billion to $5 billion, depending on patient population [10][13] Clinical Data and Efficacy - **Palazestrant's Mechanism**: Complete estrogen receptor antagonism with a long half-life of eight days, allowing continuous receptor occupation [4][5] - **Progression-Free Survival (PFS)**: - OPERA-01 aims for a two-month additional PFS benefit over current standards [23] - Data suggests a median PFS of 5.5 months in the ESR1 wild-type setting, which has not been achieved by other agents [11][24] - **Combination with Ribociclib**: Demonstrated a year of median PFS in patients previously treated with CDK4/6 inhibitors [7][10] Competitive Landscape - **Differentiation Strategy**: Emphasis on the properties of palazestrant and its potential to provide better outcomes than existing therapies [36][37] - **Regulatory Strategy**: Separate analyses for ESR1 mutant and wild-type populations in trials to meet regulatory requirements [22][23] Future Plans - **NDA Filing**: Anticipated filing for palazestrant in 2027 following positive trial results [10][12] - **Commercialization Strategy**: Plans to market palazestrant in the U.S. and seek a collaborator for international markets [12][30] - **KAT6 Inhibitor Development**: OP3136 is expected to enter phase III trials in breast cancer by 2028, with potential applications in other cancers [15][16][41] Additional Insights - **KAT6 Inhibitor Profile**: OP3136 aims for better tolerability compared to existing KAT6 inhibitors, with a focus on minimizing cytopenias [39][41] - **Collaboration with Pfizer**: Exploring combination therapies with Pfizer's atirmociclib, targeting improved outcomes in breast cancer treatment [33][34] Conclusion Olema Pharmaceuticals is positioned to address significant unmet needs in the treatment of ER-positive, HER2-negative breast cancer through innovative therapies like palazestrant and OP3136, with substantial market opportunities and a clear strategy for clinical development and commercialization.

Market Opportunity - The global metastatic breast cancer market presents a $20B+ opportunity, with $10B+ potential for 1L ER+/HER2- MBC and $5B+ for 2/3L ER+/HER2- MBC[4]. - The majority of breast cancers are ER+/HER2-, with approximately 150K+ patients in the 2/3L category and 100K+ in the 1L category[4]. - Planning for the commercial launch of palazestrant as a monotherapy in late 2027, targeting a U.S. market potential of approximately $3-5 billion in the 2/3L ER+/HER2- metastatic breast cancer setting[30]. Product Development and Trials - Palazestrant is currently in Phase 3 trials for both monotherapy and in combination with ribociclib for ER+/HER2- metastatic breast cancer (MBC) with pivotal trials OPERA-01 and OPERA-02 ongoing[11][14]. - The OPERA-02 Phase 3 trial is ongoing with approximately 1,000 patients, comparing palazestrant plus ribociclib against standard care, focusing on progression-free survival (PFS) as the primary endpoint[21]. - The anticipated top-line data for OP-3136 is expected in mid-2026, with a pivotal readout for palazestrant in 2/3L MBC scheduled for fall 2026[10]. - The OPERA-01 trial is set to announce top-line results in Fall 2026, with a potential New Drug Application submission anticipated in 2027 for palazestrant as a monotherapy in 2/3L ER+/HER2- metastatic breast cancer[24]. - The ongoing pivotal Phase 3 trial OPERA-02 is evaluating palazestrant in combination with ribociclib in 1L MBC, with anticipated results in 2028[9]. Efficacy and Safety - Palazestrant has shown a median progression-free survival (PFS) of 13.8 months in 2L+ ESR1 mutant patients and 9.2 months in 2L+ ESR1 wild-type patients[6]. - The Phase 1b/2 study of palazestrant in combination with ribociclib has a median progression-free survival (mPFS) of 15.5 months for patients with prior CDK4/6 inhibitors[18]. - In the same study, mPFS for ESR1 mutant patients was 9.2 months, while for ESR1 wild-type patients it was 13.8 months[19]. - The safety profile of palazestrant shows that 65% of patients experienced Grade 1/2 treatment-emergent adverse events, with nausea being the most common[26]. - Neutropenia occurred in 84% of patients receiving palazestrant 120 mg plus ribociclib, with 50% experiencing Grade 3[17]. - Safety profile of palazestrant in combination with ribociclib showed no dose-limiting toxicities (DLTs) and was well tolerated[17]. Strategic Goals - The company aims for a product approval and launch for palazestrant in 2/3L MBC in 2027, subject to FDA approval[10]. - The company aims to advance patient enrollment in pivotal trials to support the development of palazestrant as a leading treatment option for MBC[11]. - Olema aims to transform the metastatic breast cancer treatment paradigm, with significant shareholder value generation projected by 2030[38]. - The company is focused on advancing innovative treatments for breast cancer, with a strong pipeline and strategic milestones ahead[39]. Financial Position - The company is well-capitalized with over $500M in cash, cash equivalents, and marketable securities expected as of December 31, 2025[10]. - Olema is well-capitalized with over $500 million in cash as of December 31, 2025, supporting its late-stage development efforts[38]. Combination Therapies - The combination of palazestrant with ribociclib is expected to set a new standard of care in 1L ER+/HER2- MBC, with a potential market opportunity of $10B+[6]. - The combination therapy demonstrated activity in both ESR1 mutant and wild-type tumors, indicating its potential as a backbone ER therapy[19]. - Palazestrant is being evaluated in combination with Pfizer's atirmociclib, with a dose escalation study initiated in H2 2025[23]. - OP-3136 has shown synergistic activity in combination with palazestrant in preclinical models, enhancing anti-tumor efficacy compared to other combinations[36]. Drug Development of OP-3136 - OP-3136, a KAT6 inhibitor, is currently in Phase 1 studies and has a potential global market opportunity of $5B+[8]. - OP-3136, a KAT6A/B inhibitor, is currently in Phase 1 development, with initial monotherapy and combination data anticipated in 2026[31]. - The Phase 1 study for OP-3136 is ongoing, focusing on safety, tolerability, and pharmacokinetics, with enrollment in both monotherapy and combination arms[37]. - OP-3136 demonstrated over 500-fold selectivity against other essential KAT family members, indicating a potential safety advantage[35].

Company Overview - Olema Pharmaceuticals is a biotechnology company focused on therapies for women's cancers, particularly breast cancer, with a strategy centered on advancing its proprietary drug candidate, OP-1250, through clinical development to meet significant unmet medical needs [1] Stock Performance and Transactions - The weighted average sale price of Olema Pharmaceuticals' stock was approximately $29.73 per share, which is 7.5% higher than the market close of $27.93 on December 19, reflecting a one-year total return of 326.50% as of the transaction date [2] - Ian T. Clark, a board member, executed a disposition of 264,800 shares through an option exercise and immediate sale, resulting in a complete exit from direct equity holdings, with 100% of his pre-trade shares disposed of [4][5] - The transaction was driven by option-related mechanics rather than a long-held equity sale, indicating a strategic move to capitalize on the stock's significant appreciation [3][8] Financial Performance - Olema's research and development spending increased to $40.0 million in Q3, reflecting the expansion of Phase 3 programs, while the net loss widened to $42.2 million from $34.6 million a year earlier, consistent with increased clinical activity [7] - The company ended the quarter with $329 million in cash, cash equivalents, and marketable securities, providing a financial runway into 2028 as it advances multiple late-stage trials [7] - A significant equity raise of $218.5 million was completed in late November, strengthening the company's balance sheet [7] Market Sentiment - Sentiment for Olema Pharmaceuticals has shifted rapidly, with most of the stock's explosive growth occurring since late November, driven by analyst upgrades and positive clinical updates for palazestrant [6]

Core Viewpoint - The U.S. Attorney's Office for the District of New Jersey has filed criminal charges against six individuals for securities fraud, insider trading, and conspiracy, with allegations stemming from insider information related to merger and acquisition deals [1] Group 1: Allegations and Charges - The SEC alleges that between June 2020 and February 2024, an investment banker named Kim provided insider information to Saad Shoukat regarding nine potential merger and acquisition deals [1] - Saad Shoukat allegedly shared this insider information with his brothers, Khan and Okonkwo, leading to illicit trading profits of approximately US$41 million [2] Group 2: Manipulation of Securities - The Shoukat brothers are accused of manipulating the securities of Olema Pharmaceuticals Inc. and Opiant Pharmaceuticals Inc. [2] - In the Olema case, Saad and Arham Shoukat allegedly impersonated doctors to obtain confidential information about clinical trials and published false positive results to inflate the stock price [3] - They profited from trading Olema's stock before the misinformation was corrected, benefiting from the temporarily inflated stock price [4] Group 3: False Press Releases - In a separate scheme, the Shoukat brothers purchased Opiant stock based on insider information from Kim, which indicated that Opiant was a takeover target [5] - When the anticipated deal did not occur, the brothers allegedly issued a false press release about a fictitious partnership to artificially boost Opiant's stock price, allowing them to sell at a higher price [5] Group 4: Regulatory Actions - The SEC is seeking permanent injunctive relief, disgorgement of ill-gotten gains with interest, and civil penalties against the six individuals involved, along with a permanent prohibition against Kim [6]

Core Viewpoint - Olema Pharmaceuticals, Inc. is set to present at the 44th Annual J.P. Morgan Healthcare Conference, highlighting its focus on targeted therapies for breast cancer and its ongoing clinical trials [1] Company Overview - Olema Oncology is a clinical-stage biopharmaceutical company dedicated to improving outcomes for breast cancer patients through innovative therapies [3] - The company is advancing a pipeline that includes palazestrant (OP-1250), an orally available complete estrogen receptor antagonist and selective estrogen receptor degrader, currently in two Phase 3 clinical trials [3] - Olema is also developing OP-3136, a potent lysine acetyltransferase 6 inhibitor, which is in a Phase 1 clinical study [3] - The company is headquartered in San Francisco with operations in Cambridge, Massachusetts [3]

Core Viewpoint - The article highlights the offerings of the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and investment opportunities in the biotech sector [1][2]. Group 1: Service Offerings - Biotech Analysis Central provides a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and live chat features for investors [2]. - The service is available for $49 per month, with a discounted annual plan at $399, representing a 33.50% savings for subscribers [1]. Group 2: Analyst Background - The author, Terry Chrisomalis, is a private investor with a background in Applied Science, focusing on generating long-term value in the healthcare sector [2]. - The analysis provided aims to assist healthcare investors in making informed decisions based on comprehensive research and insights [2].