最新ニュース Omeros (NASDAQ:OMER) 株価情報

Omeros

Omeros Corp is a United States-based clinical-stage biopharmaceutical company engaged in discovering, developing, and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders. The drug candidate in the pipeline of complement-targeted therapeutics is narsoplimab (OMS721), a proprietary, patented human monoclonal antibody targeting mannan-binding lectin-associated serine protease 2, the key activator of the lectin pathway of complement. Clinical development of narsoplimab is currently focused on hematopoietic stem cell transplant-associated thrombotic microangiopathy and immunoglobulin nephropathy.

Omeros Corp

Omeros Corporation&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMER#NASDAQ">OMER</a>) on Thursday established the Omeros Oncology Clinical Steering Committee to advance Omeros&#8217; OncotoX biologics program focused on <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">acute myeloid leukemia (AML)</a>.
AML is the most fatal form of leukemia. It accounts for approximately 80% of acute leukemias in adults and one-third of all cancers <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/b44733942/omeros-announces-the-omeros-oncology-clinical-steering-committee-for-aml-to-help-guide-omeros-prop" rel="noreferrer noopener">affecting the blood/bone marrow</a>.
Omeros&#8217; OncotoX program for AML consists of proprietary targeted, engineered molecules (about half the size of an antibody) that deliver a toxic payload within the cancer cells, thereby killing them.
Also Read: <a target="_blank" href="https://www.benzinga.com/24/12/42598739/omeros-antibody-improves-overall-survival-in-rare-complication-after-stem-cell-transplant-stock-surges" rel="noreferrer noopener">Omeros Antibody Improves Overall Survival In Rare Complication After Stem Cell Transplant, Stock Surges</a>
The steering committee will assist Omeros with developing the OncotoX-AML program, designing clinical trials, and interacting with institutional review boards, and it will also participate in OncotoX-AML clinical trials.
In vivo&nbsp;and&nbsp;ex vivo&nbsp;studies have shown that the OncotoX-AML therapeutic is highly effective even at very low doses, providing a significant survival benefit over currently approved combination therapy, like AbbVie Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Genentech&#8217;s Venclexta (venetoclax) and Bristol Myers Squibb &amp; Co&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) Vidaza azacitidine).
In studies using primary AML derived from patients, the OncotoX molecule preferentially and efficiently kills AML blasts (abnormal myeloid cells).
OncotoX-AML also targets leukemia stem cells (LSC), often refractory to chemotherapy.
The OncotoX-AML therapeutic is designed specifically to kill both AML blasts and LSCs that can lead to relapse.
Preliminary&nbsp;in vivo&nbsp;tolerability studies demonstrate that the OncotoX therapeutic is well tolerated at doses substantially greater than one order of magnitude above efficacious doses without causing neutropenia or meaningful changes in blood chemistry values.
Omeros is initiating IND-enabling work for its OncotoX-AML therapeutic.
D. Boral analyst Jason Kolbert writes, &#8220;This development is particularly important given the persistent challenges in AML treatment. Despite recent drug approvals, therapeutic options for AML remain limited, especially for patients who are elderly, relapse-prone, or harbor high-risk mutations.&#8221;
Kolbert adds that chemotherapy and existing antibody-drug conjugates often fail to provide durable responses due to narrow therapeutic indices and toxic side effects. By demonstrating high efficacy in preclinical models without significant toxicity, OncotoX-AML presents the potential to address long-standing gaps in AML care.
The analyst maintains a Buy rating on Omeros with <a target="_blank" href="https://www.benzinga.com/quote/OMER/analyst-ratings" rel="noreferrer noopener">a price target of $36</a> while modeling Omeros&#8217; lead therapy, narsoplimab.
In February, the company resubmitted biologics license application for narsoplimab for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). Omeros expects the target date for FDA action under the Prescription Drug User Fee Act to be six months following the date of resubmission to the FDA, meaning, in this case, the PDUFA date would be<a href="https://www.benzinga.com/pressreleases/25/03/b44570592/omeros-corporation-reports-fourth-quarter-and-year-end-2024-financial-results" target="_blank" rel="noreferrer noopener"> September 2025</a>.
The company expects to submit our European marketing authorization application for narsoplimab in TA-TMA in the first half of 2025.&nbsp;
Price Action: OMER stock is up 13.2% at $6.64 at last check Friday.
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Omeros' New Leukemia Drug Team Ignites Hope For Cancer Fight

D. Boral Capital analyst Jason Kolbert maintains Omeros (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMER#NASDAQ">OMER</a>) with a Buy and maintains $36 price target.

Price Target

D. Boral Capital Maintains Buy on Omeros, Maintains $36 Price Target

– The Steering Committee brings together distinguished clinical experts in AML from leading National Comprehensive Cancer Network Centers –
Omeros Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMER#NASDAQ">OMER</a>) today announced the establishment of the Omeros Oncology Clinical Steering Committee to advance Omeros' OncotoX biologics program focused on acute myeloid leukemia (AML). AML is the most fatal form of leukemia and accounts for approximately 80 percent of acute leukemias in adults and one-third of all cancers affecting the blood/bone marrow, representing a high unmet need. Omeros' OncotoX program for AML consists of proprietary targeted, engineered molecules (about half the size of an antibody) that deliver a toxic payload within the cancer cells, thereby killing them.

Omeros Establishes Oncology Clinical Steering Committee Of Leading AML Experts From Top Cancer Centers To Advance Its OncotoX Biologics Program Targeting High-Unmet-Need Acute Myeloid Leukemia With Proprietary Engineered Molecules Designed To Deliver Cancer-Killing Payloads

Needham analyst Serge Belanger reiterates Omeros (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMER#NASDAQ">OMER</a>) from Hold to Hold.

Reiteration

Needham Reiterates Hold on Omerosto Hold

Omeros (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMER#NASDAQ">OMER</a>) reported quarterly losses of $(0.63) per share which beat the analyst consensus estimate of $(0.82) by 23.17 percent. This is unchanged from the same period last year.

Earnings

Earnings Beats

Omeros Q4 2024 GAAP EPS $(0.63) Beats $(0.82) Estimate

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This article was generated by Benzinga's automated content engine and reviewed by an editor.

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Earnings Scheduled For March 31, 2025

Omeros (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMER#NASDAQ">OMER</a>) is set to give its latest quarterly earnings report on Monday, 2025-03-31. Here's what investors need to know before the announcement.
Analysts estimate that Omeros will report an earnings per share (EPS) of $-0.71. 
Anticipation surrounds Omeros's announcement, with investors hoping to hear about both surpassing estimates and receiving positive guidance for the next quarter.
New investors should understand that while earnings performance is important, market reactions are often driven by guidance.
<h3>Earnings Track Record</h3>
In the previous earnings release, the company beat EPS by $0.06, leading to a 65.87% increase in the share price the following trading session.
Here's a look at Omeros's past performance and the resulting price change:

<table>
<thead>
<tr>
<th>Quarter</th>
<th>Q3 2024</th>
<th>Q2 2024</th>
<th>Q1 2024</th>
<th>Q4 2023</th>
</tr>
</thead>
<tbody>
<tr>
<td>EPS Estimate</td>
<td>-0.70</td>
<td>-0.69</td>
<td>-0.58</td>
<td>-0.55</td>
</tr>
<tr>
<td>EPS Actual</td>
<td>-0.64</td>
<td>-0.97</td>
<td>-0.63</td>
<td>-0.63</td>
</tr>
<tr>
<td>Price Change %</td>
<td>66.0%</td>
<td>-6.0%</td>
<td>-21.0%</td>
<td>-4.0%</td>
</tr>
</tbody>
</table>

<img src="https://www.benzinga.com/files/images/story/2025/1743174069_0.png" alt="eps graph" />
<h3>Omeros Share Price Analysis</h3>
Shares of Omeros were trading at $8.92 as of March 27. Over the last 52-week period, shares are up 173.04%. Given that these returns are generally positive, long-term shareholders should be satisfied going into this earnings release. 
<a href="https://www.benzinga.com/quote/OMER/earnings">To track all earnings releases for Omeros visit their earnings calendar on our site.</a>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

What's Next: Omeros's Earnings Preview

Omeros Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMER#NASDAQ">OMER</a>) will release its fourth-quarter financial results after the <a href="https://www.benzinga.com/quote/OMER/earnings">closing bell on Monday, March 31.</a>
Analysts expect the Seattle, Washington-based company to report quarterly loss at 78 cents per share, versus a year-ago loss of 69 cents per share, according to data from <a href="https://pro.benzinga.com/dashboard">Benzinga Pro</a>.
On March 21, Omeros issued an update of ongoing Zaltenibart Phase 3 PNH clinical trial program.
Omeros shares gained 4.7% to close at $8.92 on Thursday.
Benzinga readers can access the latest analyst ratings on the <a href="https://www.benzinga.com/analyst-ratings/analyst-color/22/09/28888638/exclusive-study-finds-benzinga-analyst-ratings-data-yields-market-beating-strategie">Analyst Stock Ratings</a> page. Readers can sort by stock ticker, company name, analyst firm, rating change or other variables.
Let's have a look at how Benzinga's most-accurate <a href="https://www.benzinga.com/quote/OMER/analyst-ratings">analysts have rated the company</a> in the recent period.
<ul>
<li>Needham analyst Serge Belanger reiterated a Hold rating on Jan. 17, 2025. This analyst has an accuracy rate of 68%.</li>
<li>Cantor Fitzgerald analyst Olivia Brayer reiterated a Neutral rating on Nov. 14, 2024. This analyst has an accuracy rate of 62%.</li>
</ul>
Considering buying OMER stock? Here&#8217;s what analysts think: 
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Photo: Shutterstock

Markets

Top Wall Street Forecasters Revamp Omeros Price Expectations Ahead Of Q4 Earnings

-- Phase 3 Data Needed for BLA Submission Expected in the Fourth Quarter 2026 --
Omeros Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMER#NASDAQ">OMER</a>) today reported that clinical trial site activation for enrollment is underway for the company's Phase 3 program evaluating zaltenibart in paroxysmal nocturnal hemoglobinuria (PNH). Zaltenibart (OMS906) is Omeros' investigational inhibitor of MASP-3, the key and most proximal activator of the alternative pathway of complement. Zaltenibart inhibits the intravascular hemolysis treated by C5 inhibitors as well as the extravascular hemolysis caused by C5 inhibitors in patients suffering from PNH while leaving intact the infection-fighting lytic arm of the classical pathway of complement.
A total of 120 clinical investigative sites across 30 countries have been chosen for clinical trial participation in the zaltenibart Phase 3 program in PNH, a good number of which have already identified pools of PNH patients ready to participate in the zaltenibart trials, and Omeros continues collaborating with sites to identify additional eligible and already available PNH patients. Data needed for submission of the biologics licensing application (BLA) and global approval dossiers for zaltenibart in PNH remain on track for the fourth quarter of 2026.

Omeros Announces Phase 3 Trials For Zaltenibart In PNH With Data Expected In Q4 2026; 120 Sites In 30 Countries Activated; Focus On Intravascular And Extravascular Hemolysis With 8-Week Dosing

U.S. stock futures were lower this morning, with the Dow futures falling around 100 points on Monday.
Shares of Incyte Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/INCY#NASDAQ">INCY</a>) fell sharply in today's pre-market trading after reporting topline results from two Phase 3 clinical trials of Povorcitinib in patients with Hidradenitis Suppurativa.
Incyte shares dipped 15.3% to $57.50 in the pre-market trading session.
Here are some other stocks moving lower in pre-market trading.
<ul>
<li>USA Rare Earth, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/USAR#NASDAQ">USAR</a>) fell 13.8% to $16.00 in pre-market trading after jumping over 70% on Friday.</li>
<li>Affirm Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AFRM#NASDAQ">AFRM</a>) dipped 12.1% to $44.01 in pre-market trading after gaining around 7% on Friday.</li>
<li>Tyra Biosciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TYRA#NASDAQ">TYRA</a>) fell 8.7% to $10.50 in pre-market trading after gaining 7% on Friday.</li>
<li>Omeros Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMER#NASDAQ">OMER</a>) shares dipped 4.4% to $8.05 in pre-market trading after gaining 7% on Friday.</li>
<li>Neogen Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NEOG#NASDAQ">NEOG</a>) fell 3.8% to $8.71 in pre-market trading.</li>
<li>Innventure, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/INV#NASDAQ">INV</a>) slipped 3.3% to $7.62 in pre-market trading.</li>
<li>Kamada Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KMDA#NASDAQ">KMDA</a>) fell 3% to $6.77 in pre-market trading.</li>
<li>Tesla, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NASDAQ">TSLA</a>) slipped 1% to $ 247.77 in pre-market trading.</li>
</ul>
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Incyte, Tesla And Other Big Stocks Moving Lower In Monday's Pre-Market Session

Shares of Precision BioSciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DTIL#NASDAQ">DTIL</a>) rose sharply in today's <a href="https://www.benzinga.com/quote/DTIL">pre-market trading</a>.
Precision BioSciences reported clearance of investigational new drug application by the U.S. FDA for first-in-class PBGENE-HBV designed to eliminate root cause of chronic hepatitis B.
Precision BioSciences shares climbed 10.8% to $5.58 in the pre-market trading session.
Here are some other stocks moving in pre-market trading.
<h3 class="wp-block-heading">Gainers</h3>
<ul>
<li>NanoVibronix, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NAOV#NASDAQ">NAOV</a>) gained 42.3% to $3.11 in pre-market trading.</li>
<li>Lytus Technologies Holdings PTV. Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LYT#NASDAQ">LYT</a>) rose 36.7% to $0.1532 in pre-market trading after dipping 20% on Friday.</li>
<li>SES AI Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SES#NASDAQ">SES</a>) gained 29.1% to $0.5675 in pre-market trading after gaining 9% on Friday.</li>
<li>Aclarion, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACON#NASDAQ">ACON</a>) gained 27.4% to $0.9837 in pre-market after gaining 13% on Friday.</li>
<li>Quantum-Si incorporated (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QSI#NASDAQ">QSI</a>) gained 21.3% to $1.65 in pre-market trading after jumping 19% on Friday.</li>
<li>Inuvo, Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/INUV#NYSE">INUV</a>) gained 18.2% to $0.45 in pre-market trading.</li>
<li>Direct Digital Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DRCT#NASDAQ">DRCT</a>) gained 16.5% to $0.9076 in pre-market trading.</li>
<li>Quantum Computing Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QUBT#NASDAQ">QUBT</a>) rose 15% to $8.15 after jumping 29% on Friday.</li>
<li>KULR Technology Group, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/KULR#NYSE">KULR</a>) rose 11% to $1.61 in pre-market trading after jumping 14% on Friday.</li>
</ul>
<h3 class="wp-block-heading">Losers</h3>
<ul>
<li>Fold Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FLD#NASDAQ">FLD</a>) shares fell 18.8% to $6.00 in pre-market trading after gaining around 8% on Friday.</li>
<li>Incyte Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/INCY#NASDAQ">INCY</a>) fell 15.3% to $57.50 in pre-market trading after reporting topline results from two Phase 3 clinical trials of Povorcitinib in patients with Hidradenitis Suppurativa.</li>
<li>Planet Green Holdings Corp. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PLAG#NYSE">PLAG</a>) dipped 14.4% to $1.71 in pre-market trading.</li>
<li>Revelation Biosciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REVB#NASDAQ">REVB</a>) declined 14.1% to $2.92 in pre-market trading.</li>
<li>USA Rare Earth, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/USAR#NASDAQ">USAR</a>) fell 13.8% to $16.00 in pre-market trading after jumping over 70% on Friday.</li>
<li>Linkage Global Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LGCB#NASDAQ">LGCB</a>) shares tumbled 13.5% to $0.1537 in pre-market trading after dipping over 22% on Friday.</li>
<li>Polar Power, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/POLA#NASDAQ">POLA</a>) shares fell 12.3% to $2.36 in pre-market trading.</li>
<li>Aspira Women&#8217;s Health Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AWH#NASDAQ">AWH</a>) fell 10.8% to $0.1250 in today's pre-market trading after dipping over 8% on Friday. Aspira Women&#8217;s Health recently announced closing of $1.37 million private placement of convertible notes.</li>
<li>Tyra Biosciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TYRA#NASDAQ">TYRA</a>) fell 8.7% to $10.50 in pre-market trading after gaining 7% on Friday.</li>
<li>Omeros Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMER#NASDAQ">OMER</a>) shares dipped 4.4% to $8.05 in pre-market trading after gaining 7% on Friday.</li>
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Why Precision BioSciences Shares Are Trading Higher By Over 10%; Here Are 20 Stocks Moving Premarket

WIIM

Omeros shares are trading after the company announced results for its narsoplimab expanded access program.

– Results Demonstrate Marked Survival Superiority of Narsoplimab-Treated EAP Patients, in Stand-Alone and Combined Analyses with Narsoplimab Pivotal Trial Patients, over External Control Patients –
<ul>
<li>Results of statistical analyses of survival in narsoplimab-treated expanded access program (EAP) TA-TMA patients compared to similarly at-risk external control registry patients were consistent with those of previously reported analyses comparing survival between narsoplimab-treated OMS721-TMA-001 pivotal trial and external control registry patients</li>
<li>The analyses conducted on the combined population of the 49 previously untreated high-risk adult (at least 16 years of age) allogeneic-transplant EAP patients and the 28 OMS721-TMA-001 patients were the same as the complete set of primary statistical and sensitivity analyses comparing survival in the narsoplimab pivotal trial to the external control TA-TMA patients, with representative analyses demonstrating that:
<ul>
<li>Narsoplimab reduced the risk of mortality in high-risk TA-TMA patients by over 2-fold (hazard ratio = 0.46 [95 percent confidence interval:0.30, 0.60]) to approximately 3-fold (hazard ratio = 0.34 [95 percent confidence interval: 0.21, 0.53])</li>
<li>P-values ranged from 0.00002 to less than 0.00001</li>
</ul>
</li>
<li>In the EAP allogeneic transplant population, 16 adult and 20 pediatric high-risk TA-TMA patients had failed one or more treatment regimens – most commonly eculizumab – prior to receiving narsoplimab, with 1-year survival of 41 and 47 percent, respectively – over 2-fold higher than the less-than-20-percent historical 1-year survival for patients who fail targeted TA-TMA therapy</li>
<li>These results complete the set of independently conducted analyses for inclusion in the narsoplimab BLA resubmission to FDA planned for later this quarter and in the MAA submission to European regulators targeted by mid-year. Together with the previously reported primary and sensitivity analyses, the results are uniformly robust and support the clinical benefit of narsoplimab in TA-TMA, a life-threatening complication of hematopoietic stem cell transplantation with no currently approved treatment</li>
</ul>
Omeros Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMER#NASDAQ">OMER</a>) today announced statistical analysis results related to the expanded access program (EAP) for narsoplimab, Omeros' first-in-class monoclonal antibody inhibiting the lectin pathway of complement, in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), a life-threatening complication in both adult and pediatric hematopoietic stem cell transplantation (HSCT). These latest analyses, conducted by an independent statistical group, comprise multiple survival comparisons between narsoplimab-treated EAP patients and similarly at-risk TA-TMA patients in the external control registry. The results from these analyses further support the robustness of the previously reported results from the statistical analysis plan agreed with FDA, with representative analyses of the combined EAP and pivotal trial patients yielding hazard ratios ranging from 0.34 (95 percent confidence interval: 0.21, 0.53) to 0.46 (95 percent confidence interval: 0.35, 0.60) and p-values ranging from less than 0.00001 to 0.00002. Consistent with all previous clinical experience with narsoplimab, no safety signals of concern were observed.

Omeros Announces Results For Narsoplimab Expanded Access Program In TA-TMA; Results Demonstrate Marked Survival Superiority Of Narsoplimab-Treated EAP Patients, In Stand-Alone And Combined Analyses With Narsoplimab Pivotal Trial Patients, Over External Control Patients

&nbsp;– Newly Completed Sensitivity Analyses Demonstrate Robustness of Previously Announced Survival Superiority Over External Control in Patients with TA-TMA –
<ul>
<li>Sensitivity analyses support the results of the primary endpoint analysis, with representative sensitivity analyses demonstrating:
<ul>
<li>Narsoplimab-treated patients had an over 2-fold reduction (hazard ratio = 0.42 [95% confidence interval: 0.21, 0.83]) to an over 4-fold reduction (hazard ratio = 0.24 [95% confidence interval: 0.13, 0.47] in risk of mortality</li>
<li>P-values ranging from 0.0124 to &lt; 0.00001</li>
</ul>
</li>
<li>The primary endpoint analysis, previously reported on December 19, 2024, showed an over 3-fold reduction in risk of mortality (hazard ratio = 0.32 [95% confidence interval: 0.23, 0.44]; p &lt; 0.00001) in TA-TMA patients treated with narsoplimab compared to the external control registry TA-TMA patients not treated with narsoplimab</li>
<li>Omeros plans to resubmit to FDA later this quarter the BLA for narsoplimab to become the first approved therapeutic for TA-TMA, a life-threatening complication of hematopoietic stem cell transplantation; MAA submission to European regulators targeted by mid-year</li>
</ul>
Omeros Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMER#NASDAQ">OMER</a>) today announced statistical sensitivity analysis results related to the primary endpoint analysis for narsoplimab, Omeros' first-in-class monoclonal antibody inhibiting the lectin pathway of complement, in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), a life-threatening complication in both adult and pediatric hematopoietic stem cell transplantation. The sensitivity analyses, conducted by an independent statistical group, demonstrate the robustness of the results of the previously reported primary endpoint analysis, with representative hazard ratios ranging from 0.24 (95 percent confidence interval: 0.13, 0.47) to 0.42 (95 percent confidence interval: 0.21, 0.83) and p-values ranging from less than 0.00001 to 0.0124.
The following are representative sensitivity analyses conducted by the independent statistical group:
<figure class="table"> 
<table>
<tbody>
<tr>
<td colspan="1" rowspan="1">1.</td>
<td colspan="3" rowspan="1">Overall survival with only treatment as a factor using Inverse Probability of Treatment Weighting (IPTW):</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="2" rowspan="1">Hazard ratio = 0.40 (95 percent confidence interval: 0.29, 0.54)</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="2" rowspan="1">P-value &lt; 0.00001</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td>&nbsp;</td>
</tr>
<tr>
<td colspan="1" rowspan="1">2.</td>
<td colspan="3" rowspan="1">Testing proportional hazards assumptions in a sequence of four models in which patient follow-up is truncated at 100 days, 6 months, 1 year, and 2 years using IPTW:</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">100 days:</td>
<td colspan="1" rowspan="1">Hazard ratio = 0.37 (95 percent confidence interval: 0.25, 0.54)</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">P-value &lt; 0.00001</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">6 months:</td>
<td colspan="1" rowspan="1">Hazard ratio = 0.32 (95 percent confidence interval: 0.22, 0.45)</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">P-value &lt; 0.00001</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">1 year:</td>
<td colspan="1" rowspan="1">Hazard ratio = 0.30 (95 percent confidence interval: 0.22, 0.42)</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">P-value &lt; 0.00001</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">2 years:</td>
<td colspan="1" rowspan="1">Hazard ratio = 0.29 (95 percent confidence interval: 0.21, 0.41)</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">P-value &lt; 0.00001</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
</tr>
<tr>
<td colspan="1" rowspan="1">3.</td>
<td colspan="3" rowspan="1">Overall survival with day zero for the external control registry patients set at the median time between the date of TA-TMA diagnosis and the date of narsoplimab treatment initiation for the patients in the OMS721-TMA-001 pivotal trial using IPTW:</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="2" rowspan="1">Hazard ratio = 0.32 (95 percent confidence interval: 0.23, 0.44)</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="2" rowspan="1">P-value &lt; 0.00001</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
</tr>
<tr>
<td colspan="1" rowspan="1">4.</td>
<td colspan="3" rowspan="1">Overall survival with and without all specified risk factors (RFs) using 1:1 and 1:2 patient propensity score matching (OMS721-TMA-001 trial patients versus external control registry patients):</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">1:1 with RFs:</td>
<td colspan="1" rowspan="1">Hazard ratio = 0.29 (95 percent confidence interval: 0.14, 0.61)</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">P-value = 0.0012</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">1:1 w/out RFs:</td>
<td colspan="1" rowspan="1">Hazard ratio = 0.42 (95 percent confidence interval: 0.21, 0.83)</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">P-value = 0.0124</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">1:2 with RFs:</td>
<td colspan="1" rowspan="1">Hazard ratio = 0.24 (95 percent confidence interval: 0.13, 0.47)</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">P-value &lt; 0.0001</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">1:2 w/out RFs:</td>
<td colspan="1" rowspan="1">Hazard ratio = 0.40 (95 percent confidence interval: 0.22, 0.72)</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">P-value = 0.0024</td>
</tr>
</tbody>
</table>
</figure>
As reported on December 19, 2024, narsoplimab met its primary endpoint, with TA-TMA patients in its OMS721-TMA-001 pivotal trial demonstrating clinically meaningful and statistically significant superiority in overall survival – a hazard ratio of 0.32 (95 percent confidence interval: 0.23 to 0.44) with p-value less than 0.00001 – compared to the TA-TMA registry patients. The hazard ratio of 0.32 indicates that the narsoplimab-treated TA-TMA patients had an over 3-fold reduction in risk of mortality. Across all its clinical trials in various indications to date, narsoplimab has been well tolerated and has shown no safety signal of concern.

meros Announces Sensitivity Results For Narsoplimab In TA-TMA Patients, Confirming Over 3-Fold Mortality Risk Reduction; Primary Endpoint Met. BLA Resubmission To FDA This Quarter, MAA Submission In Europe By Mid-Year.

Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades and downgrades, please see our <a href="https://www.benzinga.com/analyst-stock-ratings">analyst ratings page</a>.
<ul>
<li>Scotiabank analyst Sung Ji Nam initiated coverage on Thermo Fisher Scientific Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TMO#NYSE">TMO</a>) with a Sector Perform rating and announced a price target of $605. Thermo Fisher Scientific shares closed at $524.05 on Friday. <a href="https://www.benzinga.com/quote/TMO/analyst-ratings">See how other analysts view this stock.</a></li>
<li>Goldman Sachs analyst Allen Chang initiated coverage on Pony AI Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PONY#NASDAQ">PONY</a>) with a Buy rating and announced a price target of $19.6. Pony AI shares closed at $13.16 on Friday. See how other analysts view this stock.</li>
<li>Compass Point analyst Dominick Gabriele initiated coverage on NCR Atleos Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NATL#NYSE">NATL</a>) with a Buy rating and announced a price target of $57. NCR Atleos shares closed at $32.33 on Friday. <a href="https://www.benzinga.com/quote/NATL/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>D. Boral Capital analyst Jason Kolbert initiated coverage on Omeros Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMER#NASDAQ">OMER</a>) with a Buy rating and announced a price target of $36. Omeros shares closed at $10.31 on Friday. <a href="https://www.benzinga.com/quote/OMER/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Alliance Global Partners analyst Aaron Grey initiated coverage on Worksport Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/WKSP#NASDAQ">WKSP</a>) with a Buy rating and announced a price target of $2. Worksport shares closed at $0.8465 on Thursday. <a href="https://www.benzinga.com/quote/WKSP/analyst-ratings">See how other analysts view this stock.</a></li>
</ul>
Considering buying OMER stock? Here&#8217;s what analysts think: 
<figure class="wp-block-image size-large is-resized"><img loading="lazy" decoding="async" width="1024" height="573" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/12/23103558/image-192-1024x573.png" alt="" class="wp-image-704444" style="width:622px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/12/23103558/image-192-1024x573.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/12/23103558/image-192-300x168.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/12/23103558/image-192-768x430.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/12/23103558/image-192.png 1102w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>
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Initiation

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WKSP

This Omeros Analyst Begins Coverage On A Bullish Note; Here Are Top 5 Initiations For Monday

Press Releases

Omeros Announces Update on Statistical Analysis of Narsoplimab Pivotal Trial Primary Endpoint

Omeros Corporation Announces Upcoming Presentations Detailing Outcomes of Narsoplimab Treatment for TA-TMA Under an Expanded Access Program

Omeros Corporation Announces Availability on its Website of Materials Accompanying Narsoplimab Presentations at the 2025 Tandem Meetings

Omeros Announces Robust Results for Narsoplimab Expanded Access Program in TA-TMA

Omeros Corporation Receives Commitment of Over $4 Million from NIDA for Further Development of the Company's OMS527 Program to Treat Cocaine Use Disorder

Omeros Corporation Provides Update of Ongoing Zaltenibart Phase 3 PNH Clinical Trial Program

Omeros Corporation to Announce Fourth Quarter and Year-end Financial Results on March 31, 2025

Omeros Corporation Reports Fourth Quarter and Year-End 2024 Financial Results

Omeros Corporation To Introduce Its Proprietary T-CAT™ Program for the Treatment of Multidrug-Resistant Pathogens in Plenary Session at Upcoming European Congress on Infectious Diseases

Omeros Announces the Omeros Oncology Clinical Steering Committee for AML to Help Guide Omeros' Proprietary OncotoX-AML Clinical Program

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