Omeros announces completion of nonhuman primates OncotoX-AML study
Omeros (OMER) has completed an initial study in nonhuman primates for its OncotoX-AML cancer therapeutic platform, which targets acute myeloid leukemia. The study showed that a single course of OncotoX-AML treatment led to a significant, selective, and reversible reduction of myeloid progenitor cells by up to 99% while being well-tolerated with no significant safety signals. This development is promising as current AML treatments are often limited by substantial side effects.
Omeros Announces Successful Primate Study in OncotoX-AML™ Drug Program
Omeros Corporation announced the successful completion of an initial nonhuman primate study for its OncotoX-AML™ cancer therapeutic platform, targeting acute myeloid leukemia (AML). The study showed that a single treatment course led to a significant, selective, and reversible reduction in myeloid progenitor cells by up to 99 percent, with no major safety signals. Omeros plans to initiate IND-enabling studies to advance OncotoX-AML™ to clinical trials, aiming for a first-in-human trial in late 2027.
Omeros stock jumps premarket after FDA approves first drug for rare transplant complication — retail sees big upside
Omeros (OMER) stock surged in premarket trading following FDA approval for its drug, narsoplimab, the first treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). This approval is seen as a significant long-term growth driver, with analysts predicting substantial revenue and potential for Omeros to become a major pharmaceutical company, despite concerns about trial sizes.
Omeros Achieves Commercial Milestone with First Approved Drug Launch
Omeros Corporation has commenced the commercial launch of its FDA-approved drug, YARTEMLEA®, in the U.S. for transplant-associated thrombotic microangiopathy (TA-TMA). This milestone, along with a significant licensing deal with Novo Nordisk for $2.1 billion, positions Omeros as a commercial-stage entity with bolstered financial resources. The company anticipates an EMA decision for YARTEMLEA® mid-year and plans to release its Q4/full-year 2025 financial results between March 3 and April 2.
Omeros Achieves Commercial Milestone with First Approved Drug Launch
Omeros Corporation has launched its first FDA-approved therapy, YARTEMLEA®, in the U.S. for transplant-associated thrombotic microangiopathy (TA-TMA), marking its transition into a commercial-stage company. Concurrently, Omeros secured a significant licensing deal with Novo Nordisk for its investigational drug, Zaltenibart, including an upfront payment of $240 million, which is expected to cover debt and operations for over a year. The company aims for positive cash flow by 2027 and anticipates a European marketing authorization decision for YARTEMLEA® around mid-year.
Omeros Corporation's (NASDAQ:OMER) market cap dropped US$60m last week; individual investors who hold 50% were hit as were institutions
Omeros Corporation (NASDAQ: OMER) saw its market cap fall by US$60 million last week, impacting both individual investors, who collectively own 50% of the company, and institutional investors holding 47%. The article highlights the significant influence individual investors have due to their substantial ownership and notes insider selling activity. Despite this, institutional holdings suggest some professional credibility, and analysts are covering the stock.
Omeros Corporation (NASDAQ:OMER) Sees Large Growth in Short Interest
Omeros Corporation (NASDAQ:OMER) experienced a significant 24% increase in short interest in January, reaching over 16.4 million shares, which represents about 26.6% of its shares sold short. This surge comes as institutional investors like UBS and Vanguard reportedly increased their holdings in the company. Despite insider selling by the CAO, analysts maintain a "Moderate Buy" consensus rating for Omeros, with a target price of $40.33.
Omeros begins commercial distribution of TA-TMA treatment Yartemlea By Investing.com
Omeros Corporation has commenced commercial distribution of its FDA-approved drug, Yartemlea (narsoplimab-wuug), for the treatment of stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The company's stock has seen significant returns despite recent volatility, with analysts projecting considerable upside. While Omeros appears overvalued by some metrics, analysts anticipate profitability this fiscal year, alongside recent positive financial news including a narrower-than-expected loss in Q3 2025 and a substantial deal with Novo Nordisk.
Omeros (NASDAQ:OMER) Given "Buy" Rating at D. Boral Capital
D. Boral Capital has reiterated a "Buy" rating for Omeros (NASDAQ:OMER) with a price target of $36.00, suggesting a potential upside of over 200%. The biopharmaceutical company currently holds a "Moderate Buy" consensus rating from analysts, with an average target price of $40.33. This report also highlights recent insider selling activity and institutional investor sentiment.
Omeros stock rises as first commercial YARTEMLEA shipments begin
Omeros Corporation (NASDAQ:OMER) saw its stock rise after commencing commercial shipments of YARTEMLEA (narsoplimab-wuug), its FDA-approved therapy for stem cell transplant-associated thrombotic microangiopathy (TA-TMA). This makes YARTEMLEA the first and only FDA-approved treatment for this potentially fatal condition, benefiting both adult and pediatric patients. A marketing authorization application is also under review by the European Medicines Agency.
Omeros Announces First Commercial Sales of YARTEMLEA®
Omeros Corporation has announced the first commercial sales of its drug YARTEMLEA® (narsoplimab-wuug), the first and only FDA-approved therapy for stem cell transplant-associated thrombotic microangiopathy (TA-TMA). Initial shipments have been sent to distributors, and the drug is now being administered to both adult and pediatric TA-TMA patients in various transplant centers. A marketing authorization application for YARTEMLEA is also under review by the European Medicines Agency.
Omeros wins first commercial sales of Yartemlea (OMER:NASDAQ)
Omeros Corporation (OMER) shares rose after the company announced its first commercial shipments of Yartemlea. This recently FDA-approved therapy is designed to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy, a complication that can arise from stem cell transplantation. The news highlights a significant commercial milestone for the Seattle-based biotech firm.
Omeros Corporation (NASDAQ:OMER) Receives Consensus Rating of "Moderate Buy" from Brokerages
Omeros Corporation (NASDAQ:OMER) has received a consensus "Moderate Buy" rating from five brokerages, with an average 12-month price target of $40.33. Recent analyst upgrades include HC Wainwright raising its target to $40 and WBB Securities issuing a $45 strong-buy rating. The company's stock trades around $11.53, and analysts forecast a -3.09 EPS for the current fiscal year, despite a recent quarterly earnings beat.
Omeros wins FDA nod for transplant therapy
Omeros has received FDA approval for its transplant therapy. This regulatory milestone marks a significant achievement for the company in the pharmaceutical industry. The approval is expected to impact the treatment landscape for transplant patients.
Omeros wins FDA nod for transplant therapy
This article reports that Omeros has received approval from the FDA for its transplant therapy. This significant regulatory milestone is expected to impact the company's market position and patient treatment options.
Omeros Shares Face Headwinds Amid Mixed Signals
Omeros Corporation's stock is experiencing significant volatility due to insider selling, a mixed market reaction to regulatory approval, and conflicting analyst opinions. While the FDA approved YARTEMLEA, investors are focusing on its commercial launch trajectory after Omeros divested rights to another therapy. Insider transactions, such as the Chief Accounting Officer selling shares, have further impacted market sentiment.
Omeros (NASDAQ:OMER) Shares Down 5.8% Following Insider Selling
Omeros (NASDAQ:OMER) shares dropped 5.8% after CAO David J. Borges sold 30,000 shares for $369,300. The biopharmaceutical company has a consensus "Moderate Buy" rating from analysts with an average target price of $40.33, significantly higher than its current share price of approximately $12.32. Institutional investors and hedge funds own 48.79% of the company's stock.
Omeros VP Borges sells $750k in shares
Omeros' VP of Finance & CAO, David J. Borges, sold 60,000 shares of common stock for over $750,000. He also exercised options to acquire 30,000 shares. This news follows the company's positive third-quarter 2025 financial results, FDA approval for Yartemlea, and a significant transaction with Novo Nordisk for its MASP-3 inhibitor.
Omeros (OMER) Price Target Increased by 29.70% to 44.54
The one-year price target for Omeros (OMER) has been increased by 29.70% to $44.54 per share, up from $34.34. This new average target is based on analyst estimates ranging from $36.36 to $57.75 and represents a significant increase of 240.65% from its latest closing price of $13.08. Institutional ownership in Omeros remains strong, with a slight decrease in the number of funds holding positions but an overall increase in total shares owned by institutions.
Omeros (NASDAQ:OMER) CAO Sells 30,000 Shares
Omeros Corporation's (NASDAQ:OMER) Chief Administrative Officer, David Borges, sold 30,000 shares of the company's stock on January 13th for a total of $369,300. This insider transaction comes as Omeros shares traded up on Wednesday, with a market capitalization of $927.37 million. Analysts have mixed but generally positive ratings for OMER, with a consensus target price of $40.33.
Omeros VP Borges sells $750k in shares By Investing.com
Omeros's VP of Finance & CAO, David J. Borges, sold 60,000 shares of common stock for approximately $750,915 and also exercised options to acquire 30,000 shares. This insider trading news follows Omeros' positive third-quarter 2025 financial results, including lower-than-expected losses, FDA approval for its drug Yartemlea, and a significant transaction with Novo Nordisk for its MASP-3 inhibitor, zaltenibart, valued up to $2.1 billion.
Omeros VP Borges sells $750k in shares
Omeros's VP of Finance & CAO, David J. Borges, sold 60,000 shares of common stock for approximately $750,915 and exercised options to acquire 30,000 shares for $91,800. This insider trading news follows Omeros's positive third-quarter 2025 results, including a narrower-than-expected loss and FDA approval for its drug Yartemlea, as well as a significant licensing deal with Novo Nordisk for zaltenibart.
Omeros Corp Sells Immune-System Drug To Novo Nordisk In $2.1B Deal — Retail Shifts Focus To Narsoplimab FDA Call
Omeros Corp has sold its immune-system drug, narsoplimab, along with its complement inhibitor platform, to Novo Nordisk for up to $2.1 billion. This divestiture allows Omeros to focus on securing FDA approval for narsoplimab to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), a life-threatening rare disease. The deal includes an upfront payment and potential milestone payments, providing Omeros with significant capital to advance its regulatory and clinical efforts.
Omeros Corp Sells Immune-System Drug To Novo Nordisk In $2.1B Deal — Retail Shifts Focus To Narsoplimab FDA Call
Omeros Corp has sold its immune-system drug, narsoplimab, to Novo Nordisk for $2.1 billion. This transaction allows Omeros to focus on getting FDA approval for narsoplimab, which it retained rights to for all ophthalmic indications. The deal significantly boosts Omeros's financial position, providing capital for pipeline expansion and potential stock buybacks.
Omeros Corp Sells Immune-System Drug To Novo Nordisk In $2.1B Deal — Retail Shifts Focus To Narsoplimab FDA Call
Omeros Corp has sold its immune-system drug, narsoplimab, along with its complement inhibitor platform, to Novo Nordisk for $2.1 billion. The deal includes an upfront payment and potential royalties, and will allow Omeros to reduce its debt. Following the sale, Omeros will focus on the FDA approval process for narsoplimab, specifically for atypical hemolytic uremic syndrome (aHUS) and hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
What is HC Wainwright's Forecast for Omeros Q1 Earnings?
HC Wainwright analyst B. Folkes has set a Q1 2026 EPS forecast of ($0.59) for Omeros, maintaining a Buy rating and raising the price target to $40. While sequential quarterly losses are modeled for 2026, a significant long-term rebound is projected with FY2030 EPS of $6.69, contrasting with the current full-year consensus loss. The company's recent FDA approval and Yartemlea pricing of $36,000 per vial offer potential revenue upside, though payer and access uncertainties could impact near-term uptake.
Omeros stock garners high retail attention ahead of FDA verdict for life-saving drug
Omeros (OMER) stock is experiencing significant retail investor attention in anticipation of an upcoming FDA verdict for its life-saving drug. The company's future stock performance largely hinges on this pivotal regulatory decision, making it a key event for investors to monitor closely.
Omeros stock rises in premarket after $36,000-a-vial Yartemlea price is set
Omeros (OMER.O) shares rose approximately 4% in premarket trading after the company announced a $36,000 per vial price for its newly approved drug Yartemlea, used to treat transplant-associated thrombotic microangiopathy (TA-TMA). With a typical treatment course requiring 8 to 10 vials, the total cost could range from $288,000 to $360,000 before rebates. Analysts reacted positively, with H.C. Wainwright and D. Boral Capital reiterating "Buy" ratings and increasing price targets, highlighting both the opportunity and the financial implications tied to insurance reimbursement.
Omeros (NASDAQ:OMER) Trading Up 10.3% on Analyst Upgrade
Omeros (NASDAQ:OMER) shares surged 10.3% after HC Wainwright significantly increased its price target from $20 to $40, maintaining a "buy" rating. The stock's price target averages around $40.33 among analysts, with a consensus of "Moderate Buy." Omeros recently surpassed quarterly EPS estimates and boasts substantial institutional ownership.
Omeros Details Yarcomlia U.S. Launch After FDA Approval, Pricing and Supply Outlook in Focus
Omeros (NASDAQ: OMER) announced the U.S. launch of Yarcomlia (narsoplimab) following its FDA approval on December 23, 2025, for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TATMA). The company detailed its commercialization strategy, including an initial price of $36,000 per vial, targeting 80 transplant centers, and expecting a drug supply to last until late 2029. Omeros also outlined its reimbursement and coding plans, anticipating a new technology add-on payment (NTAP) to be effective in October 2026 to support hospital reimbursement.
Omeros prices transplant complication drug at $36,000 per dose
Omeros Corporation has priced its newly FDA-approved drug, Yartemlea, for transplant complications at $36,000 per dose. Yartemlea is indicated to treat thrombotic microangiopathy caused by stem-cell transplants. This pricing announcement follows the FDA's approval of Yartemlea on December 24.
Why Did Omeros Stock Jump 5% In After-Hours Trading Today?
Omeros Corp shares rose about 5% in after-hours trading after the company announced pricing and rollout details for its newly approved drug, Yartemlea. The drug, priced at $36,000 per vial, is used to treat a rare transplant complication, and initial U.S. deliveries for its full rollout are expected later in January. Investors reacted positively to the clearer commercial outlook for the drug.
Assessing Omeros (OMER) Valuation After YARTEMLEA’s FDA Approval And Planned US Launch
Omeros (OMER) has garnered investor interest following FDA approval of YARTEMLEA, leading to significant share price increases. A discounted cash flow (DCF) model suggests a fair value of $123.68, indicating the stock is currently undervalued despite its current lack of revenue and net loss. However, risks remain regarding commercialization and future trials.
Will FDA Approval of YARTEMLEA in TA-TMA Redefine Omeros' (OMER) Commercial Trajectory?
Omeros Corporation received FDA approval for YARTEMLEA (narsoplimab-wuug) to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy, with U.S. launch preparations underway. This approval marks Omeros' first marketed complement-inhibiting therapy and comes with dedicated billing codes and a patient assistance program. The company's future investment narrative now heavily relies on the successful U.S. launch of YARTEMLEA and careful management of its balance sheet, as it operates with negative equity and ongoing losses.
Assessing Omeros (OMER) Valuation After YARTEMLEA’s FDA Approval And Planned US Launch
Omeros (OMER) has garnered significant investor attention following FDA approval of YARTEMLEA, driving substantial stock price gains. Despite its current $0 revenue and net loss, a discounted cash flow (DCF) model estimates a fair value of $123.68, suggesting the stock is significantly undervalued compared to its last close at $16.38. However, risks such as ongoing net losses and uncertainties in future commercialization remain.
Will FDA Approval of YARTEMLEA in TA-TMA Redefine Omeros' (OMER) Commercial Trajectory?
Omeros has received FDA approval for YARTEMLEA (narsoplimab-wuug) to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy, marking its first marketed complement-inhibiting therapy. This approval shifts Omeros's investment narrative, with the company now focusing on the U.S. launch of YARTEMLEA and careful balance sheet management. Despite the positive news, the company still faces challenges with negative equity, ongoing losses, and a pipeline requiring substantial funding.
Omeros Corporation (NASDAQ:OMER) Receives Consensus Rating of "Moderate Buy" from Brokerages
Omeros Corporation (NASDAQ:OMER) has received a consensus "Moderate Buy" rating from five brokerage firms, with an average 12-month price target of $33.67. Despite beating quarterly EPS estimates, analysts still project a negative full-year EPS for the company. Institutional investors have been actively modifying their holdings in OMER, which currently has a market cap of $1.22 billion.
Omeros (NASDAQ:OMER) Trading Up 4.6% - Here's Why
Omeros (NASDAQ:OMER) saw its stock price jump 4.6% on Tuesday, trading up to $17.34 on approximately 1.34 million shares. This increase comes despite mixed analyst sentiment, with an average rating of "Moderate Buy" and a target price of $33.67. The biopharmaceutical company also reported beating quarterly EPS estimates, though it remains unprofitable.
Omeros Corp Announces FDA Approval of YARTEMLEA for TA-TMA
Omeros Corporation announced FDA approval of YARTEMLEA for treating TA-TMA. This marks the first approved treatment for TA-TMA in adults and children 2+ years, demonstrating high complete response rates and favorable survival rates in trials. The U.S. launch is planned for January 2026.
Omeros Gets FDA Approval for YARTEMLEA as First Therapy for TA-TMA
Omeros Corporation announced FDA approval for YARTEMLEA (narsoplimab-wuug) to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adults and pediatric patients aged two and older. This marks the first and only approved therapy for TA-TMA, a life-threatening condition. The approval is a significant milestone for Omeros, transforming it into a revenue-generating company with its first commercial product, and is supported by strong clinical results and a favorable safety profile.
Omeros Announces New Date for YARTEMLEA® Approval Conference Call
Omeros Corporation has rescheduled its conference call to discuss the recent FDA approval of YARTEMLEA® (narsoplimab-wuug), the first and only therapy for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The call will now take place on Wednesday, January 7, 2026, at 4:30 p.m. Eastern Time, allowing broader participation and accommodating holiday schedules. YARTEMLEA® is a monoclonal antibody that inhibits the lectin pathway of complement, providing a targeted treatment for this severe and often fatal complication.
Omeros Announces New Date for YARTEMLEA® Approval Conference Call
Omeros Corporation has rescheduled its conference call to discuss the FDA approval of YARTEMLEA® (narsoplimab-wuug), the first and only therapy for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The call will now occur on Wednesday, January 7, 2026, at 4:30 p.m. Eastern Time, to accommodate holiday schedules and allow for broader participation. YARTEMLEA® is also under review by the European Medicines Agency, with a decision expected in mid-2026.
Omeros Announces New Date for YARTEMLEA® Approval Conference Call
Omeros Corporation has announced a revised date for its conference call discussing the FDA approval of YARTEMLEA® (narsoplimab-wuug), the first and only therapy for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). To accommodate holiday schedules and ensure broad participation, the call will now be held on Wednesday, January 7, 2026, at 4:30 p.m. Eastern Time. The company is excited to share more details about this landmark approval and the planned U.S. market launch of YARTEMLEA on January 2, 2026.
Omeros (NASDAQ:OMER) Sees Large Volume Increase - Still a Buy?
Omeros (NASDAQ:OMER) experienced a significant trading volume increase of 3% on Friday, with approximately 1.78 million shares traded, though the stock saw a 5.1% decline. Despite mixed analyst ratings, the consensus remains a "Moderate Buy" with a target price of $33.67, and the company recently beat EPS estimates even while remaining unprofitable. Several hedge funds have also adjusted their positions in Omeros, indicating ongoing investor interest.
Omeros scores its 1st FDA nod as stem cell transplant drug Yartemlea approved
Omeros has received its first FDA approval with Yartemlea, a stem cell transplant drug for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), marking the company's first U.S. approval in 31 years. The approval came after a previous rejection and a successful appeal process, with the drug now set for a U.S. launch in January 2026. The approval led to a significant increase in Omeros's share price, and the company has also sold another pipeline candidate to Novo Nordisk to facilitate Yartemlea's launch.
Omeros rockets as FDA approves Yartemlea
Omeros Corp (Nasdaq: OMER) shares surged 75.5% after the US FDA approved its drug Yartemlea (narsoplimab-wuug) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). Yartemlea is the first and only approved lectin pathway inhibitor for this often-fatal complication. The global market for complement-mediated thrombotic microangiopathy therapies reached $2.14 billion in 2024 and is projected to grow with a CAGR of 10.7%.
Omeros (OMER) Stock Surges After Hours on Dec. 24, 2025 After FDA Approves Yartemlea — What to Know Before the Next Market Open
Omeros Corporation (NASDAQ: OMER) saw its stock surge dramatically after hours on December 24, 2025, following FDA approval of its product YARTEMLEA (narsoplimab‑wuug). This approval marks the company's first commercial product and is significant as it's the only FDA-approved therapy for hematopoietic stem cell transplant–associated thrombotic microangiopathy (TA‑TMA). The article discusses the reasons behind the market's strong reaction, including the drug's "first and only" positioning and differentiated mechanism, and outlines key information for investors ahead of the next market open, including launch plans, analyst reactions, and potential continued volatility.
FDA Approves Omeros' First-In-Class Drug For Rare Transplant Complication
Omeros Corporation received FDA approval for Yartemlea (narsoplimab-wuug), a first-in-class drug, to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). Yartemlea is the first and only approved lectin pathway inhibitor, demonstrating significant efficacy and improved survival rates in clinical studies. Omeros plans a U.S. launch in January 2026, with a European decision expected mid-2026.
Omeros (OMER) Stock Surges After FDA Approval of Yartemlea: Latest News, Analyst Forecasts, and 2026 Outlook
Omeros (OMER) stock surged after the FDA approved Yartemlea (narsoplimab-wuug), the first and only therapy for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). This approval removes a significant regulatory overhang and positions Omeros for a U.S. launch in January 2026. The company's financial position was also bolstered by a recent $240 million upfront payment from Novo Nordisk for zaltenibart, reducing prior cash burn concerns and enabling focus on the Yartemlea commercialization.
Corient Private Wealth LLC Reduces Stock Holdings in Omeros Corporation $OMER
Corient Private Wealth LLC reduced its stake in Omeros Corporation by 26.3% in Q2 2025, selling 189,808 shares and ending the quarter with 530,614 shares valued at $1.59 million. This move comes as Omeros benefits from the FDA approval of YARTEMLEA, its first commercial product, which has generated positive media attention and analyst support. Despite the optimism and a consensus "Moderate Buy" rating from analysts, execution, uptake in the small TA-TMA market, and profitability remain key risks for the company.
