Category Archives: pharmaceuticals

Omeros (OMER) Stock Rallies 149% on $2 Billion Novo Nordisk Deal

Omeros Corporation (NASDAQ: OMER) stock soared 149% to close at $10.19 on October 15, up $6.09 from the previous day’s close of $4.10. This dramatic surge followed the announcement of a $2.1 billion licensing and asset purchase agreement with Danish pharmaceutical giant Novo Nordisk for Omeros’ MASP-3 inhibitor drug candidate, zaltenibart (formerly OMS906).

### Significant Licensing Deal with Novo Nordisk

The deal grants Novo Nordisk exclusive worldwide rights to develop and commercialize zaltenibart, which targets rare blood and kidney disorders. Under the agreement, Omeros will receive $340 million in upfront and near-term payments, with potential milestone payments boosting the total deal value to $2.1 billion. Additionally, Omeros stands to earn royalties on future sales if zaltenibart successfully reaches the market.

Trading volume exploded to 77.9 million shares on October 15, a huge increase compared to the typical daily volume of 1.2 million shares. The stock opened the day at $11.53, hitting an intraday high of $12.77 before settling at $10.19. Over the past 52 weeks, OMER stock has traded between $0.92 and $12.87.

### Financial Position and Impact of the Deal

As of June 30, 2025, Omeros held just $28.7 million in cash and short-term investments and reported a cash burn of $58.9 million during the first half of the year. Without any current product sales and operating at a chronic loss, the company’s financial position has been precarious.

The $340 million upfront payment from Novo Nordisk is expected to bolster Omeros’ cash reserves significantly, enabling the company to pay down debts and fund operations for more than a year. Despite this, at midday on October 15, Omeros’ market capitalization was just under $700 million.

### Update on Lead Drug Candidate: Narsoplimab

While zaltenibart is a promising asset, it is not Omeros’ most advanced drug candidate. Their lead product, narsoplimab, a MASP-2 inhibitor, is currently under FDA review for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The FDA initially rejected narsoplimab’s application in 2021, citing difficulties in estimating treatment effects and requesting additional data.

Omeros submitted further data in December 2021. The FDA set an initial target decision date of September 25, 2025, but this was later extended to December 26, 2025. This delay extends the uncertainty regarding narsoplimab’s approval and commercial potential.

Adding to the concerns, narsoplimab failed a pivotal 2023 trial testing its efficacy in treating kidney damage from an autoimmune disorder different from HSCT-TMA. Moreover, the FDA likely requested a randomized controlled trial in 2021, a study Omeros did not conduct. Instead, the company compared a small group of 28 treated patients to similar untreated patients outside the trial.

### Looking Ahead

Omeros signaled in August 2025 that a significant deal was imminent, highlighting advanced negotiations around zaltenibart. The licensing agreement with Novo Nordisk represents a critical milestone for Omeros, potentially stabilizing the company’s finances while expanding the development prospects of zaltenibart under a major pharmaceutical partner.

Investors will be closely watching the FDA’s December decision on narsoplimab, which remains pivotal to Omeros’ future commercial success.

*The above content is based on developments as of October 15, 2025.*
https://bitcoinethereumnews.com/tech/omeros-omer-stock-rallies-149-on-2-billion-novo-nordisk-deal/?utm_source=rss&utm_medium=rss&utm_campaign=omeros-omer-stock-rallies-149-on-2-billion-novo-nordisk-deal

Kerala Bans All Sresan Pharmaceuticals Medicines From Sale Following Tamil Nadu License Cancellation

Kerala (Thiruvananthapuram): Health Minister Veena George has announced a ban on all medicines manufactured by Sresan Pharmaceuticals, a company based in Kanchipuram, Tamil Nadu. This decision follows the cancellation of the company’s manufacturing license by the Tamil Nadu Drugs Controller. Consequently, these medicines are prohibited from distribution and sale within Kerala.

In a related development, the Gujarat Drugs Controller reported that Respifresh TR syrup (60ml, Batch No. R01GL2523), produced by Rednex Pharmaceuticals Pvt. Ltd., Ahmedabad, failed to meet required quality standards. In response, the Kerala Drugs Control Department has immediately halted the distribution and sale of this medicine throughout the state. The syrup had been distributed by five suppliers in Kerala, all of whom have now been instructed to stop its distribution. Strict action will be taken against anyone found selling the drug illegally.

The public has been advised not to use this medicine if they currently possess it. The Health Minister clarified that these banned medicines are not supplied through government hospitals. Additionally, strict action will be taken against establishments that provide this medicine to children under 12 years of age without a prescription from a registered doctor.

Earlier, following the death of at least 14 children after consuming Coldrif syrup in Madhya Pradesh’s Chhindwara, the Kerala government constituted a committee to submit a report on the management of pediatric cough syrups. On Tuesday, Kerala Health Minister Veena George stated that the State Drugs Controller has imposed a ban on the specific cough syrup Coldrif, and the Kerala Medical Services Corporation Limited (KMSCL) does not supply this syrup to government hospitals.

Speaking to ANI, Minister Veena George said, “It’s unfortunate that 16 children died after consuming the cough syrup Coldrif. The Government of India has issued an advisory regarding the consumption of cough syrup. In Kerala, the Drugs Controller has issued a notification banning the sale of this particular cough syrup Coldrif in all pharmacies across the state.”

She further emphasized, “ColdRif is not included in our essential drugs list. It is not provided by KMSCL, which supplies medicines to government hospitals. However, we are ensuring that the sale of this syrup is completely stopped in private hospitals and pharmacies.”

The Minister noted that the committee on pediatric cough syrups will soon submit its report to the Kerala Government. “We have previously taken similar strict enforcement actions regarding antibiotics within the state. This committee specifically focuses on the management of pediatric cough, ensuring irrelevant combinations are not present in syrups. We plan to issue comprehensive guidelines concerning pediatric cough management, which is crucial,” she explained.

Minister Veena George also raised concerns about medical prescriptions saying, “Doctors have been prescribing cough syrups to children under the age of two years, which is neither advisable nor scientific. We do have protocols in place prohibiting cough syrup administration to children under two.”

She added, “This incident highlights the disregard for these protocols. The Kerala Health Department has instructed the Drugs Controller to issue notices to pharmacies prohibiting the sale of pediatric drugs without a doctor’s prescription.”

The Kerala government remains committed to ensuring the safety and well-being of children by strictly regulating the distribution and sale of pediatric medicines across the state.

*(This article has been auto-generated from an agency feed and has not been edited by FPJ’s editorial team, except for the headline.)*
https://www.freepressjournal.in/india/kerala-bans-all-sresan-pharmaceuticals-medicines-from-sale-following-tamil-nadu-license-cancellation

AstraZeneca gets nod to market cancer drug in India

AstraZeneca Pharma announced on Tuesday that it has received approval from the national drug regulator to market a new cancer treatment drug in India.

The company has been granted approval by the Central Drugs Standard Control Organisation (CDSCO) to import, market, and distribute Trastuzumab Deruxtecan for an additional indication in the country, according to an official statement.

With this approval, Trastuzumab Deruxtecan is now indicated for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumours. These patients must have received prior systemic therapy and have no satisfactory alternative treatment options.

This approval marks the first and only antibody-drug conjugate in India with a tumour-agnostic indication, representing a significant advancement in precision oncology, AstraZeneca said.

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https://www.mid-day.com/news/india-news/article/astrazeneca-gets-nod-to-market-cancer-drug-in-india-23597685

Dyne’s Investigational DMD Drug DYNE-251 Gets Japan Orphan Drug Status After Strong Trial Data

Dyne Therapeutics Inc. (NASDAQ: DYN) stands out as one of the best stocks to buy under $20.

On September 29, Dyne Therapeutics announced a significant milestone: Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug designation for its investigational therapeutic, DYNE-251.

This designation targets individuals with Duchenne muscular dystrophy (DMD) who have mutations in the DMD gene that are amenable to treatment with DYNE-251.

The Orphan Drug status is a crucial step in the development of DYNE-251, potentially providing benefits such as market exclusivity and regulatory assistance, which can accelerate the availability of this promising therapy for patients in need.

Investors and stakeholders will be closely watching Dyne Therapeutics as it advances its pipeline and seeks to address unmet medical needs in the muscular dystrophy community.
https://ca.finance.yahoo.com/news/dyne-investigational-dmd-drug-dyne-205457972.html