Connect with us

Healthcare

Zydus Lifesciences Limited (zyduslife) Receives Approval for Phase III Trial of Desidustat in Sickle Cell Disease Patients

Zydus Lifesciences Limited (ZYDUSLIFE) gets approval for Phase III trial of Desidustat for sickle cell disease patients.

seema chauhan author

Published

on

Zydus Lifesciences Limited Zyduslife Phase III Trial

Zydus Lifesciences Limited (ZYDUSLIFE), an innovation-led global lifesciences company, has received approval to conduct a Phase III clinical trial of Desidustat for patients with sickle cell disease. Conducted in collaboration with the Indian Council of Medical Research (ICMR), the 203-day study will evaluate the efficacy and safety of Desidustat oral tablets in treating anemia. The trial will enroll 164 patients diagnosed with the disease. Sickle Cell Disease is a significant public health concern in India, especially among tribal populations where prevalence is higher. According to National Health Mission estimates, nearly 20 million people live with the condition, and roughly 50,000 children are born with sickle cell anemia annually.

Desidustat: A Potential First-in-Class Therapeutic

Desidustat represents a potential first-in-class therapeutic opportunity for the treatment of sickle cell disease which will be studied further in Phase III clinical trial. The US FDA has granted Orphan Drug Designation (ODD) to Zydus’ Desidustat for treating two rare blood disorders: Sickle Cell Disease (SCD) and beta-thalassemia. The Phase III trial will be a double blind, randomized, placebo controlled, parallel, multicentre study to evaluate the efficacy and safety of Desidustat oral tablets for treatment of anemia in sickle cell disease patients.

Successful Collaboration with ICMR

Zydus and ICMR successfully completed the Phase II Proof-of-concept (PoC) trial to evaluate the efficacy and safety of Desidustat oral tablet for treatment of sickle cell disease. The study met its primary endpoint, demonstrating positive outcomes in line with the trial objectives. Dr. Rajiv Bahl, Secretary, Department of Health Research & Director General, ICMR, said, “We have successfully completed the Phase II study of Desidustat in Sickle Cell Disease in collaboration with Zydus Lifesciences. This truly marks a significant leap forward for patients who have limited options beyond hydroxyurea. As we move towards Phase III trials, we see a huge potential of this Indian innovation in addressing severe health challenge. This collaboration reflects our commitment to clinical research through strong public–private partnerships.”

As a result, Zydus Lifesciences Ltd. is optimistic about the potential of Desidustat to provide a new treatment option for sickle cell disease patients. Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Ltd., said, “Sickle cell disease severely impacts the lives of millions of people and represents a high unmet medical need. We are happy to collaborate with ICMR to develop new and effective therapeutic options for patients living with Sickle Cell Disease. Desidustat, discovered and developed at the Zydus Research Centre, reflects our commitment to advancing novel innovations and improve quality of life for patients.”

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Zydus Lifesciences Limited

Zydus Lifesciences Limited belongs to the › sector. Here’s a quick read on where the business and the stock stand today.

ZYDUSLIFE
Healthcare › Drug Manufacturers - Specialty & Generic
CONSOLIDATING DOWN
86
Fundamental
64
Technical
76
Overall

1W +0.49%
1M +1.4%
3M -1.81%
P/E: 25 Cap: Large
AI-Powered Analysis • TradeAlone
Download the App for in-depth analysis of this stock

Zydus gains 19.0% over three months and trades near its 52-week highs. The PEG of 0.61 signals undervaluation relative to growth. It is a potential re-rating candidate. The business compounds revenue at 16.5% and profits at 37.0% CAGR. That is strong double-digit growth on both counts. The stock trades at 84% of its 52-week range — near its best levels of the year. Clearly, the market pays a premium for this name. Both the business and the stock move in the right direction. Revenue grows at 16.5%, profits at 37.0%, and the PEG sits at 0.61 — below its growth rate. That combination is rare. Check Fundamentals of Zydus Lifesciences Limited.

CORONA

Corona Remedies Limited (corona) Secures Anvisa GMP Certification for Bhayla Manufacturing Facility

CORONA Remedies Limited (CORONA) receives ANVISA GMP certification for Bhayla manufacturing, reinforcing its commitment to ‘One World, One Quality’.

adit chauhan author tradealone

Published

on

Corona Remedies Limited (corona) Anvisa GMP Certification Bhayla

CORONA Remedies Limited (CORONA) has received Good Manufacturing Practice (GMP) certification from Brazil’s National Health Surveillance Agency (ANVISA) for its Bhayla manufacturing facility in Ahmedabad. This certification covers both Oral Solid Dosage (OSD) and Women’s Hormone production lines. This milestone further strengthens CORONA’s manufacturing credentials and reaffirms its commitment to maintaining high standards of quality, compliance, and operational excellence.

Reaffirming the Philosophy of ‘One World, One Quality’

While India will remain the company’s primary market, contributing over 96% of its revenue, the ANVISA GMP certification further strengthens CORONA’s manufacturing credentials. This marks CORONA’s third major GMP accreditation, building on its EU-GMP approvals for the Women’s Hormone and OSD facilities and its EAEU-GMP certification for the OSD facility. Brazil represents one of the largest pharmaceutical markets in Latin America, with an estimated market size of USD 44 billion, presenting opportunities for pharmaceutical manufacturers with strong quality systems and regulatory capabilities.

Commitment to Quality and Compliance

Together, these recognitions reflect the company’s continued focus on strengthening quality systems, maintaining regulatory compliance, and fostering a culture of continuous improvement across its manufacturing operations. Commenting on this achievement, Mr. Viral Sitwala, Executive Director, CORONA Remedies Limited, said: “Quality has always been central to the way we work at CORONA Remedies. Our philosophy of ‘One World, One Quality’ reflects our belief that the standards we follow must remain consistent and uncompromised. The ANVISA GMP certification for our Bhayla manufacturing facility is an important recognition of the systems, discipline, and collective efforts that go into maintaining these standards. While India remains our primary market and the focus of our business, such accreditations further strengthen our manufacturing credentials and reaffirm our commitment to quality and compliance. We will continue to strengthen our capabilities and uphold the quality standards that guide everything we do.”

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of CORONA Remedies Limited

CORONA Remedies Limited belongs to the › sector. Here’s a quick read on where the business and the stock stand today.

CORONA
Healthcare › Drug Manufacturers - General
—
76
Fundamental
80
Technical
79
Overall

1W -0.99%
1M -6.52%
3M -2.83%
P/E: 61.6 Cap: —
AI-Powered Analysis • TradeAlone
Download the App for in-depth analysis of this stock

CORONA holds in the upper half of its 52-week range, a sign the market backs the stock. The PEG of 2.07 is on the high side. However, it is acceptable for a quality compounder with a strong moat. The business compounds revenue at 16.6% and profits at 29.7% CAGR. That is strong double-digit growth on both counts. Buyers show up with 2.0x the volume of sellers. Moreover, they dominated on 17 of recent sessions versus 13 for sellers — a healthy accumulation pattern. The business grows revenue at 16.6% and profits at 29.7%, with D/E of 0.14. The stock reflects that strength. Moreover, when fundamentals and price action align, the PEG of 2.07 premium is usually justified. Check Fundamentals of CORONA Remedies Limited.

Continue Reading

Health Information Services

Sagility Limited (NSE: Sagility) Q2 FY27: 11.9% Y-o-y Constant Currency Organic Growth

Sagility Limited (NSE: SAGILITY) reports Q2 FY27 results with 11.9% Y-o-Y constant currency organic growth and $40.2M ACV.

Pranab Tyagi at TradeAlone

Published

on

Sagility Limited NSE Sagility Q2 FY27 Results

Sagility Limited (NSE: SAGILITY) has announced its Q2 FY27 results, showcasing robust performance with 11.9% year-over-year constant currency organic growth. The company won $40.2M in ACV from 31 existing clients and 1 new logo, indicating increasing traction in larger deals.

Financial Highlights

The financial performance highlights include a revenue of ₹ 20,321 Million, an Adjusted EBITDA of ₹ 5,353 Million, and an Adjusted PAT of ₹ 3,254 Million. The company’s margin stood at 26.3% for Adjusted EBITDA and 16.0% for Adjusted PAT.

Growth and Expansion

Sagility’s growth is further supported by its acquisition of Chirok Health LLC, which adds specialized CDI and coding capabilities, extending its end-to-end RCM offering and unlocking new growth opportunities. The acquisition is expected to broaden Sagility’s provider footprint and deliver greater client value.

As a result, Sagility continues to strengthen its market position and drive forward-looking growth prospects.

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of SAGILITY LIMITED

SAGILITY LIMITED belongs to the › sector. Here’s a quick read on where the business and the stock stand today.

SAGILITY
Healthcare › Health Information Services
APPROACHING RESISTANCE
86
Fundamental
68
Technical
77
Overall

1W +2.95%
1M +0.62%
3M +8.5%
P/E: 21.4 Cap: Large
AI-Powered Analysis • TradeAlone
Download the App for in-depth analysis of this stock

SAGILITY rises 8.5% over three months, with buying pressure holding steady. The PEG of 0.25 is extremely low. Either the market misses the growth story, or there is a catch worth investigating. The business compounds revenue at 19.5% and profits at 86.1% CAGR. That is strong double-digit growth on both counts. The stock holds at 43% of its 52-week range with RSI at 56. In other words, neither side has a clear edge right now. Revenue grows at 19.5% and profits at 86.1%. The business is in good shape. Moreover, a stock that does not move despite strong fundamentals often offers better value than one already priced for perfection. Check Fundamentals of SAGILITY LIMITED.

Continue Reading

Drug Manufacturers - General

Kopran Limited (kopran): EU Medicine Authority Conducts Successful GMP Inspection at Khopoli Facility

Kopran Limited (KOPRAN) announces successful EU Medicine Authority GMP inspection at Khopoli facility, with no critical observations.

jyoti sharma

Published

on

Kopran Limited Kopran EU GMP Inspection Khopoli

Kopran Limited (KOPRAN) announced the successful completion of a GMP inspection by the European Union Medicines Authority at its Formulation manufacturing facility in Khopoli. The inspection, conducted from September 18 to September 23, 2026, concluded with no critical observations, one major observation, and some minor observations. Notably, there were no data integrity related observations. The company is currently preparing compliance responses to the EU authorities, expected to be submitted within a fortnight.

Inspection Details

The Medicine Authority European Union (EU) inspected the Khopoli facility to ensure compliance with Good Manufacturing Practices (GMP). The team evaluated various aspects of the manufacturing process, including quality control, production, and documentation. The inspection was thorough and comprehensive, covering all critical areas of the facility.

Compliance and Future Steps

Kopran Limited is in the process of addressing the minor and major observations noted during the inspection. The company is committed to maintaining the highest standards of manufacturing and will submit the required compliance responses to the EU authorities by October 2026. This proactive approach ensures that the facility continues to meet stringent regulatory requirements.

As a result, Kopran Limited reaffirms its dedication to quality and compliance, which is essential for its reputation and continued success in the pharmaceutical industry.

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Kopran Limited

Kopran Limited belongs to the › sector. Here’s a quick read on where the business and the stock stand today.

KOPRAN
Healthcare › Drug Manufacturers - General
CONSOLIDATING DOWN
42
Fundamental
86
Technical
64
Overall

1W +8.01%
1M +3.94%
3M +33.16%
P/E: 54.3 Cap: Small
AI-Powered Analysis • TradeAlone
Download the App for in-depth analysis of this stock

Kopran gains 33.2% over three months and trades near its 52-week highs. Razor-thin margins below 5% make profitability extremely vulnerable — this business needs scale or pricing power urgently. 1 loss quarter(s) over five years signals earnings fragility — not chronic but worth noting. Buyers show up with 5.0x the volume of sellers. Moreover, they dominated on 18 of recent sessions versus 12 for sellers — a healthy accumulation pattern. The stock rises 33.2% in three months. Yet revenue grows at only 7.2% and the PEG stands at 99.00. Either the market prices in a turnaround that has not shown up yet, or this is momentum without substance. Check the next two earnings prints before drawing conclusions. Check Fundamentals of Kopran Limited.

Continue Reading

Trending

Exit mobile version