Acetaminophen

Bengaluru: Granules India reported a drop in fourth-quarter adjusted profit on Wednesday, hurt by weak pricing and stiff competition in its key European and North American markets . Profit before exceptional items and tax fell to 1.67 billion rupees ($19.6 million) for the quarter ended March 31, from 1.76 billion rupees a year earlier. The drugmaker logged a one-time gain of 307.5 million rupees related to an insurance claim it received during the reported quarter. Including the gain, consolidated profit rose 17 per cent. Granules, which generates about two-thirds of its revenue from North America and 19% from Europe, posted a 2 per cent rise in its revenue from operations. Key context Granules, which holds a 30% share of the global paracetamol market , supplies the drug as an active pharmaceutical ingredient (API) and as a ready for consumption form in Europe, Canada, and South Africa. APIs are the active and key components in a drug that produce the intended therapeutic effects. Indian API makers have been grappling with weak pricing in key European and North American markets due to tough competition, even as global drugmakers turn to India to limit their reliance on Chinese contractors. PEER COMPARISON Valuation (next Estimates (next 12 Analysts' sentiment 12 months) months) RIC PE EV/EBITDA Revenue Profit Mean No. of Stock to Div growth (%) growth (%) rating analysts price yield target (%) Granules India 20.33 11.53 13.86 27.62 Strong 4 0.82 0.29 Buy Alivus Life 23.32 16.46 10.87 12.96 Strong 2 0.86 2.04 Sciences Buy Laurus Labs (Reporting by Kashish Tandon in Bengaluru; Editing by Rashmi Aich)

Unlike a post-review rejection in the form of a complete response letter, an refuse to file letter means the FDA has declined to evaluate Savara’s application as submitted. Despite hiring a commercial chief and sponsoring disease awareness efforts last year, Savara will have to wait a while longer for a potential approval of its inhaled lung disease asset molgramostim.The FDA has slapped Savara with a refuse to file (RTF) letter after the biotech in March applied for approval of molgramostim in the rare disease autoimmune pulmonary alveolar proteinosis (aPAP).Unlike a post-review rejection in the form of a complete response letter, an RTF letter means the FDA has declined to evaluate Savara’s application as submitted.The FDA has determined that Savara’s initial filing was “not sufficiently complete to permit substantive review,” the biotech said in a Monday press release. The regulator has in turn asked Savara to provide additional chemistry, manufacturing and controls (CMC) data, suggesting some sort of production hang-up played a part in the FDA’s decision.The FDA did not flag any safety concerns related to molgramostim, nor did it request or recommend additional efficacy studies, Savara explained. Savara plans to request a meeting with the FDA in the next 30 days.“Based on our understanding of the letter, we are confident we can thoroughly address the agency’s request and expect to resubmit our [biologics license application] in the fourth quarter of 2025,” Savara CEO Matt Pauls said in a statement. The company is already in the process of generating the CMC data requested by the FDA, Pauls added.“We remain highly confident in our program for autoimmune PAP and believe that our clinical data demonstrate that Molbreevi improves pulmonary gas transfer and respiratory health-related quality of life in this rare disease,” the CEO said, referring to molgramostim by its intended trade name.Savara is developing molgramostim to treat aPAP, a rare disease that clogs the air sacs in the lungs, potentially leading to serious complications like lung fibrosis and the need for a lung transplant. As a granulocyte-macrophage colony-stimulating factor, molgramostim is designed to work by clearing surfactant—a mixture of fat and proteins in the lungs—from the alveoli, or air sacs, in the organs.The drug is delivered via an investigational nebulizer specifically designed by Germany’s PARI Pharma to work with molgramostim, Savara said in its release. Savara has been working on molgramostim for years now, facing various struggles along the way, though the company appeared to believe an approval was in reach as it started making commercial preparations last year.In September, Savara hired Orchard Therapeutics veteran Braden Parker as its chief commercial officer. Parker was primarily brought on to assist with molgramostim’s potential launch, which the company had positioned at the time for late 2025 or 2026.And, in October, Savara also sponsored an episode of “The Balancing Act," a morning talk show that airs on Lifetime, highlighting the stories of patients with rare and genetic diseases. The primary focus of the sponsored program was aPAP, molgramostim’s intended indication.Savara’s continued devotion to molgramostim comes after the company underwent a major pipeline shake-up in 2020, during which it scrapped multiple other assets to hone its focus on aPAP.