Wockhardt USA LLC

Wockhardt receives favourable recommendation from CDSCO's SEC for its novel antibiotic Miqnaf, developed for treating community-acquired bacterial pneumonia (CABP) in adults. Miqnaf, a 3-day treatment, targets CABP, including cases caused by multi-drug resistant bugs. India contributes to 23% of the global CABP burden. Wockhardt shares rose 5% to Rs 994.95 on BSE.

FDA grants Fast Track designation to Wockhardt's once-a-day antibiotic WCK 6777 for cUTI and cIAI. WCK 6777, active against meropenem-resistant Gram negative pathogens, completed a Phase I study with a promising safety profile.

Zaynich, a potential treatment for drug-resistant infections, will complete global Phase 3 trials in 2-3 months, with regulatory filings expected in Q2 next year and potential approvals in early 2026. The drug has a high susceptibility breakpoint of 64 mg/litre for gram-negative pathogens, indicating greater efficacy. Zaynich has successfully treated meningitis and has been used in 35 compassionate cases, showing safety over 70-day treatments with no side effects. It aims to address the global issue of multi-drug resistance, which causes five million deaths annually, including 1.1 million in India.

Wockhardt's WCK 5222, Zaynich, shows promise in treating drug-resistant meningitis; phase three trials to complete by early 2026, with a global launch expected by mid-2026. The drug could benefit over 1.8 million patients in the US and India, with an estimated market of $5-6 billion.

SEBI Chairperson Madhabi Puri Buch and her husband Dhaval Buch refute conflict of interest claims, detailing Dhaval's extensive qualifications and experience, and emphasizing transparency in their financial dealings, including consulting assignments and rental income.

Congress alleges Madhabi Puri Buch's husband received Rs 4.78 crore from M&M while Sebi issued orders related to M&M. M&M denies allegations, stating Dhaval Buch was hired for supply chain expertise. Congress claims conflict of interest with Puri Buch's consultancy firm Agora Advisory, which received income from M&M and others. Sebi and Buchs deny all allegations.