CIPLA LIMITED

A phase I/II trial compared 3 azithromycin doses in children with severe malaria, randomizing 105 cases to 10, 15, or 20 mg/kg over 5 days, while 50 controls received standard care. The study aimed to determine optimal azithromycin doses for future trials, with co-primary outcomes of CRP change and microbiological cure. Results showed similar CRP reductions across doses, with no significant differences in survival or adverse events. Pharmacokinetic analysis suggested allometric dosing for consistent exposure, contrasting with the trial's mg/kg regimens.

Sun Pharma's shares dropped 3.4% after the U.S. District Court of New Jersey barred the launch of its alopecia drug, Leqselvi, until December 2026. The company plans to appeal, and while Nomura analysts see near-term growth risks, they do not expect a significant long-term impact. Sun Pharma's YTD gain of 42% exceeds peers Cipla and Dr Reddy's.

Cipla's share price rose 10% after its Goa facility was classified as Voluntary Action Indicated (VAI) by the USFDA, allowing the launch of large products in the US. The facility, inspected between June 10-21, is compliant with Good Manufacturing Practices (cGMP), paving the way for the generic version of the oncology drug Ambraxane.

Cipla Ltd. shares surged 10% after USFDA classified its Goa facility as 'Voluntary Action Indicated', enabling key niche launches like the Abraxane generic. Citi expects potential $24-$48 million sales in FY26-27, with a 'buy' recommendation and price target of ₹1,830.

Cipla faces delays in launching key drugs Advair and Abraxane due to regulatory hurdles, projecting a mid-FY26 launch for Advair and pending clearance for Abraxane's Goa facility. Competitors gaining ground could impact market share and revenue potential.

The Menopausal Hot Flashes Market report by DataM Intelligence analyzes market trends, key players (Pfizer Inc, AbbVie Inc., Bayer, etc.), and growth projections through 2024-2031. It highlights advancements in medical technologies and patient-centered care driving market growth, with regions including North America, Europe, Asia Pacific, and more covered. Key developments include Veozah's FDA approval and Elda Health's product launch.

Cipla's Q2 earnings on Oct 29 expected to show 5% net profit growth to Rs 1,215 crore and 5% revenue growth to Rs 6,996 crore, with EBITDA margin around 26%. US sales growth forecast at 3% to $235 million, domestic sales likely high single-digit growth. Margin growth expected to remain capped due to lack of high-margin drug launches in the US.

The 'Antibiotic Resistance Markets - Therapeutics by Pathogen and Therapy Type' report outlines market players addressing antimicrobial resistance, including drug manufacturers, biotech companies, and regulatory bodies. It highlights the role of diagnostics in combating AMR and identifies 6 key market opportunities. The report provides five-year market forecasts and profiles over 100 biotech companies.

Alvotech announced EMA accepted a Marketing Authorization Application for AVT03, a biosimilar candidate to Prolia® and Xgeva® (denosumab). AVT03 met primary endpoints in studies demonstrating clinical similarity to Prolia in efficacy, safety, immunogenicity, and pharmacokinetics. Alvotech partners with STADA Arzneimittel AG and Dr. Reddy’s Laboratories SA for AVT03 commercialization in Europe.

Alvotech announced EMA acceptance of its Marketing Authorization Application for AVT03, a biosimilar candidate to Prolia® and Xgeva® (denosumab). AVT03 aims to treat osteoporosis and prevent bone complications in cancer patients, potentially expanding patient access to affordable biologic medicines.