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This is the twenty-fifth edition (week ending 13-Sep-26) of our Pharma Weekly - In Case You Missed It. Key developments in the past week:

1) Roivant’s Mosliciguat delivered positive Phase 2 results in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), supporting advancement into Phase 3 (relevant for Sai Life).

2) FDA has finalized the voluntary withdrawal of BMS’s Krazati’s (Adagrasib) indication in mutated colorectal cancer (CRC), following failure of the Phase 3 trial to meet its co-primary endpoints. The withdrawal affects the CRC indication only; Krazati’s accelerated approval in second-line mutated NSCLC remains unaffected (relevant for Syngene).

3) Celltrion has received regulatory clearance for amended Phase 3 trial plans for its Keytruda biosimilar in the US. The trial will enroll a significantly fewer number of patients vs earlier (relevant for Zydus, Ipca, Dr Reddy’s, Biocon and Cipla).

4) Evommune’s EVO756 failed to meet primary and secondary endpoints in a Phase 2b trial in adults with moderate-to-severe atopic dermatitis, and the company will not advance the drug in AD. EVO756 was generally well tolerated and will continue to be evaluated for migraine prophylaxis (relevant for Piramal Pharma).

5) Lupin’s Global CFO Ramesh Swaminathan said the company would continue investing in both Somerset and Coral Springs manufacturing units in the US to manufacture products that are only economically feasible. He also said the company is scaling up its biosimilars business, targeting ~$500mn revenue over the next five years, and the company has invested ~Rs5bn in biosimilar manufacturing capacity.

6) AbbVie’s Qulipta (Atogepant) met the primary endpoint in a Phase 3 trial, showing a greater reduction in menstrual migraine days versus placebo over three menstrual cycles, while also delivering statistically significant improvements across all eight secondary endpoints; AbbVie plans to submit the data to global regulators (relevant for Sai Life).

7) Neuland Laboratories approved Rs1.26bn capex for the purchase of ~134 acres of land at Auro Industrial City, Kakinada (Andhra Pradesh), for future expansion. The company also has a right of first refusal for an additional ~66 acres, potentially taking the total land parcel to ~200 acres; the acquisition will be funded through internal accruals.

8) The FTC has urged the US Court of Appeals for the Fourth Circuit to recognize that acquiring pending patent applications can constitute exclusionary conduct under antitrust law. The case involving Amgen’s Enbrel could create a new avenue for biosimilar developers to challenge patent transactions and thickets used to delay competing products and maintain market exclusivity.

9) Novo Nordisk’s Wegovy (Semaglutide) has been approved in China for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), making it the first GLP-1 receptor agonist approved in the country for the condition. On a separate note, Novo Nordisk said 40.4% of children aged 6 to under 12 with obesity treated with Semaglutide were no longer classified as having obesity after 68 weeks in the Phase 3 trial, assuming full treatment adherence.

10) IOL Chemicals & Pharma is investing Rs3.5bn to expand its backwardintegrated Ibuprofen capacity by 6,000 MTPA, taking the total capacity to 18,000 MTPA. It is also investing Rs1.1bn in a 1.5bn tablet/year formulation CDMO facility and Rs350mn in a dedicated specialty chemicals facility, with both facilities targeted for commercialization in 3QFY27.

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