Lupin gets tentative US FDA nod for Apixaban Oral Suspension

Regulatory product approvalBusiness Updates View source PDF Explain this filing

LUPIN · price

Loading chart…

▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.

Price reactionminutes from the announcement price · days from the prior close

-1.4%Reaction day

₹2092.00

prior close

₹2087.90

announcement price

After-mkt

timing

Nifty Midcap 150market-1.6%+0.2% vs market

Pharmaceuticals peers, median of 172sector-1.5%+0.1% vs sector

On the reaction day the stock moved 0.2 pts more than Nifty Midcap 150 and 0.1 pts more than its Pharmaceuticals peers, over the same two closes: a difference in percentage points, not a measure of what the filing did.

Minutes after the announcementfrom the announcement price · no benchmark

Stock

-0.2

10m

-0.0

15m

-0.2

30m

-0.5

Sessions after the filingfrom the prior close

StockMarketvs marketSectorvs sector

Reaction day

-1.4-1.6+0.2-1.5+0.1

Next day

-1.9-2.6+0.7-1.0-1.0

-3.0-2.5-0.4-1.9-1.1

-2.9-3.5+0.6-2.4-0.5

-3.9-3.0-0.8-3.2-0.6

-3.0-2.0-0.9-2.4-0.6

-7.4-5.0-2.4-4.2-3.2

15d

-6.1-5.5-0.6-7.9+1.8

-5.6-6.1+0.5-6.6+0.9

—————

UpDownMarket · Nifty Midcap 150Sector · Pharmaceuticals peers, median of 172Pending

Minute windows have no benchmark: there is no intraday index history to compare against.

AI summary

Lupin has received tentative approval from the US FDA for its New Drug Application for Apixaban Oral Suspension 1.25 mg/mL via the 505(b)(2) pathway. Apixaban is the active ingredient in Bristol Myers Squibb's blood thinner Eliquis. The oral liquid form helps adults who struggle to swallow tablets. Upon final approval, it will be made at Lupin's Somerset, New Jersey facility. This adds to Lupin's differentiated US generics portfolio.

Likely market impact

Positive for Lupin as it expands its US portfolio with a differentiated oral suspension format of a blockbuster anticoagulant drug.