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APLLTDNSEAlembic Pharmaceuticals Limited· Pharmaceuticals & BiotechnologyHighPositive
Announced Fri, 19 Jun, 2026 · 13:00 IST

USFDA tentative approval for Binimetinib 45mg Tablets

Regulatory Product ApprovalBusiness Updates View source PDFExplain this filing

APLLTD · price

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▲ 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
+2.0%Reaction day
₹748.90
prior close
₹754.80
announcement price
In-mkt
timing
Nifty Microcap 250market+0.8%+1.2% vs market
Pharmaceuticals peers, median of 160sector+0.4%+1.6% vs sector

On the reaction day the stock moved 1.2 pts more than Nifty Microcap 250 and 1.6 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
5m
+0.3
10m
+0.6
15m
+1.1
30m
+0.4
Sessions after the filingfrom the prior close
StockMarketvs marketSectorvs sector
Reaction day
+2.0+0.8+1.2+0.4+1.6
Next day
+3.8+1.7+2.1+0.5+3.2
2d
+3.5+0.9+2.5+1.7+1.8
3d
+4.5+0.8+3.6+1.7+2.7
4d
+2.7+0.2+2.5+0.9+1.8
5d
+5.0-0.1+5.0+1.5+3.5
1w
+10.8+1.1+9.7+2.7+8.1
15d
+10.8+2.5+8.3+4.1+6.7
1m
+13.5+1.2+12.3+4.0+9.5
2m
+8.7+4.9+3.8+2.0+6.7
3m
+13.0+5.8+7.2+7.7+5.3
UpDownMarket · Nifty Microcap 250Sector · Pharmaceuticals peers, median of 160Pending

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

AI summary

Alembic Pharmaceuticals has received USFDA tentative approval for its ANDA for Binimetinib Tablets, 45 mg, used to treat unresectable or metastatic melanoma and NSCLC with BRAF mutations. Alembic is the sole first Paragraph IV filer and may get 180 days of generic marketing exclusivity in the US upon final approval. The drug has an estimated US market size of about 259 million dollars for 12 months ending March 2026 (IQVIA). Alembic now has 242 cumulative ANDA approvals (222 final and 20 tentative).

Likely market impact

Positive. Tentative approval strengthens Alembic's US pipeline and potential exclusivity, but revenue only starts after final approval and patent resolution.