Found a bug or want a feature? Verified reports earn free credits.
Log inSign up
Back to alerts
APLLTDBSEAlembic Pharmaceuticals Ltd· Pharmaceuticals & BiotechnologyHighPositive
Announced Fri, 19 Jun, 2026 · 12:57 IST

USFDA tentative approval for Alembic's Binimetinib Tablets, 45 mg

Regulatory Product ApprovalBusiness Updates View source PDFExplain this filing

APLLTD · 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
+2.0%Reaction day
₹748.90
prior close
₹747.85
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
+2.7
10m
+1.1
15m
+2.0
30m
+1.6
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 generic Binimetinib Tablets 45 mg, used to treat certain metastatic melanoma and lung cancer patients. Alembic is the sole first applicant to file with a Paragraph IV certification, making it potentially eligible for 180 days of US generic marketing exclusivity upon final approval. The drug has an estimated US market size of around USD 259 million (IQVIA, twelve months ending March 2026). This adds to Alembic's earlier tentative approval for the 15 mg strength, taking its cumulative ANDA tally to 242.

Likely market impact

Positive for Alembic's US generics pipeline. Sole first applicant status could unlock 180-day exclusivity on a USD 259 million market after final approval.