Yeji
FDA approvaloutcome: successconf 1.00

tofidence — FDA approval

$BIIB · BIOGEN INC.
Event date
September 29, 2023
981 days ago
Sponsor runway
cash-flow +
$3.38B liquid

Evidence

“openFDA ORIG (UNKNOWN) approval of TOFIDENCE — application BLA761354”
Source ↗

Comparable historical fda approvals· last 5 years · same event type

100% hit rate (10/10)
TickerDrugDateOutcome
$INCYzynyz2026-05-18success
$INCYjakafi xr2026-05-01success
$AXSMauvelity2026-04-30success
$INCYzynyz2026-03-30success
$BIIBspinraza2026-03-27success
$CORTlifyorli2026-03-25success
$RYTMimcivree2026-03-19success
$ASNDyuviwel2026-02-27success
$BMRNpalynziq2026-02-27success
$ETONdesmoda2026-02-25success

Recent insider activity· ±90 days

5 insiders · 0 buys · 4 sells
Sell10b5-1
2023-12-11
Singhal Priya
Head of Development
110 @ $248.00$27K
Tax
2023-12-08
Kramer Robin
Chief Financial Officer
170 @ $239.29$41K
Exercise10b5-1
2023-12-08
Singhal Priya
Head of Development
426 @ ——
Tax10b5-1
2023-12-08
Singhal Priya
Head of Development
206 @ $239.29$49K
Exercise
2023-12-08
Kramer Robin
Chief Financial Officer
351 @ ——
Grant
2023-11-01
Grogan Jane
Head of Research
2,085 @ ——
Sell
2023-09-26
BIOGEN INC.
10%+ Owner
6,000,000 @ $0.50$3.00M
Sell10b5-1
2023-09-05
Singhal Priya
Head of Development
431 @ $269.43$116K
Exercise
2023-09-01
MCDONNELL MICHAEL R
EVP, Chief Financial Officer
2,682 @ ——
Tax
2023-09-01
MCDONNELL MICHAEL R
EVP, Chief Financial Officer
1,372 @ $267.17$367K
Exercise
2023-09-01
MCDONNELL MICHAEL R
EVP, Chief Financial Officer
2,603 @ ——
Tax
2023-09-01
MCDONNELL MICHAEL R
EVP, Chief Financial Officer
1,332 @ $267.17$356K
Other
2023-09-01
MCDONNELL MICHAEL R
EVP, Chief Financial Officer
2,763 @ ——
Exercise10b5-1
2023-09-01
Singhal Priya
Head of Development
1,668 @ ——
Tax10b5-1
2023-09-01
Singhal Priya
Head of Development
807 @ $267.17$216K
Sell10b5-1
2023-07-03
Singhal Priya
Head of Development
81 @ $282.87$23K
← All catalysts for $BIIB