Yeji
FDA approvaloutcome: successconf 1.00

skyclarys — FDA approval

$BIIB · BIOGEN INC.
Event date
February 28, 2023
1194 days ago
Sponsor runway
cash-flow +
$3.38B liquid

Evidence

openFDA ORIG (TYPE 1) approval of SKYCLARYS — application NDA216718

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

9 insiders · 0 buys · 3 sells
Grant
2023-05-01
Keeney Adam
Head of Corporate Development
2,815 @
Sell10b5-1
2023-04-28
Gregory Ginger
EVP, Human Resources
2,681 @ $300.00$804K
Sell10b5-1
2023-04-04
Singhal Priya
Head of Development
91 @ $277.11$25K
Exercise
2023-03-31
Murphy Nicole
Head of Pharm Ops and Tech
239 @
Tax
2023-03-31
Murphy Nicole
Head of Pharm Ops and Tech
116 @ $278.03$32K
Sell
2023-03-28
Singhal Priya
Head of Development
568 @ $270.06$153K
Tax
2023-03-02
Singhal Priya
Head of Development
543 @ $268.75$146K
Exercise
2023-03-02
Singhal Priya
Head of Development
297 @
Tax
2023-03-02
Singhal Priya
Head of Development
144 @ $268.75$39K
Other
2023-03-02
Singhal Priya
Head of Development
341 @
Exercise
2023-02-17
Singhal Priya
Head of Development
460 @
Tax
2023-02-17
Singhal Priya
Head of Development
151 @ $278.38$42K
Other
2023-02-17
Singhal Priya
Head of Development
408 @
Exercise
2023-02-17
Murphy Nicole
Head of Pharm Ops and Tech
480 @
Tax
2023-02-17
Murphy Nicole
Head of Pharm Ops and Tech
233 @ $278.38$65K
Other
2023-02-17
Murphy Nicole
Head of Pharm Ops and Tech
426 @
Exercise
2023-02-17
MCDONNELL MICHAEL R
EVP, Chief Financial Officer
2,561 @
Tax
2023-02-17
MCDONNELL MICHAEL R
EVP, Chief Financial Officer
1,310 @ $278.38$365K
Other
2023-02-17
MCDONNELL MICHAEL R
EVP, Chief Financial Officer
2,271 @
Exercise
2023-02-17
Kramer Robin
Chief Financial Officer
512 @
Tax
2023-02-17
Kramer Robin
Chief Financial Officer
238 @ $278.38$66K
Other
2023-02-17
Kramer Robin
Chief Financial Officer
454 @
Exercise
2023-02-17
Izzar Rachid
Head of Global Product Strat.
767 @
Tax
2023-02-17
Izzar Rachid
Head of Global Product Strat.
371 @ $278.38$103K
Other
2023-02-17
Izzar Rachid
Head of Global Product Strat.
681 @
Exercise
2023-02-17
Gregory Ginger
EVP, Human Resources
1,792 @
Tax
2023-02-17
Gregory Ginger
EVP, Human Resources
867 @ $278.38$241K
Other
2023-02-17
Gregory Ginger
EVP, Human Resources
1,590 @
Exercise
2023-02-17
ALEXANDER SUSAN H
EVP Chief Legal Officer
1,920 @
Tax
2023-02-17
ALEXANDER SUSAN H
EVP Chief Legal Officer
929 @ $278.38$259K
Other
2023-02-17
ALEXANDER SUSAN H
EVP Chief Legal Officer
1,702 @
Exercise
2023-02-10
ALEXANDER SUSAN H
EVP Chief Legal Officer
2,575 @
Tax
2023-02-10
ALEXANDER SUSAN H
EVP Chief Legal Officer
764 @ $286.30$219K
Exercise
2023-02-10
ALEXANDER SUSAN H
EVP Chief Legal Officer
1,448 @
Tax
2023-02-10
ALEXANDER SUSAN H
EVP Chief Legal Officer
701 @ $286.30$201K
Tax
2023-02-10
ALEXANDER SUSAN H
EVP Chief Legal Officer
2,737 @ $286.30$784K
Other
2023-02-10
ALEXANDER SUSAN H
EVP Chief Legal Officer
1,770 @
Exercise
2023-02-10
Gregory Ginger
EVP, Human Resources
2,158 @
Tax
2023-02-10
Gregory Ginger
EVP, Human Resources
648 @ $286.30$186K
Exercise
2023-02-10
Gregory Ginger
EVP, Human Resources
1,132 @
Tax
2023-02-10
Gregory Ginger
EVP, Human Resources
548 @ $286.30$157K
Tax
2023-02-10
Gregory Ginger
EVP, Human Resources
2,110 @ $286.30$604K
Other
2023-02-10
Gregory Ginger
EVP, Human Resources
1,384 @
Exercise
2023-02-10
Izzar Rachid
Head of Global Product Strat.
1,515 @
Tax
2023-02-10
Izzar Rachid
Head of Global Product Strat.
462 @ $286.30$132K
Exercise
2023-02-10
Izzar Rachid
Head of Global Product Strat.
453 @
Tax
2023-02-10
Izzar Rachid
Head of Global Product Strat.
220 @ $286.30$63K
Tax
2023-02-10
Izzar Rachid
Head of Global Product Strat.
642 @ $286.30$184K
Other
2023-02-10
Izzar Rachid
Head of Global Product Strat.
553 @
Exercise
2023-02-10
Kramer Robin
Chief Financial Officer
833 @
+ 40 more