Yeji
FDA approvaloutcome: successconf 1.00

qalsody — FDA approval

$BIIB · BIOGEN INC.
Event date
April 25, 2023
1138 days ago
Sponsor runway
cash-flow +
$3.38B liquid

Evidence

openFDA ORIG (TYPE 1) approval of QALSODY — application NDA215887

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

15 insiders · 0 buys · 4 sells
Sell10b5-1
2023-07-03
Singhal Priya
Head of Development
81 @ $282.87$23K
Exercise10b5-1
2023-06-30
Singhal Priya
Head of Development
315 @
Tax10b5-1
2023-06-30
Singhal Priya
Head of Development
153 @ $284.85$44K
Tax
2023-06-30
Izzar Rachid
Head of Global Product Strat.
244 @ $284.85$70K
Exercise
2023-06-30
Izzar Rachid
Head of Global Product Strat.
504 @
Tax
2023-06-30
Kramer Robin
Chief Financial Officer
122 @ $284.85$35K
Exercise
2023-06-30
Kramer Robin
Chief Financial Officer
252 @
Grant
2023-06-26
HAWKINS WILLIAM A
Director
960 @
Grant
2023-06-26
SHERWIN STEPHEN A
Director
960 @
Grant
2023-06-26
Rowinsky Eric K
Director
960 @
Grant
2023-06-26
Mantas Jesus B
Director
960 @
Grant
2023-06-26
LANGER SUSAN
Director
960 @
Grant
2023-06-26
Freire Maria C
Director
960 @
Grant
2023-06-26
DORSA CAROLINE
Director
1,580 @
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
144 @ $268.75$39K
Tax
2023-03-02
Singhal Priya
Head of Development
543 @ $268.75$146K
Exercise
2023-03-02
Singhal Priya
Head of Development
297 @
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
Izzar Rachid
Head of Global Product Strat.
1,515 @
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
+ 42 more