CHMP to Delay Nod on Biogen (BIIB), Eisai's Alzheimer's Drug [Yahoo! Finance]
Biogen Inc. (BIIB)
Last biogen inc. earnings: 4/22 07:12 am
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Source: Yahoo! Finance
Per the companies, this delay is entirely related to procedural reasons at the EMA and is not related to the marketing authorization application (MAA) submitted for lecanemab. This MAA has been under EMA's review since January 2023. This delay is in consequence of an EU court ruling passed on Mar 14 that had "implications on EMA's policy on the handling of competing interests of experts." Due to this reason, the EMA also had to call off the advice it received at the Scientific Advisory Group on Neurology (SAG-N) meeting for lecanemab held on Mar 11. The EU regulator intends to reconvene another SAG-N meeting but has yet to schedule it. Biogen has developed Leqembi in collaboration with Eisai, with the latter leading the clinical development and regulatory submissions. Though the companies co-commercialize and co-promote the drug, Eisai has the final decision-making authority. The Biogen-Eisai partnered drug is currently approved for AD indication in the United States, Japan and
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- Biogen Inc. (NASDAQ: BIIB) had its price target lowered by analysts at Barclays PLC from $215.00 to $200.00. They now have an "equal weight" rating on the stock.MarketBeat
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- Biogen Inc. (NASDAQ: BIIB) had its price target raised by analysts at Wedbush from $213.00 to $215.00. They now have a "neutral" rating on the stock.MarketBeat
BIIB
Earnings
- 4/25/24 - Beat
BIIB
Sec Filings
- 4/26/24 - Form ARS
- 4/26/24 - Form DEFA14A
- 4/26/24 - Form DEF
- BIIB's page on the SEC website