Biogen Wins Approval with FDA for Alzheimer’s Drug

This morning Biogen (NASDAQ:BIIB) received approval from the FDA for their Alzheimer’s drug aducanumab. The FDA decision marks the first new Alzheimer’s disease drug since 2003 to receive approval and the first that aims to slow disease progression.

The drug aims to remove sticky deposits of a protein called amyloid-beta from the brains of patients in earlier stages of Alzheimer’s. The goal of the drug is to stave off its ravages, which include memory loss and the ability to care for one’s self.

The FDA decision was originally supposed to land in March, but was extended in January for additional review. The early data on the drug showed mixed results with some doctors saying clinical trial results were inconsistent and further confirmation was needed.

Selkirk Copper Mines — sponsored Sponsored · Selkirk Copper Mines

Before this decision landed, J.P. Morgan analyst Cory Kasimov called the FDA’s decision “the mother of all binary events.”

The stock is currently halted and last traded at $286.43


Information for this briefing was found via the FDA, Biogen, JP Morgan, and Reuters. The author has no securities or affiliations related to this organization. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security. The author holds no licenses.

Video Articles

Tungsten Went 6X. I Went to See the Deposit Time Forgot | DD-on-the-GO! – Rackla Metals Inc

The World’s Largest Undeveloped Gold Project Nears a Deal | Rudi Fronk – Seabridge Gold

One of the World’s Biggest Copper Mines Could Reopen Just to Shut Down | First Quantum

Recommended

First Majestic Produces 3.4 Million Ounces of Silver in Q3 2026, Jerritt Canyon Restart Remains on Track

Altamira Gold Drills 134 Metres of 0.5 g/t Gold at Maria Bonita, Hole Ends in Mineralization

Related News

JUUL Slapped with FDA Warning Letter for Health Claims

JUUL Labs, an e-cigarette products company that is 35% owned by Altria (NYSE: MO) and...

Monday, September 9, 2019, 12:01:14 PM

Tobacco (Finally) Falls Out of Favor As Legal Marijuana Continues to Gain Public Support

American society is witnessing a remarkable shift in attitudes toward cannabis and tobacco. Once upon...

Monday, March 13, 2023, 08:09:52 AM

Samsung In Talks To Acquire Biotech Firm Biogen In A US$42 Billion Deal

The Samsung Group is reportedly in negotiations to acquire biotech firm Biogen (Nasdaq: BIIB). The...

Thursday, December 30, 2021, 11:40:00 AM

FDA Grants PharmaTher Pre-IND Meeting For Treatment Of Parkinson’s With Ketamine

PharmaTher Inc (CSE: PHRM) this morning announced that the US Food and Drug Administration has...

Thursday, December 10, 2020, 09:04:12 AM

Mass Layoffs Hit FDA, CDC and Other Health Agencies

The Trump administration has initiated sweeping layoffs at key US health agencies, with approximately 10,000...

Wednesday, April 2, 2025, 02:19:00 PM