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The Latest Breaking News from Amylyx

Amylyx Crashes 32% On A Quarterly Report That Doesn't Bode Well For 2024

Amylyx missed Wall Street's expectations on Thursday amid struggles for its amyotrophic lateral sclerosis drug, and AMLX stock crashed.

Investors Business Daily

Amylyx Unexpectedly Hits Breakeven With Breakneck Speed — But Shares Dip

Amylyx Pharmaceuticals hit breakeven in its second quarter with a product on the market, an analyst noted Friday. But AMLX stock dipped.

Investors Business Daily

Amylyx, A Top 5% Biotech Stock, Just Scored A Huge Win In ALS Treatment

Amylyx's new ALS treatment crushed Wall Street's fourth-quarter expectations, pushing AMLX stock briefly above its 50-day line Tuesday.

Investors Business Daily

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ALS patients contend with $158K price tag on new drug

For two years, Becky Mourey pushed the Food and Drug Administration to approve an experimental drug for her Lou Gehrig’s disease

The Independent UK

Biotech Stocks Embrace The Neuroscience Renaissance With Biogen, Amylyx At The Helm

The neuroscience renaissance is here. Biotech stocks are soaring this year on expectations for new treatments in brain-health disorders.

Investors Business Daily

Ice bucket challenge helps to fund FDA-approved motor neurone medication

Millions of dollars raised during the ice bucket challenge craze of 2014 have been used in the development of a new FDA-approved treatment.

The New Daily

ALS drug's approval draws cheers from patients, questions from skeptics

A controversial new drug for ALS could add months to patients' lives – if it actually works

WEKU

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Highly Rated Amylyx Pharma Skids After Hard-Fought FDA Approval For ALS Drug

The Food and Drug Administration granted Amylyx Pharmaceuticals a hard-won approval in ALS treatment, but AMLX stock sank Friday.

Investors Business Daily

ALS drug wins FDA approval despite questionable data

U.S. health officials have approved a much-debated drug to treat the deadly illness known as Lou Gehrig's disease

The Independent UK

‘If not for the Ice Bucket Challenge, we wouldn’t be here’: Cambridge company on the brink of FDA-approved ALS treatment

BOSTON — Eight years after the ALS Ice Bucket Challenge went viral across social media and raised hundreds of millions of dollars for research, a Cambridge company is on the brink of a major breakthrough for ALS patients.

Boston Herald

ALS drug gets rare second review at high-stakes FDA meeting

The Food and Drug Administration is holding an unusual second meeting to review a closely watched drug for the illness known as Lou Gehrig’s disease

The Independent UK

The FDA's Mixed Messages Sent Amylyx Pharmaceuticals Stock Off A Cliff

The FDA offered mixed messages Friday for Amylyx Pharmaceuticals' experimental neurological treatment, and shares crashed.

Investors Business Daily

FDA still skeptical of ALS drug ahead of high-stakes meeting

The U.S. Food and Drug Administration has posted another negative review of a closely watched drug for the deadly neurodegenerative disease ALS

The Independent UK

Bluebird bio Seeks Back-to-Back Nods, 'Go' or 'No-Go' For Revance's Botox Rival, Amylyx' Twin Hurdles And More: September's Key PDUFA Catalysts Biotech Investors Must Know

After August’s mixed tally for Food and Drug Administration approvals, investors turn to a new month, which has a fairly loaded calendar.

Benzinga

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Investors Business Daily

Why IPO Stock Amylyx Pharmaceuticals Is Beginning To Heat Up — Again

IPO stock Amylyx Pharmaceuticals jumped Monday as the Food and Drug Administration prepares to review its controversial ALS treatment again.

Benzinga

Here's How Citi Views Amylyx Pharma

Citi Research has raised the price target on Amylyx Pharmaceuticals Inc's (NASDAQ:AMLX) to $33 from $32, with a Buy rating. It says the small market opportunity for the newly approved amyotrophic lateral sclerosis (ALS) drug in Canada (~$100 million peak) bodes well for ongoing FDA review. Availability in Canada and using ALSFRS-R data as the primary basis…

Benzinga

Canada Approves Amylyx's ALS Drug; FDA To Consider Approval In September

The Canadian government has given its approval to AMX0035, a new drug from Cambridge, Massachusetts-based Amylyx Pharmaceuticals Inc.

Investors Business Daily

Former Red-Hot IPO Amylyx Soars On New Hopes For Its ALS Drug

The FDA pushed its review date for Amylyx Pharmaceuticals' controversial ALS treatment on Friday, and the biotech stock skyrocketed.

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Benzinga

Here's Why Amylyx Pharmaceuticals Shares Are Skyrocketing Today

Amylyx Pharmaceuticals Inc (NASDAQ: AMLX) shares are trading higher by 37.67% at $13.45 after the company announced the FDA extended the review timeline of the New Drug Application for AMX0035.

Investors Business Daily

Reata Stock Enjoys A Two-Day Climb — Why It Could Still Be Facing Everest

U.S. officials will soon examine Reata's request to treat a neurodegenerative condition, and RETA stock continued its two-day climb Friday.

Tribune News Service

Commentary: FDA shouldn’t approve ALS drug without more data

A panel of the Food and Drug Administration’s expert advisers on Wednesday voted 6 to 4 against approving Amylyx Pharmaceuticals’ treatment for ALS. The FDA now has until June 29 to decide whether to follow the panel’s advice or let the closely watched drug on to the market.

Benzinga

The Daily Biotech Pulse: Amylyx Announces Negative Adcom Vote, Clovis Jumps On Ovarian Cancer Data, Masimo Warns Of Q1 Shortfall

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga

FDA Panel Votes Down On Amylyx's ALS Drug, Further Fading Its Hope For Regulatory Success

An advisory committee of the

The Independent UK

FDA panel narrowly sides against experimental ALS drug

Federal health advisers have narrowly ruled against an experimental drug for the debilitating illness known as Lou Gehrig’s disease

Investors Business Daily

Former IPO Scorcher Amylyx Dives After FDA Panel Strikes Down ALS Drug

Shares of IPO stock Amylyx crumbled Thursday after a split FDA committee voted against its experimental ALS treatment.

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