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The Latest Breaking News from Amylyx

Amylyx Pharmaceuticals Eyes Phase 3 AVEXITIDE Readout as 2027 Launch Comes Into Focus

Amylyx Pharmaceuticals (NASDAQ:AMLX) is preparing for a pivotal Phase 3 readout for AVEXITIDE, its lead asset for post-bariatric hypoglycemia, or PBH, with data from the LUCIDITY trial expected in the third quarter, Co-Chief Executive Officer Joshua Cohen said at the BofA Annual Healthcare Conferenc

MarketBeat

Amylyx Halts Rare Brain Disorder Drug Program After Disappointing Trial

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) on Wednesday decided to discontinue the ORION program of AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO, also known as ursodoxicoltaurine]) in adults living with progressive supranuclear palsy (PSP).

Benzinga

Steve Cohen's Point72 Goes Heavy on Tech and Pharma Stocks, Investing Over $330M in Two Trades

Point72 Asset Management recently purchased over 10 million shares of Confluent and Amylyx Pharma common stock, worth more than $334.17 million.

International Business Times UK

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Lots of drug companies talk about putting patients first — but this one actually did

When Amylyx Pharmaceuticals found out its ALS drug Relyvrio didn't work, the company took the unusual step of voluntarily pulling it off the market.

WEKU

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

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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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

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

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.

Benzinga

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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.

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

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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

Benzinga

Amylyx Shares Plummet On Skeptical FDA Adcomm Docs On ALS Drug

The FDA released its briefing documents for the advisory committee to discuss Amylyx Pharmaceuticals Inc's (NASDAQ:AMLX) sodium phenylbutyrate/taurursodiol (AMX0035) powder for amyotrophic lateral sclerosis (ALS). Agency statisticians called into question the Company's efficacy and survival analyses, raising concern that the modest survival benefit seen may potentially be due to underlying disease heterogeneity rather than…

The Independent UK

FDA skeptical of benefits from experimental ALS drug

The Food and Drug Administration has issued a negative review of a closely watched experimental drug for the debilitating illness known as Lou Gehrig’s disease

The Independent UK

FDA reviews ALS drug after lobbying by patients, politicians

The Food and Drug Administration meets next week to review a closely watched drug for ALS, or Lou Gehrig’s disease, following months of lobbying by patient groups and congressional lawmakers

Benzinga

FDA Sets Up Adcomm To Review Amylyx's ALS Drug Next Month

The FDA's Peripheral and Central Nervous System Drugs Advisory Committee will review Amylyx Pharmaceuticals Inc's (NASDAQ: AMLX) marketing application for AMX0035 (sodium phenylbutyrate [PB] and taurursodiol)

Benzinga

The Daily Biotech Pulse: J&J Unit Announces Research Collaboration With Remix, Regencell Touts COVID Data, Decision Day For Agios

Here's a roundup of top developments in the biotech space over the last 24 hours: Stocks In Focus Amylyx's ALS Treatment Regulatory Application To Be Reviewed By FDA Panel In Late March

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