Amylyx @AmylyxPharma Twitter profile

Amylyx Pharmaceuticals Announces Plan to Submit New Drug Application (NDA) for AMX0035 for the...

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Amylyx

@AmylyxPharma

4 years

Today, an overall survival analysis from the CENTAUR trial, which evaluated AMX0035 in people with ALS, was published in Muscle & Nerve. We're thankful to all study participants, their families and the clinicians who contributed to these meaningful results

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Amylyx

@AmylyxPharma

3 years

We are thrilled to announce our intention to submit an NDA for AMX0035 for the treatment of #ALS to the U.S. FDA in the coming months. We will share any additional updates with the community as soon as we can.

Amylyx today announced its intention to submit a New Drug Application (NDA) to the U.S. FDA for AMX0035 for the treatment of ALS.

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Amylyx

@AmylyxPharma

3 years

Today, we are excited to share news of our plans to submit a New Drug Submission for AMX0035 for the treatment of #ALS with Health Canada in the first half of 2021. This decision is based on the positive clinical data from the CENTAUR trial, and feedback from Health Canada.

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Amylyx

@AmylyxPharma

2 years

We are excited to share that Health Canada approved our new therapy for the treatment of amyotrophic lateral sclerosis, or #ALS . Read more at the link below.

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Amylyx

@AmylyxPharma

2 years

#NEWS : We are thrilled to share that the @US_FDA has approved our new therapy. We’ve had the privilege of working closely with the broader community for nearly a decade and are grateful to all of those who continue to support our mission and our clinical programs.

Learn more:

Amylyx Pharmaceuticals Announces FDA Acceptance and Priority Review of New Drug Application (NDA)...

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Amylyx

@AmylyxPharma

2 years

We are excited to share that the FDA has accepted for priority review the New Drug Application (NDA) for AMX0035 for the treatment of #ALS .

Amylyx Pharmaceuticals today announced that the U.S. FDA has accepted for review its New Drug Application for AMX0035 for the treatment of ALS.

Amylyx Pharmaceuticals Submits New Drug Application (NDA) for AMX0035 for the Treatment of ALS

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Amylyx

@AmylyxPharma

3 years

We are excited to share that we filed a New Drug Application (NDA) to the FDA for AMX0035 (PB/TURSO) for the treatment of #ALS . This submission represents a major milestone in our efforts to develop a potential new treatment option for the ALS community.

Amylyx today announced the submission of a New Drug Application (NDA) to the U.S. FDA for AMX0035 for the treatment of ALS.

Amylyx Pharmaceuticals Announces Launch of U.S. Expanded Access Program for AMX0035

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Amylyx

@AmylyxPharma

3 years

Today, we are pleased to share that we filed a New Drug Submission (NDS) to Health Canada for AMX0035 (PB-TURSO) for the treatment of #ALS . We look forward to continuing in our efforts to develop a potential new treatment option for ALS.

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Amylyx

@AmylyxPharma

4 years

We are excited to share the full results from our Phase 2/3 CENTAUR trial with the #ALS community in @NEJM . The data are a landmark for those living with the disease and we are looking forward to pursuing next steps for AMX0035.

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Amylyx

@AmylyxPharma

2 years

Today, we announced the launch of an Expanded Access Program (EAP) in the U.S. for our investigational #ALS therapy. Read more here:

Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) announced today the launch of an Expanded Access Program (EAP) for AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO;...

Amylyx Pharmaceuticals Announces Health Canada Accepts for Review the New Drug Submission for...

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Amylyx

@AmylyxPharma

2 years

We at Amylyx, like so many people, are devastated by the loss of @SandyMorris333 . Sandy's force of will was unstoppable - she was a lion - and her dedication to the highest principles and ethics while advocating for herself and others was unwavering.

Sandy Morris

@sandymorris333

2 years

And then there were 4. We are the Truest Most Beautiful Love Story. You won't 'move on' but you will move forward-w/all the love I was able to pour into your hearts w/the time allowed. It was my privilege & honor being your mom. Until we meet again my beloveds 💫 #MomIs #SandyIs

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Amylyx

@AmylyxPharma

3 years

When @pjgreen was diagnosed with #ALS in 2018, he chose to dedicate his life to advocate for those affected by the disease. Along the way, Phil has impacted so many, including his friend Dan White who got tatted in honor of his close friend. #INKEDforALS

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Amylyx

@AmylyxPharma

1 month

Today we shared an update on our next steps, including a process we’ve initiated to remove our ALS treatment from the market and provide free access to therapy for those who wish to stay on. These decisions were informed by people who will be impacted and engagement with…

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Amylyx

@AmylyxPharma

4 years

People with #ALS have no time to wait, which is why we’re investing every possible minute to move ahead and share the detailed results of the CENTAUR clinical trial as soon as we can. It’s our mission to do so efficiently and we will keep you informed on all developments.

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Amylyx

@AmylyxPharma

3 years

Health Canada has accepted for review our New Drug Submission for AMX0035 (PB-TURSO) for the treatment of #ALS . Read more here:

Amylyx today announced that Health Canada has accepted for review the New Drug Submission (NDS) for AMX0035 for the treatment of ALS.

Amylyx Pharmaceuticals Announces FDA Advisory Committee Voting Outcome

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Amylyx

@AmylyxPharma

2 years

We’re pleased to share that our new treatment for #ALS is now commercially available in Canada. Learn more at the link below.

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Amylyx

@AmylyxPharma

4 years

Thanks to all who’ve shared their encouragement and support today. To all those who are affected by #ALS and have questions about the CENTAUR trial results, you’re welcome to join our webinar on September 8th at 5pm ET:

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Amylyx

@AmylyxPharma

2 years

#NEWS : Today, we announced the voting outcome from the reconvened @US_FDA advisory committee meeting discussing our investigational therapy for the treatment of #ALS . Read here:

Amylyx Pharmaceuticals Closes $135M Series C Financing Led by Viking Global Investors to Support...

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Amylyx

@AmylyxPharma

4 years

On the morning of the CENTAUR study topline results announcement, advocates from @iamalsorg took over Times Square to raise awareness of the need to develop new treatments for #ALS and other neurodegenerative diseases. Today’s events are a reminder that together, we can #EndALS

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Amylyx

@AmylyxPharma

3 years

We’re excited to announce our intention to submit a Marketing Authorization Application (MAA) for AMX0035 for the treatment of #ALS to the European Medicines Agency & the start of a Phase 3 trial in Europe & the U.S.

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Amylyx

@AmylyxPharma

3 years

To further advance the clinical development and potential launch of a therapy for ALS, we have raised $135 million in a Series C Financing.

Amylyx Pharmaceuticals, Inc. today announced the closing of an oversubscribed $135 million Series C financing, led by Viking Global Investors.

Amylyx Pharmaceuticals Announces FDA Advisory Committee Meeting to Review New Drug Application for...

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Amylyx

@AmylyxPharma

3 years

“I was originally just fighting for my husband, now I’m fighting for them all.” Selfless #ALS caregivers and passionate advocates like Cali inspire us to keep pressing ahead for the many people and their families with this disease.

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Amylyx

@AmylyxPharma

2 years

We’re excited to announce the launch of the Amylyx Care Team (ACT) Support Program, a new resource that provides individuals who have been prescribed our therapy, and their loved ones, with a dedicated, single point of contact to guide their treatment journey.

Learn more

amylyxcareteam.com

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Amylyx

@AmylyxPharma

2 years

On March 30, 2022, a @US_FDA advisory committee will meet to review data supporting the NDA for our investigational therapy for the treatment of #ALS . Read more here:

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Feb. 16, 2022-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) today announced that a virtual meeting of the U.S. Food and Drug Administration’s (FDA) Peripheral and...

investors.amylyx.com

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Amylyx

@AmylyxPharma

4 years

We're proud to announce the @CentaurStudy topline results today. Thank you to the participants and their families, clinics and groups who supported this trial. We're encouraged and incredibly eager to press ahead in the fight for people with #ALS #endALS

Amylyx Pharmaceuticals Announces AMX0035 Demonstrated Statistically Significant Treatment Benefit...

Amylyx Pharmaceuticals Announces AMX0035 Demonstrated Statistically Significant Treatment Benefit for People with ALS in the CENTAUR Trial

Amylyx Pharmaceuticals Plans Regulatory Filing of AMX0035 for the Treatment of ALS in Canada

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Amylyx

@AmylyxPharma

3 years

Amylyx is working to submit a NDS for AMX0035 with Health Canada and actively pursuing early access options. In addition, Amylyx continues to discuss AMX0035 with global health authorities to determine the most appropriate path forward in each territory.

Amylyx Pharmaceuticals plans to submit a New Drug Submission (NDS) for AMX0035 for the treatment of ALS with Health Canada in the first half of 2021.

The Canadian Neuromuscular Disease Registry and Amylyx Pharmaceuticals Partner on Real-World...

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Amylyx

@AmylyxPharma

3 years

We are diligently working with global regulatory authorities to determine the best regulatory and clinical development paths forward for AMX0035 in #ALS . We look forward to sharing further updates on the NDS in Canada, MAA in Europe, and the Phase III trials in Europe & U.S.

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Amylyx

@AmylyxPharma

2 years

We are excited to announce our partnership with the Canadian Neuromuscular Disease Registry (CNDR). Through this collaboration, we hope to collect key insights and provide guidance for best practices in #ALS treatment for the benefit of the community.

The Canadian Neuromuscular Disease Registry (CNDR), an independent, academic registry based out of the University of Calgary, and Amylyx Pharmaceuticals (NASDAQ: AMLX) today announced they are...

Amylyx Pharmaceuticals Receives Notification of PDUFA Date Extension for AMX0035 for the Treatment...

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Amylyx

@AmylyxPharma

4 years

Along with the #ALS community, we are looking forward to sharing full detailed results from our Phase 2/3 CENTAUR trial soon. For more background and updates on our clinical trials in #neurodegenerativediseases , visit our website:

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Amylyx

@AmylyxPharma

3 years

We are continuing conversations with global regulatory agencies to most efficiently bring AMX0035 through the clinical development process and to those living with #ALS . Thank you to all who have supported the community and brought attention to the need for potential therapies.

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Amylyx

@AmylyxPharma

3 years

We're delighted to welcome Jim Frates as chief financial officer at Amylyx. Jim is an experienced leader and shares a deeply personal mission to improve the lives of people with #neurodegenerative diseases like #ALS , in honor of his cousin Pete Frates.

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Amylyx

@AmylyxPharma

4 years

Honored to be among @BosBizJournal drug makers to watch. Here’s to making 2020 a transformative year for those impacted by neurodegenerative diseases #ALS #Alzheimersdisease

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Amylyx

@AmylyxPharma

2 years

As part of our commitment to bring a potential new treatment option to the #ALS community around the globe, we are excited to share that our MAA to the EMA’s CHMP for AMX0035 for the treatment of #ALS has been validated and is now under CHMP review. "

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Amylyx

@AmylyxPharma

3 years

Congratulations to @PaganoniMDPhD , principal investigator, and all researchers involved in the CENTAUR trial for which was named a finalist in the Top 10 Clinical Research Achievement Awards! Thank you for your dedication to all those with #ALS and this important clinical study.

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Amylyx

@AmylyxPharma

3 years

We continue to make progress with our global clinical & regulatory plans. We are on track to submit an MAA for AMX0035 to the European Medicines Agency CHMP by end of 2021 and initiate a Phase 3 clinical trial in Europe and the U.S. by Q3 2021.

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Amylyx

@AmylyxPharma

1 year

We’re encouraged by the research and positive advancements being made to address the urgent needs of the #ALS community. Thank you to the @ALSTDI team for the special campus tour and important discussion on the transition of its #precisionmedicineprogram . #TeamAmylyx

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Amylyx

@AmylyxPharma

4 years

Co-founders and co-CEOs, Joshua Cohen and Justin Klee, were named to @BusinessInsider ’s 30 under 40 leaders transforming health care. We’re honored for recognition in advancing #neurodegenerative care and look forward to rewriting what’s possible.

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Amylyx

@AmylyxPharma

3 years

We have a responsibility to move AMX0035 through the clinical development process as quickly as possible for those who need it, as people living with #ALS do not have time to wait. We are working diligently with health authorities to explore all possible options.

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Amylyx

@AmylyxPharma

3 years

Today, we announced that the first participants have been dosed in the international Phase 3 PHOENIX trial (NCT05021536) designed to further evaluate the safety and efficacy of AMX0035 in people with #ALS .

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Amylyx

@AmylyxPharma

2 years

Earlier this month we announced the first approval globally of our new treatment for #ALS in Canada. We are working tirelessly to make the treatment available to people living with ALS in Canada as soon as possible. For updates, visit:

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Amylyx

@AmylyxPharma

3 years

Thank you to @ALSAMA for hosting today’s CEO Soak where we watched our co-CEOs Josh Cohen & Justin Klee get drenched from Boston’s famous Rings Fountain! Our team was thrilled to participate in this fun event and raise money for the #ALS community all at once.

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Amylyx

@AmylyxPharma

4 years

#ALS leaves no part of the body untouched—impacting the ability to speak, breathe, walk, talk, dress and eat. Every day matters for the development of new therapies, because every day matters for people living with ALS. We’re committed to helping patients and their families.

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Amylyx

@AmylyxPharma

3 years

Thank you to the #ALS community and the collaborative partnerships with the CENTAUR research team and advocacy partners for helping to bring AMX0035 one step closer to people living with ALS in Canada. Please stay tuned for further updates.

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Amylyx

@AmylyxPharma

3 years

Thank you to the CENTAUR trial participants, trial investigators, advocacy partners & the #ALS community who contributed to achieving today’s milestone in Canada.

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Amylyx

@AmylyxPharma

4 years

The need for an effective treatment for #ALS doesn’t stop, so neither will we. Even during the current pandemic, we are working tirelessly to support the community and to #EndALS .

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Amylyx

@AmylyxPharma

3 years

Hearing stories from advocates living with #ALS like Phil drives our team to search for answers and treatment options. The ALS community has no time to wait.

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Amylyx

@AmylyxPharma

4 years

Last Wednesday, we announced that AMX0035 was granted Orphan Drug Designation for #ALS treatment by the European Medicines Agency. We’re encouraged to press ahead and share trial results with you as soon as they are published #rarediseases

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Amylyx

@AmylyxPharma

1 year

People living with ALS face rapid and relentless loss of physical functions, which has a devastating impact on those living with ALS and their loved ones. We are always in search of new solutions to end the suffering caused by ALS #TogetherForALS

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Amylyx

@AmylyxPharma

3 years

We are excited to continue conversations with the EMA, advocacy partners, EU clinicians and #ALS patient communities across Europe as we bring AMX0035 through the regulatory review process as quickly as possible.

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Amylyx

@AmylyxPharma

4 years

We are continuing to work tirelessly to bring AMX0035 through clinical development as quickly as possible. We know that those living with #ALS and their families deserve answers and do not have time to wait.

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Amylyx

@AmylyxPharma

2 years

Today, we provided an update that the @US_FDA has extended the review time of our NDA for our investigational therapy for the treatment of #ALS . Read more at the link below:

New PDUFA goal date scheduled for September 29, 2022 to allow time to review additional data CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jun. 3, 2022-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx”...

investors.amylyx.com

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Amylyx

@AmylyxPharma

4 years

Every day at Amylyx we’re working to turn #neurodegenerativediseases from rapidly progressing conditions into ones that can be managed medically. Together we can rewrite what’s possible. #ALS

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Amylyx

@AmylyxPharma

7 months

Today, our #ALS analysis comparing the long-term survival of participants in the CENTAUR trial versus a historical clinical trial control group was published in the Annals of Clinical and Translational Neurology ( @ANA_journals ). Learn more:

Amylyx Pharmaceuticals Announces Publication of Survival Analysis Comparing CENTAUR to Historical...

Results demonstrated a 10.4 month difference in overall survival and a 52% lower risk of death over the duration of the follow-up period Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the...

Amylyx Pharmaceuticals Announces Publication of Data Showing Randomization to AMX0035 Prolonged...

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Amylyx

@AmylyxPharma

4 years

We’re aiming to share detailed and published results from the CENTAUR ALS study this year, and will be sure to keep you apprised of any updates regarding access to AMX0035 once we know more.

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Amylyx

@AmylyxPharma

4 years

The disease course for every individual with #ALS is different. However, the disease is relentlessly progressive. We will not stop our fight until we #EndALS .

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Amylyx

@AmylyxPharma

4 years

The principal investigator of the CENTAUR study, @PaganoniMDPhD , spoke about the ALSFRS-R during our #ALS Educator Summit and what a small change on the scale can mean for those living with ALS. We can’t thank @PaganoniMDPhD enough for her devotion to patients and improving care.

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Amylyx

@AmylyxPharma

2 years

We are excited to announce the @JNNP_BMJ publication of an additional long-term analysis of the potential benefits of our investigational therapy including lower risk of death, first hospitalization, and tracheostomy/permanent assisted ventilation in #ALS .

Adding to previously reported overall functional and survival benefit data for AMX0035, these findings support effect of AMX0035 on disease progression in ALS Randomization to AMX0035 resulted in a...

#INKEDforALS During ALS Awareness Month

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Amylyx

@AmylyxPharma

4 years

@NEJM Thank you to the #ALS community, all CENTAUR trial participants, their families, the clinics, @PaganoniMDPhD , @MeritCudkowicz , @MGHNeurology , @NEALSConsortium , @alsassociation and ALS Finding a Cure Foundation for your support and playing a vital role in reaching this milestone.

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Amylyx

@AmylyxPharma

4 years

This year, there are no walks to support #ALSAwarenessMonth . That's why we started the #INKEDforALS campaign - to help connect the #ALS community in a safe & memorable way. Our co-founders have a message for all who participated from home 🗣️

Amylyx Pharmaceuticals Announces Topline Results From Global Phase 3 PHOENIX Trial of AMX0035 in ALS

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Amylyx

@AmylyxPharma

3 years

Our team at Amylyx is so thankful for the connections made in the #ALS community, and excited for the major strides in advancing research. We are committed to doing our part in improving the lives of all those touched by ALS.

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Amylyx

@AmylyxPharma

4 years

Last December, we shared the positive topline results from our Phase 2/3 CENTAUR trial, which assessed AMX0035 in the treatment of #ALS . Our co-founders, Joshua Cohen and Justin Klee spoke with @WSJ about the trial and how Amylyx got its start.

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Amylyx

@AmylyxPharma

3 years

This year for #ALSAwareness Month, we’re proud to donate to @MDAorg , @iamalsorg , @alsassociation , @LesTurnerALS , @ALSCanada & @ComCareALS . Thank you for all you do for the #ALS community. Order your free temporary tattoo & download a Facebook frame today!

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Amylyx

@AmylyxPharma

4 years

Listen to our co-founder and co-CEO, Joshua Cohen, share what it means to work in the #ALS community, and how the company is continuing to work “on the ALS clock” to support those suffering from the disease, which remains to be true today and each day.

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Amylyx

@AmylyxPharma

3 years

The @ALSMNDAlliance observes June 21st as the global day of recognition of ALS/MND in honor of the summer solstice. The day symbolizes hope for the future of disease research and treatment. Visit for ways to spread the word. #ALSMNDWithoutBorders

ALS/MND Alliance

@ALSMNDAlliance

3 years

June 21 is Global Day! #ALSMNDWithoutBorders #ALS #MND

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Amylyx

@AmylyxPharma

4 years

Last week, we shared the results of our Phase 2/3 CENTAUR trial news with the #ALS community and remain committed to working nonstop to provide the support patients deserve.

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Amylyx

@AmylyxPharma

4 years

When metabolism and protein folding are not functioning properly, #neurons stop key functions and can eventually die. AMX0035 is designed to help facilitate restoring those functions to assist in slowing down nerve cell death and degeneration.

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Amylyx

@AmylyxPharma

2 months

Today, we shared the topline results from our Phase 3 PHOENIX trial. Read more in our press release: On behalf of the entire Amylyx team, we are grateful to the ALS community and for the dedication of trial participants, investigators, and study site…

- PHOENIX Study Did Not Meet Prespecified Primary or Secondary Endpoints - Data From 664-Participant Study Reinforce That AMX0035 is Generally Safe and Well-Tolerated - Within the Next Eight Weeks,...

Amylyx Pharmaceuticals Announces FDA Plan to Reconvene Advisory Committee to Review AMX0035 NDA for...

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Amylyx

@AmylyxPharma

3 years

Researchers around the world are working tirelessly to find therapies to fight #ALS as fast as possible. The Healey Center at @MGHNeurology is just one of the groups leading the charge. Learn more about their ALS platform trial:

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Amylyx

@AmylyxPharma

4 years

Despite two currently available therapies to treat the disease, #ALS remains fast progressing and fatal. Learn about the work we are doing to fight this #neurodegenerativedisease at .

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Amylyx

@AmylyxPharma

2 years

Happy New Year from Amylyx Pharmaceuticals! We are looking forward to a busy year ahead for #TeamAmylyx as part of our ongoing commitment and support for those living with #neurodegenerative diseases.

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Amylyx

@AmylyxPharma

3 years

Cali, an #ALS caregiver and advocate, reminds us of the importance of banding together in support of this amazing community. We will never stop in our pursuit of pushing this fight forward for Cali, her husband and all those living with this disease.

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Amylyx

@AmylyxPharma

2 years

Today, we announced that the @US_FDA plans to reconvene an Advisory Committee meeting on September 7, 2022, as part of their ongoing review of our investigational therapy for the treatment of #ALS . Read more at the link below.

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that the U.S. Food and Drug Administration (“FDA” or the “Agency”) has informed the Company that the Agency is...