Key PointsAmylyx may get its flagship treatment for ALS approved by the European Medicines Agency (EMA), opening another avenue for revenue growth.  Puma Biotechnology will begin a mid-stage trial for its lead cancer drug.  Cassava Sciences forecasts top-line results for a Phase 3 study on its Alzheimer's disease drug to be available by the end of the calendar year.  5 stocks we like better than Amylyx PharmaceuticalsThere's a reason that many biotech investors prefer to stick with large-cap stocks. Investi ...

Investors with an interest in Medical - Drugs stocks have likely encountered both Amylyx Pharmaceuticals, Inc. (AMLX) and Neurocrine Biosciences (NBIX) . But which of these two companies is the best option for those looking for undervalued stocks? Let's take a closer look.The best way to find great value stocks is to pair a strong Zacks Rank with an impressive grade in the Value category of our Style Scores system. The Zacks Rank favors stocks with strong earnings estimate revision trends, and our Style Sco ...

Stocks in the biotech sector are always going to have massive potential. Health is arguably the most important aspect of life. In turn, the firms that can produce therapeutics that address human disease will always command high prices. That’s why we curated this list of the top-rated biotech stocks. Novel treatments with greater efficacy create incredible returns for firms and investors. Of course, Wall Street and the analysts who work at its firms pay close attention to this sector at all times. Those firm ...

While the technology sector – especially regarding artificial intelligence – may have captured the spotlight, investors ought to consider adding healthcare stocks to their portfolio. If I had to boil it down to one phrase, it would be permanent relevance. A bold claim but I believe there’s much validity to it.First and foremost, advanced medicine stocks help improve the human condition. Nobody in their last moments wished they had spent more time in the office. Instead, they regret that they didn’t spend en ...

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) Q3 2023 Earnings Conference Call November 9, 2023 8:00 AM ET Company Participants Lindsey Allen - Head of Investor Relations & Communications Josh Cohen - Co-CEO & Co-Founder Justin Klee - Co-CEO & Co-Founder Margaret Olinger - Chief Commercial Officer James Frates - Chief Financial Officer Conference Call Participants Corinne Jenkins - Goldman Sachs Geoff Meacham - Bank of America Umer Raffat - Evercore ISI Marc Goodman - Leerink Partners Graig Suvannavejh - Mizuh ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | |----------------------------------------------------------------------------------------------------| | | | For the transition period from ___________________ to | | Commission F ...

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) Q2 2023 Earnings Conference Call August 10, 2023 4:30 PM ET Company Participants Lindsey Allen - Head of Investor Relations & Communications Justin Klee - Co-Chief Executive Officer Margaret Olinger - Chief Commercial Officer Jim Frates - Chief Financial Officer Josh Cohen - Co-Chief Executive Officer Conference Call Participants Corinne Jenkins - Goldman Sachs Geoff Meacham - Bank of America Michael DiFiore - Evercore Marc Goodman - Leerink Partners Graig Suvannav ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | |-----------------------------------------------------------------------------------------------------| | | | For the transition period from ___________________ to ___________________ ...

Financial Data and Key Metrics Changes - The company reported net product revenues of $71.4 million for Q1 2023, a significant increase from $21.9 million in Q4 2022, primarily driven by the launch of RELYVRIO [4][25]. - The net adjustments for the quarter were approximately 16%, consistent with expectations in the 15% to 20% range [25]. - The company achieved a net income of $1.6 million just two quarters into the commercial launch [26][27]. - Cash and short-term investments at the end of the quarter were $345.7 million with no debt, positioning the company to fund its programs without needing additional capital [27]. Business Line Data and Key Metrics Changes - RELYVRIO has seen a rapid uptake, with over 3,000 patients on the treatment by the end of Q1, more than double the number at the start of the quarter [8][12]. - Approximately 10% of patients receiving RELYVRIO were part of interim access or patient assistance programs [14][25]. - The company noted that 65% of the top 500 US prescribers and 95% of key ALS centers had prescribed RELYVRIO to at least one patient since launch [10]. Market Data and Key Metrics Changes - The company is preparing for international expansion, with ongoing regulatory reviews in Europe and expectations for a decision by Q3 2023 [7][29]. - In Canada, interest in ALBRIOZA remains high, and the company is negotiating public insurance coverage [16]. Company Strategy and Development Direction - The company aims to make RELYVRIO a foundational therapy for ALS and is focused on expanding its reach to all eligible patients globally [6][15]. - Plans to initiate a global pivotal phase three study of AMX0035 in Progressive Supranuclear Palsy (PSP) were announced, targeting a significant unmet need in this area [19][20]. - The company is also investing in research for other neurodegenerative diseases, including Wolfram syndrome and ALS, to build a robust pipeline [23]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong demand for RELYVRIO and the potential for profitability ahead of expectations [25][27]. - The company remains focused on executing its launch strategy and pipeline development, with a commitment to helping patients with ALS and other neurodegenerative diseases [28][29]. Other Important Information - The company is experiencing a high level of interest from the ALS community, with broad insurance coverage for RELYVRIO [6][12]. - The average time from receiving an enrollment form to shipping RELYVRIO has improved to about 30 days, down from over 45 days in the previous quarter [14]. Q&A Session Summary Question: What is the expectation for the rate of new patient additions? - Management indicated that while the initial demand was high, the rate of new patient additions is expected to moderate in Q2 compared to Q4 and Q1, but significant growth opportunities remain [31][36]. Question: How long will it take to reach the target of 10,000 patients on therapy? - The company has not provided a specific timeline but remains focused on making RELYVRIO the standard of care for ALS [40]. Question: Will the company maintain profitability through the year? - Management refrained from providing specific guidance on profitability but emphasized that revenue growth outpacing expense growth is key to maintaining profitability [42]. Question: What is the rationale for moving directly into a phase three study for PSP? - The decision was based on meeting all criteria for prioritization, including significant unmet need and strong scientific rationale [43]. Question: How is RELYVRIO being used in patients? - The drug is being utilized in a mix of monotherapy and combination therapy, with a broad patient population being treated [51]. Question: What insights can be shared about the mechanism of AMX0035? - AMX0035 targets pathways related to neurodegeneration, with evidence supporting its efficacy in reducing tau levels in preclinical and clinical studies [56].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |----------------------------------------------------------------------------------------------------|------------------------------------------| | | | | For the transition peri ...