Latest news with #LUMRYZ
Yahoo
10-07-2025
- Business
- Yahoo
Avadel Pharmaceuticals Receives Unanimous Appeals Court Affirmation for LUMRYZ FDA Approval
Avadel Pharmaceuticals (NASDAQ:AVDL) is one of the most undervalued small-cap stocks to buy according to analysts. On June 30, Avadel Pharmaceuticals announced that the US Court of Appeals for the District of Columbia Circuit (Appeals Court) unanimously affirmed a previous decision by the US District Court for the District of Columbia (District Court). This ruling was in favor of the US FDA regarding its approval of LUMRYZ (sodium oxybate), which is a once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness/EDS in patients 7 years of age and older with narcolepsy. The lawsuit had been brought by Jazz Pharmaceuticals Inc. (NASDAQ:JAZZ). A biopharmaceutical research laboratory filled with scientists in white coats, discovering new drugs. The ruling confirms the FDA's finding, which the Appeals Court noted was undisputed, that LUMRYZ's once-at-bedtime dosing offers clinical superiority to all first-generation, immediate-release oxybates and represents a major contribution to patient care. Avadel Pharmaceuticals intends to continue advancing its commercial strategy to transform the sleep treatment paradigm for the narcolepsy community and increase the number of patients treated beyond the current thousands. Avadel Pharmaceuticals (NASDAQ:AVDL) is a biopharmaceutical company in the US. Jazz Pharmaceuticals Inc. (NASDAQ:JAZZ) identifies, develops, and commercializes pharmaceutical products in the US, Europe, and internationally. While we acknowledge the potential of AVDL as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
30-06-2025
- Business
- Business Wire
ASL Strategic Value Fund Issues Open Letter to Avadel Shareholders
GREENWICH, Conn. & CHESTERFIELD, Mo.--(BUSINESS WIRE)--ASL Strategic Value Fund, LP (together with its affiliates, 'ASL Strategic Value Fund' or 'we'), a significant shareholder of Avadel Pharmaceuticals plc (NASDAQ: AVDL) ('Avadel' or the 'Company'), today issued an open letter calling on Avadel's shareholders to vote AGAINST all of the Company's director nominees up for election at the 2025 annual general meeting of shareholders scheduled for July 29, 2025 (the 'Annual Meeting'). The full text of the letter is as follows: Dear Fellow Avadel Shareholders: It has been approximately five months since we sent our previous letter to Avadel's board of directors (the 'Board'), dated February 10, 2025, where we called on the Board to embark on a new course of action designed to maximize the Company's value for all of Avadel's long-suffering shareholders. The Board has failed to appropriately respond. Accordingly, we now believe a new path forward is necessary and we urge you to vote AGAINST the Company's director nominees at the Annual Meeting. Even if you have already voted, you may change your vote at any time before the vote is taken by submitting a proxy with a later date (but to be received by the Company by 10:00 a.m. (Irish Standard Time) on July 28, 2025). Under our plan, the Company would distribute a contingent value right ('CVR') to you, the Company's shareholders, to receive any and all proceeds from the six lawsuits (or potential settlements) currently pending against Jazz Pharmaceuticals, Inc. At the recent Jefferies healthcare conference, Avadel's CEO stated that just one of these lawsuits (going to trial in four months), could bring a recovery in excess of $1 billion. Additionally, we again call on the Board to retain an investment bank to monetize the significant value inherent in the Company's best-in-class asset LUMRYZ (sodium oxybate) ('LUMRYZ'). This drug has been found by the U.S. Food and Drug Administration ('FDA') on two separate occasions to be "clinically superior" to any other sodium oxybate. Just last week the FDA granted orphan drug designation ('ODD') for LUMRYZ for a new indication idiopathic hypersonia ('IH'). The regulatory pathway for an IH approval is now quite clear, and if approved by the FDA, this additional indication could add an additional $500 million to $1 billion to the Company's annual revenues. The status quo at AVDL is unacceptable. We are shocked and disappointed that Avadel's management team has never mentioned that its primary mission is to create shareholder value for the owners of this company. This fact has been missing from the company's website, slide decks and virtually every shareholder presentation the Company has issued. Further, over the past five years, the Company's current management team has failed to create any value for the Company's shareholders. In fact, the constant mis-steps with the launch of LUMRYZ and the constant mis-communication over the last several years with investors has destroyed significant shareholder value along with management's credibility. Two years into the launch of the Company's "best in class" and "clinically superior" drug, Avadel should have converted 40 to 50 percent of the existing sodium oxybate users to LUMRYZ. We believe that this number of switch patients would translate into approximately 6,000 to 8,000 patients currently on therapy versus the approximate 1,000 switch patients the company currently has. Further, we believe that these patients would have added approximately $600 to $800 million to revenues and approximately $5 to $7 per share to earnings. Not concentrating on this patient population was a major blunder made by management who only recently realized this mistake and has finally begun to focus its attention on this patient population. The Board in turn has failed to act in accordance with its fiduciary responsibilities and hold management accountable for this failed track record. In fact, this failure has been rewarded by the Board with additional dilutive share awards to management including bonuses and option grants. During the last year the Company's shareholders have lost hundreds of millions of dollars of market capitalization and the Company's CEO was awarded $7.399 million of total compensation in 2024. The Company has recently made a number of new hires to build out its team. This again should have been an opportunity for the Board to add some much-needed talent to the team. Unfortunately, it looks like the Company ended up getting candidates with no particular track record of success. The Company's shareholders deserve better from this Board. Clearly all the many communications that the Board has received have been ignored and have fallen on deaf ears. We believe it is time for a stronger message to be sent to the existing Board. ASL Strategic Value Fund will be voting AGAINST each and every Avadel director that is standing for re-election at the upcoming Annual Meeting scheduled to be held on July 29, 2025. We also recommend that every other Avadel shareholder vote AGAINST the entire Board. According to the Company's Proxy Statement issued in connection with the Annual Meeting, even if you have already voted, you may change your vote at any time before the vote is taken by submitting a proxy with a later date (but to be received by the Company by 10:00 a.m. (Irish Standard Time) on July 28, 2025). Directors are elected by ordinary resolution (a majority of the votes cast). If any director fails to receive the requisite vote, we expect the Company to abide by corporate governance 'best practices' and facilitate each of such directors' resignation(s) from the Board. Further, if that occurs, we believe the Company's shareholders must have a say in selecting the new candidates to the Board that would (for once) be aligned with the interests of the owners of this Company. To ensure that the vote at the upcoming election is fair and honest, I am calling for an impartial election monitor to be appointed (with the approval of the shareholders). In my letter to the Board, dated May 14, 2025, I stated that I had a negative experience in a prior Avadel director election with ASL Strategic Value Fund's votes being improperly counted. In that election our approximately 1.28 million shares, which were voted AGAINST each director were not counted or disclosed in the final vote count. It was only after our counsel had contacted the Company about this serious omission that a corrective 8-K was later quietly filed with a corrected vote count. Lastly, Avadel has two very significant assets in LUMRYZ and the potential recoveries from its lawsuits against Jazz Pharmaceuticals, Inc. It is long past time that a new strategy be implemented to maximize value for the benefit of all of the Company's shareowners. As always I am available to discuss these matters. Managing Partner THIS IS NOT A SOLICITATION OF AUTHORITY TO VOTE YOUR PROXY. DO NOT SEND US YOUR PROXY CARD. ASL STRATEGIC VALUE FUND IS NOT ASKING FOR YOUR PROXY CARD AND WILL NOT ACCEPT PROXY CARDS IF SENT. ASL STRATEGIC VALUE FUND IS NOT ABLE TO VOTE YOUR PROXY, NOR DOES THIS COMMUNICATION CONTEMPLATE SUCH AN EVENT. ASL Strategic Value Fund is a Greenwich, CT based institutional money management firm, employing a disciplined approach to value investing.
Yahoo
31-05-2025
- Business
- Yahoo
Avadel Pharmaceuticals plc (AVDL) Showcases LUMRYZ Success with 14 Abstracts, 4 Oral Presentations at SLEEP 2025
Avadel Pharmaceuticals plc (NASDAQ:AVDL) announced it will present 14 new abstracts, including four oral presentations, at SLEEP 2025, highlighting significant advances for LUMRYZ, its once-at-bedtime sodium oxybate treatment for narcolepsy. Interim results from the real-world REFRESH study showed that patients switching from twice-nightly oxybate to LUMRYZ experienced clinically meaningful improvements in excessive daytime sleepiness (EDS), with many achieving normal Epworth Sleepiness Scale (ESS) scores. A scientist in a labcoat examining a vial of experimental biopharmaceuticals. Additional analyses from the pivotal Phase 3 REST-ON trial revealed that even those with the most severe baseline sleepiness saw their ESS scores normalize after 13 weeks on LUMRYZ, and the therapy did not worsen sleep apnea. Further data demonstrated a reduction in distressing hallucinations and improvement in sleep-related eating disorder (SRED) symptoms after switching to LUMRYZ. Long-term tolerability was underscored, with only 4% discontinuing due to side effects. Avadel Pharmaceuticals plc (NASDAQ:AVDL) emphasized that LUMRYZ, FDA-approved for adults and children aged 7 and older, offers a major benefit over traditional oxybate by eliminating the need for middle-of-the-night dosing, supporting better sleep continuity and patient care. With these compelling results, Avadel Pharmaceuticals plc (NASDAQ:AVDL) continues to solidify its leadership in innovative narcolepsy treatments. While we acknowledge the potential of AVDL to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than AVDL and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Sign in to access your portfolio
Yahoo
30-05-2025
- Business
- Yahoo
Avadel Pharmaceuticals plc (AVDL) Showcases LUMRYZ Success with 14 Abstracts, 4 Oral Presentations at SLEEP 2025
Avadel Pharmaceuticals plc (NASDAQ:AVDL) announced it will present 14 new abstracts, including four oral presentations, at SLEEP 2025, highlighting significant advances for LUMRYZ, its once-at-bedtime sodium oxybate treatment for narcolepsy. Interim results from the real-world REFRESH study showed that patients switching from twice-nightly oxybate to LUMRYZ experienced clinically meaningful improvements in excessive daytime sleepiness (EDS), with many achieving normal Epworth Sleepiness Scale (ESS) scores. A scientist in a labcoat examining a vial of experimental biopharmaceuticals. Additional analyses from the pivotal Phase 3 REST-ON trial revealed that even those with the most severe baseline sleepiness saw their ESS scores normalize after 13 weeks on LUMRYZ, and the therapy did not worsen sleep apnea. Further data demonstrated a reduction in distressing hallucinations and improvement in sleep-related eating disorder (SRED) symptoms after switching to LUMRYZ. Long-term tolerability was underscored, with only 4% discontinuing due to side effects. Avadel Pharmaceuticals plc (NASDAQ:AVDL) emphasized that LUMRYZ, FDA-approved for adults and children aged 7 and older, offers a major benefit over traditional oxybate by eliminating the need for middle-of-the-night dosing, supporting better sleep continuity and patient care. With these compelling results, Avadel Pharmaceuticals plc (NASDAQ:AVDL) continues to solidify its leadership in innovative narcolepsy treatments. While we acknowledge the potential of AVDL to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than AVDL and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None.
