Latest news with #Alumis
Business Insider
4 days ago
- Business
- Business Insider
Alumis resumed with an Overweight at Morgan Stanley
Morgan Stanley resumed coverage of Alumis (ALMS) with an Overweight rating and $23 price target The firm updated its model for the Acelyrin merger and Q1 earnings. The Phase 3 data from Alumis' lead pipeline program ESK-001 in psoriasis in Q1 of 2026 represents the next key catalyst for the shares, the analyst tells investors in a research note. Morgan believes the company's pipeline is on track. Confident Investing Starts Here:
Yahoo
29-05-2025
- Business
- Yahoo
Alumis Completes Enrollment of Pivotal Phase 3 ONWARD Clinical Program of Lead Candidate ESK-001, a Highly Selective, Next-Generation Oral TYK2 Inhibitor for the Treatment of Moderate-to-Severe Plaque Psoriasis
-Topline readout expected in early Q1 2026- SOUTH SAN FRANCISCO, Calif., May 29, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharma company developing next-generation targeted therapies for patients with immune-mediated diseases, today announced the completion of patient enrollment in its pivotal Phase 3 ONWARD clinical program of ESK-001 for the treatment of moderate-to-severe plaque psoriasis. "We are excited to announce the completion of patient enrollment in our pivotal Phase 3 ONWARD clinical program evaluating ESK-001 for moderate-to-severe plaque psoriasis,' said Martin Babler, President and Chief Executive Officer of Alumis. 'With over 1,700 patients enrolled across the two trials, this milestone reflects the dedication of our patients, investigators, and the Alumis team, whose efforts have made it possible. We remain on track to report topline results in early Q1 2026, bringing us closer to delivering transformative treatment solutions for patients in need." 'As we advance the development of ESK-001, we recognize the ongoing challenges patients with plaque psoriasis face in finding effective and convenient treatment options," said Dr. Jörn Drappa, Alumis' Chief Medical Officer. "Many patients cycle through therapies due to the inconvenience of injectable biologics and the diminishing effectiveness of oral treatments. With its differentiated profile, ESK-001 has the potential to provide a well-tolerated oral TYK2 inhibitor that delivers durable, biologic-like clinical responses, bridging a critical gap in treatment." The Phase 3 ONWARD clinical program consists of two parallel global Phase 3, multi-center, randomized, double-blind placebo-controlled 24-week clinical trials, ONWARD1 and ONWARD2, designed to evaluate the efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis. ONWARD 3, an optional long-term extension trial for patients who have completed Week 24, is currently ongoing to assess the durability, maintenance of response, and long-term safety of ESK-001. About ESK-001 Alumis' lead clinical candidate, ESK-001, is a highly selective, next-generation oral TYK2 inhibitor that is designed to correct immune dysregulation across a spectrum of diseases driven by proinflammatory mediators, including IL-23, IL-17, and type 1 interferon (IFN). ESK-001's selective targeting is designed to deliver maximal inhibition while minimizing off-target binding and effects. The efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis are currently being evaluated in the Phase 3 ONWARD clinical program, which consists of two parallel global Phase 3, multi-center, randomized, double-blind placebo-controlled 24-week clinical trials, ONWARD1 (NCT06586112) and ONWARD2 (NCT06588738). Over 1,700 patients were enrolled across the two trials and randomized 2:1:1 to receive ESK-001 40 mg twice-daily, placebo or apremilast. The co-primary efficacy endpoints will be the proportion of patients with moderate-to-severe plaque psoriasis achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) and sPGA score 0/1 of ESK-001 compared to placebo at Week 16. Patients completing Week 24 will have the opportunity to participate in a long-term extension trial, ONWARD3, that will evaluate durability and maintenance of response and long-term safety. The Phase 3 clinical program is supported by positive data from the Phase 2 STRIDE clinical trial (NCT05600036), and by the long-term open-label extension (CT05739435) which is currently ongoing. In parallel with the Phase 3 clinical program, Alumis is developing a once-daily modified-release oral formulation of ESK-001 designed to replace the current immediate-release oral formulation that is dosed twice daily. ESK-001 is also being evaluated in LUMUS, a Phase 2b clinical trial for the treatment of patients with systemic lupus erythematosus. In addition, Alumis continues to leverage its precision data analytics platform to explore ESK-001's potential application in other immune-mediated conditions. About AlumisAlumis is a late-stage biopharma company developing next-generation targeted therapies with the potential to significantly improve patient health and outcomes across a range of immune-mediated diseases. Leveraging its proprietary data analytics platform and precision approach, Alumis is developing a pipeline of oral tyrosine kinase 2 inhibitors, consisting of ESK-001 for the treatment of systemic immune-mediated disorders, such as moderate-to-severe plaque psoriasis and systemic lupus erythematosus, and A-005 for the treatment of neuroinflammatory and neurodegenerative diseases. In addition, the pipeline includes lonigutamab, a subcutaneously delivered anti–insulin-like growth factor 1 receptor therapy for the treatment of thyroid eye disease, as well as several preclinical programs identified through this precision approach. For more information, visit or follow us on LinkedIn or X. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of federal securities laws, including the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements. All statements, other than statements of historical facts, including without limitation those regarding the timing of Alumis' topline readout in its ONWARD Phase 3 program, the potential for ESK-001 to treat moderate-to-severe plaque psoriasis and systemic lupus erythematosus, any expectations regarding the safety, efficacy or tolerability of ESK-001 and statements regarding Alumis' future plans and prospects including development of its clinical pipeline; and any assumptions underlying any of the foregoing, are forward-looking statements. Any forward-looking statements in this press release are based on Alumis' current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in Alumis' forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to Alumis' ability to advance ESK-001 and to obtain regulatory approval of and ultimately commercialize Alumis' clinical candidates, the timing and results of preclinical and clinical trials, Alumis' ability to fund development activities and achieve development goals, Alumis' ability to protect its intellectual property and other risks and uncertainties described in Alumis' filings with the Securities and Exchange Commission (SEC), including any future reports Alumis may file with the SEC from time to time. Alumis explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. CONTACT: Alumis Contact Information Teri Dahlman Red House Communications teri@
Associated Press
29-05-2025
- Business
- Associated Press
Alumis Completes Enrollment of Pivotal Phase 3 ONWARD Clinical Program of Lead Candidate ESK-001, a Highly Selective, Next-Generation Oral TYK2 Inhibitor for the Treatment of Moderate-to-Severe Plaque Psoriasis
SOUTH SAN FRANCISCO, Calif., May 29, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharma company developing next-generation targeted therapies for patients with immune-mediated diseases, today announced the completion of patient enrollment in its pivotal Phase 3 ONWARD clinical program of ESK-001 for the treatment of moderate-to-severe plaque psoriasis. 'We are excited to announce the completion of patient enrollment in our pivotal Phase 3 ONWARD clinical program evaluating ESK-001 for moderate-to-severe plaque psoriasis,' said Martin Babler, President and Chief Executive Officer of Alumis. 'With over 1,700 patients enrolled across the two trials, this milestone reflects the dedication of our patients, investigators, and the Alumis team, whose efforts have made it possible. We remain on track to report topline results in early Q1 2026, bringing us closer to delivering transformative treatment solutions for patients in need.' 'As we advance the development of ESK-001, we recognize the ongoing challenges patients with plaque psoriasis face in finding effective and convenient treatment options,' said Dr. Jörn Drappa, Alumis' Chief Medical Officer. 'Many patients cycle through therapies due to the inconvenience of injectable biologics and the diminishing effectiveness of oral treatments. With its differentiated profile, ESK-001 has the potential to provide a well-tolerated oral TYK2 inhibitor that delivers durable, biologic-like clinical responses, bridging a critical gap in treatment.' The Phase 3 ONWARD clinical program consists of two parallel global Phase 3, multi-center, randomized, double-blind placebo-controlled 24-week clinical trials, ONWARD1 and ONWARD2, designed to evaluate the efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis. ONWARD 3, an optional long-term extension trial for patients who have completed Week 24, is currently ongoing to assess the durability, maintenance of response, and long-term safety of ESK-001. About ESK-001 Alumis' lead clinical candidate, ESK-001, is a highly selective, next-generation oral TYK2 inhibitor that is designed to correct immune dysregulation across a spectrum of diseases driven by proinflammatory mediators, including IL-23, IL-17, and type 1 interferon (IFN). ESK-001's selective targeting is designed to deliver maximal inhibition while minimizing off-target binding and effects. The efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis are currently being evaluated in the Phase 3 ONWARD clinical program, which consists of two parallel global Phase 3, multi-center, randomized, double-blind placebo-controlled 24-week clinical trials, ONWARD1 ( NCT06586112 ) and ONWARD2 ( NCT06588738 ). Over 1,700 patients were enrolled across the two trials and randomized 2:1:1 to receive ESK-001 40 mg twice-daily, placebo or apremilast. The co-primary efficacy endpoints will be the proportion of patients with moderate-to-severe plaque psoriasis achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) and sPGA score 0/1 of ESK-001 compared to placebo at Week 16. Patients completing Week 24 will have the opportunity to participate in a long-term extension trial, ONWARD3, that will evaluate durability and maintenance of response and long-term safety. The Phase 3 clinical program is supported by positive data from the Phase 2 STRIDE clinical trial (NCT05600036), and by the long-term open-label extension (CT05739435) which is currently ongoing. In parallel with the Phase 3 clinical program, Alumis is developing a once-daily modified-release oral formulation of ESK-001 designed to replace the current immediate-release oral formulation that is dosed twice daily. ESK-001 is also being evaluated in LUMUS, a Phase 2b clinical trial for the treatment of patients with systemic lupus erythematosus. In addition, Alumis continues to leverage its precision data analytics platform to explore ESK-001's potential application in other immune-mediated conditions. About Alumis Alumis is a late-stage biopharma company developing next-generation targeted therapies with the potential to significantly improve patient health and outcomes across a range of immune-mediated diseases. Leveraging its proprietary data analytics platform and precision approach, Alumis is developing a pipeline of oral tyrosine kinase 2 inhibitors, consisting of ESK-001 for the treatment of systemic immune-mediated disorders, such as moderate-to-severe plaque psoriasis and systemic lupus erythematosus, and A-005 for the treatment of neuroinflammatory and neurodegenerative diseases. In addition, the pipeline includes lonigutamab, a subcutaneously delivered anti–insulin-like growth factor 1 receptor therapy for the treatment of thyroid eye disease, as well as several preclinical programs identified through this precision approach. For more information, visit or follow us on LinkedIn or X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as 'aims,' 'anticipates,' 'believes,' 'could,' 'estimates,' 'expects,' 'forecasts,' 'goal,' 'intends,' 'may,' 'plans,' 'possible,' 'potential,' 'seeks,' 'will' and variations of these words or similar expressions that are intended to identify forward-looking statements. All statements, other than statements of historical facts, including without limitation those regarding the timing of Alumis' topline readout in its ONWARD Phase 3 program, the potential for ESK-001 to treat moderate-to-severe plaque psoriasis and systemic lupus erythematosus, any expectations regarding the safety, efficacy or tolerability of ESK-001 and statements regarding Alumis' future plans and prospects including development of its clinical pipeline; and any assumptions underlying any of the foregoing, are forward-looking statements. Any forward-looking statements in this press release are based on Alumis' current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in Alumis' forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to Alumis' ability to advance ESK-001 and to obtain regulatory approval of and ultimately commercialize Alumis' clinical candidates, the timing and results of preclinical and clinical trials, Alumis' ability to fund development activities and achieve development goals, Alumis' ability to protect its intellectual property and other risks and uncertainties described in Alumis' filings with the Securities and Exchange Commission (SEC), including any future reports Alumis may file with the SEC from time to time. Alumis explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Alumis Contact Information Teri Dahlman Red House Communications [email protected]
Yahoo
02-05-2025
- Business
- Yahoo
Acelyrin urges stockholders to vote for proposed merger with Alumis
ACELYRIN (SLRN) reiterated its confidence that the proposed combination with Alumis (ALMS) is the best path forward and the most value-maximizing outcome for all ACELYRIN stockholders. Bruce Cozadd, Chair of the ACELYRIN Board of Directors and member of the independent transaction committee, said, 'The ACELYRIN Board and management team are confident that the proposed merger with Alumis represents the most value-maximizing path forward for our company's stockholders. The agreement with Alumis follows a comprehensive and competitive process facilitated by the ACELYRIN Board. Furthermore, it reflects successful efforts by our Board to negotiate a revised agreement with a meaningful increase in ACELYRIN stockholders' ownership in the combined company. With the Special Meeting just weeks away, we urge ACELYRIN stockholders to vote FOR the proposed merger with Alumis to protect the value of your investment.' The ACELYRIN Board's disinterested and independent directors unanimously recommend that stockholders vote 'FOR' the merger with Alumis. . Discover companies with rock-solid fundamentals in TipRanks' Smart Value Newsletter. Receive undervalued stocks, resilient to market uncertainty, delivered straight to your inbox. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on SLRN: Disclaimer & DisclosureReport an Issue ACELYRIN, INC. Amends Merger Agreement with Alumis Alumis and Acelyrin sign ammended merger agreement SLRN Earnings this Week: How Will it Perform? Acelyrin adopts limited-duration stockholder rights plan Acelyrin says Concentra indication not expected to result in superior proposal
Yahoo
01-05-2025
- Business
- Yahoo
Acelyrin should liquidate instead of merging with Alumis, investor says
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. A shareholder of immune drug developer Acelyin believes the company is better off shutting down and returning cash to shareholders rather than pursuing a merger with fellow biotech Alumis. Trium Capital, an England-based investment fund and Acelyrin stockholder, revealed in a regulatory filing Tuesday that it intends to vote against the planned merger after concluding it's not in the best interest of shareholders. In a letter to Acelyrin's board dated April 28, the firm instead argued that Alumis' offer, as well as others Acelyrin has considered, are inferior to what equity holders would receive if Acelyrin were to liquidate its assets. 'We believe there is substantial upside to winding up the company as compared to the proposed merger,' Trium portfolio manager Felix Lo wrote in the letter. Trium's filing comes amid heightened investor scrutiny of companies that, like Acelyrin, have suffered a setback and are worth less than their cash holdings. These biotech 'zombies' typically pivot to a different strategy or merge with another drugmaker. Increasingly, investors have argued their cash should be put to better use. Multiple activist firms have pressured company boards in recent months and one biotech, Third Harmonic Bio, approved a liquidation plan two weeks ago. Acelyrin debuted on Wall Street in 2023 after raising $540 million in one of biotech's largest initial public offerings. But disappointing study results led the company to abandon development of the drug at the heart of that offering the following year. A second therapy that became its focus also hasn't entirely impressed, leaving the company with a depressed stock price. Acelyrin has pursued other strategic options. Trium noted how the company formed a special transaction committee and began evaluating offers, contacting over 25 parties and considering a variety of different deals. That process culminated with an announcement in February that the company planned to merge with Alumis. The planned deal is an all-stock transaction that would leave Acelyrin shareholders with about 48% of the combined company, giving them a stake in a company with a bigger cash balance and three drugs in clinical testing. The companies already amended deal terms to give Acelyrin shareholders more equity, with board chair Bruce Cozadd noting in a statement last week that he changes reflected discussions with shareholders. Acelyrin was also pursued by Tang Capital Partners, which has acquired some struggling companies and bought up shares in others in bids to liquidate them. But Acelyrin rebuffed Tang's efforts, adopted a 'poison pill' to protect itself and threw support behind the Alumis deal instead. In its letter, Trium argued Tang's bid, as well as a wind down of the company, would both be better outcomes for shareholders than an Alumis deal that values Acelyrin at less than its cash holdings and carries more risk. The firm also contended Acelyrin failed to discuss such a scenario until early 2025 and, even then, didn't seriously consider it. 'A liquidation of the company provides certainty of value well above the value from any of the offers received thus far and will allow shareholders to re-invest the proceeds as they see fit,' Lo wrote. 'We believe there is no reason for shareholders to accept any transaction that provides upfront value less than value that can be expected in a liquidation.' Acelyrin shares trade at about $2.50 apiece. Its net cash reserves of $448 million as of the fourth quarter of 2024 were worth $4.45 a share, Lo noted. Concentra Biosciences, an entity controlled by Tang, had bid $3 per share in cash as well as the right to 80% of the proceeds if Concentra were to license or sell the company's programs. Recommended Reading An investment fund sets out to free biotech's 'trapped capital' Sign in to access your portfolio
