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FOCUS LIST🔎
LYRA – Up over 180% in the pre-market after reporting positive results from the ENLIGHTEN 2 Phase 3 Trial of LYR-210 in the Treatment of Chronic Rhinosinusitis (CRS)
VERA – Up over 77% in pre after announcing Atacicept achieved 46% Proteinuria reduction in ORIGIN Phase 3 Trial in adults with IgA Nephropathy
ATAI – Up over 12% in pre after announcing combination with Beckley Psytech to create a global leader in psychedelic mental health therapies
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HOTLIST🔥
LYRA – Up over 180% in the pre-market after reporting positive results from the ENLIGHTEN 2 Phase 3 Trial of LYR-210 in the Treatment of Chronic Rhinosinusitis (CRS)
Lyra Therapeutics, Inc. (LYRA) is a clinical-stage biotechnology company developing long-acting, anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis (CRS),
In the pre-market this morning, the company announcedpositive results from the ENLIGHTEN 2 Phase 3 clinical trial of LYR-210 in adult patients with CRS.
Highlights include:
ENLIGHTEN 2 trial met primary endpoint with LYR-210 demonstrating statistically significant improvement in the composite of the three cardinal symptoms (3CS) of CRS at 24 weeks (p=0.0078)
ENLIGHTEN 2 trial also showed statistically significant improvement in key secondary endpoints in the full population of 3CS at 24 weeks (p=0.0209) and SNOT-22 score at 24 weeks (p=0.0101)
Additionally, in pooled data from ENLIGHTEN 2 and ENLIGHTEN 1 trials in 64 CRS patients with nasal polyps, LYR-210 demonstrated a consistent positive trend over 24 weeks in multiple key efficacy endpoints
Lyra plans to review the totality of the dataset from the ENLIGHTEN trials to evaluate next steps for pursuing an indication in non-polyp patients, as well as to continue development of LYR-210 in patients with nasal polyps
Shares of LYRA traded up over 180% in the pre-market in reaction to the news.
The $26 area acted as support in the pre-market and will be an important level to watch.
Above it, targets to the upside are $30, $33 and then the pre-market high at $39.38. Beyond that, there is a large gap to fill at $201.50 and round numbers such as $45 and $50 come into play.
Below $26, targets to the downside are $20, $15, $10 and then a gap fill at $4.93.
VERA – Up over 77% in pre after announcing Atacicept achieved 46% Proteinuria reduction in ORIGIN Phase 3 Trial in adults with IgA Nephropathy
Vera Therapeutics Inc. (VERA) is a clinical stage biotechnology company that focuses on the development and commercialization of transformative treatments for patients with serious immunological diseases.
In the pre-market this morning, VERA announcedthat the primary endpoint was met in the ORIGIN Phase 3 trial of atacicept for the treatment of immunoglobulin A nephropathy (IgAN) in adults.
Highlights include:
Atacicept ORIGIN Phase 3 trial met the primary endpoint of reduction in proteinuria (UPCR) at week 36; participants receiving atacicept achieved a 46% reduction from baseline and 42% reduction compared to placebo at week 36 (p<0.0001)
Other prespecified endpoints achieved similar or better results compared to the ORIGIN Phase 2b clinical trial — per FDA guidance, Vera is not sharing eGFR results at this time while the ORIGIN 3 placebo-controlled trial continues
The safety profile of atacicept was favorable, and comparable to placebo
Vera plans to meet with FDA in the coming weeks to discuss these results and the regulatory pathway; Vera currently plans to submit a Biologics License Application (BLA) for accelerated approval to the FDA in 4Q 2025; ORIGIN 3 trial continues with two-year results expected in 2027
Shares of VERA traded up over 77% in the pre-market in reaction to the news.
The $32 area acted as support in the pre-market and will be an important level to watch. Above it, targets to the upside are $34 and then the pre-market high at $35.81. Beyond that, $38 and $40 come into play.
Below $32, targets to the downside are $30, $28, $25 and then $21.
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ATAI – Up over 12% in pre after announcing combination with Beckley Psytech to create a global leader in psychedelic mental health therapies
atai Life Sciences (ATAI) is a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes.
In the pre-market this morning, the company announceda definitive agreement under which atai and Beckley plan to combine in an all-share transaction subject to pre-agreed BPL-003 (mebufotenin benzoate) Phase 2b success criteria.
Beckley Psytech Limited is a private clinical-stage biopharmaceutical company pioneering the next generation of mental health treatments.
Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-Founder of atai stated:
“The strategic combination marks a transformational moment, solidifying us as a leader in rapid-acting and accessible psychedelic treatments for mental health conditions with a pipeline of potential first-in-class and best-in-class assets,”
Shares of ATAI traded up over 12% in the pre-market in reaction to the news.
The first target for bulls is the pre-market high at $2.80. Beyond that, $3, $3.30 and $3.60 come into play.
Below $2.80, targets to the downside are $2.50 and then a gap fill at $2.31.
MARKET NEWS 📰
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