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Connect Biopharma Reports Positive Phase 2 Results for Rademikibart
Connect Biopharma announced topline results from its global Phase 2 study evaluating rademikibart, the Company's next-generation, potentially best-in-class anti-interleukin-4-receptor alpha antibody as an add-on treatment for acute exacerbations in adult participants with chronic obstructive pulmonary disease and type 2 inflammation. Key topline results include: Rademikibart significantly reduced the rate of treatment failure by 81% through Week 4 compared to placebo; Rademikibart significantly reduced the rate of new moderate to severe COPD exacerbations by 85% through Week 4 compared to placebo; Rademikibart significantly reduced new visits to emergency departments and hospital admissions for new exacerbations by 100% through Week 4 compared to placebo; Rademikibart significantly reduced the use of rescue inhalers from Week 2 through Week 7 and significantly improved COPD symptoms at Week 2 compared to placebo; Clinically meaningful 70 mL greater improvement in FEV1 at Week 4 with rademikibart compared to placebo; Rademikibart was well tolerated and no new safety signals were observed through the end of the study.
Connect Biopharma Q2 Revenue $2.77M, Below Consensus
Reports Q2 revenue $2.77M, consensus $4.42M. "During the second quarter, we achieved important milestones with the completion of enrollment in both our Phase 2 Seabreeze STAT asthma and chronic obstructive pulmonary disease (COPD) studies. With topline results on track for September 2026, we are approaching a key inflection point with randomized, controlled data of rademikibart in patients experiencing an acute exacerbation," said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. "These studies are powered to evaluate the rate of treatment failure over 28 days and will also assess improvement in lung function, providing important insight into rademikibart's potential to benefit patients in this critical period after an exacerbation. Improved lung function and reduced treatment failure would support rademikibart's potential to address this significant unmet need for patients. Following these topline readouts, we plan to engage with the U.S. Food and Drug Administration (FDA) on a potential Phase 3 program. Supported by a cash runway expected to extend at least one year from the date of this release, we believe that we are well positioned to begin executing the next phase of development."
Canaccord Analyst Says AbbVie's $10.9B Acquisition of Apogee Worth $144 per Share
Canaccord analyst Edward Nash says AbbVie's (ABBV) reported $10.9B takeover of Apogee Therapeutics (APGE) equates to roughly $144 per share. Apogee in premarket trading is up 50%, or $45.23, to $135.61. If an all-cash deal at $10.9B were to be announced and consummated, this would be a "huge win" for Apogee shareholders and for inflammation and immunology companies in general, the analyst tells investors in a research note. Canaccord sees Kymera Therapeutics (KYMR), Evommune (EVMN), Connect Biopharma (CNTB), Celldex (CLDX), and Nektar (NKTR) benefitting from a takeover of Apogee Therapeutics. The firm has a Buy rating on Apogee with a $130 price target.
Connect Biopharma Files to Sell 6.13M Ordinary Shares
Connect Biopharma files to sell 6.13M ordinary shares for holders
Connect Biopharma CEO Highlights Rademikibart's Treatment Potential
"We have had a strong start to the year as we continue to build upon the body of preclinical and clinical evidence supporting the potential of rademikibart to treat acute exacerbations of asthma and chronic obstructive pulmonary disease, each a significant commercial opportunity where no biologics are currently approved or being developed," said Barry Quart, Chief Executive Officer of Connect Biopharma. "The recent data from our Phase 1 intravenous clinical pharmacology study for rademikibart are encouraging, demonstrating faster onset, lower dosing, and the potential for differentiated pricing in the hospital setting if approved. In addition, the recent independent data monitoring committee review of the interim analysis of our Phase 2 Seabreeze STAT program gives us confidence that the studies are adequately powered. We currently remain on track to report topline results from both Seabreeze STAT studies mid-year."
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