Clinical Trials
0
0 active
Approvals
42
Total approvals
Agencies
1
Regulatory bodies
Founded
N/A
No trial phase data available
No trial data available
No trial data available
- Chugai Pharmaceutical's research on nemolizumab, a humanized anti-IL-31 receptor A monoclonal antibody, has been selected for the 11th JBDA Award for Drug Discovery. - The award recognizes the integrated drug discovery effort spanning target identification, disease biology elucidation, antibody generation, and clinical development for pruritus. - Nemolizumab addresses pruritus associated with atopic dermatitis and prurigo nodularis, symptoms that can significantly impair patients' quality of life. - The drug is marketed as Mitchga in Japan by Maruho and as NEMLUVIO by Galderma in the United States, Europe, and other regions.
- Chugai Pharmaceutical reported solid Q2 FY2026 results with core operating profit exceeding prior-year levels, driven by strong Hemlibra exports and growing royalty income from NEMLUVIO and FOUNDAYO. - Global sales of NEMLUVIO by Galderma reached $433 million in H1, capturing approximately 42% of new prescription share for prurigo nodularis in the United States. - The U.S. FDA granted Fast Track designation to AQUA07, an allosteric ALK inhibitor utilizing Chugai's proprietary SnipeTide mid-molecule technology, based on preclinical data. - The company established a Strategic Investment Department to deploy its ¥962.6 billion net cash position toward M&A and in-licensing for growth acceleration.
- Galderma reported first-half 2026 sales of $3.13 billion, a 24.6% increase driven by double-digit growth across international markets and the United States. - The Swiss skincare firm raised its full-year net sales growth guidance to 19–21%, up from the prior 17–20% range, despite flagging a potentially challenging second half. - CEO Flemming Ornskov noted manageable U.S. tariff exposure and ongoing market share gains, while acknowledging a slight softening of consumer sentiment in some markets. - The company is still awaiting U.S. FDA approval for Relfydess, a Botox rival, following a complete response letter requiring additional work.
- Attovia Therapeutics priced an upsized IPO of 17 million shares at $17.00 per share, raising $289.0 million in gross proceeds on August 4, 2026. - The clinical-stage immunology company's lead asset ATTO-1310, an IL-31-targeting fusion protein, completed Phase I dosing in Q1 2026 with data showing favorable tolerability and rapid, deep itch relief. - Proceeds will fund clinical development of ATTO-1310 and the bispecific ATTO-2306 targeting IL-13 and IL-31, with remainder allocated to the trispecific ATTO-1091 for inflammatory bowel disease. - The company had raised $255.8 million in private capital since its 2023 founding, backed by Deep Track Capital, Frazier Life Sciences, Goldman Sachs Alternatives, and venBio.
- The FDA issued a Complete Response Letter for Galderma's RelabotulinumtoxinA BLA, citing manufacturing site observations and analytical method optimization needs, with no safety or efficacy deficiencies identified. - RelabotulinumtoxinA (Relfydess) is a ready-to-use liquid neuromodulator already approved in 33 markets and launched in over 20 countries, including Europe, the Middle East, Asia, and Australia. - The manufacturing facility has completed 10 inspections by global regulatory authorities since 2022, and Galderma is implementing corrective and preventive actions to address the FDA's observations. - The CRL delays Galderma's entry into the competitive US injectable neuromodulator market, where Relfydess would be the first ready-to-use liquid formulation without reconstitution requirements.
- Galderma has launched its premium regenerative skincare brand Alastin in Taiwan, with upcoming launches in Japan, Singapore, and South Korea through September and November 2026. - The expansion follows recent launches in China and Australia, targeting the fast-growing JPAC medical aesthetics and dermatological skincare market. - Nine Alastin products featuring TriHex Technology will be available, including peri-procedural support products and daily treatment formulations for collagen and elastin renewal. - The launch underscores Galderma's Integrated Dermatology strategy, addressing rising demand for skincare solutions that support aesthetic procedure recovery and long-term skin quality.
- The U.S. FDA has approved Differin Epiduo Acne Gel (adapalene 0.1% and benzoyl peroxide 2.5%) for over-the-counter use in patients aged 12 years and older, marking the first prescription-to-OTC transition for this combination therapy. - Clinical data from multiple Phase 3 studies demonstrated the combination gel consistently outperformed individual components alone, with up to 70.3% reduction in inflammatory acne lesions at Week 12 and sustained efficacy maintaining approximately 65% total lesion reduction through 12 months. - The approval expands access to a dermatologist-trusted treatment that combines a third-generation retinoid with benzoyl peroxide, addressing multiple biological drivers of acne through a once-daily regimen. - Galderma's OTC launch will begin in summer 2026 at major retailers including Walmart, Target, Ulta, and Amazon, representing a significant milestone in acne care accessibility.
