Jun 09, 2026
MoonLake Immunotherapeutics plans to submit an FDA Biologics License Application for Sonelokimab in hidradenitis suppurativa by the end of September following a positive pre-BLA meeting. The submission is supported by clinical trial data showing 43% of patients achieved high-level improvement by Week 12 in the Mira trial. The company is also expecting multiple Phase 3 data readouts throughout the year.
May 05, 2026
AbbVie raised 2026 revenue and EPS guidance after first-quarter results beat estimates, with Skyrizi and Rinvoq driving growth. Humira erosion continued as neuroscience, oncology and pipeline assets supported the outlook.
May 03, 2026
Arcutis is in focus after new Phase 3 extension data for Zoryve cream 0.05% in young children with atopic dermatitis and ahead of its Feb. 25 Q4 results. Investors are also watching recent FDA actions and pipeline updates for additional pediatric and dermatology indications.
Apr 28, 2026
AbbVie filed an sBLA for SKYRIZI as a subcutaneous induction therapy for Crohn's disease, supported by Phase 3 AFFIRM data. SKYRIZI and Rinvoq combined for $25.9B in 2025 revenue, exceeding 2027 guidance. The FDA also approved Venclexta plus acalabrutinib in CLL.
Apr 19, 2026
AbbVie said Skyrizi and Rinvoq generated $26.0 billion in 2025 sales and are expected to exceed $31 billion in 2026. The company said the two immunology drugs continue to offset Humira erosion and drive top-line growth.
Mar 18, 2026
AbbVie reported positive Phase 3 data for Skyrizi's subcutaneous Crohn's disease treatment and is advancing lutikizumab and Rinvoq in hidradenitis suppurativa, with multiple readouts expected throughout 2026 as the company pursues combination therapy strategies.
Feb 28, 2026
Insmed reported total revenues of $606.4 million for 2025, with ARIKAYCE growing 19% annually. The FDA granted orphan drug designation to treprostinil palmitil for pulmonary arterial hypertension treatment in January 2026.
Feb 24, 2026
MoonLake Immunotherapeutics says FDA feedback indicates sufficient data to support a U.S. BLA for hidradenitis suppurativa without additional efficacy trials, while Relay Therapeutics received FDA Breakthrough Therapy designation for zovegalisib in combination with fulvestrant for PIK3CA-mutant breast cancer.
Feb 23, 2026
Novartis announced positive topline results from its Phase III RemIND trial of remibrutinib in chronic inducible urticaria, meeting the primary endpoint for the three most prevalent types of the condition with significantly higher complete response rates versus placebo.
Feb 18, 2026
Novartis reported positive Phase III RemIND trial results showing remibrutinib achieved complete response in three types of chronic inducible urticaria. The company has submitted a supplemental New Drug Application to the FDA for symptomatic dermographism.
Feb 18, 2026
Spruce Biosciences completed two Type B meetings with the FDA regarding tralesinidase alfa enzyme replacement therapy for Sanfilippo syndrome type B. The company now anticipates BLA submission in Q4 2026 to accommodate drug product process performance qualification requirements.
Feb 18, 2026
Novartis announced positive Phase III RemIND trial results for oral remibrutinib in chronic inducible urticaria, marking the first therapy to meet a Phase III primary endpoint in the condition. The company has submitted a supplemental New Drug Application to the FDA.
Feb 18, 2026
Novartis announced positive topline results from its pivotal Phase III RemIND trial of oral remibrutinib in chronic inducible urticaria, meeting the primary endpoint for three prevalent CIndU types with significantly higher complete response rates versus placebo at Week 12.
Feb 13, 2026
Arcutis Biotherapeutics is scheduled to report fourth-quarter and full-year 2025 results on Feb. 25, after market close. Investors will focus on sales performance of Zoryve and pipeline updates.
Feb 13, 2026
Engineered regulatory T cell therapies are progressing through clinical trials for autoimmune diseases and organ transplant rejection, with CAR-Treg candidates showing promising early results in rheumatoid arthritis and other conditions.
Feb 12, 2026
AbbVie reported stronger-than-expected Q4 revenue of $16.62 billion and EPS of $2.71, beating consensus estimates. The company advanced a toxin-based therapy in Phase 2 trials and filed suit challenging Medicare drug-price negotiations for Botox.
Jan 29, 2026
The FDA placed clinical holds on Regenxbio's RGX-111 and RGX-121 gene therapies following a tumor case in an MPS I patient. The company's stock fell nearly 18% on the news.
