Ritlecitinib

Sun Pharma's Leqselvi Advances Toward Launch After Favorable US Court Ruling

a month ago

• Sun Pharmaceutical Industries has gained significant legal leverage after a US Court of Appeals vacated a preliminary injunction against its alopecia areata treatment Leqselvi, potentially enabling commercialization despite ongoing litigation with Incyte. • Emkay Research projects Leqselvi could generate over $500 million in global sales by FY30, with initial US sales of $40 million expected in FY26, positioning it as a cornerstone specialty product with EBITDA margins exceeding 45%. • The brokerage firm has issued a "BUY" recommendation for Sun Pharma with a target price of Rs 2,400, representing a potential 45% upside from current levels, citing strong product pipeline and consistent execution on specialty drug launches.

U.S. Court Ruling Clears Path for Sun Pharma's Alopecia Drug Leqselvi Launch

a month ago

• The U.S. Court of Appeals for the Federal Circuit has vacated a preliminary injunction against Sun Pharma, allowing the company to proceed with launching Leqselvi (deuruxolitinib) for alopecia areata in the American market. • Sun Pharma acquired Leqselvi through its $576 million Concert Pharma acquisition in 2023, positioning it as a key product in its specialty portfolio that recently surpassed $1 billion in annual sales. • The patent infringement litigation with Incyte Corporation continues, but Sun Pharma is no longer restricted from launching the drug, which analysts project could contribute $90 million to sales in FY26 and $125 million in FY27.

Circulating DNA/RNA Market Set to Triple to $16.4 Billion by 2032, Driven by Patent Innovations

2 months ago

• The global circulating DNA/RNA market is projected to grow from $5.32 billion in 2023 to $16.4 billion by 2032, advancing at a CAGR of 13.29% according to a new patent landscape report. • Key industry players Nantomics, Genentech, and Novartis are leading innovation in the sector, with the United States dominating patent activity with over 600 patents, followed by Europe and Asia. • The oncology segment leads patent filings, with technological advancements in non-invasive diagnostics and personalized medicine driving market expansion and creating new opportunities in genomic medicine.

Androgenetic Alopecia Pipeline Shows Promise with Over 100 Therapies in Development

3 months ago

• DelveInsight's latest report reveals a robust pipeline for androgenetic alopecia with 80+ companies developing 100+ therapeutic candidates across various clinical stages. • Key emerging treatments include KX-826 from Kintor Pharma and Clascoterone from Cassiopea, which could significantly expand options beyond the current FDA-approved minoxidil and finasteride. • Recent clinical trial results from companies like Veradermics, Chong Kun Dang, and Pelage Pharmaceuticals demonstrate increasing R&D investment in addressing this common condition affecting up to 50% of both men and women.

Pfizer's Litfulo Becomes First NHS-Approved Treatment for Severe Alopecia Areata

3 months ago

• NICE has recommended Pfizer's Litfulo (ritlecitinib) as the first NHS-approved drug therapy for severe alopecia areata, affecting approximately 14,000 people in the UK. • In the ALLEGRO trial, Litfulo demonstrated significant efficacy with 23% of treated patients achieving 80% hair coverage compared to 1.6% in the placebo group. • The once-daily oral medication is approved for patients aged 12 and over, marking a breakthrough in treating this autoimmune disorder that impacts roughly 2% of the population lifetime.

Advancements in Crohn's Disease Treatment: Emerging Therapies and Market Trends

6 months ago

• The Crohn's disease market is experiencing growth, driven by increasing prevalence and advances in treatment options, with the market size expected to increase from USD ~9,000 million in 2023. • Emerging therapies like mirikizumab, guselkumab and biosimilars of ustekinumab are showing promise in clinical trials, offering improved efficacy and targeted mechanisms of action for Crohn's disease management. • Pharmaceutical companies such as Eli Lilly, Janssen, Takeda, and Dong-A-ST are actively involved in developing and launching novel treatments, including biologics and biosimilars, to address unmet needs in Crohn's disease. • Clinical trials are focusing on histologic outcomes and endoscopic remission, indicating a shift towards more comprehensive assessments of treatment efficacy in Crohn's disease patients.

Court Blocks Sun Pharma's Alopecia Drug Launch Following Incyte Patent Dispute

7 months ago

• A US district court in New Jersey has granted Incyte's preliminary injunction against Sun Pharma's Leqselvi (deuruxolitinib), halting its launch for alopecia areata treatment. • The legal dispute centers on Incyte's patent claims regarding deuterated forms of ruxolitinib, potentially impacting Sun Pharma's projected $200 million annual sales target. • Sun Pharma plans to appeal the decision, which affects their recently FDA-approved JAK 1/2 inhibitor for treating severe alopecia areata, a condition affecting over 700,000 Americans.

Aquestive Therapeutics Advances Anaphylm and Alopecia Treatment, Receives Analyst Boost

8 months ago

• Aquestive Therapeutics' Anaphylm sublingual film demonstrated rapid symptom resolution in an oral allergy syndrome challenge study, with a median time of 12 minutes. • The company plans to hold a pre-NDA meeting with the FDA in Q4 2024 and submit the NDA in Q1 2025, targeting a product launch in Q1 2026. • Aquestive is also developing AQST-108, a topical gel for alopecia areata, with a Phase 2 study expected to commence in the second half of 2025. • H.C. Wainwright raised the price target for Aquestive Therapeutics to $10, reflecting the potential of Anaphylm and AQST-108.

Drug Development Updates