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Concert Pharmaceuticals announced that the FDA has confirmed the continued Breakthrough Therapy designation for deuruxolitinib, an oral JAK inhibitor aimed at treating moderate to severe alopecia areata. Initially granted this designation in 2020 based on positive Phase 2 results, Concert submitted additional clinical data to support its retention after the FDA reviewed a competing JAK inhibitor's approval. The FDA's decision reflects that deuruxolitinib meets criteria for substantial improvement over existing therapies. Alopecia areata impacts approximately 1.5 million Americans, with limited current treatment options.
Sun Pharmaceutical Industries has announced its acquisition of Concert Pharmaceuticals for an upfront payment of
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) will participate in a fireside chat at the Jefferies London Healthcare Conference on November 16, 2022, at 10:20 a.m. GMT. Investors can access a live webcast of the presentation through the Company's website. A replay will be available for two weeks following the event. Concert is a late-stage clinical biopharmaceutical company known for developing deuruxolitinib (CTP-543), an oral JAK1/2 inhibitor for alopecia areata. The company is exploring other indications and has multiple pipeline candidates.
Concert Pharmaceuticals reported its Q3 2022 financial results, highlighting a net loss of $28.9 million, or $0.58 per share, compared to a loss of $26.7 million, or $0.78 per share, in Q3 2021. Cash and investments amounted to $148.9 million as of September 30, 2022, expected to fund operations through Q2 2023. The company plans to submit a New Drug Application (NDA) for deuruxolitinib for alopecia areata in H1 2023, following positive Phase 3 results. Research and development expenses increased to $24.4 million, driven mainly by deuruxolitinib's clinical program.
Concert Pharmaceuticals (NASDAQ: CNCE) will announce its third quarter 2022 financial results on November 7, 2022, before U.S. markets open. A conference call and webcast will be held at 8:30 a.m. ET for discussion of the results and business updates. Interested parties can register for the live call here. An audio webcast will be available on the company’s website, with a replay accessible for three months.
Concert Pharmaceuticals is focused on developing deuruxolitinib (CTP-543), a novel JAK1/2 inhibitor, having completed two Phase 3 trials for alopecia areata.
Concert Pharmaceuticals presented positive results from its Phase 3 trial, THRIVE-AA1, demonstrating that 35% of patients treated with CTP-543 at 12 mg twice daily achieved at least 90% scalp hair coverage after 24 weeks. Data also indicated significant regrowth in eyebrows and eyelashes. The treatment yielded a SALT score of 10 or less in 35% of patients, compared to 0% in the placebo group (p<0.0001). The company plans to file for FDA approval in the first half of 2023, bolstered by its Breakthrough Therapy designation, indicating high potential for this treatment in alopecia areata.
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) announced its virtual participation at the H.C. Wainwright 24th Annual Global Investment Conference on September 12, 2022. The live presentation will start at 7:00 a.m. ET and will be accessible via the Investors section of Concert's website. A replay of the webcast will be available for two weeks post-event. Concert is recognized for its late-stage development of CTP-543, a novel oral JAK1/2 inhibitor, targeting alopecia areata and other indications.
Alopecia Areata Awareness Month is recognized every September, and Concert Pharmaceuticals is promoting awareness through a campaign called Light It Up Blue 4 Alopecia Areata. Major U.S. landmarks will be illuminated blue throughout September to raise awareness for this autoimmune disease affecting approximately 1.5 million Americans. Alopecia areata has limited treatment options and can lead to significant psychological challenges, including anxiety and depression. The campaign encourages individuals to participate by changing lights to blue and sharing photos with the hashtag #LightItUpBlue4AlopeciaAreata.
Concert Pharmaceuticals (NASDAQ: CNCE) has announced that results from the Phase 3 THRIVE-AA1 trial for CTP-543 will be presented at the 31st EADV Congress in Milan, Italy, on September 10, 2022. CTP-543 is a JAK inhibitor for treating moderate to severe alopecia areata, a condition affecting about 1.5 million Americans. The presentation, led by Dr. Brett King, will cover efficacy and safety data, including Severity of Alopecia Tool (SALT) scores. CTP-543 has received Breakthrough Therapy and Fast Track designations from the FDA.
Concert Pharmaceuticals (NASDAQ: CNCE) announced the exercise of remaining tranche 1 warrants by BVF Partners L.P. and RA Capital Management, generating $20.9 million for the company. Further, there is a potential $49.2 million from tranche 2 warrants, set to expire on October 31, 2022. These exercises are tied to the clinical success of CTP-543, with positive topline results from Phase 3 trials reported in May and August 2022. The company anticipates its cash resources will sustain operations through the expected NDA submission for CTP-543 in the first half of 2023.