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Concert Pharmaceuticals (NASDAQ: CNCE) announced positive topline results from its Phase 3 trials, THRIVE-AA1 and THRIVE-AA2, for CTP-543, targeting moderate to severe alopecia areata. In THRIVE-AA1, 41.5% and 29.6% of patients on the 12 mg and 8 mg doses, respectively, achieved a SALT score of 20 or less, compared to 0.8% in placebo. THRIVE-AA2 showed similar results with 38.3% and 33.0% achieving the same outcome. Financially, the company reported a net loss of $24 million for Q2 2022, with cash reserves of $153.7 million, projecting funding into Q2 2023.
Concert Pharmaceuticals has announced positive topline results from its Phase 3 trial, THRIVE-AA2, evaluating CTP-543 for treating moderate to severe alopecia areata. The primary endpoint, a SALT score of 20 or less at 24 weeks, was met with a statistically significant proportion of patients achieving this score. The study showed a satisfaction rate of 47% in the 8 mg group and 52% in the 12 mg group. The company is gearing up for a New Drug Application (NDA) submission to the FDA in the first half of 2023, positioning CTP-543 as a potential best-in-class treatment.
Concert Pharmaceuticals (NASDAQ: CNCE) will announce its second quarter 2022 financial results on August 4, 2022, before the U.S. markets open. The company will hold a conference call at 8:30 a.m. ET to discuss these results and provide a business update. A new registration system is in place for participants who wish to ask questions. The live call can be accessed by registering here, while an audio-only webcast will be available on the company website for three months.
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) will participate in a fireside chat at the JMP Securities Life Sciences Conference on June 16, 2022, at 1:00 p.m. ET, in New York, NY. Investors can access a webcast of the chat on the Company’s website, with a replay available for two weeks post-event. Concert is a clinical stage biopharmaceutical company focusing on developing small molecule drugs, particularly its lead product candidate for alopecia areata, using its innovative DCE Platform for improved pharmacokinetics.
Concert Pharmaceuticals (NASDAQ: CNCE) published significant data from a Phase 2 trial of CTP-543, an oral JAK inhibitor, in the Journal of the American Academy of Dermatology. The trial demonstrated clinically meaningful scalp hair regrowth after 24 weeks in patients with moderate to severe alopecia areata. Both 8 mg and 12 mg doses showed statistically significant results, leading to the FDA's Breakthrough Therapy designation for CTP-543. Positive topline data from the THRIVE-AA1 trial was also reported, with further results from the THRIVE-AA2 trial expected soon.
Concert Pharmaceuticals announced the closure of its underwritten public offering of 10 million shares at $4.75 per share, generating gross proceeds of $47.5 million. Additionally, the company raised $18.9 million from exercising tranche 1 warrants, leading to total gross proceeds of $66.4 million. Jefferies and Truist acted as joint book-running managers for the offering. The offering was conducted under a shelf registration statement filed with the SEC.
Concert Pharmaceuticals announced a public offering of 10 million shares at $4.75 each, aiming for gross proceeds of approximately
Concert Pharmaceuticals (NASDAQ: CNCE) announces a proposed public offering of 10,000,000 shares of common stock, with the option to sell an additional 1,500,000 shares to underwriters. The offering is contingent on market conditions and aims to raise funds for business initiatives. The underwriters, Jefferies and Truist Securities, will manage the sale. This is conducted under a shelf registration effective since November 16, 2020. No assurance is provided regarding the offering’s completion or terms.
Concert Pharmaceuticals (NASDAQ: CNCE) announced positive topline results from its Phase 3 trial, THRIVE-AA1, for CTP-543 in treating moderate to severe alopecia areata. The study met its primary endpoint, achieving a SALT score of 20 or less in 41.5% of patients on the higher dose after 24 weeks. Key secondary endpoints were also met, with statistically significant results across both dose groups. The treatment was generally well tolerated, with no major safety concerns reported. The company plans to submit an NDA to the FDA in early 2023, contingent on forthcoming trial results.
Concert Pharmaceuticals (NASDAQ: CNCE) reported its Q1 2022 financial results, showcasing pivotal progress in its CTP-543 clinical programs for alopecia areata. The company expects to release topline data for its THRIVE-AA1 trial in Q2 2022 and THRIVE-AA2 results in Q3 2022. Financially, cash reserves were $109 million, down from $141.6 million at year-end 2021, with a net loss of $37.7 million, or $1.03 per share. The company aims to file a New Drug Application with the FDA in the first half of 2023, contingent on positive clinical outcomes.
