Day: June 17, 2023

One-Year Data from Phase 3 Trial of TransCon™ PTH in Adults with Hypoparathyroidism Presented at ENDO 2023

One-Year Data from Phase 3 Trial of TransCon™ PTH in Adults with Hypoparathyroidism Presented at ENDO 2023

– Oral presentation of results showed sustained improvements through Week 52, as well as safety and tolerability similar to that previously reported for the initial 26-week blinded portion of the Phase 3 PaTHway Trial – At Week 52, 95% of patients treated with TransCon PTH achieved independence from conventional therapy – TransCon PTH treatment improved mean patient-reported disease symptom and health-related quality of life scores, starting at the first scheduled follow up after randomization or after switching from placebo and sustained through Week 52 COPENHAGEN, Denmark, June 17, 2023 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND) today reported one-year (Week 52) data from its ongoing Phase 3 PaTHway Trial of TransCon PTH in adults with hypoparathyroidism. The data showed that treatment with TransCon...

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Rhythm Pharmaceuticals Presents Data Demonstrating BMI Reduction in Patients with Hypothalamic Obesity Treated with Setmelanotide over Six Months at ENDO 2023

Rhythm Pharmaceuticals Presents Data Demonstrating BMI Reduction in Patients with Hypothalamic Obesity Treated with Setmelanotide over Six Months at ENDO 2023

— Mean BMI reduction of 21.0% from baseline observed in 13 patients at six months, showing progression from 16.8% mean BMI reduction at 16 weeks — — Phase 3 trial evaluating setmelanotide in acquired hypothalamic obesity ongoing; completion of enrollment expected 1Q 2024 — BOSTON, June 17, 2023 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases, today announced data that showed meaningful weight loss was sustained and progressed in patients with hypothalamic obesity treated with setmelanotide for six months as part of the long-term extension of its Phase 2 trial.    “Hypothalamic...

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Vera Therapeutics Announces Positive Week 36 Efficacy and Safety Results of Phase 2b ORIGIN Clinical Trial of Atacicept in IgAN in Late-Breaking Presentation at 60th European Renal Association (ERA) Congress

Vera Therapeutics Announces Positive Week 36 Efficacy and Safety Results of Phase 2b ORIGIN Clinical Trial of Atacicept in IgAN in Late-Breaking Presentation at 60th European Renal Association (ERA) Congress

Figure 1 UPCR % Change With Atacicept 150 mg at Week 36 Figure 2 eGFR % Change With Atacicept 150 mg Through Week 36 New data at week 36 shows atacicept 150 mg resulted in a delta of 43% versus placebo in mean proteinuria reduction in per-protocol analysis and demonstrated statistically significant stabilization of eGFR versus placebo in this high-risk population Atacicept was well tolerated with safety profile similar to placebo Positive results support atacicept 150 mg as a potential disease-modifying treatment for patients with IgA nephropathy; Phase 3 (ORIGIN 3) clinical trial initiated in June 2023 Conference call and webcast to take place on June 20th, 2023, at 8:00 a.m. ET to further discuss results BRISBANE, Calif., June 17, 2023 (GLOBE NEWSWIRE) — Vera Therapeutics, Inc. (Nasdaq: VERA), a late-stage biotechnology company...

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Li Auto Inc. Hosts Family Tech Day

Li Auto Inc. Hosts Family Tech Day

BEIJING, China, June 17, 2023 (GLOBE NEWSWIRE) — Li Auto Inc. (“Li Auto” or the “Company”) (Nasdaq: LI; HKEX: 2015), a leader in China’s new energy vehicle market, today hosted a family tech day presenting the Company’s progress and plans in electrification and intelligentization. On the HPC BEV side, the Company has optimized its battery cells and upgraded its thermal management system to fully leverage the battery’s maximum 5C charging rate, enabling a peak charging power of over 500 kW. The Company has also started to self-build its 5C super charging network. As for intelligentization, the Company presented its progress and plans for smart space and autonomous driving, with city NOA beta testing planned for early bird users in Beijing and Shanghai in June. In addition, the Company plans to release commute NOA to early bird users...

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Chinook Therapeutics Presents Data from CHK-336 Phase 1 Trial in Healthy Volunteers and New Insights into the Role of Failed Repair in Chronic Kidney Disease at the 60th European Renal Association (ERA) Congress

Chinook Therapeutics Presents Data from CHK-336 Phase 1 Trial in Healthy Volunteers and New Insights into the Role of Failed Repair in Chronic Kidney Disease at the 60th European Renal Association (ERA) Congress

CHK-336 was generally well tolerated in healthy volunteers (HV) who received single doses up to 500 mg and multiple doses up to 60 mg for 14 days Pharmacokinetics (PK) was well characterized with dose-proportional exposures and a half-life that supports once-daily dosing Successful implementation of a novel 13C2-glycolate tracer established proof-of-mechanism of CHK-336 to block hepatic oxalate production in HVs One serious adverse event (SAE) of anaphylaxis occurred in a multiple ascending dose HV who received one 125 mg dose CHK-336, resulting in voluntary study pause Additional research presented on the impact of maladaptive tubular epithelial cells on progression of chronic kidney disease SEATTLE, June 17, 2023 (GLOBE NEWSWIRE) — Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery,...

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Molecular Templates Announces Debt Payoff and Restructuring

Molecular Templates Announces Debt Payoff and Restructuring

Restructuring agreement with K2 HealthVentures (K2HV) to fully discharge and satisfy outstanding debt owed to K2HV for the prepayment of $27.5 million and the granting of contingent value rights and warrants Additional reduction-in-force by approximately 44% as it continues to explore strategic alternatives AUSTIN, Texas, June 16, 2023 (GLOBE NEWSWIRE) — Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (“ETBs”), to create novel therapies with potent differentiated mechanisms of action for cancer, announced today that it has entered into a restructuring agreement (“Amending Agreement”) with K2 HealthVentures (“K2HV”) to satisfy and discharge MTEM’s...

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