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Day: January 9, 2023

Agios Unveils 2023-2026 Value-driving Catalysts Enabling Company’s Vision to Transform Patient Outcomes in Rare Diseases

– Consistent and compelling clinical data across rare hematological diseases support five ongoing pivotal trials in thalassemia, sickle cell disease and pediatric pyruvate kinase (PK) deficiency – – Driving toward two additional PYRUKYND® indications, with potential FDA approvals in thalassemia in 2025 and sickle cell disease in 2026 – – Strong cash position expected to enable completion of ongoing programs and pipeline expansion to cash-flow positivity – CAMBRIDGE, Mass., Jan. 08, 2023 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced its anticipated 2023 milestones and significant value-driving catalysts through 2026 that support the company’s mission to transform patient outcomes in rare diseases. Agios will present...

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Psyence Signs Letter of Intent with Australian CRO iNGENū

VANCOUVER, British Columbia, Jan. 08, 2023 (GLOBE NEWSWIRE) — Psyence Group Inc (CSE:PSYG | OTCQB: PSYGF), a life science biotechnology company pioneering the use of natural psilocybin in mental health and well-being, today announced that it has signed a Letter of Intent (LOI) with Contract Research Organisation (CRO) iNGENū CRO Pty Ltd (iNGENū) to execute Psyence’s strategy of market leading clinical development of psilocybin within palliative care. iNGENū is a globally focused CRO with extensive experience in working in the psychedelic pharmaceutical drug development and clinical research industry. iNGENū will be responsible for jointly designing the Phase IIb clinical trial to be conducted in Australia, in compliance with global standards. The LOI centres around Psyence’s global development and regulatory strategy of its licensed...

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Esperion Outlines Upcoming Milestones and Announces Preliminary Fourth Quarter 2022 Financial Results

– Based on the robustness of the CLEAR Outcomes data across primary and secondary endpoints, Company anticipates global regulatory submissions in 1H 2023 and believes it is entitled to receive milestone payments from partners upon regulatory approvals – – Fourth quarter 2022 U.S. net product revenue estimated between $14.4 to $15.1 million, FY growth between 38% and 40% year over year – – New partnership with RFK Racing to increase brand awareness and drive accelerated growth – – Company presenting at J.P. Morgan 41st Annual Healthcare Conference – ANN ARBOR, Mich., Jan. 08, 2023 (GLOBE NEWSWIRE) — Esperion (NASDAQ: ESPR) today announced preliminary, unaudited fourth-quarter 2022 financial results and highlighted key upcoming anticipated milestones which represent continued execution of the Company’s transformational plan. “Esperion...

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