4D Molecular Therapeutics Reports Full Year 2022 Financial Results and Operational Highlights

March 15, 2023 Download PDF EMERYVILLE, Calif., March 15, 2023 (GLOBE NEWSWIRE) — 4D Molecular Therapeutics (Nasdaq: FDMT, ‘4DMT’), a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large market diseases, today announced full year 2022 financial results and provided operational highlights. “We are proud to have validated 4DMT’s Therapeutic Vector…

Reneo Pharmaceuticals Achieves Target Enrollment in the Pivotal STRIDE Study of Mavodelpar (REN001) in Primary Mitochondrial Myopathies

Topline data from the STRIDE study expected in the fourth quarter of 2023 IRVINE, Calif., March 14, 2023 (GLOBE NEWSWIRE) — Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM), a clinical-stage pharmaceutical company focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, today announced that the company has achieved the target enrollment…

Mirum Announces Label Expansion for LIVMARLI in the United States to Include Infants Three Months of Age and Older

– LIVMARLI immediately available for prescribing for patients three months of age and older FOSTER CITY, Calif.–(BUSINESS WIRE)– Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved a reduction in age from one year to three months for LIVMARLI® (maralixibat) oral solution for the treatment of cholestatic pruritus in…

Mirum Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

FOSTER CITY, Calif.–(BUSINESS WIRE)– Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that on March 10, 2023, the Compensation Committee of Mirum’s Board of Directors granted inducement awards consisting of non-qualified stock options to purchase 40,050 shares of common stock and 20,050 restricted stock units (“RSUs”) to four new employees under Mirum’s 2020 Inducement Plan. The Compensation…

Mirum Pharmaceuticals Reports Fourth Quarter and Year-End 2022 Financial Results and Provides Business Update

– Net product sales for LIVMARLI® (maralixibat) oral solution totaled $75.1 million for first full fiscal year of U.S. commercial launch, and full year 2022 revenue totaled $77.1 million – Conference call to provide business updates today, March 8 at 1:30 p.m. PT/4:30 p.m. ET FOSTER CITY, Calif.–(BUSINESS WIRE)– Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today reported financial…

Mirum Pharmaceuticals to Announce Fourth Quarter and Year-End 2022 Financial Results and Host Conference Call on March 8, 2023

FOSTER CITY, Calif.–(BUSINESS WIRE)– Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that it will report fourth quarter and year-end 2022 financial results on Wednesday, March 8, 2023. Mirum will also host a conference call to discuss the fourth quarter and year-end 2022 financial results and recent corporate progress. Conference call details:Wednesday, March 8, 20234:30 p.m. ET…

4D Molecular Therapeutics Presents Interim Data from 4D-310 INGLAXA Phase 1/2 Clinical Trials & Development Plans for Fabry Disease Cardiomyopathy at WORLDSymposium™

February 22, 2023 Download PDF EMERYVILLE, Calif., Feb. 22, 2023 (GLOBE NEWSWIRE) — 4D Molecular Therapeutics (Nasdaq: FDMT, ‘4DMT’), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced updated interim safety and efficacy data from the two 4D-310 INGLAXA Phase 1/2 clinical trials for Fabry disease cardiomyopathy. All three…

Aura Biosciences Announces Positive Interim Phase 2 Safety and Efficacy Data of Belzupacap Sarotalocan (Bel-sar) for the First-Line Treatment of Patients with Early-Stage Choroidal Melanoma with Suprachoroidal Administration at the Macula Society 46th Annual Meeting

BOSTON–(BUSINESS WIRE)–Feb. 16, 2023– Aura Biosciences, Inc. (“Aura”) (Nasdaq: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the presentation of positive interim Phase 2 safety and efficacy data of bel-sar with nine months of follow up evaluating two key clinical endpoints: tumor control and…

4DMT to Present Interim Clinical Data from INGLAXA Phase 1/2 Trials of 4D-310 for Fabry Disease Cardiomyopathy at 19th Annual WORLDSymposium™

February 16, 2023 Download PDF EMERYVILLE, Calif., Feb. 16, 2023 (GLOBE NEWSWIRE) — 4D Molecular Therapeutics (Nasdaq: FDMT, ‘4DMT’), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced that the Company will host a live webcast on February 22 to present interim clinical data from its 4D-310 INGLAXA Phase…

Mirum Pharmaceuticals Submits Supplemental New Drug Application to FDA for LIVMARLI in Patients with Cholestatic Pruritus in Progressive Familial Intrahepatic Cholestasis

– sNDA submitted for the treatment of cholestatic pruritus in patients two months of age and older with progressive familial intrahepatic cholestasis (PFIC) – Submission based on MARCH Phase 3 study with high statistical significance (p<0.0001) between LIVMARLI versus placebo, and 62% of itch severity scores reported as mild to none – If approved, LIVMARLI…