FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov. 30, 2020-- Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biopharmaceutical company focused on the development and commercialization of novel therapies for debilitating liver diseases, today announced that the company’s Marketing Authorization Application (MAA) for its investigational medicine, maralixibat, for the treatment of patients with progressive familial intrahepatic cholestasis type 2 (PFIC2), also known as bile salt export pump (BSEP) deficiency, was accepted for review (validated) by the European Medicines Agency (EMA). The validation of the application by the EMA confirms all essential regulatory elements are included in the submission such that the EMA can begin its review.
Mirum Pharmaceuticals Announces European Medicines Agency Validation of the Marketing Authorization Application for Maralixibat in Patients with PFIC2
VelosBio to be Acquired by Merck for $2.75 billion
RESEARCH TRIANGLE PARK, NC, Nov. 5, 2020 -- Pappas Capital, a leading venture capital firm focused on advancing life sciences, today announced that its portfolio company, VelosBio Inc. ("VelosBio" or the "Company"), has entered into a definitive agreement to be acquired by a subsidiary of Merck (NYSE: MRK) for $2.75 billion in cash, subject to customary adjustments. The exit is amongst Pappas Capital's most successful in its 25-plus-year history.
VelosBio Announces First Patient Dosed in Phase 2 Trial of VLS-101 in Solid Tumors
SAN DIEGO -- Oct. 19, 2020 -- VelosBio Inc. (VelosBio), a clinical-stage biopharmaceutical company committed to developing first-in-class cancer therapies targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), today announced that the first patient has been dosed in a Phase 2 trial of VLS-101 in patients with solid tumors. VLS-101, the company’s lead product candidate, is an antibody-drug conjugate (ADC) that targets ROR1.
Mirum Pharmaceuticals Initiates Rolling Submission of a New Drug Application for Maralixibat
FOSTER CITY, Calif. --Sep. 1, 2020-- Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biopharmaceutical company focused on the development and commercialization of novel therapies for debilitating liver diseases today announced that it has submitted the first portion of its rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for maralixibat. Maralixibat is a novel, minimally absorbed, orally administered apical sodium dependent bile acid transporter (ASBT) inhibitor being evaluated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS). Mirum expects to complete the NDA submission in the first quarter of 2021.
4D Molecular Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial of 4D-125 by Intravitreal Injection for the Treatment of X-Linked Retinitis Pigmentosa
EMERYVILLE, CA -- 4D Molecular Therapeutics (4DMT), a clinical-stage leader in the development of precision-guided AAV gene medicines based on directed evolution, announced that the first patient has been dosed in the Phase 1/2 clinical trial of 4D-125 for X-Linked Retinitis Pigmentosa (XLRP), a blinding and currently untreatable inherited retinal disease. 4D-125 is an AAV gene therapy with an optimized and proprietary vector designed to deliver a functional copy of the RPGR gene to photoreceptors in the retina. This vector enables both administration by intravitreal injection, a safe and routine clinical route, plus the potential to treat broader and earlier-stage patient populations as compared to subretinal approaches. 4D-125 is a 4DMT-declared ophthalmology therapeutic candidate under 4DMT’s collaboration with Roche, where Roche has an option to take an exclusive world-wide license prior to initiation of a pivotal trial.
Amplyx Doses First Patient in Phase 2 Clinical Trial of Anti-BKV Monoclonal Antibody in Renal Transplant Recipients
SAN DIEGO, Aug. 17, 2020 -- Amplyx Pharmaceuticals, a clinical-stage biopharmaceutical company developing innovative therapies for debilitating and life-threatening diseases in patients with compromised immune systems, today announced that the first patient has been dosed in its Phase 2 clinical trial evaluating the efficacy and safety of MAU868 for the treatment of BK viremia in kidney transplant recipients. MAU868 is a novel, human monoclonal antibody that potently neutralizes all four major genotypes of BK virus (BKV). BKV-associated nephropathy is a leading cause of kidney allograft loss.
Cyclerion Therapeutics Completes $24 Million Private Placement
- Additional capital to accelerate clinical development of IW-6463 in two CNS indications and olinciguat for sickle cell disease -
- IW-6463 translational pharmacology and olinciguat STRONG Phase 2 top line clinical study results remain on track for late summer and late Q3 2020, respectively
CAMBRIDGE, Mass., July 30, 2020 -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company developing treatments for serious and orphan diseases, today announced a direct private sale of $24 million of Cyclerion shares of common stock to Slate Path Capital LP and Pappas Capital.
BioAtla Raises $72.5 Million In Series D Financing
SAN DIEGO, July 15, 2020 -- BioAtla, Inc., a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced closing of a Series D financing round raising $72.5 million. The financing was led by Soleus Capital and joined by several new investors including HBM Healthcare Investments as co-lead, Cormorant Asset Management, Farallon Capital, Pappas Capital, funds managed by Janus Henderson, Boxer Capital, and one other institutional investor. Current investor Pfizer Ventures, the venture capital arm of Pfizer Inc. (NYSE: PFE), also participated in the financing.
VelosBio Raises $137 Million in Series B Financing
SAN DIEGO -- VelosBio Inc. (“VelosBio”), a clinical-stage biopharmaceutical company committed to developing novel, first-in-class cancer therapies targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), today announced the completion of an oversubscribed Series B financing of $137 million led by Matrix Capital Management and Surveyor Capital (a Citadel company). The Company has raised a total of $202 million in gross proceeds from private financings since its founding in 2017.
New investors participating in the Series B financing round include Adage Capital Management LP, Cormorant Asset Management, Farallon, Foresite Capital, Janus Henderson Investors, Logos Capital, OrbiMed, funds and accounts advised by T. Rowe Price Associates, Inc., Venrock Healthcare Capital Partners, Viking Global Investors, and Wellington Management Company, which are joining existing investors Arix Bioscience, Decheng Capital, Pappas Capital, Sofinnova Ventures, and Takeda Ventures.
4D Molecular Therapeutics Raises $75 Million in Series C Financing
EMERYVILLE, CA, June 16, 2020 - 4D Molecular Therapeutics (4DMT), a clinical-stage leader in the development of precision-guided AAV gene medicines based on directed evolution, announced the closing of its $75 million Series C financing. The round was led by Viking Global Investors, with participation from new investors including Amzak Health, Casdin Capital, Cystic Fibrosis Foundation, Longevity Vision Fund, MiraeAsset Financial Group, Octagon Investments, and QUAD Investment Management. Existing investors also participated in the financing, including Arrowmark Partners, Berkeley Catalyst Fund, BVF Partners L.P., Pappas Capital & Chiesi Ventures, Perceptive Advisors, Pfizer Ventures, and Ridgeback Capital Investments.
