News and Events

ZYCUBO® is now the first and only therapy approved for the treatment of Menkes disease in the United States Solana Beach, CA – JANUARY 13, 2026 – Sentynl Therapeutics Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences Limited (“Zydus Group”), announced that the U.S. Food and Drug Administration (“FDA”) has approved ZYCUBO® […]

The investigational copper histidinate candidate receives new PDUFA Target Action Date of January 14, 2026 Solana Beach, CA – December 15, 2025 – Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. (“Zydus Group”), today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of […]

Solana Beach, CA – OCTOBER 1, 2025 – Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. (“Zydus”), announced today that the U.S. Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) relating to its New Drug Application (NDA) for copper histidinate (CUTX-101), intended to treat Menkes disease […]

Manuscript in the Journal of Inherited Metabolic Disease indicates increased survival in patients treated with fosdenopterin Solana Beach, CA – April 2, 2025 – Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. (“Zydus Group”), is pleased to announce the publication of NULIBRY’s three clinical studies comparing the treatment effect of […]

Six-month priority review granted for CUTX-101 copper histidinate with PDUFA target action date set for June 30, 2025 CUTX-101 has potential to be the first FDA-approved treatment for Menkes disease, a rare and fatal pediatric disease Solana Beach, CA, Ahmedabad, India, and Miami, FL – January 6, 2025 — Sentynl Therapeutics, Inc. (“Sentynl”), a […]

Zydus Americas had a 94% employee survey response rate and 90% of employees described the company as a great place to work. Solana Beach, CA, and Ahmedabad, India – June 3, 2024 — Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. (Zydus Group) today announced that it received accreditation […]

Sentynl, a Zydus Group company, receives worldwide proprietary rights to Zokinvy, adding to portfolio of biopharmaceuticals for rare and ultra-rare diseases. Zokinvy is approved in the U.S. (2020), European Union and Great Britain (2022), and Japan (2024) for the treatment of progeria, a collection of ultra-rare, fatal, genetic premature aging diseases that accelerate mortality in […]

NULIBRY is the first and only treatment in Great Britain for patients with molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening genetic disorder that often progresses rapidly in infants with a median overall survival age of about four years. The Medicines and Healthcare products Regulatory Agency’s (MHRA) decision is based on efficacy and safety […]

Sentynl receives worldwide proprietary rights and rolling New Drug Application with U.S. FDA pertaining to CUTX-101 copper histidinate CUTX-101 has potential to be the first FDA-approved treatment for Menkes disease; rolling submission of New Drug Application to FDA is ongoing and expected to be completed in 2024 Solana Beach, CA and Ahmedabad, India – December […]

Risk of death was 5.1 times higher in untreated patients versus patients treated with NULIBRY Treatment also led to improvements in urinary biomarker levels and development outcomes NULIBRY is the first therapy to reduce the risk of mortality in patients with known or presumed MoCD Type A Solana Beach, CA – […]

Sentynl celebrates one year as a founding member of BeginNGS™ and continues support to advance screening for 419 treatable, genetic disorders in newborns Solana Beach, CA – July 20, 2023 — Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases, announced its continued support […]

Solana Beach, CA – April 25, 2023 — Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases, will participate in the 2023 Pharmaceutical Compliance Congress hosted by Informa Connect Life Sciences on Thursday, April 27, at 2 p.m. ET […]

San Diego, CA and California, MD – Nov. 8, 2022 – Sentynl Therapeutics, Inc. (“Sentynl”) a US-based biopharmaceutical company focused on bringing innovative therapies to patients living with rare disease, joins the global Menkes disease community including the Menkes Foundation (“Menkes Foundation”) in recognizing the month of November as Menkes Disease Awareness Month. In support […]

– The first and only treatment in Europe to treat patients with molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening genetic disorder that often progresses rapidly in infants with a median overall survival age of about four years.  – European Commission (EC) decision is based on the efficacy and safety data collected to date […]

– NULIBRY is the first and only approved therapy in the United States (U.S.) and in Israel to treat patients with MoCD Type A, an ultra-rare, life-threatening genetic disorder that often progresses rapidly in infants with a median overall survival age of about four years – NULIBRY received a positive opinion from the Committee for […]

CHMP recommendation for approval of NULIBRY in the European Union (EU) for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A is based on the efficacy and safety data collected to date compared to data from a natural history study  Under an accelerated assessment pathway, a decision by the European Commission (EC), which […]

Solana Beach, CA – June 27, 2022 —Sentynl Therapeutics, Inc. (Sentynl), a U.S. based biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases owned by Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), today announced that NULIBRY (fosdenopterin) was honored with a 2022 Industry Innovation Award by the National […]

Solana Beach, CA – April 25, 2022 — Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases, owned by Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), today announced the continued availability of NULIBRY (fosdenopterin) for Injection and the launch of Sentynl Cares. NULIBRY […]

Cyprium Therapeutics, a subsidiry of Fortress Biotech, is developing CUTX-101 for the treatment of Menkes disease CUTX-101 has potential to be first FDA-approved treatment for Menkes disease; rolling submission of New Drug Application to FDA is ongoing and expected to be completed in mid-year 2022  New York, NY, and Solana Beach, […]

Palo Alto and Solana Beach, CA – March 8, 2022 — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company that focuses on genetic diseases and cancers, and Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases owned by Zydus Lifesciences Ltd. (formerly known […]

New York, NY, and Solana Beach, CA — Cyprium Therapeutics, Inc. (“Cyprium”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) partner company, with support from its licensing partner Sentynl Therapeutics, Inc. (“Sentynl”), a wholly owned subsidiary of Cadila Healthcare Limited (“Zydus”), today announced the initiation of a rolling submission of a New Drug Application (“NDA”) to […]

Solana Beach, CA, and California, MD/PRNewswire — Sentynl Therapeutics, Inc. (“Sentynl”), a US-based biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases, joins the global Menkes disease community including the Menkes Foundation (“Menkes Foundation”) in recognizing the month of November as Menkes Disease Awareness Month. In support of the patients and […]

New York, NY, and Solana Beach, CA — Cyprium Therapeutics, Inc. (“Cyprium”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) partner company, with support from its licensing partner Sentynl Therapeutics, Inc. (“Sentynl”), a wholly owned subsidiary of Cadila Healthcare Limited (“Zydus”), today announced positive results from an efficacy and safety analysis of data […]

New York, NY, and Solana Beach, CA — Cyprium Therapeutics, Inc. (“Cyprium”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) partner company, and Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based specialty pharmaceutical company owned by the Zydus Group, today announced the execution of an asset purchase agreement to commit development funding for and acquire Cyprium’s proprietary rights […]