Press Releases

Step Pharma, a world leader in CTPS1 inhibition for the targeted treatment of cancer, announces today that its lead asset STP938 has cleared both an Investigational New Drug (IND) application by the Food and Drug Administration (FDA), and a clinical trial application (CTA) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), enabling Step Pharma to progress STP938, its first-in-class, selective CTPS1 inhibitor into the clinic in the US and UK. STP938 has now

Acer Therapeutics Inc. and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief), today announced the U.S. Food and Drug Administration (FDA) has accepted for review Acer’s resubmitted New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with urea cycle disorders (UCDs). The FDA designated the NDA as a Class 2 resubmission and set a Prescription Drug User Fee Act (PDUFA) target acti

Quanterix Corporation , a company expanding the limits of exploration with ultrasensitive biomarker detection, today announced the validation of a laboratory developed test (LDT) to quantitatively measure phospho-Tau 181 (pTau-181) in plasma as an aid in diagnostic evaluation of Alzheimer’s disease (AD). Quanterix’ LDT – the first pTau-181 plasma test released for clinical use in the U.S. – is a quantitative immunoassay intended for the measurement of pTau-181 concentr

For years, ketamine was known for its use as an anesthetic or as a recreational drug. Its ability to provide quick and safe sedation saved many lives during the Vietnam war and is still the preferred anesthetic in battlefield situations. It can be used to induce a kind of trance-like state which wipes away pain. Ketamine may turn out to be more than an anesthesia drug or an illegal means of getting high. While more research needs to be done, recent studies point to its ability to relieve trea

Acasti Pharma Inc. today announces the initiation of its planned pharmacokinetic (PK) bridging study to evaluate the relative bioavailability of GTX-101 compared to the reference listed drug bupivacaine in 48 healthy subjects. Feedback from FDA was obtained on the study protocol, and the non-objection letter was received on July 12th from Health Canada. The First-Subject, First-Dose was administered on July 26th. The PK study is the next step in the proposed 505(b)(2) regulatory pathway for G

MoonLake Immunotherapeutics AG , a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced that it has signed a Master Development Services Agreement with Vetter Pharma International GmbH (Vetter), a leading global contract development and manufacturing organization for fill and finish services, ranging from development support, including clinical manufacturing, through to commercial supply. Under the agreement Vetter

Aisa Pharma, Inc. a privately-funded, clinical-stage biopharmaceutical company, today announced that the Data Safety Monitoring Board (DSMB) for the RECONNOITER Phase 2 study of Aisa’s Profervia® once-daily novel, oral calcium-channel antagonist has met and unanimously recommended continuing to the next stage in the trial and approved a go-forward dose level. In addition, the DSMB found no safety issues of concern and encouraging early efficacy trends in this first-ever clinical tri

BridgeBio Pharma, Inc.  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.  today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that the European Commission authorize marke

 Ascentage Pharma , a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, and Tanner Pharma Group ("Tanner Pharma"), a global pharmaceutical services provider of specialty access solutions, have jointly launched an innovative Named Patient Program (NPP) for olverembatinib. This collaboration will allow access to Ascentage Pharma's novel drug candidate, olverembatinib on a named patient basi

Qiming Venture Partners' portfolio company InventisBio , a leading company in innovative drug development, today listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange. The issue price is CNY 18.12 per share, representing a market cap of CNY 10.419 billion. Qiming Venture Partners invested in InventisBio in September 2020. The successful listing of the company marks the fourth IPO in Qiming's portfolio in 2022. InventisBio has become the ninth p