News

Apr 3 2022

BridgeBio Pharma Presents Updated Results from Phase 2 Open-label Extension Study of Acoramidis in Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Apr 3 2022

PALO ALTO, CA – April 3, 2022 — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced updated data from its ongoing Phase 2 open-label extension (OLE) study of acoramidis (AG10) in patients with symptomatic transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM). The results were featured in an oral presentation at the American College of Cardiology (ACC) Annual Scientific Session & Expo, taking place in Washington, D.C. on April 2 – 4, 2022.

READ MORE

Mar 31 2022

CIDARA THERAPEUTICS ANNOUNCES THE COMPLETION OF DOSING THE FIRST COHORT OF HEALTHY VOLUNTEERS IN THE PHASE 1 TRIAL OF CD388 IN DEVELOPMENT FOR UNIVERSAL PREVENTION AND TREATMENT OF SEASONAL AND PANDEMIC INFLUENZA

Mar 31 2022

SAN DIEGO, CA – March 31, 2022 — Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics designed to help improve the standard of care for patients facing serious diseases, today announced that the first cohort of healthy volunteers has been dosed in its Phase 1 trial of CD388, a highly potent long-acting antiviral immunotherapy designed to deliver universal prevention of seasonal and pandemic influenza. The study is being conducted under an exclusive worldwide license and collaboration agreement with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize Cidara’s Cloudbreak drug-Fc conjugates (DFCs) for the prevention and treatment of seasonal and pandemic influenza.

READ MORE

Mar 30 2022

Antios Therapeutics’ ATI-2173 Demonstrates Suppression of Hepatitis B Virus in Phase 1b and 2a Studies

Mar 30 2022

DOYLESTOWN, PA – March 30, 2022 – Antios Therapeutics, Inc. (Antios), a clinical-stage biopharmaceutical company developing innovative therapies to treat and cure chronic hepatitis B virus (HBV), today announced new data from the Phase 1b and 2a clinical trials of ATI-2173, its investigational proprietary drug candidate and the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development for HBV. These data showed that ATI-2173 alone, or in combination with tenofovir disoproxil fumarate (TDF), was generally well-tolerated among the cohorts, and ATI-2173 and TDF suppressed HBV DNA and induced declines in biomarkers of cccDNA activity. Data from these trials will be presented in two poster sessions during the 31st Conference of the Asian Pacific Association for the Study of Liver (APASL), taking place in Seoul, South Korea on March 30, 2022 – April 3, 2022.

READ MORE

Mar 29 2022

Prolacta - Independent, head-to-head study shows significant health benefits of early fortification associated with Prolacta Bioscience’s 100% human milk-based fortifiers compared to cow milk-based fortifiers for premature infants

Mar 29 2022

DUARTE, CA- March 29, 2022 – An independent, head-to-head study from Neuburg, Germany, shows extremely low birth weight preterm infants fed Prolacta Bioscience® 100% human milk-based fortifiers (HMBF) as part of an Exclusive Human Milk Diet (EHMD) had reduced incidences of life-threatening comorbidities and experienced shorter stays in the neonatal intensive care unit (NICU), compared to those fed cow/bovine milk-based fortifiers (CMBF), offsetting the higher therapeutic costs of HMBF.1

The study, “Nutrition of Infants with Very Low Birth Weight Using Human and Bovine Based Milk Fortifier: Benefits and Costs,” was published in Neonatal and Pediatric Medicine and is the first head-to-head clinical trial of nutritional fortifiers conducted within Germany’s national health care system. The findings corroborate the results from more than 20 peer-reviewed studies demonstrating the benefits of Prolacta’s 100% human milk-based fortifiers, compared to cow-milk based fortifiers.2-15

READ MORE

Mar 25 2022

ADMA Biologics Announces FDA Approval of Extended Shelf Life for ASCENIV™ & BIVIGAM® from 24 to 36 Months

Mar 25 2022

RAMSEY, NJ and BOCA RATON, FL – March 25, 2022 — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, announced the United States Food and Drug Administration’s (“FDA”) approval to extend the expiration dating from 24 to 36 months for both its ASCENIV and BIVIGAM immune globulin (“IG”) drug product stored at 2-8°C. The expiration date extension applies to all existing ASCENIV and BIVIGAM lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM in all vial sizes, production scales as well as internal and external fill-finished drug product.

READ MORE

Mar 22 2022

ObsEva Announces Additional Efficacy Results for Linzagolix 200 mg with Add-Back Therapy (ABT) and Linzagolix 75 mg without ABT in the Phase 3 EDELWEISS 3 Trial in Patients with Moderate-to-Severe Endometriosis-Associated Pain

Mar 22 2022

GENEVA, Switzerland – March 22, 2022 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies for women’s health, today announced additional efficacy results from the Phase 3 EDELWEISS 3 trial of linzagolix, an oral GnRH antagonist, in women with moderate-to-severe endometriosis-associated pain (EAP). The results build upon the positive topline results announced in January 2022.

READ MORE

Mar 14 2022

Elevation Oncology Appoints David Dornan, Ph.D., as Chief Scientific Officer

Mar 14 2022

NEW YORK, NY – March 14, 2022 — Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical-stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, today announced the appointment of David Dornan, Ph.D. as the Company’s Chief Scientific Officer.

READ MORE

Mar 24 2022

ADMA Biologics Announces Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update, Including $175M Debt Refinance with Hayfin Capital Management

Mar 24 2022

RAMSEY, NJ and BOCA RATON, FL – March 24, 2022 — ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced its fourth quarter and full year 2021 financial results. Additionally, ADMA today announced the closing of a debt refinancing with Hayfin Capital Management (“Hayfin”) of $150 million, and up to an additional $25 million tied to the achievement of certain revenue targets during 2022.   The first tranche of the newly issued loan from Hayfin was fully drawn and used to completely repay the obligations under the Perceptive Advisors (“Perceptive”) senior secured notes, including all associated prepayment fees.

READ MORE

Mar 17 2022

AVROBIO Reports Fourth Quarter and Fiscal Year 2021 Financial Results and Provides Business Update

Mar 17 2022

CAMBRIDGE, MA.- March 17, 2022– AVROBIO, Inc. (Nasdaq: AVRO), a leading clinical-stage gene therapy company with a mission to free people from a lifetime of genetic disease, today reported financial results for the fourth quarter and year ended Dec. 31, 2021, and provided a business update.

“After a busy 2021 with new patients dosed across three clinical trials, we acted in early January to strategically position AVROBIO for long-term success by reprioritizing our leading lysosomal disorder pipeline. Four weeks after, we reinforced that position by releasing strong interim data from the Phase 1/2 collaborator-sponsored clinical trial for cystinosis at the WORLDSymposiumTM 2022,” said Geoff MacKay, president and CEO of AVROBIO. “We look forward to sharing new data on the three patients dosed to date in our Gaucher disease type 1 program in 2022 and providing updates for our other pipeline programs following meetings with regulatory agencies planned for later this year. We potentially have many exciting catalysts ahead of us and believe that our strong balance sheet will support continued progress through anticipated milestones and into the first quarter of 2024.”

Program Updates

Presented interim data from Phase 1/2 clinical trial of AVR-RD-04 in cystinosis at the 18th Annual WORLDSymposium™ 2022:

  • First three patients dosed to date remain off oral cysteamine with follow up durations ranging between 12- and 26-months post-gene therapy infusion. Sustained engraftment has been observed in each of these patients, as evidenced by stable vector copy number (VCN) levels.
  • Reduction in number of cystine crystals as measured in skin and intestinal mucosa biopsies observed across these three patients.
  • A fourth patient was infused in November 2021.
  • No adverse events (AEs) related to the drug product have been reported in the four patients infused to date. All AEs observed have been attributed to myeloablative conditioning, stem cell mobilization, underlying disease or pre-existing conditions.
  • Clinical proof-of-concept in adult patients lays the groundwork for potential AVROBIO-sponsored trial planned to begin in 2023.
  • The company hosted a conference call providing a full data update.
READ MORE

Mar 15 2022

Wugen Announces First Patient Dosed in Phase 1/2 Trial of WU-CART-007 for the Treatment of Patients with R/R T-ALL/LBL

Mar 15 2022

ST. LOUIS, MO and SAN DIEGO, CA – March 15, 2022 – Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced that the first patient has been dosed in a Phase 1/2 trial of WU-CART-007 for the treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). WU-CART-007 is an off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Additionally, Wugen announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to WU-CART-007 for the treatment of acute lymphoblastic leukemia.

READ MORE