News

BOSTON, December 18, 2019 – BridgeBio Pharma, Inc. (Nasdaq: BBIO) subsidiary Origin Biosciences, a company focused on developing and commercializing a treatment for Molybdenum Cofactor Deficiency (MoCD) Type A, and Medison Pharma Ltd., a leading commercial biotech partner that operates in Israel, Canada and Central and Eastern European countries, have entered into an exclusive license agreement under which Medison received rights from Origin to distribute, market, sell and otherwise commercialize Origin’s drug product known as fosdenopterin (BBP-870/ORGN001) in Israel.

Collaboration leverages Genentech’s MORPHEUS studies to accelerate development of AB928, a potential best-in-class therapy targeting the adenosine axis to stimulate immune responses against cancer

HAYWARD, Calif.–(BUSINESS WIRE)– Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company discovering and developing highly-differentiated therapies, today announced a clinical collaboration with Genentech, a member of the Roche group, for the evaluation of novel combinations with AB928, Arcus’s dual antagonist of adenosine receptors A_2aR and A_2bR, for colorectal (CRC) and pancreatic (PDAC) cancers. The collaboration will utilize the MORPHEUS Phase 1b/2 platform for rapid and efficient combination development, with upfront randomization versus control groups, in two studies:

• Third-line metastatic CRC: two combination arms, (1) AB928 plus atezolizumab (TECENTRIQ^®) and regorafenib, and (2) atezolizumab plus regorafenib, will be randomized versus regorafenib monotherapy.
• First-line metastatic PDAC: the combination of AB928 plus atezolizumab and gemcitabine/nab-paclitaxel will be randomized versus gemcitabine/nab-paclitaxel.

• Phase 3 trial (PRIMROSE 2) met primary and secondary efficacy endpoints
• 93.9% responder rate for 200 mg with ABT (p < 0.001)
• 56.7% responder rate for 100 mg without ABT (p < 0.001)
• Both doses achieved important clinically relevant secondary endpoints including amenorrhea (p < 0.001), reduction in pain (p < 0.001), improvement in quality of life (p < 0.001) and improvement in hemoglobin levels (p < 0.002)

GENEVA, Switzerland and BOSTON, MA (December 9, 2019) – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today reported positive Phase 3 trial results from the PRIMROSE 2 trial of linzagolix for the treatment of heavy menstrual bleeding (HMB) due to uterine fibroids.

SOUTH SAN FRANCISCO, Calif., Dec. 05, 2019 (GLOBE NEWSWIRE) — Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced data from the Company’s Phase 1b/2 clinical trial of its non-covalent BTK inhibitor vecabrutinib in adults with relapsed/refractory chronic lymphocytic leukemia (CLL) and other B-cell malignancies.

REDWOOD CITY, Calif., Dec. 03, 2019 (GLOBE NEWSWIRE) — Atreca, Inc. (Atreca) (NASDAQ: BCEL), a biotechnology company focused on the development of novel cancer therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application. Atreca expects to initiate a first-in-human Phase 1b clinical trial of ATRC-101 in patients with solid tumors in early 2020.

BOSTON, December 3, 2019 – BridgeBio Pharma, Inc. (Nasdaq: BBIO) subsidiary Origin Biosciences has initiated a rolling submission of a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) for fosdenopterin (BBP-870/ORGN001) for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.

– Trial rapidly enrolled in 8 months

– Trial size expanded to accommodate 24 more patients than planned

SAN FRANCISCO – December 2, 2019 – PellePharm, Inc., a BridgeBio Pharma, Inc. (Nasdaq: BBIO) company, today announced the completion of enrollment for its pivotal Phase 3 clinical trial of Patidegib Topical Gel 2% vs. vehicle gel in patients with Gorlin Syndrome. PellePharm is a late clinical-stage biopharmaceutical company committed to targeting rare forms of basal cell carcinoma.

AG10 was Well Tolerated with Median 65 Weeks Follow-up since Phase 2 Initiation

Rates of All-Cause Mortality (Including Either Death or Cardiac Transplantation, 8.5%) and Cardiovascular Hospitalization (25.5%) Observed in Exploratory Analysis Were Lower than Rates Observed in Placebo-treated Participants in the ATTR-ACT Study

Near-complete Stabilization of TTR Maintained in Participants Throughout Duration of Study

Serum TTR levels, a Prognostic Indicator of Survival in ATTR-CM Patients, Were Elevated and Maintained in the Normal Range Throughout the Study Duration

Cardiac Biomarkers and Echocardiographic Parameters Were Stable Throughout Trial Duration

Presentation from AHA 2019 Scientific Sessions Available on Company Websites (eidostx.com and bridgebio.com) 

San Francisco, November 16, 2019 — BridgeBio Pharma, Inc. (BridgeBio) (Nasdaq:BBIO) and Eidos Therapeutics, Inc. (Eidos) (Nasdaq:EIDX), today presented positive data from the companies’ ongoing Open Label Extension (OLE) of the Phase 2 clinical trial studying AG10 in patients with symptomatic transthyretin (TTR) amyloidosis cardiomyopathy (ATTR-CM). ATTR-CM is a progressive and fatal disease that is an under recognized cause of heart failure. The data were presented in a late-breaking featured science oral presentation at the American Heart Association (AHA) Scientific Sessions in Philadelphia, Pennsylvania.

If approved, A-101 45% Topical Solution would be the first FDA-approved prescription treatment for common warts

• Highly statistically significant results for the primary efficacy endpoint
• Highly statistically significant results for all secondary efficacy endpoints
• Management to host conference call at 4:30 PM ET today

WAYNE, Pa., Oct. 24, 2019 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced positive results from its second Phase 3 clinical trial, THWART-1 (WART-301), of A-101 45% Topical Solution (A-101 45%), an investigational new drug, for the potential treatment of common warts (verruca vulgaris). A-101 45% met the primary and all secondary efficacy endpoints, achieving clinically meaningful and statistically significant clearance of common warts. A-101 45% is a proprietary high-concentration hydrogen peroxide topical solution being developed as a potential prescription treatment for common warts.

RAMSEY, N.J. and BOCA RATON, Fla., Oct. 22, 2019 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and the prevention of certain infectious diseases, today announced that it has been named Company of the Year by BioFlorida, in recognition of ADMA’s significant achievements over the past year.

“We are honored to receive this award from BioFlorida and to be recognized for the recent achievements at our Boca Raton, Florida biologics manufacturing and laboratory campus,” stated Adam Grossman, President and Chief Executive Officer. “Over the past year, we were granted two U.S. Food and Drug Administration (“FDA”) biologic product approvals for ASCENIV™ and BIVIGAM®, improved our current good manufacturing practice (“cGMP”) compliance classification with FDA, and secured funding that will support our ongoing commercial product launches and operations. We are extremely proud of these accomplishments and attribute our success to our passionate and dedicated team who worked so hard to revitalize our biologics manufacturing business. We look forward to continuing to contribute to the growing pharma and biotech community in Florida and to continue to expand our operations and grow our workforce to support the increasing demand of our therapeutic products.”