News

REDWOOD CITY, CA - January 6, 2022 -  Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of irreversible small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, announced today that BMF-219 displayed remarkable activity in both the Zucker Diabetic Fatty (ZDF) Rat and the Streptozotocin-Induced Diabetes (STZ) animal models of type 2 diabetes.

GENEVA, Switzerland - January 6, 2022 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies for women’s health, today announced positive topline results from the Phase 3 EDELWEISS 3 trial of linzagolix, an oral GnRH antagonist, in women with moderate-to-severe endometriosis-associated pain (EAP). Two doses were tested, a 200 mg once-daily dose of linzagolix in combination with add-back therapy (ABT) and a 75 mg dose of linzagolix without ABT.

FREMONT, CA -  January 05, 2022 -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced the publication of Phase 1 clinical trial data in an article titled, “Immunogenicity and Safety of Inactivated Influenza Split-Virion Vaccine Administered via a Transdermal Microneedle System” in the Journal of Vaccines and Immunology. The data demonstrated that a low dose of a trivalent influenza vaccine administered via its transdermal microneedle system produced antibody levels that met EMEA’s three guidelines for influenza vaccine efficacy and was generally well tolerated.

LONDON and RALEIGH, NC - January 05, 2022 -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces enrollment completed in the 48-week subset of the ENHANCE-1 trial in December 2021. The ENHANCE-2 trial has completed screening with 788 subjects randomized as of January 4, 2022, and full enrollment is expected by the end of January 2022. The Phase 3 ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) program is evaluating nebulized ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”).

CAMBRIDGE, MA - January 4, 2022 -- AVROBIO, Inc. (Nasdaq: AVRO), a leading clinical-stage gene therapy company with a shared purpose to free people from a lifetime of genetic disease, today announced that it is shifting its portfolio priorities to focus on other clinical-stage programs and extending its cash runway into the first quarter of 2024. The company is deprioritizing its Fabry disease program due to several factors, including new clinical data showing variable engraftment patterns from the five most recently dosed Phase 2 FAB-GT patients which would significantly extend the program’s development timeline, as well as an increasingly challenging market and regulatory environment for Fabry disease.

Denmark - January 03, 2022 - Novo Holdings A/S (“Novo Holdings”), a leading global life sciences investor, today announced that it has agreed to acquire Medical Knowledge Group from Court Square Capital and Aisling Capital. Medical Knowledge Group (“MKG”) is an analytics-driven drug commercialisation platform servicing the biopharmaceutical industry. Through its various operating companies, MKG delivers healthcare provider-targeted solutions designed to maximise the clinical and commercial potential of the brands they support. MKG partners with some of the world’s largest biopharmaceutical companies as well as niche biotechnology firms.

PALO ALTO, CA – December 27, 2021 — BridgeBio Pharma, Inc. (Nasdaq: BBIO) today announced topline results from Month 12 (Part A) of ATTRibute-CM, an ongoing global Phase 3 study investigating acoramidis for the treatment of symptomatic transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM). The mean observed decline in 6MWD at Month 12 in participants receiving acoramidis or placebo with baseline eGFR ≥ 30 mL/min/1.73m² were 9 meters and 7 meters, respectively. Decline observed in both arms of ATTRibute-CM was similar to expected functional decline in healthy elderly adults.¹ The declines were also substantially less than the >40 meter annual declines observed in previous untreated arms reviewed by the company.² The decline in the ATTRibute-CM placebo group was more than 70% lower than the decline observed in the ATTR-ACT treatment group.² The ATTRibute-CM independent data monitoring committee recommends continuing the study based on unblinded data reviews. Despite the unexpected performance of the six-minute walk test, the trial’s steering committee co-chairs and the Company agree that there is potential for acoramidis to demonstrate benefit on the Month 30 endpoint which includes all-cause mortality and cardiovascular hospitalizations.

Ardsley, NY – December 20, 2021 – ARMGO Pharma Inc (“ARMGO”), a leading novel small molecule therapeutics company developing treatments for cardiac, musculoskeletal, and neurological disorders today announced that it has completed a $35 million financing led by Forbion. Proceeds will fund further clinical development of its lead asset, ARM210, for the treatment of catecholaminergic polymorphic ventricular tachycardia (CPVT) as well as other cardiac and skeletal muscle indications.

GENEVA, Switzerland - December 20, 2021 - ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced it has been selected for addition to the NASDAQ Biotechnology Index (Nasdaq: NBI), effective as of market open on Monday, December 20, 2021.

SAN DIEGO, CA -  December 20, 2021 -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for P-MUC1C-ALLO1, the Company's allogeneic CAR-T product candidate targeting multiple solid tumor indications. "We are excited to begin the P-MUC1C-ALLO1 trial, an evaluation of a fully allogeneic CAR-T product candidate with the potential to treat a wide range of solid tumors, including breast, ovarian and other cancers," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida Therapeutics. "The genetic edits in P-MUC1C-ALLO1 have been shown to reduce or fully eliminate alloreactivity, and our proprietary manufacturing process, which includes our booster molecule, has the potential to treat many patients from a single manufacturing run. We look forward to beginning this trial and to presenting initial clinical data in 2022."