News

PALO ALTO, CA – January 13, 2022 — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced a non-exclusive clinical collaboration with Amgen Inc. (Amgen) to evaluate the combination of BBP-398, a potentially best-in-class SHP2 inhibitor with LUMAKRAS® (sotorasib), a KRAS^G12C inhibitor, in patients with advanced solid tumors with the KRAS G12C mutation. The Phase 1/2 study will include a dose escalation period followed by dose expansion and optimization, and is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of BBP-398 in combination with LUMAKRAS. Under the terms of the non-exclusive collaboration, BridgeBio will sponsor the study and Amgen will provide a global supply of LUMAKRAS.

DUBLIN, Ireland and FORT WASHINGTON, PA -  January 10, 2022 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced a business update today and preliminary, unaudited financial results for the fourth quarter of 2021. “We made excellent progress in 2021 in spite of the COVID pandemic and are poised for continued growth in 2022,” commented Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics. “We had a strong close to 2021 for SIVEXTRO, which contributed to extending our cash runway well into the fourth quarter of 2022 and we continue to propel the product back to historical prescription trends through our promotional efforts.” Mr. Schroeder continued, “while our commercialization efforts for XENLETA have faced significant headwinds due to the global pandemic, we remain focused on maximizing the value of this novel, first-in-class antibacterial agent in the U.S. through our focused commercial investments, and outside the U.S. by expanding our partnerships globally.”

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.