Against a backdrop of general economic uncertainty bolstered in part by a strong biopharma market, two IPOs launched June 19 and ended their first trading day well above their high-end asking prices.
Repare Therapeutics Inc., which identifies synthetic lethal precision oncology targets for drug candidates, and Forma Therapeutics Holdings Inc., which is developing therapeutics to treat rare hematologic diseases and cancers, launched IPOs with an anticipated combined value of $497.6 million in gross proceeds. Read More
Surrozen Inc., a startup developing regenerative medicines leveraging tissue-specific Wnt modulation, has raised $50 million in series C financing. Proceeds from the round will be used to advance the company’s top two antibodies to the clinic, one for the treatment of severe liver disease and a second for moderate to severe inflammatory bowel disease (IBD). Read More
DUBLIN – Top-line data from a phase II pivotal trial of CP-101, Finch Therapeutics Group Inc.’s oral microbiome therapy for chronic Clostridioides difficile infection (CDI), are technically good, but how good is the big question. Read More
BEIJING – Diabetes-focused Hua Medicine (Shanghai) Ltd. became the first drugmaker to reveal phase III data of a glucokinase activator (GKA) designed to treat type 2 diabetes. On June 18, it said its first-in-class GKA, dorzagliatin, showed sustained efficacy and safety for the 52-week treatment period with reductions in HbA1c levels in a completed phase III trial as a monotherapy. Read More
On June 17, the FDA approved checkpoint blocker Keytruda (pembrolizumab, Merck & Co. Inc.) “for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [?10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.” Read More
Evoke Pharma Inc., of Solana Beach, Calif., which has struggled in the past year through troughs in its stock price and doubts from the FDA in its quest for approval for Gimoti (metoclopramide), was vindicated today as the FDA approved the treatment for adults with acute and recurrent diabetic gastroparesis. Read More
COLOMBIA – The COVID-19 pandemic has put Latin America’s biotech sector under extreme pressure and highlighted flaws in the ecosystem throughout the region, not the least of which is a lack of viable networks to facilitate cooperation. Read More
PERTH, Australia – Australia’s largest life science investment fund is pressing the government for an urgent COVID-19 response package to support the country’s AU$170 billion (US$117 billion) life sciences sector that is struggling to survive in a post-COVID-19 ecosystem. Read More
BioWorld looks at translational medicine, including: Liver-derived protein helps lung, kidney repair; Multiracial study gives new diabetes insights; New way to target drugs, independently of drug target; Microbiome-produced metabolites improve gut health; Universal flu vaccine more challenging than anticipated; The bow ties that bind; FOXO1 regulates HIV latency; Patient genetic variants linked to wound microbiomes; New COPD target. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Acerus, Achilles Vaccines, Adamis, Assembly, Hemostemix, Immuron, Kane Biotech, Merck, Oncolys, Oryzon, Themis, Tiziana. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acasti, Ampio, Ascentage, Beigene, Innovent, Nymox, Ovid, Plakous, Redhill, Regeneron, Sanofi. Read More