Relacorilant, a cortisol modulator from Corcept Therapeutics Inc., produced new and strong phase III results in treating platinum-resistant ovarian cancer. The company also has relacorilant in studies that could eventually lead to approval in other indications. In the near term, though, the positive data led to the company’s stock (NASDAQ:CORT) closing 109% higher at $114.22 per share on March 31. Read More
Peter Marks’ March 28 letter giving one week’s notice of his resignation as director of the U.S. FDA’s Center for Biologics Evaluation and Research (CBER) is sending more ripples of uncertainty throughout the industry. Marks, who has helmed CBER for nearly a decade, blamed his departure on recently confirmed Health and Human Services (HHS) Secretary Robert Kennedy, who has made a career out of his anti-vaccine stance. Read More
Vaxcyte Inc. characterized its latest phase II data with VAX-24 as positive but Wall Street wasn’t so sure about the dose-finding outcomes with the 24-valent pneumococcal conjugate vaccine (PCV), and shares of the San Carlos, Calif.-based firm (NASDAQ:PCVX) closed March 31 at $37.76, down $31.70, or 46%. Read More
After announcing that lead candidate sozinibercept (OPT-302) failed the phase III Coast trial in wet age-related macular degeneration (AMD), Opthea has now decided to close the Coast trial as well as the Shore trial. As reported by BioWorld, Opthea announced last week that it was considering its options after lead candidate sozinibercept (OPT-302) failed the phase III Coast trial in wet AMD. Read More
Otsuka Pharmaceutical Development & Commercialization Inc. filed its BLA with the U.S. FDA for sibeprenlimab to treat immunoglobulin A nephropathy (IgAN). The company’s first BLA, sibeprenlimab is a monoclonal antibody (MAb) that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with IgAN. Read More
French biotech Pep-Therapy SAS is in the midst of raising a €20 million (US$21.62 million) round and, at the same time, prospecting for potential partners after winning FDA orphan drug designation for its bifunctional peptide Pep-010 in the treatment of pancreatic cancer. Pep-010 currently is moving to the conclusion of a phase Ib trial and the new money will fund phase II development. Read More
The biopharma sector is still trying to get its wind and resume its once-powerful investment ways. Medical technology has sidestepped much of biopharma’s issues by being more flexible along the development path, according to BioWorld MedTech Editor Annette Boyle in this edition of the podcast. Boyle described the current financing climate on the newest BioWorld Insider podcast and explained why the sector is performing well year to date.
Biopharmas raising money in public or private financings, including: Calidi, DBV, Dermata, Eli Lilly, Isomorphic, Lomond, Maat, Novartis, Savara. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biontech, Irlab, Johnson & Johnson, Merck, Palatin, Shanton. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bioatla, Biontech, Bio-Thera, Curevac, Dr. Reddy’s, Molteni, Oncozenge. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accuredit, Alteogen, BMS, Crinetics, Eli Lilly, Fresenius, Genmab, J&J, Merck, Milestone, Mirum, Sanoti, Shanghai Henlius, Takeda, Valneva. Read More
