Erasca reported updated Phase 1 data for its cancer candidate ERAS-0015 and priced an upsized $550 million public stock offering. Following this, the U.S. FDA granted Fast Track designation to pelareorep for treating advanced anal canal carcinoma. Additionally, Monopar Therapeutics initiated a rolling New Drug Application submission for ALXN1840 to treat Wilson disease.
The SHASTA study showed triglyceride reductions up to 81% and a 78% decrease in pancreatitis events, supporting a 2026 FDA filing.
Read the full storyScancell and Neuphoria enter an all-share merger agreement to create a combined entity trading on Nasdaq under the ticker SCLT.
Monopar Therapeutics has started a rolling NDA submission to the FDA for its Wilson disease treatment, potentially accelerating the regulatory review process.
The U.S. FDA expedited the review of a promising anal cancer treatment, targeting a $1 billion market with no current second-line therapies.
The biotech firm reported positive Phase 1 data for ERAS-0015 while upsizing its equity offering to fund upcoming pivotal clinical trials.