Last week, Bristol Myers Squibb marched out long-term data for its heart drug mavacamten ahead of what execs had hoped would be a positive FDA decision in January. But regulators are saying they need a bit more time to think.

The FDA has extended mavacamten’s PDUFA date three months, from Jan. 28 to April 28, Bristol Myers announced on Friday. The news came just a few days after independent drug pricing watchdog ICER raised concerns about the candidate’s long-term safety in its final evidence report.

A suite of drugmakers is looking to topple Dupixent in the eczema market — and on Thursday, China-based Connect Biopharma uncorked some mid-stage results it says will pave the way to a pivotal trial. But investors want hard numbers, and without any to share, the company’s stock $CNTB plunged more than 50% on Friday.

Connect’s monoclonal antibody CBP-201 met the primary endpoint in a Phase II trial, showing significant improvements in Eczema Area and Severity Index (EASI) scores in all three dose groups, according to the biotech. The treatment arms — 300 mg every two weeks, 150 mg every two weeks, or 300 mg every four weeks — were all statistically superior to placebo at Week 16, and all showed significant improvements in the proportion of patients achieving at least a 50% or 75% reduction in EASI score (EASI-50 or EASI-75, respectively).

A Massachusetts biotech will discontinue the development of its oral drug intended to treat patients suffering from chronic hepatitis B infections, the company said Thursday.

Enanta Pharmaceuticals will no longer develop EDP-721. The news comes after safety signals were seen in healthy participants in a Phase I trial after they were administered the drug, and despite a clean safety profile demonstrated in preclinical trials.

In a surprise setback, Merck has slammed the brakes on the development of an experimental HIV drug — including a Phase II trial — after investigators flagged a drop in immune cell counts that an external committee determined was related to treatment.

The Phase II study that first sounded the alarm, dubbed IMAGINE-DR, was testing the once-weekly combination of MK-8507 (a non-nucleoside reverse transcriptase inhibitor) and islatravir, or ISL, a nucleoside reverse transcriptase translocation inhibitor.

New follow-up data suggest that AstraZeneca’s long-acting antibody can protect high-risk populations from contracting Covid-19 for as long as six months, beefing up the case for it as a form of “passive immunization” or “passive vaccination.”

At a six-month cutoff for the Phase III PROVENT trial, investigators tracked an 83% reduction in risk of symptomatic Covid-19 after one dose of the antibody among 4,991 volunteers. The company did not spell out case counts on either arm, noting only that there were no severe disease or Covid-related deaths in the AZD7442 arm and two additional cases of severe Covid-19 in the placebo arm (for a total of five severe cases and two related deaths).

The race to develop a cell therapy for type 1 diabetes is heating up, and the team at ViaCyte and CRISPR Therapeutics appears to have pulled ahead by a hair.

ViaCyte announced Tuesday it’s putting a new therapy in the clinic derived from “off-the-shelf,” gene-edited, immune-evasive stem cells, the first time such a treatment will be tested in humans. The move comes after its clinical trial application was accepted by Canadian regulators, and patient enrollment is expected to start by the end of the year.