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Kevin Gorman, Neurocrine CEO

Bounc­ing back from a PhII flop in schiz­o­phre­nia, Neu­ro­crine steers in­to the busy M4/M1 path­way with a $100M cash deal

Eight months after Neurocrine $NBIX chronicled a flop for a mid-stage schizophrenia drug, the biotech is headed right back into Phase II armed with a new drug candidate from Sosei Heptares.

Neurocrine outlined a deal that provides Sosei Heptares $100 million upfront, R&D expenses and a motherlode of milestones worth up to $2.6 billion if successful. That starting figure closely resembles what the biotech paid Takeda to land 3 programs, including the schizophrenia drug TAK-831, which failed to measure up in the clinic.

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FDA de­lays its de­ci­sion on Bris­tol My­er­s' $13B heart drug an­oth­er three months

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.

Zheng Wei, Connect Biopharma CEO

Con­nect Bio­phar­ma cel­e­brates a mid-stage win for its Dupix­ent ri­val, but shares tank af­ter in­vestors clam­or for da­ta

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).

Dai­ichi Sankyo looks to bring FLT3 drug back from the dead with late-stage win in ear­ly AML pa­tients

Daiichi Sankyo was on the receiving end of an FDA slapdown more than two years ago for FLT3 drug quizartinib and some flimsy data in acute myeloid leukemia. Looking to salvage a bad situation, Daiichi is now touting results in earlier AML patients with hopes for a better outcome with regulators.

Quizartinib added to a chemo regimen and then continued solo significantly extended the lives of patients with newly diagnosed acute myeloid leukemia with the FLT3-ITD mutation over chemo alone, according to topline results from the Phase III QuANTUM-FIRST study released Friday.

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Mathai Mammen, head of R&D for J&J’s Janssen unit (Rob Tannenbaum)

As J&J moves to split its busi­ness, ex­ecs lay out fu­ture R&D fo­cus — and tout megablock­buster po­ten­tial

Last week, J&J took a step familiar to other pharma conglomerates in spinning out its consumer business to focus on R&D, but offered few details on what that might look like. But on Thursday, the company followed up with the scoop, and it’s making some bold predictions.

Over the course of a two-plus hour presentation on its pharmaceutical business, execs outlined their strategy for the new, slimmer J&J, promising investors it will file about 14 drugs for approval through 2025. Across all these drugs, J&J said it expects $4 billion average peak annual sales, and five could top the $5 billion mark.

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Jay Luly, Enanta CEO (via YouTube)

Safe­ty threat forces Enan­ta to scrap HBV tri­als — send­ing dis­cov­ery team back to draw­ing board

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.

Mer­ck hits the brakes on de­vel­op­ment pro­gram as safe­ty fears trig­ger alarm

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.

Mene Pangalos (AstraZeneca via YouTube)

Pas­sive vac­ci­na­tion? As­traZeneca spot­lights six-month pro­tec­tion with Covid-19 an­ti­body among vul­ner­a­ble group

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).

Cas­sava's prob­lems just got much worse as SEC launch­es probe in­to da­ta ma­nip­u­la­tion claims — re­port

The US Securities and Exchange Commission has launched a probe into claims that Cassava Sciences, an Austin-based drug developer, manipulated data key to its case for its experimental Alzheimer’s drug simufilam, the Wall Street Journal reported Wednesday.

The report comes just two days after Cassava in an SEC filing revealed that “certain government agencies” had asked the biotech for documentation. It wasn’t clear which agencies were inquiring or what information they sought, and Cassava went out of its way to say the requests weren’t accusations of wrongdoing.

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Michael Yang, ViaCyte CEO

CRISPR, Vi­a­Cyte beat Ver­tex to the clin­ic with di­a­betes cell ther­a­py that evades the im­mune sys­tem

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.