Gilead Sciences Inc. is taking over Cymabay Therapeutics Inc. for $32.50 per share in cash, for a total equity value of $4.3 billion to bring aboard seladelpar for primary biliary cholangitis (PBC), under priority review by the U.S. FDA, with a decision due this year. The drug, intended for PBC that includes pruritis, adds to Foster City, Calif.-based Gilead’s liver portfolio. Shares of Cymabay (NASDAQ:CBAY), based in Newark, Calif., were trading at $32.10, up $6.41, or 25%, on Feb. 12. Seladelpar is an oral selective peroxisome proliferator-activated receptor delta agonist, proven to regulate metabolic and liver disease pathways. The drug bears a PDUFA date of Aug. 14.

AN2 sinks on phase III pause in mycobacterial lung disease

Shares of AN2 Therapeutics Inc. plummeted more than 70% Feb. 12 after the company reported it was voluntarily pausing enrollment in the phase III portion of its phase II/III EPO-301 study testing boron-based, oral candidate epetraborole in treatment-refractory Mycobacterium avium complex lung disease, citing potential lower-than-expected efficacy from a blinded aggregate analysis of the phase II portion. AN2 was quick to note that the move was not due to safety concerns, but rather to allow time to further evaluate the data and possibly amend the protocol for the ongoing phase III trial.

Takeda quickly follows Sanofi-Regeneron with esophagitis approval

Less than a month after the U.S. FDA approved Sanofi SA and Regeneron Pharmaceuticals Inc.’s IL-4/IL-13 inhibitor Dupixent (dupilumab) for treating eosinophilic esophagitis (EE) in children ages 1 to 11, the agency has approved Takeda Pharmaceutical Co. Ltd.’s Eohilia (budesonide oral suspension) for the same indication but for an older group. Takeda’s glucocorticoid receptor agonist was approved for those age 11 and older and is the first FDA-approved oral therapy in the age group. EE is a chronic, progressive disease in which type 2 inflammation damages the esophagus, impacting the ability to eat, resulting in heartburn, vomiting, abdominal discomfort, trouble swallowing, food refusal and the failure to thrive.

Medicxi merges six startups to form dermatology firm Alys Pharma

Medicxi is spinning six of its early stage companies into an immuno-dermatology specialist and turbocharging development with a $100 million seed round. The European venture capital firm is now looking to raise a further $200 million from external investors to fund a three-year plan that is intended to deliver phase Ib/II proof of concept for seven to 10 of the 14 programs held by the new company, Alys Pharmaceuticals Inc. Bringing six startups together to form a multiplatform pipeline will “transform innovation” in the exploding field of immune-mediated dermatology indications, said Francesco De Rubertis, chair of Alys and partner at Medicxi. Alys “will benefit hugely from this change of scale and facilitated access to capital,” he said.

CSL’s phase III misses primary endpoint in reducing cardiac events

CSL Ltd. will review the data further to see if there is a path forward for CSL-112 (human apolipoprotein A-I) after the phase III AEGIS-II trial failed to meet the primary efficacy endpoint in reducing the risk of major adverse cardiovascular events in patients following an acute heart attack. The trial was CSL’s largest trial ever, enrolling more than 18,200 patients from over 850 sites in 49 countries, and it was “the most ambitious study in our company's history,” said Bill Mezzanotte, CSL executive vice president and head of R&D. Begun in 2017, CSL said it expected to spend between $450 million and $550 million on the study.

US FDA hints at wider use of data monitoring for clinical trials

The U.S. FDA has released a draft guidance for the use of data monitoring committees (DMCs) for clinical trials for devices and drugs, which would overwrite a similar guidance from 2006. This new draft guidance explicitly states that clinical studies more commonly employ DMCs than was the case 18 years ago, and would seem to suggest that the agency will more routinely require the use of DMCs than was common practice in the past.

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