Senators accuse Teva, Mylan of stonewalling price fixing probe; Myriad Genetics shares skid on dismal quarterly results
→ US lawmakers have written to Teva $TEVA, Mylan $MYL and privately-held Heritage Pharmaceuticals asking for documents as part of a sweeping congressional probe into generic drug price hikes, accusing the companies of “apparent efforts to stonewall” the investigation, Reuters reported. The probe was first launched in 2014, and earlier this year 44 US states filed a lawsuit alleging drug price-fixing by the trio of drugmakers. Now, senators Elijah Cummings and Bernie Sanders are investigating a purported “coordinated obstruction” of the probe, cited in the State’s complaint, the report said.
→ Shares of molecular diagnostic test maker Myriad Genetics $MYGN tumbled about 34% to $29.41 on Wednesday morning, after the company posted disappointing fiscal fourth quarter results and initial 2020 guidance. “MYGN once again faced a number of negative surprises in the quarter driven by impact of LBM (Lab Benefit Managers) on its Carrier testing business combined with recently heightened FDA scrutiny of pharmacogenomic testing (GeneSight). MYGN continues to disagree on changes required to the test, and we believe that will continue to remain an overhang until resolved,” SVB Leerink analysts wrote in a note.
→ With the brief stint at Acceleron behind him, Robert Zeldin has found his next CMO role at Roivant’s new autoimmune-focused offshoot, Immunovant. The appointment brings Zeldin back to his roots in immunology and leverages his more recent experience with clinical development to advance IMVT-1401, an antibody that facilitates the degradation of pathogenic IgG. Bradford Middlekauff, a Medarex alum and biotech vet, is also joining Pete Salzmann’s team as general counsel.
→ Rare disease drug developer Akari Therapeutics has won fast track status from the FDA for its lead experimental drug, nomacopan, for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) in pediatric patients. The condition, for which there are no approved therapies, has an estimated 80% mortality rate. Akari’s shares $AKTX jumped about 34% to $2.41 in early trading. The company has recently undergone a period of upheaval — last year, Nasdaq threatened to scrap its position on the exchange after Akari failed to file its annual report on time, days after the New York City biotech ousted its former CEO David Horn Solomon for allegedly abusing the company credit card.