> Shares in Midatech Pharma fell by one-third after it shared details of the FDA’s feedback on its plan for the clinical development of its treatment for carcinoid cancer and acromegaly. The FDA told the British biotech it needs to run a multidose study in healthy volunteers or a trial in patients before filing a NDA, ending hopes it could use pharmacodynamic data from a single dose study in healthy volunteers. Midatech subsequently unveiled plans to raise £8 million ($10 million). Statement | More
> The FDA granted fast-track designation to Innate Pharma’s anti-KIR3DL2 antibody IPH4102 in adults with relapsed or refractory Sézary syndrome. Innate plans to start a phase 2 trial in the first half of the year. Release
> Destiny Pharma posted skin irritation data from a phase 1 trial of its antimicrobial XF-73 nasal gel. Statement
> Denoive turned down its option on Redx’s bacterial topoisomerase inhibitor program. Separately, Denoive outlined plans to run a phase 2 trial of another drug in Clostridium difficile infections. Statement | More
> Valneva shared phase 1 data on its Lyme disease vaccine. Booster doses of the vaccine increased antibody titers. Release
> Mithra released phase 3 data on its oral contraceptive. The trial met its primary efficacy goal, setting Mithra up to file for approval in the U.S. and Europe by the end of the year. Statement