Esperion shares surge as FDA waves off panel review; Adaptimmune buoyed by a positive data snapshot
→ Esperion got a 15% bump on its stock price $ESPR this morning after the biotech reported that the FDA had said it didn’t expect to call an advisory panel together to review the newly accepted NDAs for bempedoic acid (BPA) and their bempedoic acid/ezetimibe combination tablet. Investors saw that as a positive sign for the LDL-lowering therapy. The PDUFA date is February 21. The lack of an ad-com is an “important, incremental positive given the investor controversies surrounding BPA’s safety and the assumption among most investors that an adcom was a foregone conclusion; however we would note, the FDA could still convene an adcom if it feels one is needed at any point during the review process,” Stifel‘s Derek Archila wrote in a note.
→ Shares of Adaptimmune perked up Monday after the biotech $ADAP reported out a snapshot of early positive data from their ADP-A2M4 pilot study. Researchers for the UK/US biotech say the T cell therapy kicked up a response in 4 out of 5 synovial sarcoma patients. CEO James Noble touted the data, saying they were now ready to launch their SPEARHEAD-1 trial in patients with synovial sarcoma and myxoid/round cell liposarcoma this year, putting them on track for a market launch slated for 2022. Shares were up 13% in morning trading.
→ After poaching Novartis $NVS oncology group head Liz Barrett into taking charge of the small biotech, UroGen $URGN in January reported that its lead drug, UGN-101, scored in a late-stage study in patients with low-grade upper tract urothelial cancer. Over the weekend, UroGen presented a secondary analysis of the trial, in which 71 patients were treated and all have undergone primary disease evaluation. The complete response (CR) rate was 59% — consistent with Urogen’s January presentation — and well above what the company and our consultants have previously indicated would be necessary to support approval (~20% CR), Cowen‘s Boris Peaker wrote in a note. “The…update indicates that none of the patients who were initially resectable had disease recurrence within 6 months, a key data point in establishing UGN-101 as an alternative to surgery. Based on the results to date, we anticipate that UGN-101 will show favorable durability compared to available options.”
→ Savara‘s rare lung disease drug Molgradex has won the FDA’s fast track status. The drug is the company’s lead experimental treatment and is being evaluated in pivotal study in patients with the treatment of autoimmune pulmonary alveolar proteinosis (aPAP), for which topline results are expected in June.
→ After Regulus Therapeutics $RGLS pulled off a reverse split of its stock, and offloaded its lead drug to its partners at Sanofi $SNY last year, the troubled La Jolla-based company has amended its loan with Oxford Finance LLC. It provides Regulus with a new twelve-month period of interest-only payments, commencing May 2019 and a two-year extension of its maturity date to May 2022.