With the FDA go-ahead for Vyleesi (bremelanotide) in generalized hypoactive sexual desire disorder (HSDD), Amag Pharmaceuticals Inc.'s comparison of prospects for the compound to those of depression drugs in an earlier time gained more scrutiny, as Wall Street continued trying to guess revenues due from the auto-injectable melanocortin receptor agonist.
Attendees of the International Conference on Malignant Lymphoma in Lugano, Switzerland, got even more interim data than expected from Epizyme Inc.'s phase II trial with lead candidate tazemetostat for relapsed or refractory follicular lymphoma (FL) in patients who have undergone at least two prior lines of systemic therapy.
Minneapolis-based Diamedica Therapeutics Inc. shares (NASDAQ:DMAC) closed Thursday at $4.94, up $1.12, or 29%, after trading as high as $5.93 as Wall Street made known its appreciation of positive interim data from the phase Ib study from 28 evaluable participants with moderate and severe chronic kidney disease (CKD).
As the weekend PDUFA date for bremelanotide approaches, investors in Waltham, Mass.-based Amag Pharmaceuticals Inc. hope an approval will revive the stock, on the slide since last summer. Generating interest at the same time, though, is ciraparantag, brought in-house via the buyout in December of Perosphere Pharmaceuticals Inc., of Danbury, Conn.
Last week at the Goldman Sachs Healthcare Conference in Rancho Palos Verdes, Calif., Sarepta Therapeutics Inc. CEO Douglas Ingram noted that "more than a kid a day dies" from Duchenne muscular dystrophy (DMD) in the U.S., adding that officials at his Cambridge, Mass.-based firm "feel an enormous obligation to move heaven and earth to get this [gene] therapy to the community if it's possible" and quickly.
Pfizer Inc. wasn't shy about talking specifics with regard to synergy in its merger with Array Biopharma Inc., for which the pharma giant has agreed to pay $48 per share in cash – a 62% premium to Friday's closing price of $29.59 – in a deal with an enterprise value of about $11.4 billion. The boards of both companies have approved the merger, expected to finish in the second half of this year.
Kura Oncology Inc. CEO Troy Wilson told BioWorld that, based on powerful interim data with tipifarnib (often called "tipi" by researchers) in relapsed or refractory peripheral T-cell lymphoma (PTCL), to amend the ongoing phase II study – which has been rejiggered once already – into a registrational experiment is "a possibility. I think that would not be our preference, but you could do that."
Prelude Therapeutics Inc. founder and CEO Kris Vaddi said the new $60 million in series B money – which brings to $95 million the amount raised since the firm's inception in 2016 – should pull the current phase I research through proof-of-concept stage, targeting protein arginine methyltransferase 5 (PRMT5) in cancer.
Cymabay Therapeutics Inc.'s chief scientific officer, Charles McWherter, told BioWorld that the concept of liver enzyme scores as a powerful indicator of efficacy vs. liver fat reductions in nonalcoholic steatohepatitis (NASH) "is not an entirely made-up idea, just because we got this result" in the phase IIb study of peroxisome proliferator-activated receptor (PPAR) delta agonist seladelpar. "If you had to choose between reducing fat, which can be harmful or can be inert, or showing evidence of improving the underlying lesions and injury" as a way of showing a drug's worth in NASH, he said, researchers might choose the latter as "more proximal to the injury," McWherter said. As Newark, Calif.-based Cymabay's chief medical officer, Pol Boudes, put it, "the fat story is not the end of the story" in NASH.
