CEO David Epstein said Black Diamond Therapeutics Inc. was “delighted” with phase I data testing BDTX-189 in advanced solid tumors harboring EGFR or HER2 alterations, but Wall Street seemed less so. Shares (NASDAQ:BDTX) closed at $13.93, down $8.30, or 37%.
Reneo Pharmaceuticals Inc.’s $93.8 million IPO last month brought renewed attention to primary mitochondrial myopathy (PMM), a genetic disorder that impairs oxidative phosphorylation, affecting mainly muscles. The San Diego-based firm sold about 6.2 million shares at $15 each, but the stock (NASDAQ:RPHM) has since taken a dive, closing May 19 at $8.83.
The anti-TIGIT bispecific antibody AGEN-1777’s preclinical status didn’t stand in the way of Bristol Myers Squibb Co.’s whopper deal with Agenus Inc., which is collecting $200 million up front and as much as $1.36 billion in potential milestone payments in trade for development and commercial rights to the Fc-enhanced compound.
As investors await interim data this quarter from Arcus Biosciences Inc.’s ARC-7 phase II effort with domvanalimab (AB-154) in non-small-cell lung cancer, the anti-TIGIT space continues to bubble, with Wall Street busy trying to sort out the odds of various players.
Allogeneic chimeric antigen receptor T cell (AlloCAR T) specialist Allogene Therapeutics Inc.’s promise of data readouts at this year’s American Society of Clinical Oncology meeting, along with the virtual CD19 forum slated by the company for May 19, whetted investor thirst in the space.
The FDA’s Arthritis Advisory Committee panelists groped through cloudy data while complaining about the design of the phase III trial for Chemocentryx Inc.’s avacopan, and after going overtime ended up without consensus. Briefing documents ahead of the meeting darkened what had been a fairly bright picture for the complement C5a receptor inhibitor for anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, but Wall Street held out hope. Wainwright analyst Edward White opined in a May 5 report that the adcom’s outcome “could still be positive,” and a May 4 dispatch from Canaccord Genuity’s Michelle Gilson said the briefing docs “miss[ed] the big picture.”
As investors await an MAA submission to the EMA for U.S.-approved Mycapssa (octreotide) in acromegaly, Chiasma Inc. disclosed its plan to merge with Amryt plc in an all-stock deal, thereby gaining a global commercial presence. Terms call for the exchange of each Chiasma share for 0.396 American depositary share of Amryt. The latter closed May 4 at $12.95, so the deal values Chiasma at $5.13 per share, an 81% premium over the previous day’s ending price, noted Piper Sandler analyst Edward Tenthoff. The stock (NASDAQ:CHMA) rose $1.14, or 40%, to finish at $3.98.
Stock-price weakness that has beset Chemocentryx Inc. since early March – likely based on jitters ahead of the FDA advisory panel for avacopan slated for May 6 – became an outright tumble when Wall Street got a gander at briefing documents related to the meeting. Shares of the San Carlos, Calif-based firm (NASDAQ:CCXI) closed at $22.19, down $26.63, or 45%, as company backers sifted paperwork on the complement C5a receptor inhibitor for anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The compound has been assigned a PDUFA date of July 7.
Astrazeneca plc followed up its win a year ago in heart failure (HF) with yet another approval for its oral SGLT2 inhibitor, Farxiga (dapagliflozin), now cleared by the FDA to reduce the odds of kidney function decline, failure, cardiovascular death and hospitalization for HF in adults with chronic kidney disease (CKD) at risk of disease progression.
Emergent Biosolutions Inc. CEO Robert Kramer assured investors that he takes “full responsibility” for woes that beset the firm after the FDA’s Form 483 found serious manufacturing problems at the Baltimore, Md.-based Bayview plant. “You have my commitment that we're going to do everything we can to resolve these issues quickly, and as safely as possible,” he said during an April 29 conference call on first-quarter financial results.
