A half-day open meeting intended to examine “how the public perceives and values pharmaceutical quality,” convened by the Robert J. Margolis Center for Health Policy at Duke University in cooperation with the FDA, included a rundown of the agency’s oversight program, results of surveys to measure viewpoints of patients and providers – and tart commentary from a two-member “reactant panel.”
Shares of Bridgewater, N.J.-based Insmed Inc. (NASDAQ:INSM) closed at $28.88, up $8.34, or 40.6%, on positive top-line results from the global, randomized, double-blind placebo-controlled phase II study called Willow, testing INS-1007 once daily in adults with non-cystic fibrosis bronchiectasis (NCFBE).
The EMA’s Committee for Medicinal Products for Human Use (CHMP) looked with favor on a bucketload of would-be drugs, issuing positive opinions for the European Commission to consider across a range of indications.
Wall Street’s enthusiasm ran high for Cambridge, Mass.-based Black Diamond Therapeutics Inc. (BDT), shares of which (NASDAQ:BDTX) closed 108% higher at $39.48, after the company priced its upsized IPO of about 10.5 million shares at $19 each, for gross proceeds of about $201 million. As recently as December, the company pulled down $85 million in a series C financing. BDT’s lead product candidates target oncogenic driver mutations of the ErbB kinases in EGFR and HER2. At the time, the firm noted that it had raised $194 million thus far. With the IPO, which first set sights on 8.9 million shares in the range of $16 to $18 each, the picture grows even brighter.
Bayer AG and Merck & Co. Inc. took Wall Street by surprise in November with their phase III success testing vericiguat in heart failure (HF), such that the guanylate cyclase stimulator’s odds not only have improved significantly but also in a different way than imagined before.
As attendees of last year’s American Society of Hematology (ASH) meeting heard, B-cell maturation antigen (BCMA)-targeting therapies are steadily gaining ground on various fronts, even as companies such as Springworks Therapeutics Inc. bring forward candidates that might boost activity of the class.
Matthew Ros, chief strategy and business officer for Epizyme Inc., said the company is “not providing specific guidance at the moment” about the sales force that will be deployed to market Tazverik (tazemetostat) in follicular lymphoma (FL), an indication for which U.S. regulators are considering the oral, first-in-class EZH2 inhibitor. “But I can assure you we’ve planned very thoughtfully” about the effort, he said. “That's always been a part of why we thought epithelioid sarcoma [ES] was such a strategically important component of the overall business strategy to get on-the-ground experience.” The sales force numbers 19 for now.
Kintai Therapeutics Inc. CEO, president and board member Paul-Peter Tak told BioWorld that the company aims to reach the clinic in the first quarter of next year with obesity agent KTX-0200, which has begun IND-enabling studies after showing sustained weight loss and improved markers of health in preclinical experiments.
Shanghai-based I-Mab Biopharma Co. Ltd. became the first IPO out of the gate this year, pricing its IPO of about 7.4 million American depositary shares (ADSs) – each 10 representing 23 ordinary shares of the company, par value $0.0001 per share – at $14 each, within the planned range of $12 at the low end and $15 at the high. But the stock’s performance might not have been all investors hoped, as shares (NASDAQ:IMAB) closed at $12.50 Jan. 17.
Shanghai-based I-Mab Biopharma Co. Ltd. became the first IPO out of the gate this year, pricing its IPO of about 7.4 million American depositary shares (ADSs) – each 10 representing 23 ordinary shares of the company, par value $0.0001 per share – at $14 each, within the planned range of $12 at the low end and $15 at the high. But the stock’s performance might not have been all investors hoped, as shares (NASDAQ:IMAB) closed at $12.50 Jan. 17.
