PERTH, Australia – Cyclopharm Ltd. said it received a complete response letter (CRL) from the FDA for its Technegas NDA for pulmonary embolisms. The CRL relates to better defining and validating production and delivery of the Technegas particle and other aspects of crucible manufacturing and dosimetry that need to be addressed before the NDA can be approved.
The U.S. Supreme Court will not take up Amarin Corp. plc’s appeal of a September Federal Circuit decision that opened the door for generics of the company’s fish oil-derived cardiovascular drug, Vascepa (icosapent ethyl), to enter the U.S. market.
New and updated preclinical and clinical data presented by biopharma firms at the American College of Cardiology annual meeting, including: Amarin, Attralus, BMS, Esperion, Imbria, Janssen, Milestone, Stealth.
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.”
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.
Plx Pharma Inc. is not letting out the details just yet about next quarter’s launch of liquid-filled aspirin capsule Vazalore, recently cleared by the FDA in 81-mg and 325-mg doses, but CEO Natasha Giordano said cardiologists are “essential to our strategy. We have developed very deep sales plans [that are] laser-focused.”
Xenter Inc. has officially launched, positioning itself as the first startup device/data/drug med-tech company. The company is developing wireless solutions for interventional cardiology, interventional radiology and neurointerventional radiology.
Mineralys Therapeutics Inc., a Philadelphia-based company developing an aldosterone synthase inhibitor in-licensed from Mitsubishi Tanabe Pharma Corp. (MTPC), has raised $40 million in series A funding to complete a phase II proof-of-concept study in hypertension for the candidate, known as MLS-101.
Inflarx NV has submitted a special protocol assessment (SPA) to the FDA for the phase III trial with vilobelimab against the skin disorder hidradenitis suppurativa (HS), pleasing investors with clarity regarding the path forward for the drug, which is in the works for antineutrophil cytoplasmic antibody-associated vasculitis (AAV) as well – and faces competition on both fronts.
Barely five and a half years since the company was founded, Kiniksa Pharmaceuticals Ltd. has moved its first drug over the finish line, winning FDA approval for interleukin-1 blocker (IL-1) rilonacept to treat recurrent pericarditis and reduce the risk of recurrence in adults and children 12 and older.
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