The FDA has issued two new approvals, one for a cell-based pandemic influenza A (H5N1) vaccine and the other is the first approval for treating peanut allergy.
Vertex Pharmaceuticals Inc. brought in $4.16 billion in product revenues in 2019, bolstered in large part by the late October approval of Trikafta, earning $420 million in the few weeks that remained in the year.
Eli Lilly and Co. and Incyte Corp. are working on atopic dermatitis (AD) from several angles and finding success. The most recent example is the positive top-line results from their collaborative phase III trial of baricitinib in treating adults with moderate to severe atopic dermatitis that show the oral selective JAK inhibitor met the study’s primary and secondary endpoints.
In its first step into Japan, Agex Therapeutics Inc. accelerates its development of engineering hypoimmunogenic cells, universal cells that can be used on patients who didn’t generate the original cell and without the need to use immunosuppressants.
As Acceleron Pharma Inc.’s phase II trial of sotatercept hit its primary endpoint and some key secondary endpoints in significantly reducing pulmonary vascular resistance, the stock (NASDAQ:XLRN) reacted accordingly, gaining 50% on Jan. 28. The stock ended the day at $79.39, up $26.52.
It was a trifecta to remember for Neurotrope Inc. on Wednesday as the company cast revealing light on a seemingly failed clinical program involving its lead candidate, had the NIH offer a grant to create a phase II trial to explore the program’s strengths, and then found institutional investors and individuals to pony up an $18 million registered direct offering for the company’s securities. It was a re-examination of data that resurrected Neurotrope’s hopes for its lead candidate months after a confirmatory phase II of bryostatin-1 failed to outperform a placebo in people with moderately severe to severe Alzheimer’s disease (AD) in the absence of Namenda (memantine, Allergan plc), an NMDA receptor antagonist.
What’s new inevitably includes an element of the old. Clene Nanomedicine Inc., which just completed enrollment and dosed the first patient in its phase II trial in amyotrophic lateral sclerosis (ALS), literally contains an element of the old in its lead nanocatalytic therapy: gold.
Iterum Therapeutics plc found a lifeline in the securities purchase agreement it made with an investors group for a $51.9 million private placement. The company plans to use that money to develop sulopenem, a penem anti-infective compound with oral and I.V. formulations.
Frazier Healthcare Partners closed Frazier Life Sciences X LP, the company’s third fund, by exceeding its target with more than $617 million in capital commitments in an oversubscribed fundraiser.
Not only did newly emergent Kyverna Therapeutics Inc. burst out of the gate with a $25 million series A, but it enhanced its entrance with a deal from Gilead Sciences Inc., one of the company’s initial funders, potentially worth $587.5 million.
