→ Takeda’s $TAK first set of financial results since consummating its $62 billion acquisition of Shire is in, and it’s giving analysts a negative surprise. Citing costs for integrating the Ireland-based Shire, the Japanese drugmaker forecasts an operating loss of $1.7 billion (193 billion yen) for the year through March 2019 — where analysts surveyed by Refinitiv estimated a profit of $2.08 billion (227.5 billion yen), according to Reuters. The predictions come as Takeda attempts to relieve its massive debt burden by divesting its non-core assets, including a dry eye drug and a surgical patch sold to Novartis and J&J last week, respectively.
→ About a year after luring Novartis executive Bill Hinshaw to run its operations, Flagship Pioneering-backed Axcella Health closed its IPO on Monday, raising $71.4 million to fund the development of its preclinical pipeline of drugs designed to modulate metabolic activity.
Axcella has worked on preclinical models to determine which combination of amino acids can repair dysregulated metabolic pathways — and the platform has delivered programs for liver, metabolic, CNS, and orphan diseases. The company’s lead experimental drug is being developed for hepatic encephalopathy, which are neuropsychiatric abnormalities associated with patients suffering from liver dysfunction, typically chronic liver disease.
The Cambridge, Massachusetts-based biotech — that commenced trading under the symbol $AXLA on May 9 — sold about 3.6 million shares at $20, the low end of the range of $20 to $22. Apart from Flagship, which owns a meaty 42.5% of Axcella, Fidelity Investments has a 13.1% share and Nestlé Health Sciences US Holdings has a 10.4% stake.
→ Fresh off a $142 million venture raise — in lieu of an IPO — Poseida Therapeutics is now armed with an orphan drug designation as it heads into the BCMA frenzy. The San Diego-based biotech, backed by Novartis and the California Institute for Regenerative Medicine, is developing an autologous CAR-T made with stem cell memory T cells. “P-BCMA-101 has demonstrated outstanding potency, with strikingly low rates of toxicity in our phase 1 clinical trial,” said CEO Eric Ostertag in a statement. “In fact, the FDA has approved fully outpatient dosing in our Phase II trial starting in the second quarter of 2019.”
→ Onconova has picked up a few million in cash to fund the Phase III program for its lead drug, rigosertib, by licensing the myelodysplastic syndromes treatment to its partner in China. HanX is dishing out $2 million in cash and committing $2 million to buy Onconova equity at a premium, in exchange for development and commercialization rights in the region. The duo first teamed up in 2017 over a preclinical CDK 4/6 inhibitor.
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