Rapport Therapeutics Inc. added $20 million to its cash runway for its lead phase III oral seizure drug, RAP-219, through a potential $328 million license deal signed with Tenacia Biotechnology Co. Ltd.
Patrick Cassells, of Fulshear, Texas, was sentenced March 6 to more than seven years in prison and ordered to pay more than $25 million in restitution and forfeiture after he pleaded guilty nearly two years ago to one count of health care fraud that involved the three durable medical equipment companies he owned and operated.
Although Aisa Pharma Inc’s cilnidipine (AISA-021) failed to meet the primary endpoint, multiple secondary endpoints showed statistically significant improvement in treating sclerosis-associated Raynaud's phenomenon, potentially positioning the drug for a phase III program in a disease with no approved oral therapies globally.
The failure of the Persevera study, sponsored by Roche Holding AG’s Genentech unit, disrupts advancement of giredestrant in combination with palbociclib (Ibrance, Pfizer Inc.) as a first-line treatment for ER-positive, HER2-negative, locally advanced or metastatic breast cancer. For competitor Olema Pharmaceuticals Inc., which has palazestrant for the same indication, missing the phase III Persevera primary endpoint of progression-free survival translated to a 25.8% stock slide (NASDAQ:OLMA) to a $16 close on March 9.
Ipsen SA withdrew Tazverik (tazemetostat) from the U.S. market after evidence emerged of secondary hematological malignancies in an ongoing phase Ib/III study in follicular lymphoma.
Agilent Technologies Inc. has agreed to buy Biocare Medical LLC for $950 million in cash in a bid to strengthen its pathology portfolio. The deal adds Biocare’s complementary immunohistochemistry antibodies, reagents and instruments portfolio to Agilent’s existing offerings, and expands its ability to serve a wider range of pathology laboratories across clinical and research settings.
As soon as Dianthus Therapeutics Inc. disclosed its early “go” decision on claseprubart in chronic inflammatory demyelinating polyneuropathy (CIDP), Wall Street set about comparing the phase III monoclonal antibody (mAb) to other prospects in the space, with particular focus on Sanofi SA’s riliprubart (SAR-455088).
The regulatory clouds that have been darkening the U.S. FDA landscape of late for Uniqure NV’s gene therapy AMT-130 in Huntington’s disease may be parting a bit with the announced departure of Vinay Prasad as director of the agency’s CBER at the end of April.
Any lingering disappointment in the delay for Xenon Pharmaceuticals Inc.’s readout of the phase III X-Tole2 study testing azetukalner in focal onset seizures (FOS) appeared thoroughly extinguished as the company’s KV7 potassium channel opener yielded better-than-expected data, even besting earlier phase IIb findings and positioning the drug for an NDA submission later this year.
Pricing shares at $20 each, below the intended price range, insulin delivery company Minimed Group Inc. debuted with an IPO on Nasdaq March 6, raising $560 million. The company offered a total of 28 million shares, which would have brought the Northridge, Calif.-based company $742 million in gross proceeds if the IPO had priced at the midpoint of the $25-to-$28 price range disclosed in February.
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