Sanofi says sutimlimab met endpoint in Phase 3 study
Sanofi (SNY +2.3%) moves higher after saying sutimlimab met its primary endpoint for safety and efficacy in a Phase 3 trial for patients with cold agglutinin disease with a history of recent transfusions.
Sutimlimab is the first investigational complement inhibitor for the treatment of CAD, a rare but severe blood disorder that results in the constant and premature destruction of red blood cells by the body’s immune system.
The primary efficacy outcome was response rate based on a composite of an increase in hemoglobin from baseline or reaching a hemoglobin level at treatment assessment endpoint and the absence of transfusions during weeks 5-26 of the trial.
HMS Holdings to acquire payment accuracy business Accent
HMS Holdings (HMSY +1.7%) will buy Accent, a payment accuracy and cost containment business, for ~$155M, plus net working capital on a cash-free and debt-free basis.
HMS expects to fund the deal with cash on hand.
Accent generated ~$50M in net revenue in the last 12 months and produced adjusted EBITDA margins that are comparable to HMS’s overall company margin, HMS said.
Sees deal completed in Q4 FY2019.
FDA win for Alnylam Pharmaceuticals
Oppenheimer says the FDA approval on Alnylam Pharmaceuticals’ (ALNY -1.7%) Givlaari treatment came in about three months ahead of schedule and sets up the company for upside.
“Following this early US approval, we expect a YE19 launch, and model 2020-24 WW net sales of $47M, $97M, $138M, $191M, and $236M, respectively. With Givlaari being the second RNAi drug to reach to market following Onpattro (and the first GalNAc conjugate), yesterday’s announcement provides incremental support to our positive outlook on the prospects for ALNY’s platform and pipeline.”
The firm has an Outperform rating on ALNY and price target of $128.
FDA clears Bio-Path’s IND for BP1002
The FDA has reviewed and cleared Bio-Path Holdings’ (NASDAQ:BPTH) IND application for BP1002 (liposomal Bcl-2), the Company’s second drug candidate.
An initial Phase 1 clinical trial will evaluate the ability of BP1002 to treat refractory/relapsed lymphoma and chronic lymphocytic leukemia patients.
Shares are up 15% premarket.
Sanofi weighing options for consumer healthcare unit – Reuters
Sanofi (NASDAQ:SNY) +1.6% pre-market following a Reuters report that it is considering a joint venture, IPO or outright sale of its consumer healthcare unit.
A JV with a large peers would allow SNY to benefit from cost cuts and later reap a higher valuation in a possible eventual sale or IPO of the unit, according to the report, which says an IPO could be worth ~$30B.
Analysts have speculated over a possible divestment or spinoff of the consumer healthcare business, whose revenue rose 3% at constant exchange rates last year to €4.7B ($5.21B), arguing proceeds would enable SNY to invest more in internal research.
