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Wednesday, November 6, 2019

Gilead HIV meds show sustained benefit in late-stage studies

Gilead Sciences (NASDAQ:GILD) announces new data from two Phase 3 clinical trials presented at the European AIDS Conference in Basel, Switzerland.
96-week results from the DISCOVER study showed non-inferiority of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for HIV pre-exposure prophylaxis (PrEP) compared with Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg), in men and transgender women who have sex with men and are at risk for sexually acquired HIV infection while demonstrating less stress on bone and kidneys.
Results from two Phase 3s, Study 1489 and Study 1490, evaluating Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) compared to dolutegravir-containing regimens for the treatment of HIV-1 infection in adults new to HIV therapy showed high rates of virologic suppression through week 144 with a favorable safety profile.
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ArQule down 17% on early-stage data on ARQ 531

ArQule (ARQL -17.2%) slumps on increased volume in early trade in apparent response to a just-released abstract on blood cancer candidate ARQ 531, a reversible BTK inhibitor, that will be presented at ASH next month.
Interim results from a dose-escalation Phase 1 clinical trial showed partial responses in 10 patients, mostly in the higher dose cohorts. On the safety front, however, there were serious and life-threatening treatment-related adverse events, including decreased neutrophil count, febrile neutropenia, cellulitis, decreased platelet count, increased lipase and rash. The highest dose of 75 mg once-daily appeared to be too toxic so the 65 mg dose will be used in the expansion phase, although one patient experienced dose-limiting toxicity with 65 mg (serious rash).
Investors appear to be reacting to how well ARQ 531 compares to Eli Lilly’s (LLY +1.5%) LOXO-305, also a reversible BTK inhibitor. Phase 1 data also showed preliminary efficacy but with a more favorable safety profile. All treatment-related adverse events were mild or moderate with no dose-limiting toxicities.
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Amneal in-licenses myasthenia gravis candidate from Kashiv Bio

Amneal Pharmaceuticals (AMRX -18.6%) inks an agreement with privately held Kashiv BioSciences for exclusive U.S. rights to Phase 2-stage K127 (pyridostigmine) for the treatment of myasthenia gravis, a rare autoimmune disorder characterized by weakness in the skeletal muscles.
Under the terms of the deal, Kashiv will be responsible for all development and clinical work to support a U.S. marketing application while Amneal will file the NDA and commercialize, if approved.
Amneal will pay Kashiv $1.5M upfront, up to $16.5M in milestones and tiered low-double-digit-to-mid-teens royalties on net sales.
Shares are down in reaction to its Q3 report and guidance cut.
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Nu Skin -15% after guidance limps in

Nu Skin (NYSE:NUS) fall sharply after setting guidance below expectations.
The company anticipates Q4 revenue of $570M to $590M vs. $642M consensus and EPS of $0.68 to $0.75 vs. $0.91 consensus.
China was a major topic on the firm’s earnings call (39 mentions on the transcript), with execs highlighting some of the challenges in the region, but maintaining a confident tone for the future.
Shares of Nu Skin are down 14.66% to trade at their lowest level since early August.
Previously: Nu Skin EPS beats by $0.03, misses on revenue (Nov. 5)
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Radius Health down 14% on extended timeline for osteoporosis patch

Radius Health (RDUS -14.3%) is down on 25% higher volume despite reporting Q3 results that beat expectations.
Investors appear to be reacting to an extended timeline for its abaloparatide patch for osteoporosis. Citing slower-than-expected recruitment due to a higher-than-anticipated rejection rate at screening, topline data from its Phase 3 wearABLe study will not be available until H2 2021. A revised enrollment plan is being implemented to address the issue.
Sales of injectable abaloparatide, branded as Tymlos, were $47M in the quarter, up 69%.
Recruitment in the Phase 3 EMERALD trial evaluating elacestrant in patients with ER+/HER2- breast cancer should be completed in Q3 2020. This is the only study that it plans to complete because it intends to divest its oncology assets.
Previously: Radius Health EPS beats by $0.29, beats on revenue (Nov. 5)
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Analysts handicap Walgreens buyout

Walgreens Boots Alliance (WBA -2.8%) slips below $60 the day after the blockbuster news that the company is mulling over a PE-backed leveraged buyout.
Analysts are still buzzing over the M&A wildcard. This morning, Jefferies calls the odds of a takeout low and Wells Fargo places the probability of a deal below 50%. Meanwhile, Mizuho thinks any buyout deal would land in the $60 to $67 range. Even at that level, a LBO would be among the largest in history, although shares of Walgreen were swapping hands as high as $86 late last year. Other analysts see the LBO exploration as a possible precursor to asset sales by Walgreens or cost-cutting initiatives.
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Constellation Pharma up 152% on positive CPI-0610 data

Thinly traded Constellation Pharmaceuticals (CNST +151.7%) is up on a healthy 16x surge in volume in the early going in reaction to preliminary data from a Phase 2 clinical trial, MANIFEST, evaluating BET protein inhibitor CPI-0610, combined with Incyte’s (INCY -0.2%) Jakafi (ruxolitinib), in myelofibrosis (MF) patients.
The combination showed a generally favorable safety profile with early clinical activity. All four evaluable patients achieved at least a 35% reduction in spleen volume and at least a 50% improvement in total symptom score (TSS) as early as three months after treatment. Suppression of pro-inflammatory proteins (IL-8, IL-18 and C-reactive protein) were also observed.
CPI-0610 showed encouraging action in JAK inhibitor-naive anemic MF patients, a population with a poor prognosis, as well as ruxolitinib-refractory MF patients.
The primary completion date of MANIFEST is August 2021.
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