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Friday, June 21, 2019

Morgan Stanley boosts Merck after analyst day

Morgan Stanley maintains an Overweight rating on Merck (NYSE:MRK) and raises the target from $84 to $90 after yesterday’s analyst day, the company’s first in five years.
The firm left the meeting with “greater confidence in the company’s ability to outgrow the drug industry over the next several years.”
Morgan raises its long-term revenue projections for Keytruda, Gardasil, and Animal Health but expresses disappointment in the lack of new drug candidates.
Merck shares are down 0.2% pre-market to $84.41.
Merck has an Outperform average Sell Side rating.

Achieve Life Sciences up after cytisinicline data OKd for presentation

Achieve Life Sciences (NASDAQ:ACHVannounces that an abstract featuring data from the Phase 2b ORCA-1 dose-selection study of cytisinicline for smoking cessation has been accepted for oral presentation at the Society for Research on Nicotine & Tobacco Europe (SRNT-E) Annual Conference, to be held in Oslo, September 12-14, 2019.
The study demonstrated a significant improvement in quit rates over a 25-day treatment period. In the trial, adherence to study treatment was greater than 98.5% across all arms and cytisinicline was well-tolerated with no serious adverse events reported.
Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor.
Shares are up 15% premarket.

Arrowhead’s ARO-APOC3 an Orphan Drug in U.S. for FCS

The FDA has granted orphan drug designation to Arrowhead Pharmaceuticals’ (NASDAQ:ARWR) ARO-APOC3 for the treatment of familial chylomicronemia syndrome (FCS).
Currently no therapy is available in U.S. that can adequately treat FCS.
Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.

AnaptysBio hit on Regeneron data, downgrades

Update with more details on stock movement and downgrade:
AnaptysBio shares are sliding after Regeneron says its medicine that’s similar to ANAB’s etokimab failed to differentiate from Dupixent as an asthma therapy.
Stifel also downgrades ANAB from Buy to Hold citing decreased confidence that etokimab will be meaningfully differentiated from Dupixent.
Credit Suiise analyst Martin Auster says the results were in-line with expectations and don’t change his thesis on the stock.
ANAB shares are down 13.8% at 9:40 AM.
Original post: Credit Suisse downgrades AnaptysBio (NASDAQ:ANAB) from Outperform to Neutral and slashes the price target from $137 to $79, an 18% upside.
ANAB shares are down 3% pre-market to $65.

FDA approves Allergan’s sNDA for BOTOX for pediatric upper limb spasticity

The FDA has approved Allergan’s (NYSE:AGN) supplemental biologics application (sBLA) for BOTOX for the treatment of pediatric patients (2 to 17 years of age) with upper limb spasticity.
The FDA is also reviewing an additional sBLA for the use of BOTOX to treat pediatric patients with lower limb spasticity, with a decision expected in Q4.

Verastem unveils Copiktra data in peripheral T-cell lymphoma

Verastem (NASDAQ:VSTM+3.8% pre-market after presenting supportive Phase 1 clinical data for duvelisib (Copiktra) in patients with relapsed or refractory peripheral T-cell lymphoma at International Conference on Malignant Lymphoma currently underway in Switzerland.
“Patients with relapsed or refractory PTCL who were treated with duvelisib demonstrated preliminary but compelling clinical activity,” says Steven Horwitz of Memorial Sloan Kettering Cancer Center, co-principal investigator of the Phase 1 and 2 studies, and lead author of the oral presentation. “Although the patient numbers are small in these two Phase 1 studies, we see a positive trend in response rates.”
Duvelisib was approved by the Food and Drug Administration for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma after at least two prior therapies in September 2018.

Dicerna reports additional data for DCR-PHXC in PH1 and PH2 patients

Dicerna Pharmaceuticals (NASDAQ:DRNAannounces updated data from its ongoing PHYOX1 Phase 1 trial evaluating DCR-PHXC, a GalXC product candidate.
Investigators reported additional results evaluating DCR-PHXC in patients with primary hyperoxaluria type 1 (PH1) and type 2 (PH2), showing substantial reductions in 24-hour urinary oxalate levels following a single-dose of DCR-PHXC. It was also well-tolerated.
The results will be presented at the Oxalosis & Hyperoxaluria Foundation International Hyperoxaluria Workshop in Boston on June 22.
The latest data from PHYOX1 provide more information on the effects of DCR-PHXC in individuals with PH1 as well as with PH2.
Also, the enrollment is underway in pivotal PHYOX2 trial of DCR-PHXC.