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Thursday, January 9, 2020

Fed’s Williams: World Will Be Dealing With Low Interest Rates a Long Time

Federal Reserve Bank of New York President John Williams said Thursday low interest rates are likely to be a persistent issue for some time to come, which will create challenges for how central banks operate.
Mr. Williams, whose comments came from the text of remarks to be given in London, didn’t comment about the outlook for short-term rates and the economy. Mr. Williams is also vice chairman of the rate-setting Federal Open Market Committee, which is due to meet at the end of the month in a gathering that is almost certain to leave the overnight federal-funds rate target range unchanged at between 1.50% and 1.75%.
In his remarks, Mr. Williams affirmed what he saw as the strong value of the central bank’s inflation targeting system, even as the Fed has consistently failed to achieve its 2% goal since adopting it in 2012.
The low level of rates now seen in the economy “are largely a result of global, longer-term structural factors,” Mr. Williams said. “They’re driven by demographic changes, slow productivity growth, and demand for safe assets — all of which are unlikely to reverse any time soon.”
With interest rates and inflation at historically low levels it means the Fed won’t be able to raise rates as much as it once did, and when the next downturn arrives, it increases the chance short-term rates will be lowered to near-zero levels, where monetary policy resided for the bulk of the financial crisis and its aftermath.

Axonics sees FY 2019 revenue as high as $14M

Axonics Modulation Technologies (NASDAQ:AXNX) has reported preliminary Q4 and FY 2019 revenue.
Q4 and FY 2019 revenue is expected to be ~$10M and ~$14M, respectively.
In the U.S., Q4 revenue was ~$8.4M following the launch of commercial sales of the Axonics r-SNM System.
Revenue from international markets totaled ~$1.6M in Q4.
For all of 2019, international sales from Europe and Canada totaled ~$5.4M.
Complete financial results for Q4 and FY 2019 are anticipated to be announced on March 4.

FDA places Innate Pharma lacutamab study on partial clinical hold

Enrollment has been suspended in a Phase 2 clinical trial, TELLOMAK, evaluating Innate Pharma SA’s (NASDAQ:IPHA) lacutamab (IPH4102) in patients with advanced T-cell lymphomas. The company says it took action after the FDA placed the study on partial clinical hold due to deficiencies at a subcontractor responsible for fill and finish operations.
It is in the process of transferring the fill and finish business to a new contract manufacturing organization. A new GMP-certified batch should be available in H2.
A partial clinical hold suspends enrollment but allows current participants in the study to continue treatment.

Sanofi reports pre-quarterly results

Sanofi (NASDAQ:SNYexpects 2019 flu vaccines to exceed prior year (at CER).
Q4 sales of Plavix and Aprovel family products are expected to decrease significantly due to net price adjustments of inventory in the channel.
The Company estimates that the favourable currency impact will be between approx. +1.5% and +2.5% on Q4 net sales and approx. +3% and +4% on Q4 business EPS.

The Joint updates 2019 metrics and clinic guidance for 2020

The Joint (NASDAQ:JYNTprovides metrics for FY 2019 and established new clinic guidance for 2020.
FY 2019 Highlights: Increased system-wide sales 33% in 2019 from 2018.
Achieved comp sales of 25%, consistent with 2018 growth.
Sold 126 franchise licenses, compared to 99 in 2018.
Grew total clinics to 513 at December 31, 2019.
2020 New Clinic Guidance: The company expects to open 80 to 90 franchised clinics, up from 71 in 2019 and 47 in 2018.
Increase company-owned or managed portfolio clinics by 16 to 20 through new greenfield clinics and franchised clinic buybacks, up from 13 in 2019 and 1 in 2018.

Regeneron’s garetosmab shows benefit in patients with rare bone growth disorder

Regeneron Pharmaceuticals (NASDAQ:REGNannounces results from a Phase 2 clinical trial, LUMINA-1, evaluating garetosmab (REGN2477) in patients with fibrodysplasia ossificans progressiva (FOP), a rare inherited disorder in which muscle and connective tissue are gradually replaced by bone (ossification).
After 28 weeks of treatment with the Activin A inhibitor, total lesion activity dropped by 25% as measure by PET bone scans (results were not statistically significant – p=0.07). The number of new lesions decreased ~90% compared to placebo. There was a 25% relative decrease in bone lesion volume (new and existing) as measured by CT scan (also not statistically significant – p=0.37) and almost a 90% drop in new bone lesions as measured by CT. Patient-reported flare-ups decreased by 50% (p=0.03).
On the safety front, 100% of patients in both the treatment and placebo arms experienced treatment-emergent adverse events, most mild or moderate. Garetosmab-related imbalances were noted in epistaxis (acute bleeding from the nose or nasopharynx) (50.0% vs. 16.7%), skin events (madarosis [loss of eyebrows, 25.0% vs 0%], acne [30.0% vs 8.3%] and a composite of skin infections including abscess, carbuncle, folliculitis, furuncle).
Activin A is a protein that plays a key role in the development of FOP.
Detailed data will be submitted for presentation at a future medical conference and will be the basis for regulatory filings.

Amicus Therapeutics sees FY 2019 Galafold revenue as high as $181M

Amicus Therapeutics (NASDAQ:FOLDannounces preliminary 2019 revenue and Galafold (migalastat) commercial updates.
Global revenue for Galafold in Q4 was ~$54M and for FY 2019 was ~$181M, exceeding updated 2019 guidance of $170M to $180M.