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Thursday, January 9, 2020

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.
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Sanofi reports pre-quarterly results

Sanofi (NASDAQ:SNY) expects 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.
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The Joint updates 2019 metrics and clinic guidance for 2020

The Joint (NASDAQ:JYNT) provides 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.
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Regeneron’s garetosmab shows benefit in patients with rare bone growth disorder

Regeneron Pharmaceuticals (NASDAQ:REGN) announces 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.
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Amicus Therapeutics sees FY 2019 Galafold revenue as high as $181M

Amicus Therapeutics (NASDAQ:FOLD) announces 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.
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Analyst action, Jan. 9

Aptose Biosciences (APS CN) initiated with Overweight rating at Piper Sandler. Shares up 2% premarket in U.S. (NASDAQ:APTO).
BioDelivery Sciences (NASDAQ:BDSI) initiated with Overweight rating and $9 (58% upside) price target at Piper Sandler.
BiomX (NYSEMKT:PHGE) initiated with Overweight rating and $16 (67% upside) price target at Cantor Fitzgerald.
Enlivex Therapeutics (NASDAQ:ENLV) initiated with Buy rating and $20 (131% upside) price target at H.C. Wainwright. Shares down 6% premarket.
Karuna Therapeutics (NASDAQ:KRTX) initiated with Market Perform rating and $122 (71% upside) price target at JMP Securities.
Mylan N.V. (NASDAQ:MYL) initiated with Neutral rating with a $21 (flat) price target at Piper Sandler.
Phreesia (NYSE:PHR) initiated with Overweight rating and $32 (18% upside) price target at Cantor.
UroGen Pharma (NASDAQ:URGN) initiated with Neutral rating and $37 (15% upside) price target at National Securities.
DBV Technologies (NASDAQ:DBVT) upgraded to Buy with an $18 (60% upside) price target at Stifel. Shares up 21% premarket on positive three-year Viaskin Peanut data.
Halozyme Therapeutics (NASDAQ:HALO) upgraded to Outperform at BMO.
Madrigal Pharmaceuticals (NASDAQ:MDGL) upgraded to Buy with a $127 (47% upside) price target at UBS. Shares up 2% premarket.
Patterson Companies (NASDAQ:PDCO) upgraded to Neutral at Bank of America. Shares up 1% premarket.
Fate Therapeutics (NASDAQ:FATE) downgraded to Market Perform at BMO. Shares down 3% premarket.
Henry Schein (NASDAQ:HSIC) downgraded to Underperform at BofA. Shares down 1% premarket.
OrganiGram (OGI CN) downgraded to Market Perform at Raymond James. Shares (NASDAQ:OGI) down 1% premarket in U.S.
Teladoc (NYSE:TDOC) downgraded to Neutral with a $90 (4% upside) price target at BofA. Shares down 1% premarket.
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ADMA Bio up on 2020 strategic outlook

ADMA Biologics (NASDAQ:ADMA) is up 10% premarket on announcing preliminary Q4 and FY 2019 revenues, providing updates on the commercial launches of BIVIGAM and ASCENIV, as well as introducing 2020 strategic outlook.
Q4 and FY 2019 total revenues of $11.9M and $29.2M, respectively.
Commercial launches for BIVIGAM and ASCENIV progressing in line with expectations. The Company continues to ramp up production of these two products and build inventory to support continued growth and market supply.
ADMA is focused on the following key strategic priorities in 2020: Continue to expand the commercial traction of BIVIGAM and ASCENIV.
Evaluate and implement strategies for manufacturing capacity expansion as well as strengthening the supply chain capabilities.
Secure new supply contracts for potential CMO opportunities as well as explore business development opportunities.
ADMA plans to host a conference call and webcast to discuss its Q4 full year 2019 financial results during Q1 2020.
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