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Thursday, January 9, 2020

Intellia Therapeutics highlights anticipated 2020 milestones

Intellia Therapeutics (NASDAQ:NTLA) updates on recent progress and the Company’s 2020 priorities and expected milestones.
ATTR Program: Intellia remains on track to submit an IND application in mid-2020 for NTLA-2001, for treatment of transthyretin amyloidosis (ATTR). The first patient is expected to be dosed in H2 2020.
AML Program: Intellia today announced NTLA-5001 as its first engineered T cell therapy development candidate for the treatment of acute myeloid leukemia (AML).
The Company expects to present preclinical data in support of NTLA-5001 at an upcoming scientific meeting in Q1 2020 and plans to submit an IND application in H1 2021.
HAE Program: Today, Intellia announced that the Company is committed to developing a CRISPR/Cas9-based therapy for hereditary angioedema (HAE) as its third development program. The Company plans to present preclinical data at an upcoming scientific meeting in Q1 2020.
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Strongbridge Bio sees Keveyis net sales for FY 2019 as high as $21.7M

Strongbridge Biopharma (NASDAQ:SBBP) announces preliminary Q4 and full-year 2019 results and provided an update on key corporate priorities for 2020.
The Company anticipates that it will achieve KEVEYIS net product sales of ~$5.6M for Q4 and ~$21.7M for FY 2019, exceeding its previous $18M to $20M guidance range.
The Company projects that the full-year 2020 revenue guidance for KEVEYIS will be ~$26 to $27M.
Key Corporate Priorities for 2020: Complete enrollment in the Phase 3 LOGICS study of RECORLEV in endogenous Cushing’s syndrome. To date, the trial is more than 70 percent enrolled.
Report top-line results for the Phase 3 LOGICS study in Q2 or Q3 2020 and submit a NDA for RECORLEV to the FDA approx. six months after reporting top-line LOGICS results.
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Pfizer teams up with eFFECTOR Therapeutics in cancer

Pfizer (PFE +0.3%) enters into a global license and collaboration agreement with eFFECTOR Therapeutics aimed at developing small molecule eukaryotic initiation factor 4E (eIF4E) inhibitors for the treatment of cancers with poor prognoses and resistance to certain therapies.
Under the terms of the partnership, PFE will pay TXMD $15M upfront, up to $492M in R&D funding and milestones and royalties on net sales. TXMD will have the option to co-promote and share P&L in the U.S.
TXMD says eIF4E, an effector protein, is a highly oncogenic and historically intractable target that is activated in range of treatment-resistant cancers.
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Foamix up 7% on U.S. acne foam launch

Foamix Pharmaceuticals (FOMX +7%) is up on below-average volume on the heels of its announcement that acne treatment Amzeeq (minocycline) topical foam, 4% is now available in U.S. pharmacies for patients at least nine years old.
The FDA approved it in October 2019.
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Zynex up 20% on improved fundamentals

Thinly traded micro cap Zynex (ZYXI +20.4%) is up on a healthy 43x surge in volume in response to a recent acceleration in its business.
Q4 orders were up 129% from a year ago and up 31% sequentially. Expected revenue is now $14.0M – 14.5M (+52.5% from midpoint) from $12.3M – 12.8M. Non-GAAP EBITDA: $3.6M – 4.1M from $2.3M – 2.8M.
2019 revenue estimate: $45.3M – 45.8M.
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Almirall announces three business development deals

Almirall S.A. (OTC:LBTSF) is starting the new year with a flurry of deals.
Agreement with genetics research outfit 23andMe for global rights to the latter’s bispecific monoclonal antibody designed to inhibit all three members of the proinflammatory IL-36 cytokine subfamily. Financial terms undisclosed.
Collaboration agreement with WuXi Biologics (OTCPK:WXXWY -0.2%) aimed at developing therapies for skin diseases. The partnership will leverage WuXi’s proprietary antibody platforms, including WuXiBody. Financial terms undisclosed.
Option agreement to acquire Irvine, CA-based Bioniz Therapeutics, a developer of multi-cytokine inhibitors, in exchange for a $15M payment. If it opts in, it will enter into a research agreement with Bioniz aimed at delivering at least three IND-approved candidates. It will also gain access to Bioniz’s lead candidate BNZ-1, in Phase 1/2 development for refractory cutaneous T-cell lymphoma and alopecia areata (autoimmune disorder characterized by hair loss).
The decision to acquire Bioniz will trigger an additional $47M payment (in installments) and development, regulatory and commercial milestones.
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FDA OKs Blueprint kinase inhibitor for GI tumor

The FDA approves Blueprint Medicines’ (BPMC +0.9%) Ayvakit (avapritinib) for the treatment of adults with unresectable/metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha ((PDGFRA)) exon 18 mutation, including PDGFRA D842V-positive GIST, the most common exon 18 mutation.
Avapritinib is an oral inhibitor of KIT- and PDGFRA-mutant kinases which are highly active in GIST.
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