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.

https://seekingalpha.com/news/3530785-almirall-announces-three-business-development-deals

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.

https://seekingalpha.com/news/3530801-fda-oks-blueprint-kinase-inhibitor-for-gi-tumor

Ultragenyx up 7% after hours on positive DTX301 data

Ultragenyx (NASDAQ:RARE) announces positive results from cohort 3 and longer-term data from cohort 2 in an ongoing Phase 1/2 clinical trial evaluating gene therapy DTX301 in patients with ornithine transcarbamylase deficiency.

In cohort 3 (n=3), there were two confirmed female responders and one potential male responder (longer follow-up needed to confirm).

In cohort 2, one female patient showed a response starting at week 52 that was confirmed at week 78. Two previously reported responders in cohorts 1&2 remain clinically and metabolically stable at weeks 104 and 78, respectively.

Management will host a conference call at 4:30 pm ET to discuss the results.

Shares up 7% after hours.

https://seekingalpha.com/news/3530819-ultragenyx-up-7-after-hours-on-positive-dtx301-data

Flexion sees Zilretta sales as high as $135M for 2020

On a preliminary basis, Flexion Therapeutics (NASDAQ:FLXN) expects Q4 and 2019 revenue to be $23.7M (+149%) and $73.0M (+224%), respectively.

2020 guidance: Zilretta sales: $120M – 135M.

https://seekingalpha.com/news/3530839-flexion-sees-zilretta-sales-high-135m-this-year

Portola down after hours on weak Q4 prelim

Portola Pharmaceuticals (NASDAQ:PTLA) slumps 39% after hours in reaction to preliminary Q4 and 2019 results that are significantly below consensus.

Q4 Andexxa/Ondexxya sales will be ~$32M.

Global 2019 revenues should be ~$111M, 17% below consensus of $134M.

The company says Andexxa sales in the U.S. were negatively impacted by a $5M gross-to-net adjustment to a return reserve for short-dated product and flat demand due to an increase in utilization, mostly in tier 1 accounts.

Cash balance at year-end: $464M.

https://seekingalpha.com/news/3530833-portola-down-39-after-hours-on-weak-q4

Intuitive Surgical sees 22% growth in Q4 top line

On a preliminary basis, Intuitive (NASDAQ:ISRG) announces Q4 and 2019 results. Highlights:

Q4: Revenue: $1.278B (+22%). Da Vinci procedures up 19%, 336 system shipments (+16%).

2019: Revenue: $4.479B (+20%). Da Vinci procedures up 18%, 1,119 system shipments (+21%).

Shares are higher by 2.8% after hours.

https://seekingalpha.com/news/3530825-intuitive-sees-22-growth-in-q4-top-line-shares-rise-2_8

La Jolla Pharma sees FY 2019 Giapreza net sales as high as $23M

La Jolla Pharmaceutical (LJPC +9.5%) announces preliminary GIAPREZA (angiotensin II) net sales for the three and twelve months ended December 31, 2019.

Q4 GIAPREZA net sales were $7.2M, up 71% Y/Y. Hospital demand for vials of GIAPREZA grew 74%.

For FY 2019, GIAPREZA net sales were $23.1M, +129% Y/Y.

Net cash used in operating activities for Q4 2019 was ~$17M.

https://seekingalpha.com/news/3530706-la-jolla-pharma-sees-fy-2019-giapreza-net-sales-high-23m