Thinly traded nano cap NanoViricides (NYSEMKT:NNVC) perks up 7% premarket on light volume in response to its announcement that it has completed genetic toxicology testing on NV-HHV-101, a skin cream for the potential treatment of shingles. The data will support an IND application.
Thursday, January 9, 2020
Pacira Bio sees FY 2019 net revenue as high as $421M
Q4 and FY 2019 net revenue of $122.4M and $421M, respectively.
Q4 and FY 2019 EXPAREL net product sales were $116.9M and $407.9M, respectively.
Q4 and FY 2019 iovera° net product sales were $3.2M and $7.9M, respectively.
Q4 royalty revenue was $0.6M and full-year was $2.1M.
The company’s 2019 financial guidance was as follows: EXPAREL and and iovera° net product sales in the range of $400M to $410M and $8M to $10M, respectively.
Pacira expects to report its complete Q4 and FY 2019 financial results in Q1 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.
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.
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.
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.
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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