The company redeemed its priority review voucher for the filing.
Wednesday, January 22, 2020
Jazz Pharma submits marketing application for JZP-258
Jazz Pharmaceuticals (NASDAQ:JAZZ) has submitted a New Drug Application (NDA) to the FDA seeking approval for JZP-258 for the treatment of cataplexy and excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
Genmab earns $150M Darzalex milestone from J&J
Triggered by the achievement of $3B in global Darzalex (daratumumab) sales in 2019, Genmab A/S (NASDAQ:GMAB) earns a $150M milestone payment from Johnson & Johnson (NYSE:JNJ) unit Janssen Biotech.
It also earns royalties on net sales under the exclusive license agreement.
Proteostasis up ahead of CF data presentation
Nano cap Proteostasis Therapeutics (NASDAQ:PTI) is up 6% premarket on modest volume ahead of a presentation of results from an ex vivo study of its cystic fibrosis transmembrane conductance regulator (CFTR) modulators in organoids from individuals with CF who are ineligible for current standard-of-care CFTR modulator therapies due to their genotype (~2,300 European adults). The data, based on samples from up to 500 patients, are being presented at the Keystone Symposia on Tissue Organoids in Vancouver, BC.
The study is assessing responsiveness to the company’s CFTR potentiator dirocaftor, corrector posencaftor and amplifier nesolicaftor.
The European Commission is funding the organoid program as part of a strategic initiative aimed at building a road map for personalized treatments for CF.
Axsome up on advancement of AXS-05
Axsome Therapeutics (NASDAQ:AXSM) completes patient randomization in a Phase 3 clinical trial, STRIDE-1, evaluating AXS-05 in patients with treatment-resistant depression.
The primary endpoint is the change from baseline at week 6 in the total score of a scale called MADRS. Topline results should be available later this quarter.
Neurotrope jumps on data on lead drug
Thinly traded nano cap Neurotrope (NTRP +113.1%) rallies on a healthy 57x surge in volume in reaction to data from a Phase 2 clinical trial evaluating lead candidate Bryostatin-1 in patients with moderately severe-to-severe Alzheimer’s disease (AD) who are not on memantine (Namenda).
The company says there was a “significant” imbalance in the baseline Severe Impairment Battery (SIB) scores between the treatment and placebo groups that it says was due to chance (primary endpoint).
As a result, a post-hoc analysis was done using paired data for individual participants, each serving as his/her own control. On this basis, there was a statistically significant treatment effect as measured by the improvement from baseline at week 13 in SIB score. The control group, however, also showed a statistically significant improvement in SIB score at week 13.
There was no statistically valid treatment effect observed in either arm as measured by a scale called MMSE-2, a secondary endpoint.
The company plans to meet with the FDA to review the “totality” of clinical data on Bryostatin-1 (two Phase 2 trials).
JNJ EPS up 34% in Q4
Johnson & Johnson (JNJ) Q4 results: Revenues: $20,747M (+1.7%); Consumer: $3,567M (+0.9%); Pharmaceutical: $10,548M (+3.5%); Medical Devices: $6,632M (-0.5%).
Net Income: $4,010M (+31.8%); EPS: $1.50 (+33.9%); non-GAAP Net Income: $5,027M (-6.4%); non-GAAP EPS: $1.88 (-4.6%).
Key Product Sales: Remicade: $1,035M (-16.4%); Simponi/Simponi Aria: $515M (+6.6%); Stelara: $1,700M (+17.7%); Tremfya: $270M (+53.9%); Darzalex: $830M (+42.1%); Xarelto: $609M (+0.4%); Zytiga: $677M (-13.8%); Imbruvica: $875M (+24.5%); Velcade: $115M (-54.6%); Invega Sustennn/Xeplion/Trinza/Trevicta: $871M (+14.2%); Edurant/rilpivirine: $222M (+15.2%); Prezista/Prezcobix/Rezolsta/Symtuza: $544M (+9.9%); Procrit/Eprex: $183M (-17.0%); Opsumit: $326M (+1.0%); Uptravi: $208M (+14.8%); Invokana/Invokamet: $177M (-22.2%).
2020 Guidance: Revenues: $85.4B – 86.2B; Non-GAAP EPS: $8.95 – 9.10.
Exact Sciences up 10% on diminished competitive concerns
Exact Sciences (EXAS +9.6%) is up on average volume in apparent response to data from colorectal cancer (CRC) biopsy samples generated by privately held Freenome. William Blair’s Brian Weinstein says the results, as they relate to CRC screening, do not present a threat to Cologuard. BTIG’s Amanda Murphy agrees, adding that Freenome’s approach comparing results across trials is “flawed.”
The data are being presented at the ASCO GI Cancers Symposium in San Francisco.
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