Target to $48 from $34
Monday, July 8, 2019
Catalyst Bio’s MarzAA successful in mid-stage hemophilia study
A Phase 2 trial of Catalyst Biosciences’ (NASDAQ:CBIO) subcutaneous (SQ) Factor VIIa (FVIIa) variant marzeptacog alfa (activated) (MarzAA) for prophylaxis met the primary endpoint of significantly reducing the annualized bleed rate (ABR) in patients with hemophilia A or B with inhibitors.
The study also met all secondary endpoints of safety, tolerability and lack of anti-drug antibody or inhibitor formation.
Daily SQ administration for 50 days at an individual’s final dose of MarzAA significantly reduced the mean 6-month pre-study ABR from 19.8 to 1.6 and Proportion of Days with Bleeding (PDB), from 12.3% to 0.8%, during treatment.
The median ABR and PDB were both reduced to zero.
The Company will host a conference call today, at 8:00 a.m. EDT to discuss the MarzAA and DalcA data.
Shares are down 2% premarket.
Aytu Bio up 8% premarket on encouraging Natesto data
Aytu BioScience’s (NASDAQ:AYTU) study titled, Efficacy of Nasal Testosterone Gel (Natesto) Stratified by Baseline Endogenous Testosterone Levels, achieves similar symptom improvement, regardless of the degree of patients’ testosterone deficiency, while maintaining function of the Hypothalamic-Pituitary-Gonadal (HPG) axis in hypogonadal men.
The Phase 3 study enrolled 306 patients, who were treated with Natesto for up to one year. Each dose of Natesto resulted in a short-term return of testosterone to the upper normal range (800 ng/dL) irrespective of how low the patient’s baseline testosterone was prior to the study.
A mean average serum testosterone level of 295 ng/dL was achieved, in patients with the lowest baseline testosterone level.
Statistically significant improvements in symptom relief (erectile function, mood and lean body mass) were observed in these patients.
Shares are up 8% premarket.
Intra-Cellular hit on uneven results from lumateperone studies
Intra-Cellular Therapies (NASDAQ:ITCI) slips 9% premarket on increased volume on the heels of its announcement of results from two Phase 3 clinical trials evaluating lumateperone in patients with bipolar depression.
Study 404 met the primary endpoint of a statistically significant change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (p<0.001). Key secondary endpoints were also met.
Study 401, however, failed to achieve the primary endpoint due to an unexpectedly high response rate in the placebo arm. Specifically, patients receiving the 42 mg dose or the 28 mg dose of lumateperone showed least squares (LS) mean reductions from baseline in MADRS score of 20.7 points and 18.9 points compared to 19.7 points for control.
No new safety signals were observed.
Additional results will be released in the near future.
Management will host a conference call this morning at 8:00 am ET to discuss the results.
Sangamo up 14% premarket on positive hemophilia A gene therapy data
Sangamo Therapeutics (NASDAQ:SGMO) is up 14% premarket on light volume in response to updated results from the Phase 1/2 ALTA study evaluating gene therapy SB-525 in patients with severe hemophilia A. The data were presented at the International Society on Thrombosis and Hemostasis Congress in Melbourne.
The first two patients treated at the 3e13 vg/kg dose level rapidly achieved normal sustained factor VIII levels with no reported bleeding events and no factor usage during the 24 weeks of follow-up. Two additional patients recently treated showed comparable results at similar early time points.
SB-525 was generally well-tolerated and demonstrated dose-dependent increases in factor VIII activity levels.
Collaboration partner Pfizer (NYSE:PFE) is unchanged in premarket action.
Array Bio’s triplet therapy extends survival in late-stage CRC study
Results from a Phase 3 clinical trial, BEACON CRC, evaluating Array BioPharma’s (NASDAQ:ARRY) BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) + Eli Lilly’s ERBITUX (cetuximab) in patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) following one or two prior lines of treatment showed a statistically significant improvement in overall survival (OS). The data were presented at the ESMO World Congress on Gastrointestinal Cancer in Barcelona.
Patients receiving the triplet therapy experienced median OS of 9.0 months compared to 5.4 months for ERBITUX + irinotecan-containing regimens (control arm) (p<0.0001). The objective response rate (ORR) in the triplet therapy group was also superior, 26.1% vs. 1.9% (p<0.0001).
Median OS in the BRAFTOVI + MEKTOVI doublet arm was 8.4 months vs. 5.4 months in the control arm (p=0.0003). The ORR was 20.4% vs. 1.9% for control (p<0.0001).
The data were first reported in May.
Related ticker: Pfizer (NYSE:PFE)
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