Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling the Peaks
(Stocks hitting 52-week highs on July 9)
- Aerpio Pharmaceuticals Inc ARPO
- Arrowhead Pharmaceuticals Inc ARWR
- OptiNose Inc OPTN
- Regenxbio Inc RGNX
- Veracyte Inc VCYT
- Vital Therapies Inc VTL
Down In The Dumps
(Stocks hitting 52-week lows on July 9)
- Achaogen Inc AKAO
- Auris Medical Holding AG EARS
- ContraVir Pharmaceuticals Inc CTRV
- CytRx Corporation CYTR
- Opiant Pharmaceuticals Inc OPNT
- Oramed Pharmaceuticals, Inc. ORMP
See Also: The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trials
Stocks In Focus
Acceleron-Celgene Combo's Blood Disorder Drug Aces Mid-stage Trial
Acceleron Pharma Inc XLRN and Celgene Corporation CELG announced their luspatercept, which is being evaluated in a Phase 2 study called BELIEVE in adults with transfusion-dependent beta-thalassemia achieved primary and all secondary endpoints.
The pipeline candidate achieved a highly statistically significant improvement in the primary endpoint of eythroid response, defined as at least a 33 percent reduction from baseline in RBC transfusion burden, with a reduction of at least 2 units for 12 consecutive weeks, from week 13 to week 24 compared to placebo.
The companies said they plan to submit regulatory filings in H1'19.
Acceleron shares rallied 12.87 percent to $53.50 in after-hours trading.
OncoCyte's Lung Cancer Diagnostic Blood Test Found Effective
OncoCyte Corp OCX said its lung cancer diagnostic blood test named DetermaVu produced encouraging results in a most recent study of clinical samples, with performance better than previously anticipated. The company said the study supports moving the testing to a leading diagnostic testing platform.
Oncocyte shares soared 50.82 percent to $4.60.
Inspire's Device to Get Aetna Coverage
Inspire Medical Systems Inc INSP announced that health insurer Aetna Inc AET will provide coverage for its Inspire therapy, effective immediately.
"Aetna's plan provides coverage for approximately 22 million members," Inspire said.
The Inspire therapy, according to the company, is a closed-loop, minimally invasive solution that provides comfort and convenience, resulting in high compliance for patients with moderate to severe obstructive sleep apnea.
The stock jumped 7.36 percent to $39.80 in after-hours trading.
Aquinox to Trim Workforce By 53 Percent
Aquinox Pharmaceuticals Inc AQXP said in a filing that the Compensation Committee of its board approved a restructuring plan to reduce costs following its failed rosiptor trail announced in late June. The restructuring action includes reduction of its workforce by 30 employees or 53 percent.
The stock slumped 9.31 percent to $2.63 in after-hours trading.
On The Radar
Zogenix, Inc. ZGNX is due to announce the results of the Phase 3 study of its ZX008, assessed in a study called Study 1504 for Dravet syndrome in early July.
FDA Tidbits
FDA Commissioner Scott Gottlieb released a statement, wherein he said the agency is focused on striking a balance between reducing the rate of new addiction by reducing exposure to opioids, while at the same time enabling appropriate access to those patients who have legitimate medical need for these medicines.
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