News
Sep 22
2016
Syros Announces First Patient Enrolled in Phase 2 Clinical Trial of SY-1425 in Genomically Defined Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome
Sep 22
2016
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep. 22, 2016-- Syros Pharmaceuticals (NASDAQ: SYRS) announced today that the first patient has been dosed in the Phase 2 clinical trial of its lead drug candidate, SY-1425, a first-in-class selective retinoic acid receptor alpha (RARα) agonist, in genomically defined subsets of patients with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) identified using a novel biomarker discovered by its gene control platform.
READ MORE about Syros Announces First Patient Enrolled in Phase 2 Clinical Trial of SY-1425 in Genomically Defined Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome
Sep 22
2016
T2 Biosystems Announces $40 Million Equity Investment by Partner Canon U.S.A.
Sep 22
2016
LEXINGTON, Mass., Sept. 22, 2016 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a company developing innovative diagnostic products to improve patient health, today announced the purchase by Canon U.S.A., of approximately $40 million of the company’s stock in a private placement. The shares were purchased at $6.56, the closing market price of Tuesday, September 20, 2016. With this investment, Canon owns 19.9 percent of T2 Biosystems and Canon’s chief administrative officer and general counsel,Seymour Liebman has joined the company’s board of directors. This private placement closed on September 21, 2016.
READ MORE about T2 Biosystems Announces $40 Million Equity Investment by Partner Canon U.S.A.
Sep 19
2016
Spirox Announces Positive Clinical Study Results for LATERA Implant in Patients with Nasal Valve Collapse, a Major Cause of Nasal Obstruction
Sep 19
2016
MENLO PARK, Calif.--(BUSINESS WIRE)--Spirox™, Inc., a company committed to transforming treatment of nasal obstruction, today announced positive results from a prospective, multi-center study of the LATERA™ Absorbable Nasal Implant. The study showed that the device provides a significant reduction in nasal obstruction symptoms in patients with nasal valve collapse—an important, but often overlooked, cause of nasal obstruction—and that early improvements were maintained through one year. The results were selected for presentation as one of the 10 “Best of Orals” sessions, out of 700 submissions, at the 2016 Annual Meeting of the American Academy of Otolaryngology-Head and Neck Surgery.
READ MORE about Spirox Announces Positive Clinical Study Results for LATERA Implant in Patients with Nasal Valve Collapse, a Major Cause of Nasal Obstruction
Sep 19
2016
Intersect ENT Announces American Rhinologic Society Endorsement of the Use of Drug Eluting Sinus Implants
Sep 19
2016
MENLO PARK, Calif.--(BUSINESS WIRE)--Intersect ENT, Inc. (NASDAQ:XENT) announced the publication of a position statement from the American Rhinologic Society (ARS) endorsing the utilization of drug eluting sinus implants.
READ MORE about Intersect ENT Announces American Rhinologic Society Endorsement of the Use of Drug Eluting Sinus Implants
Sep 12
2016
Versartis Presents Data From Up to 30 Months of Somavaratan Treatment for Pediatric Growth Hormone Deficiency at the 2016 ESPE Annual Meeting
Sep 12
2016
MENLO PARK, Calif., Sept. 12, 2016 (GLOBE NEWSWIRE) -- Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced that efficacy, safety, and adherence data from up to 30 months of somavaratan treatment in the Phase 2a trial and VISTA long-term safety study for pediatric GHD were presented during the 55th Annual Meeting of the European Society of Paediatric Endocrinology (ESPE). The meeting was held September 10-12, 2016, in Paris.
READ MORE about Versartis Presents Data From Up to 30 Months of Somavaratan Treatment for Pediatric Growth Hormone Deficiency at the 2016 ESPE Annual Meeting
Sep 2
2016
Versartis Presents Efficacy, Safety, Metabolic and Adherence Data for Somavaratan in Oral Session at the International Congress of Endocrinology
Sep 2
2016
MENLO PARK, Calif., Sept. 02, 2016 (GLOBE NEWSWIRE) -- Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced that data on efficacy, safety (including metabolic parameters), and treatment adherence from up to 30 months of somavaratan treatment in the pediatric long-term safety study (now named VISTA), were presented during the 17th International Congress of Endocrinology, being held August 31 to September 4, 2016, in Beijing. Highlights from the three oral presentations include:
READ MORE about Versartis Presents Efficacy, Safety, Metabolic and Adherence Data for Somavaratan in Oral Session at the International Congress of Endocrinology
Aug 31
2016
Sunovion Pharmaceuticals to Acquire Cynapsus Therapeutics
Aug 31
2016
MARLBOROUGH, Mass. & TORONTO--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) and Cynapsus Therapeutics Inc. (Cynapsus) (NASDAQ: CYNA) (TSX: CTH) today announced that the companies have signed a definitive agreement under which Sunovion will acquire Cynapsus for US$40.50 per share in cash. The transaction has received unanimous approval by the Board of Directors of both companies and values Cynapsus at approximately US$624 million (or approximately CAN$820 million). The acquisition will be funded with cash on hand. The transaction is expected to close in the fourth quarter of 2016 (third quarter of Sunovion’s fiscal year). This agreement reflects Sunovion’s global strategy to expand and diversify its portfolio in key therapeutic areas, including neurology.
READ MORE about Sunovion Pharmaceuticals to Acquire Cynapsus Therapeutics
Aug 29
2016
Cynapsus Receives FDA Fast Track Designation for APL-130277 for the Treatment of OFF Episodes in Patients with Parkinson’s Disease
Aug 29
2016
TORONTO, Aug. 29, 2016 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for APL-130277, a product candidate for the treatment of OFF episodes in patients with Parkinson’s disease (PD).
READ MORE about Cynapsus Receives FDA Fast Track Designation for APL-130277 for the Treatment of OFF Episodes in Patients with Parkinson’s Disease
Aug 23
2016
Cempra Announces European Medicines Agency Validates MAA for Solithromycin for Treatment of CABP
Aug 23
2016
CHAPEL HILL, N.C., Aug. 23, 2016 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced that the European Medicines Agency (EMA) has validated the company's marketing authorization application (MAA) seeking approval of oral capsule and intravenous formulations of solithromycin for the treatment of community-acquired bacterial pneumonia (CABP, also referred to as community-acquired pneumonia (CAP) in the EU).
READ MORE about Cempra Announces European Medicines Agency Validates MAA for Solithromycin for Treatment of CABP
Aug 22
2016
Versartis Announces Completion of Enrollment in Phase 3 VELOCITY Trial of Somavaratan in Pediatric GHD
Aug 22
2016
MENLO PARK, Calif., Aug. 22, 2016 (GLOBE NEWSWIRE) -- Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced the completion of enrollment in the Phase 3 VELOCITY trial of somavaratan in pediatric GHD. With 137 patients enrolled, the trial is powered at > 90% to demonstrate non-inferiority of somavaratan compared to daily rhGH. Patients will be followed for the primary trial endpoint of height velocity at 12 months, as well as safety and pharmacodynamic secondary endpoints. Top-line results are anticipated in Q3 2017.
READ MORE about Versartis Announces Completion of Enrollment in Phase 3 VELOCITY Trial of Somavaratan in Pediatric GHD