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Sep 29 2016

Cempra Announces Anti-NASH Effects of Solithromycin: Interim Results From Phase 2 Study

Sep 29 2016

CHAPEL HILL, N.C., Sept. 29, 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 interim results showing anti-NASH effects in the first six nonalcoholic steatohepatitis (NASH) patients dosed with solithromycin in a Phase 2 study.

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Sep 26 2016

Versartis Initiates Phase 3 Trial of Somavaratan in Japan for Children with Growth Hormone Deficiency Following Completion of Phase 2

Sep 26 2016

MENLO PARK, Calif., Sept. 26, 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 initiation of the Phase 3 portion of its J14VR5 trial in Japanese children with GHD following the completion of the Phase 2 portion of the trial. Versartis noted the following:

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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.

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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.

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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.

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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.

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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.

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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:

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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.

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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).

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