News
Jul 13
2015
TransEnterix, Inc. Announces Exercise of Option to Purchase Additional Shares
Jul 13
2015
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery, today announced that the underwriters of its previously announced public offering of common stock partially exercised the option to purchase additional shares granted at the time of the public offering and have purchased 2,075,000 shares of common stock at the public offering price of $3.00 per share, less underwriting discounts and commissions.
READ MORE about TransEnterix, Inc. Announces Exercise of Option to Purchase Additional Shares
Jul 8
2015
Intersect ENT Enrolls First Patient in Pivotal Study to Evaluate the NOVA Sinus Implant
Jul 8
2015
MENLO PARK, Calif.--Intersect ENT, Inc. (Nasdaq:XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced the enrollment of the first patient in the company’s pivotal study of its latest bioabsorbable steroid releasing sinus implant, currently called NOVA. NOVA is designed to mechanically prop sinuses open while delivering anti-inflammatory medication following surgical interventions such as sinus surgery in the operating room or in-office sinus dilation. NOVA’s unique hourglass shape and lower profile is designed to allow for placement in the smaller frontal and maxillary sinus openings, and may expand the applicable patient population for steroid releasing implants.
READ MORE about Intersect ENT Enrolls First Patient in Pivotal Study to Evaluate the NOVA Sinus Implant
Jul 7
2015
Cempra Completes Patient Enrollment of Solitaire-IV Phase 3 Clinical Trial
Jul 7
2015
CHAPEL HILL, N.C., July 7, 2015 (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 the completion of enrollment for the global Solitaire-IV Phase 3 trial of solithromycin in adult patients with moderate to moderately severe community-acquired bacterial pneumonia (CABP). Top-line efficacy and safety data from this study are expected to be announced by the end of the year.
READ MORE about Cempra Completes Patient Enrollment of Solitaire-IV Phase 3 Clinical Trial
Jul 7
2015
Esperion Therapeutics Announces Removal of 240 mg Partial Clinical Hold for ETC - 1002
Jul 7
2015
ANN ARBOR, MI -- (Marketwired) -- 07/07/15 -- Esperion Therapeutics, Inc. (NASDAQ: ESPR), an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-cholesterol) lowering therapies for the treatment of hypercholesterolemia and other cardiometabolic risk markers, today announced the U.S. Food and Drug Administration (FDA) has removed the 240 mg partial clinical hold on ETC-1002 (bempedoic acid). This action by FDA will now allow ETC-1002 to be used at doses above 240 mg in clinical studies. Esperion plans to initiate the Phase 3 clinical program for ETC-1002 in the fourth quarter of this year using the already optimized 180 mg dose.
READ MORE about Esperion Therapeutics Announces Removal of 240 mg Partial Clinical Hold for ETC - 1002
Jul 6
2015
Versartis Announces Removal of FDA Partial Clinical Hold and Continuation of VRS-317 Phase 3 Clinical Trial
Jul 6
2015
MENLO PARK, Calif., July 6, 2015 (GLOBE NEWSWIRE) -- Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing VRS-317, a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced that the US Food and Drug Administration (FDA) has removed the partial clinical hold on the Company's Investigational New Drug Application for VRS-317. With this action, the Company will proceed with the Phase 3 registration trial, VELOCITY, of VRS-317 in children with GHD.
READ MORE about Versartis Announces Removal of FDA Partial Clinical Hold and Continuation of VRS-317 Phase 3 Clinical Trial
Jul 1
2015
Advion Acquired by Bejing Bohui Innovation Technology, Inc.
Jul 1
2015
July 1, 2015 – Ithaca, NY – As previously mentioned in the June 5, 2015 announcement of the signing of the Merger Agreement, effective July 1, 2015, Beijing Bohui Innovation Technology, Ltd. completed the acquisition of Advion, Inc.
READ MORE about Advion Acquired by Bejing Bohui Innovation Technology, Inc.
Jun 30
2015
ViewRay Secures Up To $50M in Debt Financing From CRG
Jun 30
2015
Funding to Drive Global Expansion of its MRI-Guided Radiation Therapy Business
June 30, 2015
CLEVELAND, June 30, 2015 — ViewRay™, makers of MRIdian™, the world’s first and only clinical MRI-guided radiation therapy system, announced today that the company has secured up to $50 million in debt financing from CRG (formerly Capital Royalty L.P.), a premier healthcare investment firm.
READ MORE about ViewRay Secures Up To $50M in Debt Financing From CRG
Jun 30
2015
ADMA Biologics Receives Notice of Allowance for U.S. Patent Pertaining to Its Lead Product Candidate RI-002
Jun 30
2015
RAMSEY, N.J., June 30, 2015 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company, announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. patent application 14/592,721 entitled Compositions and Methods For The Treatment of Immunodeficiency.
READ MORE about ADMA Biologics Receives Notice of Allowance for U.S. Patent Pertaining to Its Lead Product Candidate RI-002
Jun 29
2015
Cynapsus Therapeutics Enrolls First Patient in Pivotal Phase 3 Efficacy Study Evaluating Sublingual, Film Strip Delivery of Apomorphine to Turn Parkinson’s Disease Patients from the OFF to the ON State
Jun 29
2015
CTH-300 Clinical Trial to Assess Effectiveness and Safety of APL-130277
TORONTO – (Marketwired) – Cynapsus Therapeutics Inc. (NASDAQ: CYNA) (TSX: CTH) (the “Company”) today announced enrollment of the first patient in the CTH-300 clinical trial, a pivotal Phase 3 study to examine the efficacy, safety and tolerability of APL-130277 for the acute treatment of OFF episodes in patients with Parkinson's disease (PD).
READ MORE about Cynapsus Therapeutics Enrolls First Patient in Pivotal Phase 3 Efficacy Study Evaluating Sublingual, Film Strip Delivery of Apomorphine to Turn Parkinson’s Disease Patients from the OFF to the ON State
Jun 25
2015
Cynapsus Therapeutics’ APL-130277 Improved Parkinson’s Symptoms and Rapidly Turned Patients from OFF to ON in Data Presented at the International Congress of Parkinson's Disease and Movement Disorders
Jun 25
2015
APL-130277, Sublingual Apomorphine, for On-Demand Treatment of OFF Episodes Associated with Parkinson’s Disease
TORONTO – (Marketwired) – Cynapsus Therapeutics Inc. (NASDAQ: CYNA) (TSX: CTH) (the “Company”) today announced that it presented data from clinical trials of APL-130277, a sublingual apomorphine thin film under development for the on-demand treatment of OFF episodes associated with Parkinson’s disease (PD). Data from the Company’s CTH-105, CTH-104 and CTH-103 clinical studies, presented at the 19th International Congress of Parkinson's Disease and Movement Disorders (MDS) in San Diego, California, showed APL-130277 significantly improved PD symptoms (as measured by MDS-UPDRS Part III), rapidly turned patients from the OFF to ON state and was generally safe and well tolerated.
READ MORE about Cynapsus Therapeutics’ APL-130277 Improved Parkinson’s Symptoms and Rapidly Turned Patients from OFF to ON in Data Presented at the International Congress of Parkinson's Disease and Movement Disorders