Posts tagged NASDAQ
FDA advisory vote on TLANDO not a knockout for Lipocine

Although Lipocine (NASDAQ:LPCN) is disappointed by a FDA advisory committee vote against the benefit/risk profile of TLANDO, its oral testosterone replacement therapy (TRT), the company believes there is still a path forward for TLANDO.

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Chi-Med transforming into fully integrated pharma

After 17 years of blistering growth in China, Hutchison China Meditech (Chi-Med) (AIM, NASDAQ:HCM) is taking center stage as a global drug innovator, with a fully integrated pipeline approaching regulatory approvals, a prolific discovery engine and an established commercial organization.

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Mazor’s odyssey to spine robotic surgery leader

Since its founding 15 years ago, Mazor Robotics (NASDAQ, TASE:MZOR) has overcome challenges typical to medical device startups to become the leader and possibly the standard of care in spine robotics surgery.

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Flex Pharma focused on 3 clinical readouts in 2018

Flex Pharma (NASDAQ:FLKS) expects to report clinical readouts in 2018 from three Phase 2 studies of its anti-cramping drug candidate, FLX-787, in amyotrophic lateral sclerosis (ALS), Charcot-Marie-Tooth disease (CMT) and multiple sclerosis (MS).

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Titan’s next ProNeura implant could be game changer in PD

After gaining widespread attention with its FDA-approved Probuphine implant for the maintenance treatment of opioid addiction, Titan Pharmaceuticals (NASDAQ:TTNP) is setting out to develop an implant to treat Parkinson’s disease (PD).

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Diffusion Pharma readies pivotal hypoxic GBM trial

Diffusion Pharmaceuticals (NASDAQ:DFFN) expects to begin before the end of 2017 a pivotal clinical trial with its trans sodium crocetinate (TSC) lead compound to re-oxygenate oxygen-deprived tissue in patients with inoperable glioblastoma (GBM) brain cancer prior to conventional radiation and chemotherapy.

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Titan’s next ProNeura-based implant dovetails with PD awareness month

After receiving FDA approval last year for its Probuphine implant as a maintenance treatment for opioid addiction, Titan Pharmaceuticals (NASDAQ:TTNP) is employing its ProNeura drug delivery technology to develop an implant to treat Parkinson’s disease.

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Checkpoint targeting registration studies by end of 2018

Checkpoint Therapeutics (OTCQX:CKPT) is taking an “aggressive path forward” with its clinical programs and expects to be in registration studies at the end of 2018 with its lead targeted anti-cancer agent, CK-101, and lead immuno-oncology (IO) agent, CK-301.

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Lion Biotechnologies spearheading TILs in solid tumors

Lion Biotechnologies (NASDAQ:LBIO) is establishing a leading position in immuno-oncology through its tumor-infiltrating lymphocyte (TIL) technology to deliver personalized oncology therapies to patients with unmet medical needs.

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Histogenics to complete Phase 3 enrollment in Q2

Histogenics (NASDAQ:HSGX) expects to complete enrollment by the end of the second quarter this year in a Phase 3 clinical trial of its NeoCart biologic cell therapy and tissue engineering solution for knee cartilage regeneration.

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Jaguar, Napo merger set for transformative growth

The proposed merger of Jaguar Animal Health (NASDAQ:JAGX) and closely-held Napo Pharmaceuticals is expected to create a combined company with prescription product revenue, potential line extensions and an expanded pipeline.

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In conversation with Chiara Russo

As a specialty pharmaceuticals analyst with Cantor Fitzgerald for the past 2 1/2 years, Chiara Russo covers developmental-stage companies that are on the cusp of changing the medical landscape as we know it. A philosophy major with an MBA from the Olin School of Business at Babson College, Ms. Russo was a R&D innovation consultant for Cubist Pharmaceuticals before becoming a sell-side equity research analyst. On the Street, she has been a research associate at ThinkEquity and VP and specialty pharmaceuticals analyst at Janney Montgomery Scott. In this interview with BioTuesdays.com, Ms. Russo discusses industry trends and some of the stocks she likes.

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Arbutus taking multi-faceted approach to HBV

Arbutus Biopharma (NASDAQ:ABUS) is developing a portfolio of drug candidates, each with different mechanisms of action that it believes will result in a combination therapy to cure patients infected with hepatitis B virus.

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In conversation with Mohit Trikha

As chief scientific officer, EVP and head of closely held Triphase Accelerator, Mohit Trikha has parlayed a successful 20-year track record in oncology drug development into a home run, selling Triphase’s first asset, a proteasome inhibitor known as marizomib, to Celgene (NASDAQ:CELG). Prior to joining Triphase, Dr. Trikha was associate VP of clinical development at Ambit Biosciences; director of BioOncology and early development at Genentech; and assistant director of oncology research at J&J’s Centocor. 

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Athersys poised to launch pivotal stroke study next summer

After receiving a Special Protocol Assessment (SPA) from the FDA at the end of September, Athersys (NASDAQ:ATHX) hopes to launch a pivotal trial next summer administering its intravenous MultiStem cell therapy in patients following an ischemic stroke.

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