BIOINVEST BREAKING NEWS – Special Update – ANTH — As IgAN Data Nears, The Case For A Reduction In Proteinuria. With Anthera shortly delivering its first new clinical trial results in a long time, the implications of the IgAN data, in our opinion the implications of the IgAN data, while not yet valued by investors, are many. Read more…
IONS Huge Winner as GILD Ruled to Infringe on IONS/Merck HCV Patent –Yesterday, a California District Court jury determined GILD’s blockbuster hepatitis C drugs Sovaldi and Harvoni infringe on two Merck/IONS patents. Read more…
Anthera (ANTH) Strengthens Senior Management With President/COO & Chief Technology Officer – Craig Thompson is joining ANTH as President and Chief Operating Officer. He comes with an experienced Big Pharma strategic marketing background (~10 years at Merck, ~8 at Pfizer), and will oversee both of the Company’s late-stage development programs and commercial preparation efforts. read more…
BIOINVEST BREAKING NEWS – Special Update – Anthera (ANTH) – Ending Japanese Deal Is No Big Deal; All B-Mod/Sollpura Programs/Timelines Unchanged – Reiterate BUY – Despite helping financially when ANTH needed the funds last year, no Wall Street models included a Japanese approval for IgAN. The receipt of a termination notice from its development partner in Japan, Zenyaku, was “at will” and alleged no breach of the License Agreement by Anthera. read more…
BIOINVEST BREAKING NEWS – Special Update – ACAD – Nuplazid Receives Positive 12-2 Vote From FDA Advisory Panel – Acadia’s Nuplazid was favorably reviewed by an FDA advisory panel today. The vote was 12-2 on efficacy, 11-3 on safety, and most importantly, 12-2 on the drug’s overall risk/benefit for Parkinson’s disease psychosis (PDP). Read more…
Intrexon (XON) – Two Health Care Deals Signed For Metabolic Diseases and RA – The first deal is with Janssen Pharmaceutica NV (JNJ’s Euro Division) is to discover and develop ActoBiotics therapies directed against selected targets to treat Type 2 diabetes (T2D), obesity and/or metabolic disorders related to energy dysregulation. XON’s ActoBiotics platform represents an innovative oral delivery system for biological effectors ideally suited to tackle multiple aspects of T2D with the potential to improve efficacy in maintaining glycemic control in the long term. Read more…
BIOINVEST BREAKING NEWS – Special Update – OncoGenex (OGXI) – Custirsen Misses First Shot on Goal as PP Subset Fails to Deliver in Phase III AFFINITY, Overall Trial Continues as ITT Population Passes Both Futility & Safety Hurdle. Read more…
Special Update – The Medicines Company (MDCO) – ALN-PCS Data Appear To Be Best Case Scenario – The ALN-PCS (PCSK-9 RNAi) data presented today (8/30) at the European Society of Cardiology (ESC, London) – albeit only Phase I results – have met or exceeded consensus expectations on the three main criteria that might lead to a Best-In-Class blockbuster drug for reducing read more…
BIOINVEST BREAKING NEWS – Special Update – ACAD – Nuplazid Receives Positive 12-2 Vote From FDA Advisory Panel – Acadia’s Nuplazid was favorably reviewed by an FDA advisory panel today. The vote was 12-2 on efficacy, 11-3 on safety, and most importantly, 12-2 on the drug’s overall risk/benefit for Parkinson’s disease psychosis (PDP). Read more…
Five Prime (FPRX) – Poised For Big Time 2016; Raising Buy & Target – FPRX had a great year in 2015 with the BMS deal being one of the best we have ever seen for a Phase I compound. The company continues to click on all cylinders and in our view, with the strength and depth of that deal, the Company is gaining further momentum. Early 2016 is ripe with three clinical trials releases that should serve as important catalysts to begin the year. Read more…
BIOINVEST BREAKING NEWS – Special Update – OncoGenex (OGXI) – Rainier Fails To Show A Benefit in Apatorsen in Metastic Pancreatic Cancer; Not Really A Surprise & Many More Shots To Go – Our BUY Thesis Remains Intact – While we do not have exact details, the addition of apatorsen to ABRAXANE and gemcitabine did not demonstrate a survival benefit compared to ABRAXANE and gemcitabine alone.. read more…
Special Update – NVAX – Positive Phase II RSV Vaccine Data De-Risks The Crown Jewel – Raising Buy Limit and Target Price – In the large Phase II trial, NVAX has delivered excellent RSV F protein vaccine data in the most difficult-to-treat elderly population (>60 years old). The study is the first ever demonstration of efficacy of an active RSV vaccine in humans, read more…
