This was originally going to be titled “Ahead of the AdCom” but that no longers seems fitting. The highly anticipated Advisory Committee meeting originally scheduled for Friday January 22 was canceled due to blizzard conditions. Extremely negative reviews in Briefing documents [link] from the FDA are leading many to expect a denial for Eteplirsen’s drug […]
XBI – A Look At The Near and Long Term In The Biotech Sector
SPDR S&P Biotech ETF (XBI)–NYSE We will maintain our focus on the XBI as the biotech barometer, many are waiting for the XBI to outperform the IBB again and lead the way to a real recovery, to give us the sign that the technical correction is done and we are back to a […]
BLCM: Limited Opportunities In a Changing Environment
The driving interest in Bellicum revolves around its safety switch for use in hematologic stem cell transplants. It’s product, BPX-501, is a T-cell therapy containing a caspase-9 gene that can be activated by the compound rimiducid, leading to cell apoptosis. BPX-501 is initially being positioned as an adjunct T-cell therapy for allogeneic HSCT. Stem […]
LOXO: Staying On TRK
Loxo Oncology presented highly anticipated results from its ongoing Phase 1 study of TRK inhibitor LOXO-101 yesterday November 8, in a latebreaker at AACR-NCI-EORTC; they did not disappoint. Disclosure of a response from just one patient with diagnosed TRK fusion mutation in a July publication of Cancer Discovery set much of this excitement in motion. […]
SRPT: Better The Devil You Know
The Bull/Bear tussle in Sarepta has been ongoing for years now. Long term investors have ridden a rollercoaster as excitement has inevitably been followed by disappointment. Its Exon 51 skipping drug eteplirsen is set for an Advisory Committee meeting January 22, 2016 with the PDUFA date tentatively set for February 26. A war of words […]
Global Blood Therapeutics: Targeting Sickle Cell Disease
Global Blood Therapeutics (GBT) is a recent graduate of Third Rock Ventures, a highly regarded firm with a list of innovative portfolio companies including Bluebird Bio, Foundation Medicine, Agios, and Sage Therapeutics. The company’s most advanced program is a compound in Phase 1 for the treatment of patients with Sickle Cell Disease. Sickle cell disease […]
Raptor Pharma: Of Cystinosis and Huntingtons
Raptor Pharmaceuticals is a small Novato, CA. company that markets Procysbi for the treatment of nephropathic cystinosis. It has active clinical trials in Huntington’s Disease and Leigh Syndrome. A recent acquisition has provided entry into the Cystic Fibrosis field. Procysbi- also known as RP103- took a different route to market from that of most newly […]
STARTRK-1: Lost In Space [RXDX]
This is a brief analysis of recent entrectinib data presented by Ignyta. Entrectinib is a multi-kinase inhibitor with potent activity against TrkA/B/C, ROS1, and ALK. It was licensed from Nerviano Medical Sciences in November 2013, whereupon Ignyta took over development of the compound. Entrectinib is currently being studied in two Phase 1 studies- one in […]
INCY: Predicting Success in Pancreatic Cancer
Incyte Pharmaceuticals’ lead drug Jakafi (Ruxolitinib) is approved for the treatment of the bone marrow disorders Myelofibrosis and Polycythemia Vera. It is expected to reach blockbuster sales despite these relatively niche indications. The company has ambitions to expand Jakafi into solid tumors with Pancreatic cancer leading the way. Top line data from a Phase 2 […]
SRPT Breakout- A Quick Look At The Chart
Sarepta Therapeutics, Inc. (SRPT) – Nasdaq After three years of a roller coaster, Sarepta getting closer to the the real deal, started with the NDA acceptance by the FDA on August 25th and a PDUFA date set on Feb 26th, 2016, but still waiting for the final date of the FDA Advisory Committee (AdCom) that […]
Loxo Oncology: One to Watch
Loxo Oncology (LOXO) is a biotech company built around the idea that cancer is best treated with highly targeted drugs paired to companion diagnostics. CEO Josh Bilenker, a partner at Aisling Capital, founded the company in 2013. Research and Development is outsourced, allowing about a dozen employees to manage company operations. Loxo acquired essentially all […]
Trevena Scores In Pain Study
Trevena Inc. (TRVN) presented positive Phase 2b results Monday August 31 from its TRV130 pain study. The primary endpoint of superior pain reduction compared to placebo was met, as well as superiority to morphine in the secondary endpoint of lower rates of nausea, vomiting, and hypoventilation. The results were quite good, and together with the previous […]
BioBlast Pharma: an under the radar ultra-rare disease company
Bio Blast Pharma Ltd. (ORPN) – Nasdaq BioBlast Pharma (ORPN) is a clinical-stage biotech company, focused on treatments for rare and ultra-rare diseases, especially genetic and metabolic diseases. The company has three diversified platforms currently address five different diseases. The platforms include Cabaletta, which is a platform for diseases characterized by mutated proteins; BBrm platform is a […]
TRIL – Preparing For The Next Move Upward
Trillium Therapeutics Inc. (TRIL) – Nasdaq Trillium (TRIL) is developing the next-generation of cancer immunotherapies. TRIL’s lead program, SIRPαFc, targets CD47 to prevent cancer cells from delivering a “do not eat” signal to macrophages. High expression of CD47 by tumor cells has been correlated with more aggressive disease and poor survival. SIRPαFc is initially being developed […]
The Reality for Mannkind
Mannkind, the maker of the inhaled insulin product Afrezza, is the 11th best performing biotech stock according to Finviz in the last month, up 62%. That performance is in line with several big ASCO winners such as Oncothyreon, Ignyta and Immunogen. Also on the list is DMD company Sarepta, which has new hope for an […]
13F Analysis of Best Performing Healthcare Hedge Funds (Q1 2015)
13F filings have arrived and it’s like Christmas day for me. I’ve been pouring through the filings, tweeting the interesting ones, and probably annoying everyone on twitter. These filings are a great idea generation tool, a starting place for due diligence, and way to get a peek at the focus of the best minds in […]
Chimera Research Group Catalyst Summary for April 2015
At the end of each month Chimera Research Group provides you with a monthly summary of ten notable catalysts/events that have been completed during the past month. APRIL 2015: Gilead Sciences (NASDAQ: GILD) exceeded analyst expectations reporting $7.6 billion in first quarter revenue , including $4.55 billion from their HCV portfolio of Harvoni and Sovaldi. Revenue […]
The Week Ahead in Earnings
A second busy week of earnings is due out in the space this week. We will see 3 of the 4 remaining large caps report (Gilead, Celgene, Vertex) and a smattering of big pharma reports as well. Given the sell off today, earnings reports could stem the fall, or exacerbate it further with poor results. […]
CYNAF is OFF the Mark
Cynapsus is developing a sublingual film formulation of apomorphine for the treatment of acute “Off” episodes in patients with Parkinson’s Disease resulting from long term use of Levodopa. While Levodopa is considered the single best treatment for Parkinson’s, long term use of the medicine leads to motor fluctuations as its efficacy declines. Patients then begin […]
Chimera Research Group Catalyst Summary for March 2015
At the end of each month Chimera Research Group provides you with a monthly summary of TEN notable catalysts/events that have occurred during the past month. MARCH 2015: 1) Bristol-Myers Squibb Company (NYSE:BMY) announced that the FDA approved the expanded use of Opdivo to treat patients with advanced squamous non-small cell lung cancer (NSCLC). Approval came just over two […]
