FOLD – Quick Take – Amigal P3 Monotherapy
Amicus Therapeutics is expected to unveil results from its Phase III registration trial for migalastat (Amigal) as monotherapy for the treatment of Fabry disease in the third quarter of this year. The study, if successful, will allow Amicus to file for marketing approval in the U.S. A separate global Phase III is also in progress. […]
Upcoming FDA Decisions
We will have several regulatory decisions expected this week, some more important than others. This coming week got slightly tamer with the FDA’s approval decision for Carfilzomib on Friday for Onyx and Ligand. Horizon Pharmaceuticals (NASDAQ: HZNP) has a PDUFA date of Thursday, July 26, 2012 for LODOTRA(delayed-release low-dose prednisone), for the treatment of rheumatoid […]
CYTK – Cytokinetics Part 1: Omecamtiv mecarbil a promising drug that faces a tough road ahead.
This is the first of a two part series on Cytokinetics Inc (NASDAQ: CYTK). For the first article, we’ll discuss its cardiac program and in the second part, we’ll focus on the skeletal muscle program. Over the last few quarters, Cytokinetics has continued its downtrend amidst no relevant catalysts in the very short term, a […]
ALNY ISIS – Updates from the JMP Healthcare Conference
If you aren’t a long-time BiotechDueDiligence blog reader or Chimera Research Group subscriber, you may wonder what one of our updates from biotech investor conferences and quarterly earnings conference calls looks like. These reports are not a detailed thesis about the company, nor do they purport to summarize everything the company said on the webcast. […]
SNTA SPPI – Updates from JMP Securities Healthcare Conference
Next up in our dispatches from the JMP Securities Healthcare conference is a pair of oncology companies, Spectrum Pharma SPPI and Synta Pharma SNTA, that always seem to generate strong opinions among biotech investors. Spectrum Pharma $SPPI presentation by Shiv Kapoor, VP of Strategic Planning and Investor Relations This year we have already made […]
LGND – Updates from the JMP Securities
The JMP Securities Healthcare Conference was held July 12-13, a rare biotech investor event during the summer doldrums [webcast link and check back at BiotechDueDiligence where I will archive select slides]. We will follow up with reports on Synta Pharma SNTA, Biosante Pharma BPAX, Spectrum Pharma SPPI, Alnylam ALNY and Isis Pharma ISIS, but for now […]
VVUS – PDUFA approaching, company revving Branding & Marketing
Vivus’s (VVUS), a specialty pharmaceutical company, had faced many setbacks with it’s drug candidate, Qnexa, an investigational treatment for obesity, obstructive sleep apnea and diabetes. In October 2010, Vivus received a Complete Response Letter from the FDA. In March of 2011, several studies were published demonstrating teratogenicity with one of Qnexa’s main ingredients, topiramate. Despite […]
YMI – A Billion Dollar Company?
Shares of YMI are trading at about $1.96, valuing the company at $309 million; adding in 7.4 million warrants along with 8.2 million options gives a fully diluted value of $339 million. YM Biosciences has several assets: JAK inhibitor CYT387, anti-EGFR antibody Nimotuzumab, and CYT997, a so-called vascular disrupting agent. Investors are focused largely on […]
VVUS – Understanding the Upcoming PDUFA
Vivus’s July 17th PDUFA date is quickly approaching. After the FDA Advisory Committee voted strongly in favor of approving Qnexa, for the treatment of obesity, mostly all pundits and analyst have all but claimed victory for Vivus’s upcoming PDUFA date. We feel that overall, Qnexa has received significantly more positive commentary secondary to a meaningful […]
INCY – An Immunotherapy Play?
At ASCO this past June, Incyte presented early data from its new Indoleamine 2,3-dioxygenase-1 (IDO-1) inhibitor project. Their small molecule inhibitor, INCB024360, was tested primarily to determine safety and tolerability; secondary endpoints included PK, biomarkers, and signs of anti-tumor activity. The compound demonstrated a good safety profile among 38 patients, with the maximum tolerated dose […]
INFI – Pivoting From Hedgehog to PI3K
Failed trials can’t hold this stock down. In recent months, the hedgehog pathway inhibitor saridegib (also known as IPI-926) – once the company’s leading pipeline candidate – has crashed out of pancreatic cancer, chondrosarcoma and myelofibrosis trials, but the stock has since broken out to new 52-week highs. Following these disappointments, Infinity has discontinued all […]
A Look Into Some COPD Plays With Pending Catalysts
A Guest Post by Juan Pedro Rodriguez Serrate Vectura (LSE:VEC; Pink Sheets:VEGPF) British company Vectura is developing two interesting drugs for the treatment of COPD in partnership with pharma giant Novartis and Japanese company Sosei. Vectura sports a market cap of approximately £240M ($375M) at the time of this writing. – NVA237 (Seebri Breezhaler): is […]
ONXX – Upcoming events at Onyx Pharmaceuticals
Onyx Pharmaceuticals(NASDAQ: ONXX) has a pretty long list of upcoming news that will keep the stock’s momentum following the positive FDA ODAC vote for Kyprolis™ (proposed brand name for carfilzomib) in June. As we said in our blog piece, the briefing documents pointed to a very different FDA stance than what actually transpired. With that […]
OGXI – Oncogenex and Teva finally chart a path forward in NSCLC
The collaboration between Teva Pharma $TEVA and Oncogenex $OGXI for the development of custirsen (aka OGX-011, an antisense against clusterin, licensed from Isis Pharma $ISIS) was always envisioned to include three phase 3 trials, two in prostate cancer and one in non-small cell lung cancer. As I have been chronicling, there have been many false starts […]
ATRS AIS – Antares Pharma’s Overactive Bladder drug: shoulda been named “Can’t-urol”
Antares Pharma $ATRS (formerly $AIS) developed Anturol, a proprietary drug-device combination for overactive bladder (OAB) consisting of a metered-dose pump that dispenses a gel containing the active ingredient oxybutynin. The product was licensed to Watson Pharma $WPI in July 2011, received FDA approval in December 2011, and launched in April 2012 with the brand name […]
ARNA – Quick Update on Arena’s upcoming PDUFA date
Arena’s June 27th PDUFA date is quickly approaching. After the FDA Advisory Committee voted strongly in favor of approving Lorcaserin, for the treatment of obesity, mostly all pundits and analyst have all but claimed victory for Arena’s upcoming PDUFA date. We feel that despite modest efficacy, Lorcaserin has a high degree of likelihood for approval. […]
