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 […]
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. […]
A flurry of upcoming data before the end of June
With the close of the first half of 2012 upon us, we wanted to highlight some of those expected to report data or regulatory decisions before the end of June. Dynavax (NASDAQ: DVAX) is expected to report whether the FDA will designate priority review upon their Biologics License Application (BLA) for HEPLISAV. They are seeking […]
ALNY TKMR – Updates on Alnylam and Tekmira
This post will provide a few updates from a number of recent presentations by Alnylam $ALNY (First Quarter 2012 earnings call and conference call regarding ALN-RSV data) and Tekmira $TKMR (First Quarter 2012 earnings), two developers of RNAi technology and therapeutics that are simultaneously partners and bitter opponents in a series of legal battles. My […]
CELG – An analysis of Celgene’s CVR for Abraxane(CELGZ)
When Celgene (Nasdaq: CELG) acquired Abraxis back in June 2010 for around $2.9 billion, they tied contingent value rights(CVRs) to Abraxane, Abraxis’ lead drug. These CVRs trade under the ticker (Nasdaq: CELGZ). These CVRs have the potential to deliver some pretty substantial gains if any of the potential payments are delivered. There are roughly 43M […]
VRTX – Speculating on Vertex
In going through the database, I noticed that Vertex Pharmaceuticals (NASDAQ: VRTX) has a plethora of upcoming data that is worth mentioning. It’s data on literally the two hottest sectors: rare disease and hepatitis C(HCV). – Viral Kinetic Studies of Two Alios Nucleotides: Seven-day viral kinetic studies of the nucleotide analogues ALS-2200 and ALS-2158 are […]
CBST – An Outlook
Cubist management gave a five-year outlook at their Investor Day presentation on June 11; it was quite impressive. The most notable point was management’s projection of $2 billion in global revenue by the end of 2017- more than double expected 2012 sales. Moreover, Cubist aims to increase non-GAAP operating income to $700 million. Achieving the […]
IDIX – Quick Take on IDX184
Idenix released SVR4 data for its lead drug IDX184 and early 3-day results of the promising NS5A inhibitor IDX719 Tuesday afternoon. Both sets of data looked good, sending IDIX shares soaring in after-hours trading. 31 patients from the first cohort of Idenix’s Phase IIb study were randomized to either 50mg (n=16) or 100mg (n=15) IDX184 […]
INFI – Update on Infinity Pharmaceuticals
For the second time this year, on June 18th, 2012 Infinity Pharma held a conference call to discuss their hedgehog pathway inhibitor drug candidate saridegib (IPI-926). Unfortunately, as in January, the news was not good. After the data monitoring committee stopped the saridegib plus gemcitabine trial in January, Infinity decided to proceed with additional trials in […]
EXEL – Post-ASCO thoughts on Exelixis
This post will be a follow up on what was previously said[link] about Exelixis (NASDAQ: EXEL) at ASCO 2012. Their key presentations in castration-resistant prostate cancer (CRPC) took place on Monday/Tuesday of the conference. Exelixis provided a link to all of their posters and presentations at the conference[link] and held an investor briefing[link]. Cabo for […]
ONXX – Preview of Onyx Pharmaceuticals ODAC
On Monday investors are expecting the FDA’s briefing documents to be posted for Onyx Pharmaceuticals (NASDAQ: ONXX) upcoming Oncologic Drugs Advisory Committee (ODAC) to review their NDA for Krypolis(Carfilzomib) for the treatment of patients with relapsed and refractory multiple myeloma(MM) who have received at least two prior therapies. The ODAC will take place on Wednesday, […]
CLDX – Follow up on Celldex Therapeutics
It’s been a busy couple of weeks between traveling and ASCO 2012, so pardon the lateness of this report on the preliminary Phase 2 data that Celldex Therapeutics(NASDAQ: CLDX) presented on May 23rd. In our view, the data warrant further investigation of CDX-011 earlier in the disease and we look forward to the full results […]
