Investors in Amicus Therapeutics (NASDAQ: FOLD) are anxiously awaiting data from several ongoing trials in rare-diseases. We initiated coverage on Amicus back in January[link]. We are waiting data from the Phase II co-treatment data for Amigal in Fabry disease(Study 013) and the Phase 2 study of AT2220 in combo with enzyme-replacement therapy(ERT) for Pompe disease. […]
GEVA – Hype or Substance?
Synageva shares have risen sharply in the last few months from a low of $8.30 to $38.04 today, now sporting a market cap of $800 million. Its most recent catalyst came on a Morgan Stanley analyst initiation on April 20th with a $76 price target. Synageva has only been a public company for less than […]
PCYC – Update on Pharmacyclics
With the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO) rapidly approaching, Pharmacyclics will be providing several updates there that the Street will be watching closely. Their lead drug is a Bruton’s Tyrosine Kinase (Btk) inhibitor for hematological disorders, Ibrutinib(PCI-32765), which is in multiple Phase II trials. PCI-32765 is the company’s major […]
DEPO – Quick Update on Depomed’s plan to file NDA for Serada
On Tuesday, Depomed announced that they intend to file an NDA for Serada. At one point, in after hours trading the stock peaked up almost 7%, at which point we cautioned investors, here, to consider selling into this strength. Since then, it seems that the stock price had settled back down pre-news levels until […]
SGEN – Update on Seattle Genetics
A series of recent moves by Seattle Genetics is positioning the company to capitalize on its current success to build for future growth. As previously mentioned in our last report, Seattle Genetics is on track to start three Phase III studies for Adcetris in the front line setting this year: Hodgkin’s Lymphoma (HL), Mature T-cell […]
CRIS – Updates from Curis 2011 year-end conference call
Curis (NASDAQ: CRIS) currently trades with an enterprise valuation slightly over $300m. The company’s best known asset is the Hedgehog inhibitor vismodegib (ERIVEDGE) which was recently approved for advanced basal cell carcinoma (BCC) and launched by Roche/Genentech ($5.5m in sales were booked in 1q-2012 representing about the first 6 weeks on the market). This article […]
ARQL – Update on Arqule
We wanted to take some time to review some of Arqule’s (NASDAQ: ARQL) plans going forward in 2012. Management seems more confident than ever in Tivantinib(ARQ197) following their successful Phase 2 in 2nd-line hepatocellular carcinoma(HCC, liver cancer). This success helped convince investors to participate in their recent 7.1M share offering that brought in around $48.7 […]
ARRY – Initiating Coverage – The curious case of Array BioPharma
Array BioPharma (NASDAQ: ARRY) has always been one of those biotech oddities: over 9 partnerships[link] with big pharma but a marketcap under $300M? Weird. Unfortunately, I think Array has been a victim of poor clinical trial design and execution in the past by themselves and partner Astra Zeneca. Some of these missteps appear to be […]
IDIX – Quick chat w/ IDIX CEO Ron Renaud
I had a brief conversation w/ Idenix CEO Ron Renaud this afternoon. Not surprisingly, he was caught up in the deluge of EASL abstracts that were released today. Of particular concern for Idenix was one from Roche involving a trial of their nuc mericitabine and protease inhibitor danoprevir in combination with ribavirin. The trial was […]
Updates from the Roth Captial Partners Growth Conference
The annual Roth Capital Partners Growth Conference was held March 11-14, 2012. Find the complete presentation schedule and links to webcasts here. Isis Pharma (NASDAQ: ISIS) KYNAMRO (mipomersen) NDA will be filed in the next few weeks before end of quarter (missing this guidance would destroy the last shred of credibility ISIS management has […]
IDIX – Is IDX-184 Good Enough?
Idenix may have a new lease on life now that the FDA has lifted all holds on its lead nucleotide IDX184. The company is very keen to put its nuc in combination with a pan-genotypic compound, either a protease inhibitor or NS5a inhibitor. To ensure it doesn’t run into the same toxicity problems it had […]
Updates from the Cowen & Co. Healthcare Conference
The early spring biotech investor conference calendar continued with the annual Cowen & Co. Healthcare Conference held March 5-7, 2012 in Boston, MA. As always, my webcast notes below contain only key updates, changes, or new information, and do not represent a complete reprise of any presentation. Additional details on many of these companies can […]
MAPP – Thoughts on MAPP’s PDUFA for LEVADEX
With MAP Pharmaceutical’s upcoming PDUFA for tomorrow, I just wanted to lay out some of my thoughts on their LEVADEX application going into this. Bull case – 505b(2) NDA utilizing the FDA’s familiarness with DHE via injectable DHE and nasal spray, Migranal. – Successful Phase 3 trial; hit required efficacy endpoints – Compares well to […]
POZN – Succeeds In Two Pivotal Trials- A Chat With Management:
POZN Succeeds In Two Pivotal Trials- A Chat With Management: (Apologies in advance- no transcript, just some notes.) As we know, Pozen announced yesterday positive top-line results from two pivotal Phase 3 clinical trials of PA32540, a novel, coordinated-delivery tablet of immediate-release omeprazole (40 mg) and delayed release aspirin (325 mg). I spoke briefly with […]
ASCO 2012: American Society of Clinical Oncology Preview Part 2
The 2012 American Society of Clinical Oncology (ASCO) Annual Meeting[link] will take place from June 1st to 5th in Chicago. This is the world’s largest meeting of oncology professionals where some of the industry’s most important data presentations will take place. With conferences like these, come the abstracts releases for presentations; this year abstracts will […]
ARIA – Quick take on Ariad’s upcoming FDA panel
Glancing at the catalyst calendar, we see that ARIAD Pharmaceuticals (NASDAQ: ARIA) Ridaforolimus is scheduled to go before a FDA Oncologic Drugs Advisory Committee on March 20th(Monday)[link] to review their NDA. (The proposed tradename for Ridaforolimus is Taltorvic.) The briefing documents should be available for this meeting tomorrow morning. ARIAD has gone to great lengths […]
ASCO 2012: American Society of Clinical Oncology Preview Part 1
The 2012 American Society of Clinical Oncology (ASCO) Annual meeting[link] will take place from June 1st to 5th in Chicago. This is the world’s largest meeting of oncology professionals where some of the industry’s most important data presentations will take place. With conferences like these, come the abstracts releases for presentations; this year abstracts will […]
POZN – Focusing on PA32540
POZN: Focusing on PA32540 In Pozen’s last earnings call on February 28, CEO John R. Plachetka told analysts top-line results originally projected for the first half of this year, are now expected in mid-March. Refresher: PA32540 is Pozen’s aspirin/omeprazole co-formulation for the prevention of NSAID-associated upper gastrointestinal (UGI) toxicity. It contains 325 mg aspirin and […]
TZYM – Pivotal Results Approaching
TZYM: Pivotal Results Approaching Durham, North Carolina’s Tranzyme Pharma is a small biotechnology company focused on the development of novel treatments for Gastrointestinal (GI) disorders. Its main product is Ulimorelin for post-operative ileus (POI), a Ghrelin agonist designed to aid the recovery of GI function after bowel surgery. It is set to report results from […]
Updates from the Citi Global Healthcare Conference
The annual Citi Global Healthcare Conference was held February 27-29, 2012, and as always we listened in on the webcasts to identify key takeaways for Chimera Research Group shareholders. These write-ups may be brief due to overlap with comments at other recent investor conferences – see links below. Amarin $AMRN (Leerink Swann notes – company overview) “We […]
