After a while since our last update on these stocks, we wanted to provide an update to our readers on their recent developments and what to expect in the future. Stemline (STML) The company’s shares had an excellent post-IPO performance as a result of the positive data of its drug SL-401, a modified dyphtheria […]
A closer look at these veterinary stocks: PETX, KIN, PARN
Animal health (AH) is gaining more and more attention from investors as new companies go public amidst the biotech IPO frenzy. In this report, we’ll focus on three new veterinary stocks that began trading over the past few months. According to the American Pet Products Association (APPA, ref ), animal care is a market […]
CAR-T in the spotlight: Cellectis
Two weeks ago, Cellectis (ALCLS) and Pfizer (PFE) struck an agreement to develop new chimeric antigen receptor (CAR)-T-based therapies for oncology. Pfizer will pay $80M upfront and up to $185M in milestones per product plus royalties on sales. Additionally, Pfizer has acquired a 10% stake in Cellectis. Pfizer has exclusive rights to develop 15 […]
ASCO small caps: SNSS KPTI CYTR IMUC ZEL
Sunesis (SNSS) The company presented a poster of an MD Anderson-sponsored trial of its investigational drug voseroxin plus decitabine. There was intriguing data with regard to the response rates. 30 patients (pts) were evaluable for response; 13 (43%) achieved CR, 6 (20%) CRp, and 3 (10%) CRi, for an ORR of 81% with no evidence […]
Sunesis: little value in VALOR
Sunesis Pharmaceuticals (NASDAQ: SNSS) is expected to report top-line data from the Phase III VALOR study in the third or fourth quarter of this year. The VALOR study is testing vosaroxin plus cytarabine vs. cytarabine alone in patients with first relapsed or refractory acute myeloid leukemia (r/r AML), with survival as the primary endpoint. […]
INSM – Quick take on Insmed
Insmed (NASDAQ: INSM) is expected to report top-line data from a Phase II trial of Arikace in non-tuberculosis mycobacteria (NTM) infection tomorrow morning. This is a double-blind placebo-controlled study that has recruited 90 patients and is comparing the change in semi-quantitative mycobacterial culture density on a seven-point scale from baseline to the end of treatment […]
CYTK – Will tirasemtiv BENEFIT ALS patients?
As Cytokinetics confirmed in its Q4 2013 conference call, it will report top-line data from the BENEFIT-ALS study in the second quarter of this year, precisely, at the American Academy of Neurology annual meeting in Philadelphia April 26-May 3. If the company can’t have the whole data ready for that meeting, they’ll present a […]
GenVec: hearing a comeback
On the verge of shutting down just a few months ago, Genvec (NASDAQ: GNVC) has recently had a comeback that might last for a few more years if its partnered hearing loss program yields good results in the clinic. As some background, in early 2010, Genvec was running higher in hopes that its gene therapy […]
KaloBios: a look at KB003 and KB004
(jointly with Jason Chew) KaloBios (NASDAQ: KBIO) completed its initial public offering this past January, securing $61.5 million in proceeds to fund operations and it recently raised $30M in a stock offering. In contrast to many companies in this year’s IPO class, KaloBios stock has suffered a drop of about 45% from its $8 debut […]
CYTK – Flash note on ATOMIC-AHF data
Today, Amgen (NASDAQ: AMGN) and Cytokinetics (NASDAQ: CYTK) reported data from the Phase IIb ATOMIC-AHF study of i.v. omecamtiv mecarbil (OM) in patients with acute heart failure. As we hypothesized in this piece, only the high dose met the primary endpoint of improvement of dyspnea (breathlessness) after 48 hours, albeit due to a markedly lower […]
Three European biotech companies building value through partnerships
Galapagos NV Galapagos (Brussels: GLPG; Pink Sheets: GLPYY.PK) is a Belgian biotech company whose lead product is JAK1 inhibitor GLPG0634 for rheumatoid arthritis (RA) and Crohn’s disease (CD). Jason covered the drug in this article. Since then, the company has presented more data at various forums; the latest was EULAR in June. They have multiple […]
VICL – Quick take on Vical’s Allovectin failure
(With Patrick Crutcher) Today Vical (NASDAQ: VICL) reported top-line data from a Phase III trial of Allovectin-7 (A7) in patients with advanced melanoma. As we predicted in this article, the trial failed. A7 not only didn’t meet the survival endpoint, but it also missed the primary endpoint of durable response rate. Shares of Vical fell […]
MACK – Flurry of results in the second half of the year
We would like to take a closer look at the upcoming results of Merrimack Pharmaceuticals’ (MACK) lead drugs, MM-398 and MM-121. MM-398 MM-398 is a liposomal formulation of irinotecan intended for the treatment of pancreatic cancer (PC). Irinotecan is marketed by Pfizer as Camptosar® and approved for first-line treatment of colon cancer in combination with […]
ABBV – A look into Abbvie
with Patrick Crutcher and Jason Chew Abbvie (ABBV) presented data on its oncology candidates at ASCO meeting and updated investors at Jefferies Healthcare Conference last week. The stock, like other fellow big caps, has had a considerable run over the past few months and is up 25% YTD, after the split from Abbott (ABT). On […]
CYTK – Our take on the upcoming ATOMIC-AHF study results
Results from ATOMIC-AHF, a Phase IIb clinical trial of omecamtiv mecarbil, are quickly approaching. Cytokinetics (NASDAQ: CYTK) and partner Amgen (NASDAQ: AMGN) expect to release top-line data around mid-year, probably in June or July. We published a comprehensive analysis of Cytokinetics’ cardiac muscle program in this article. The ATOMIC-AHF study is a double-blind, placebo-controlled clinical […]
VICL – Bear take on Allovectin-7
with Patrick Crutcher Vical (NASDAQ: VICL) is approaching the release of top-line data from a Phase III clinical trial of Allovectin-7 (A7) in patients with metastatic melanoma. According to the company’s last earnings call, it’s slated to occur sometime during the third quarter of this year. A7, also known as velimogene aliplasmid, is a DNA […]
DCTH – Our take on Delcath’s upcoming advisory committee
The FDA’s Oncologic Drugs Advisory Committee (ODAC) is slated to review Melblez (previously known as Chemosat) on May 2nd. An FDA decision is expected on June 15th. Melblez is a chemosaturation system that isolates the liver in order to allow the administration of high doses of melphalan for the treatment of liver metastases from other […]
THRX – Insight into Relovair’s upcoming FDA Advisory Committee
On April 17th, Theravance (NASDAQ: THRX) and partner GlaxoSmithKline (LSE: GSK; NYSE: GSK) will sit in front of the FDA’s Pulmonary-Allergy Drugs Advisory Committee that will decide on whether to recommend Breo (formerly known as relovair) for approval. The FDA has set a PDUFA goal date of May 12, 2013. Breo is a combination of […]
STML – Initiating coverage on new public company Stemline Therapeutics
The IPO window was almost closed in 2008 when the financial crisis hit the markets worldwide. Companies looking to raise funds from the capital markets had to think it twice or lower their proposed price ranges considerably. Fortunately, in 2011 and 2012 the situation seems to have improved substantially and more companies are using the […]
Data and FDA decisions for 3 biotech companies EXAS PATH IPXL
Exact Sciences Exact Sciences (NASDAQ: EXAS) is expected to release full data from the DeeP-C study for Cologuard, its colon cancer screening test. The company anticipates filing a premarket approval (PMA) with the FDA in the first quarter of 2013. The DeeP-C study is being conducted in 12,700 patients, probably one of the largest prospective […]
