Pharmacyclicsâ stock is on fire as the company has presented outstanding data for ibrutinib at the American Society of Hematology meeting. We know we sound biased but the bottom line is: ibrutinib really is an unbelievable drug and the data at ASH is overwhelmingly positive in so many ways. It’s doing everything one could dream[…]
BioMarin’s stock is up significantly since the last Issue. The trigger for the strong price move was positive data from their Phase III trial in patients with the rare genetic disorder known as Morquio A Syndrome. The patients treated with a weekly infusion of GALNS were able to walk an average of 22.5 meters further[…]
Celgene’s stock is up since the last Issue on good news. The company announced that Abraxane has achieved overall survival (OS) is Phase III trial treating metastatic pancreatic cancer patients. CELG did not provide any exact results as they plan to present the data at an upcoming scientific meeting. We do know that the company designed[…]
Aastrom has announced that cell therapy regulatory and development expert Joyce L. Frey-Vasconcells, Ph.D. has been appointed to the company’s Scientific Advisory Board (SAB). Dr. Frey-Vasconcells is considered one of the foremost regulatory experts on cell therapies, tissues and gene therapies.  Dr. Frey-Vasconcells is founder and president of Frey-Vasconcells Consulting LLC and previously served as a[…]
Anthera’s CFO and Chief Medical Officer explained the detailed plans for the blisibimod (B-mod) Phase III program at the recent Piper Jaffray conference.  The Phase III development program was blessed by the FDA in September and the EU regulatory agency in April. The first Phase III – CHABLIS1 will start where PEARL was done – Asia/Pacific/S.[…]
Anthera’s stock is down sharply since the last Issue. It appears that the company had been out trying to put together a private financing but could not execute the transaction. Hurricane Sandy made it almost impossible to conduct business normally and ANTH was not able to close a transaction. Alternatively, ANTH entered into an At Market[…]
Alkermes reported financial results for its second quarter of fiscal 2013, which ended Sept. 30, 2012, and the company provided improved financial expectations for its fiscal year 2013. Total revenues for the second quarter of fiscal 2013 increased more than 72% to $124.0 million, compared to the same period in fiscal 2012, which was attributable[…]
NovaVax announced that it has raised a total of $27 million through the sale of 12,285,321 shares of its common stock to RA Capital Management, Camber Capital Management and Ayer Capital Management at a price of $2.18 per share. The shares were offered under an effective shelf registration statement previously filed with the Securities and[…]
Pacira had good news this morning and the stock is up modestly. The company announced results from the first IMPROVE study to complete its prospective Phase 4 clinical program. The IMPROVE studies compare the difference in opioid use, total hospital cost and length of stay (LOS) between patients receiving Exparel (bupivacaine liposome injectable suspension) as[…]
Nektarâs stock has had a horrible two weeks despite announcing positive top-line results from two Phase III trials and one safety extension trial in patients with non-cancer related pain and opioid-induced constipation (OIC). Last week, potential FDA concerns with CV risk associated with opioid withdrawal in chronic use of opioid antagonists became an investor issue[…]
Anthera’s stock is up since the last Issue as they have had two encouraging announcements. The most important was this week when they announced that an abstract from the Phase 2b PEARL-SC clinical study examining the treatment effect of blisibimod in systemic lupus patients has been accepted as a Late-Breaking poster presentation at the 2012 Annual[…]
Celgene’s stock is down since the last Issue as it also corrected this Friday. This week, additional information became available on the FDA’s website regarding the cancellation of the November 8th ODAC meeting originally scheduled to discuss pomalidomide. The website now specifically says that ”the issues for which the FDA was seeking the scientific input of the[…]
