EpiCept Corporation (NASDAQ:EPCT) made an ammendment to their reverse split vote to be held on June 14. Originally they were seeking approval to enforce a 1:2 to 1:4 reverse split. However, this was increased on Monday to 1:2 to 1:6.
VIVUS, Inc. (Nasdaq: VVUS) said that they are considering a resubmission of their QNEXA NDA for a limited indication for obesity, which would include only men and women of non-child bearing potential. Their goal is to resubmit the QNEXA NDA in the fourth quarter of 2011.
Neurocrine Biosciences, Inc. (NASDAQ: NBIX) gave a pipeline update saying they expect to initiate Phase 3 trials of elagolix for endometriosis in 4Q 2011. Additionally, Phase 2 trials assessing elagolix in Uterine Fibroids are expected to start 3Q 2011. A Phase 2 trial of NBI-98854 for Tardive Dyskinesia patients is expected to be initiated during 3Q 2011. A larger, longer-term Phase 2b study is planned to be initiated in early 2012 to assess three-month dosing of NBI-98854. Their Phase 2 trial of Acute Decompensated Heart Failure is ongoing.
Exelixis, Inc. (Nasdaq:EXEL) announced that they expect to file their NDA for cabozantinib in MTC by the end of 2011 pending a successful outcome of the EXAM trial. They had previously announced that they expected to file their NDA during 2H 2011, so this subtle change in wording suggests a filing is more likely during 4Q rather than 3Q. As a result this catalyst has been shifted to 4Q 11 in the FDA Calendar.
MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) maintained previous guidance that they expect to file their NDA of LEVADEX for migraine this quarter.
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA), today announced it will raise approximately $16.1 million in a registered direct offering through the sale of 11,927,034 units, each unit consisting of (i) one share of common stock and (ii) one warrant to purchase 0.35 of a share of common stock, at a purchase price of $1.35 per unit. The warrants will be exercisable six months after issuance at $1.755 per share and will expire five years from the date of issuance. They also maintained previous guidance that they intend to refile their AZ-004 NDA during July 2011.
Neoprobe Corporation (NYSE Amex: NEOP), today announced top-line results from its Lymphoseek (tilmanocept) NEO3-09 study. The NEO3-09 study met all primary and secondary endpoints. Full data will be presented at ASCO. Their NDA filing is on track for 3Q11.
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) gave a pipeline update today and maintained previous guidance that they intend to initiate a Phase 2b study of LX4211 during 2Q 2011 for diabetes. They expect to complete enrolment of LX1032 for carcinoid syndrome during 2Q 2011 and releasing results shortly thereafter. An additional Phase 2 trial of LX2931 for rheumatoid arthritis is expected to be intiated 3Q 2011.
NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) said today that they remain on track to report top-line results from the Phase 3 REPLACE study of NPSP558 for hypoparathyroidism before the end of 2011. They also expect to file their NDA of GATTEX in short bowel syndrome during 2H 2011.
Incyte Corporation (Nasdaq:INCY) maintained that they intend to file their NDA and MAA during 2Q 2011. Enrollment continues in the dose-ranging Phase 2b trial in rheumatoid arthritis patients conducted by Lilly. The trial is expected to complete enrollment by 2H 2011. INCY also noted that they expect to complete tissue analyses of its Phase 2 trial of INCB7839 for HER2-positive breast cancer by mid 2011. This data will determine whether they initiate Phase 3 trials.