|Repligen Falls After Response Letter from FDA; Alexza Announces Resubmission of ADASUVE NDA|
|By Staff and Wire Reports|
|Friday, 22 June 2012 18:41|
Shares of Repligen (NASDAQ: RGEN) are seeing increased weakness during Friday's trading session after the company received a complete response letter from the U.S. Food and Drug Administration.
The CRL from the FDA was regarding Repligen's New Drug Application for RG1068 (synthetic human secretin). RG1068 was evaluated in a Phase 3 study to improve detection of pancreatic duct abnormalities in combination with MRI in patients with known or suspected pancreatitis.
The CRL indicates that the FDA has completed its review of the RG1068 NDA and has determined that additional clinical efficacy and safety trial data will be required to support potential approval of the NDA. There were no specific safety concerns cited in the CRL, although safety will continue to be monitored in conjunction with any future clinical trial. No deficiencies were cited in the CRL with respect to the manufacturing, pharmacology or toxicology sections of the NDA.
“We will continue to engage in dialogue with the FDA to determine the design and scope of a clinical program that will address the agency's requirements for approval of RG1068,” said Walter C. Herlihy, Ph.D., President and Chief Executive Officer of Repligen. “We believe that RG1068, if approved, will provide a safe and effective means to non-invasively image the pancreas with MRI and will meet an important unmet medical need for patients with pancreatitis.”
Currently, shares of Repligen are trading down about 8.5 percent at $4.00 per share.
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced it has resubmitted its ADASUVE New Drug Application (NDA) to the U.S. FDA in response to a Complete Response Letter (CRL) received in May 2012. ADASUVE is being developed for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
In the coming weeks, Alexza expects to hear from the FDA regarding the completeness of the resubmitted NDA, the classification of the resubmission (Class 1 or Class 2) and what the new Prescription Drug User Fee Act (PDUFA) goal date will be. Class 1 and Class 2 resubmissions have targeted review periods of 2 months and 6 months, respectively.
Accelr8 Technology Corporation (NYSE MKT: AXK) announced results of two studies that it presented at the 112th annual General Meeting of the American Society for Microbiology (www.asm.org).
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the European Commission has granted marketing authorization for ferumoxytol, an intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD).
Biodel Inc. (NASDAQ: BIOD) today announced thatit has entered into a definitive securities purchase agreement with a group of institutional investors, including both existing and new investors, for the private placement of approximately 7.9 million shares of its capital stock and warrants to purchase approximately 2.7 million shares of its common stock.
BIOLASE, Inc. (NASDAQ: BIOL), the World's leading dental laser manufacturer and distributor, announced today that there is no fundamental reason for the recent decline in stock price on the NASDAQ exchange.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that people with HER2-positive metastatic breast cancer (mBC) lived significantly longer (overall survival) when treated with the combination of Perjeta™ (pertuzumab), Herceptin® (trastuzumab) and docetaxel chemotherapy, compared to Herceptin and docetaxel chemotherapy alone in the Phase III CLEOPATRA study.
GTx, Inc. (Nasdaq: GTXI) announced today that it is sponsoring at the MASCC/ISOO 2012 International Symposium, a panel presentation on “Muscle Wasting in Non-Small Cell Lung Cancer Patients: A New Scientific Approach to Management.”
iMedicor (OTCQB: VMCI) (PINKSHEETS: VMCI) today announced its success in assisting Hamilton Dental Associates (HDA), based in Hamilton Township, New Jersey and comprising 34 dentists, with their adherence to Meaningful Use guidelines and receipt this month of Federal Electronic Health Record (EHR) Incentive Funds.
NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) and Takeda Pharmaceutical Company Limited (TSE:4502, “Takeda”), jointly announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product teduglutide (tradename in Europe: Revestive®) as a once-daily treatment for adult patients with short bowel syndrome (SBS).
Nuvonyx, Inc. (PINKSHEETS: NVNX) announced today a partnership with California Plant Company to launch a retail marketing campaign that will offer free Aloe plant by mail with purchase of one of our qualifying product lines.
Repligen Corporation (NASDAQ:RGEN) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for RG1068 (synthetic human secretin).
Rosetta Genomics (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostic assays, today announced that the Company has entered into an agreement and release (the "Release Agreement") with the holders of the $1,750,000 senior secured debenture (the "Debenture") the Company sold and issued on January 27, 2012.
Tanke BioSciences Corporation (OTCQB: TNBI), a China-based integrated biotech company that develops, manufactures, and markets animal feed additives and livestock nutritional products, today announced it will be sponsoring the Fifth Biannual International Symposium on Feed Additive, Animal Nutrition & Health, June 24 and 25, at the Dragon Lake Princess Hotel in Guangzhou, China.
With epidemic levels of whooping cough reported in the state of Kansas and creating the need for more immunizations resources, Walgreens (NYSE, NASDAQ: WAG) is offering immunizations that provide protection against the highly-contagious respiratory infection (tetanus/diphtheria/pertussis-Tdap vaccine) at all of its 67 locations in Kansas and 195 drugstores in Missouri.