Receptos Inc., of San Diego, priced its initial public offering (IPO) of 5.2 million shares of common stock at $14 per share, for a total raise of $72.8 million. The stock began trading on Nasdaq under the symbol "RCPT" Thursday, closing at $14. The funds will support clinical work in multiple sclerosis (MS), inflammatory bowel disease (IBD) and allergic/immune-mediated disorders. (See BioWorld Today, April 8, 2013.) The pricing hits pretty close to the $86.3 million target set when the

When is a drug compounder a manufacturer vs. a pharmacy? That's the question the Senate Health, Education, Labor and Pensions Committee grappled with Thursday as it closed in on a bill it can send to the Senate floor that would better regulate compounding pharmacies without opening a loophole around the drug approval process. The committee's draft bill proposes a new category of drugmakers, "compounding manufacturers," which would be subject to FDA regulation and user fees. Traditional

Researchers have identified a protein that can reverse cardiac hypertrophy, the thickening of the heart muscle that is one of the key features of diastolic heart failure. More generally, though the researchers have not specifically looked at life span yet, they said they believe that the protein in question may turn out to be a whole-body regulator of the aging process. The team published its findings in the May 10, 2013, issue of Cell. The authors identified the factor, GDF-11, with so

Exelixis Inc. , of South San Francisco, reported net revenues for the quarter ended March 31, 2013, were $9.7 million, compared to $18.5 million for the comparable period in 2012. The amount included $1.9 million resulting from the sale of Cometriq (cabozantinib), which became commercially available for the treatment of progressive, metastatic medullary thyroid cancer on Jan. 24, 2013. The quarterly decrease in non-product revenues was primarily due to $10.7 million in revenue recognized in

Osaka, Japan-based Takeda Pharmaceutical Co. Ltd. is gaining access to several key vaccine candidates targeted against major infectious diseases in the developing world such as dengue and hand, foot and mouth disease (HFMD), through its acquisition of Inviragen Inc., of Fort Collins, Colo. Takeda will pay $35 million up front and up to $215 million contingent on various clinical and commercial milestones. The transaction will be conducted through Takeda's wholly owned subsidiary Takeda America

Shares of Alexza Pharmaceuticals Inc. jumped 29 percent Wednesday after the firm disclosed a U.S. commercialization partner for recently approved Adasuve, a version of antipsychotic drug loxapine delivered via the company's Staccato technology. Mountain View, Calif.-based Alexza is picking up $40 million up front in the licensing and supply deal with Teva Pharmaceutical Industries Ltd. The big pharma will take over responsibility for post-approval studies and has the right to conduct additional

With Phase II trials on the runway for several forms of adult and pediatric cholestatic liver disease, a rare condition for which no therapy exists, Lumena raised $23 million in a Series A financing that is expected to get the company through those studies, after which the firm will deliberate the matter of whether to bring aboard a partner in the rare-disease effort. "These studies should read out in the second half of next year, and the funding will take us through the end of 2014," said Mike

Responding to drugmakers' growing interest in pediatric trials, the Biotechnology Industry Organization (BIO) is teaming up with the ViS Research Institute on a two-phase initiative to tackle the biggest challenge in conducting the trials – finding qualified sites that can recruit pediatric subjects. Using ViS' online analytics platform, the initiative is expected to reduce the barriers to global pediatric clinical research by helping drugmakers identify patients, enabling streamlined trial

Oncobiologics Inc. allied with Zhejiang Huahai Pharmaceutical Co. Ltd. to develop, manufacture and commercialize biosimilar monoclonal antibody products equivalent to Humira, Rituxan, Avastin and Herceptin in a rapidly expanding subsector which has reached $2.4 billion – a 20 percent increase from 2012. The products will be commercialized by Huahai and manufactured in China at a Huahai biologics facility for the China market. The companies will also establish a co-development and

Cardio3 BioSciences (C3BS) closed a €19 million ($25 million) investment round to fund an ongoing European Phase III trial of its stem cell therapy for ischemic heart failure, C-Cure. Just €7 million of the total represents new money, however. The remainder comprises an equity conversion of existing loans. The new cash comes from the company's existing investors. C3BS, of Mont-Saint-Guibert, Belgium, is developing a therapy that originated at the Mayo Clinic, in Rochester, Minn. C-Cure (formerly

Cell Medica Ltd., of London, treated its first patient in the ASPIRE Phase I/II trial of Cytovir ADV for adenovirus infection in immunosuppressed pediatric patients following bone marrow transplantation. The project is a collaboration between Cell Medica, UCL Institute of Child Health, and Great Ormond Street Hospital for Children, funded in part by a grant from the Technology Strategy Board, the UK's innovation agency. The trial will enroll up to 15 patients and is scheduled for completion in

Merck & Co. Inc., of Whitehouse Station, N.J., said the biologics license application (BLA) for its investigational ragweed pollen (Ambrosia artemisiifolia) sublingual allergy immunotherapy tablet was accepted for review by the FDA. Merck expects the review for this BLA, as well as a BLA for its Timothy grass pollen (Phleum pretense) sublingual allergy immunotherapy tablet, to be completed in the first half of 2014. The latest application is supported by five studies evaluating the efficacy and

Cellmid Ltd., of Sydney, Australia, is acquiring Japan's Advangen Inc. in a deal that includes purchase of the company's shares for JPY120M (AU$1.2M) in cash and the issuance of 55.7 million Cellmid shares (AX:CDY) at AU5 cents each. The shares will be subject to voluntary escrow agreements for up to 12 months. Advangen owns FGF-5 inhibitor hair growth technology, including natural extracts and novel compounds. Cellmid already markets évolis hair products, derived from the FGF-5 inhibitor

Ablynx NV, of Ghent, Belgium, initiated preclinical development of next-generation anti-IgE Nanobody ALX-0962 in severe allergic asthma. ALX-0962 consists of a potent anti-IgE Nanobody with a dual mode of action – the ability to bind with high affinity to IgE while also displacing receptor-bound IgE – together with a serum albumin binding Nanobody for in vivo plasma half-life extension. AmorChem, of Montreal, and InflammatorRx Inc., of Quebec City, said they launched a research collaboration

Aileron Therapeutics Inc., of Cambridge, Mass., completed the first-in-human study of its lead stapled peptide drug, ALRN-5281. The long-acting growth hormone-releasing hormone agonist is in development for orphan endocrine disorders such as adult growth hormone deficiency and HIV lipodystrophy and broader indications in metabolic and endocrine disease. The initial Phase I evaluated the safety and tolerability of single ascending doses of ALRN-5281 administered by subcutaneous injection in

Baxter International Inc., of Deerfield, Ill., said a Phase III study testing immunoglobulin did not meet the co-primary endpoints of reducing cognitive decline and preserving functional abilities in patients with mild to moderate Alzheimer's disease. Results, however, showed a positive, numerical difference in the change from baseline vs. placebo in cognition in a subgroup analysis, though the study was not powered to show statistical significance among subgroups. Based on those data, Baxter

Eisai Inc., of Woodcliff Lake, N.J., said the European Commission granted orphan drug designation to multityrosine kinase inhibitor lenvatinib for the treatment of follicular and papillary thyroid cancer. The product previously received orphan status in the U.S. and Japan. Lenvatinib is in Phase III testing in several indications, including thyroid cancer. In separate news, Eisai said it filed a Type II variation application with the European Medicines Agency for Halaven (eribuln), requesting