Transcept Jumps After Intermezzo Announcement; Progenics Announces Strategic Focus On Oncology Print E-mail
By Staff and Wire Reports   
Thursday, 15 September 2011 19:32

Below is a look at some of the headlines for companies that made news in the healthcare sector on September 15, 2011.

Transcept Pharmaceuticals, Inc. (NASDAQ:TSPT) saw 6,884,500 shares change hands, a 2,902% increase over its 65-day average volume. Company shares rose $2.66 or 79.6% to $6.00 after they announced plans to resubmit to the U.S. FDA its New Drug Application (NDA) seeking approval of Intermezzo (zolpidem tartrate sublingual tablet) for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

The plan to resubmit the Intermezzo NDA results from a meeting with the FDA during which the FDA generally agreed with a Transcept proposal to reduce the recommended Intermezzo dose for women from 3.5 mg to 1.75 mg, and to keep the recommended Intermezzo dose for men at 3.5 mg.

The Transcept proposal also includes new instructions stating that Intermezzo should only be taken if patients have at least 4 hours of bedtime remaining, and that patients should refrain from driving for at least 1 hour after arising and until 5 hours after dosing Intermezzo.

Transcept has surged more that 97% today and becomes the largest percentage gainer on the Nasdaq after reporting that it plans to resubmit its new drug application that will look for approval for its Intermezzo drug which is used to treat insomnia. The company has stated that it has already met with the U.S. Food and Drug Administration and agreed on reducing the recommended dose of the drug from 3.5 mg to 1.75 mg. The company stated that the FDA may finish its review of the drug within the next couple of months.

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Progenics Pharmaceuticals, Inc.  (NASDAQ:PGNX) announced strategic, operational, organizational and financial changes resulting from a review of its business. These changes will increase the focus and efficiency of the Company, reduce expenditures and build on the Company's strengths. Progenics will focus on oncology, building on its PSMA ADC clinical program and its multiplex kinase inhibitor research program. They plan to increase the financial resources and personnel it dedicates to these programs and will seek to in-license complementary opportunities in the oncology space.

The Company will discontinue its efforts in virology and infectious diseases and seek to out-license those programs. Progenics will reduce headcount by 38, or approximately 26%, of its staff. This reduction arises from the closing of the manufacturing facility, discontinuation of work in virology and infectious diseases, and the completion of development activities by the Company relating to RELISTOR. Development and commercialization activities and related expenses for RELISTOR have been assumed by Salix Pharmaceuticals, (NASDAQ:SLXP), which licensed rights earlier this year. 

Progenics will make changes in its management and governance processes to improve the timeliness and quality of its decision-making and to expedite the implementation of decisions once made. The Company estimates that annual expenses will be reduced by approximately $7.5 million as a result of these actions.


Also Thursday:



Abbott (NYSE: ABT) today was named one of the top 20 employers in Sciencemagazine's 2011 Top Biopharma Employers survey.

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that the company will participate in the Sixth Annual JMP Securities Healthcare Conference, being held in New York, New York, September 27 - 28, 2011.

Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced today that it will present at the UBS Global Life Sciences Conference on Tuesday, September 20, 2011 at 4:30 p.m. EDT (1:30 p.m. PDT).

Avanir Pharmaceuticals, Inc.(NASDAQ: AVNR) today announced that company management will participate in two upcoming investment conferences.

Easton Pharmaceuticals Inc (OTC:EAPH), a specialty pharmaceutical company that designs, develops, and markets a premium array of topically-delivered therapeutic healthcare products announced today the company has entered Into Discussions with 2 groups to distribute Viorra In South East Asia and surrounding markets.

EpiCept Corporation (Nasdaq: EPCT) today announced that its common stock will begin trading on the OTCQX® U.S. trading platform effective September 19, 2011.

Idera Pharmaceuticals (Nasdaq: IDRA) today announced that Sudhir Agrawal, D.Phil., Chairman and Chief Executive Officer, is scheduled to present at the UBS 2011 Global Life Sciences Conference in New York City on Wednesday, September 21st at 7:30 am ET.

Medtronic (NYSE: MDT) announced today it received a second clearance from the Food and Drug Administration (FDA) to treat adolescent idiopathic scoliosis (AIS) with pedicle screws.

Oramed Pharmaceuticals Inc. (OTC BB: ORMP.OB)
, a developer of oral delivery systems, announced today that Ehud Arbit, M.D., the Director of R&D at Oramed, is scheduled to present at the 8th Annual Israel Strategic Partner and Venture Conference.

Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company focused on developing and marketing products to treat medical conditions in inflammatory and cardiovascular disease areas and wound healing, announced today that C. Randal Mills, Ph.D., President and Chief Executive Officer, is scheduled to present at the 2011 UBS Global Life Sciences Conference on Wednesday, September 21, 2011 at 8:30 a.m. ET in New York City.

PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) today announced that it has paid the September 15, 2011, regular quarterly dividend payment of $0.15 per share to all stockholders owning shares of PDL as of September 8, 2011, the record date.

PediatRx Inc. ("PediatRx") (OTCBB: PEDX), a hospital specialty company with a current focus on oncology supportive care, today announced the appointment of Paul J. Richardson to its Board of Directors.

Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced that Sciencemagazine has ranked Regeneron as the #2 employer in the global biopharmaceutical industry in itsannual survey of Top Employers.

The board of directors of Abbott (NYSE: ABT) today declared a quarterly common dividend of 48 cents per share.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the New England Journal of Medicine (NEJM) published data from a Phase 3 study of INCIVEK™ (telaprevir) tablets in people with genotype 1 chronic hepatitis C who were new to treatment.




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