Key Developments: Progenics Pharmaceuticals Inc (PGNX.O)
3.91USD
22 May 2013
$-0.11 (-2.74%)
$4.02
$4.02
$4.15
$3.79
335,774
472,319
$11.00
$1.41
Latest Key Developments (Source: Significant Developments)
Faruqi & Faruqi, LLP Launches Investigation Against Progenics Pharmaceuticals Inc For Potential Breaches Of Fiduciary Duties By Board Of Directors
Juan E. Monteverde, a partner at Faruqi & Faruqi, LLP, a national securities firm headquartered in New York City, is investigating the Board of Directors of Progenics Pharmaceuticals, Inc. for potential breaches of fiduciary duties in connection with their conduct in seeking shareholders' approval for an increase in the number of available shares under the Company's 2005 Stock Incentive Plan. Specifically, in the Proxy Statement filed by the Company with the Securities and Exchange Commission on May 3, 2013, the Board of Directors recommends that Progenics` shareholders vote to approve an increase in the number of available shares under the Company's 2005 Stock Incentive Plan from 8,450,000 to 10,450,000. The issuance of the additional shares could have a substantial dilutive effect on the shares of Progenics common stock. Full Article
Progenics Pharmaceuticals Inc Announces Acquisition Of Molecular Insight Pharmaceuticals, Inc
Progenics Pharmaceuticals Inc announced that it has acquired Molecular Insight Pharmaceuticals, Inc., a clinical-stage private biotechnology company with a small molecule chemistry pipeline aimed at enhancing cancer treatment. Under the terms of the all-stock transaction, Progenics exchanged 4,566,210 shares of common stock (8.9% of the total outstanding post-transaction shares) for all of the outstanding shares of Molecular Insight, which will become a wholly owned subsidiary of Progenics. Molecular Insight has no debt. Progenics may make additional milestone payments to the former owners of Molecular Insight based on future commercial sales of the Company's compounds. No royalties are due to the former owners of Molecular Insight. Full Article
AstraZeneca PLC's MedImmune Announces Agreement With Progenics Pharmaceuticals, Inc. To Develop Therapies Against Serious Bacterial Infections
MedImmune, the global biologics arm of AstraZeneca PLC, announced that it has signed an in-licensing agreement with Progenics Pharmaceuticals, Inc. for Progenics' Clostridium difficile late-stage preclinical program. The agreement was led by MedImmune's Infectious Diseases & Vaccines Innovative Medicines (iMed) Unit. Financial details of the agreement were not disclosed. Full Article
Progenics Pharmaceuticals Inc Announces Pricing Of Public Offering Of Common Stock
Progenics Pharmaceuticals Inc announced the pricing of an underwritten public offering of 11,000,000 primary shares of its common stock at a public offering price of $2.00 per share. The gross proceeds from the sale of the shares, before underwriting discounts and commissions and other offering expenses, are expected to be approximately $22,000,000. The offering is expected to close on or about December 4, 2012, subject to customary closing conditions. Progenics also granted the underwriter a 30-day option to purchase 1,650,000 additional shares of common stock. All of the shares sold in the offering are being sold by Progenics, with the proceeds to be used for research and development and general corporate purposes. Jefferies & Company, Inc. is acting as sole book-running manager for the offering. Full Article
Progenics Pharmaceuticals Inc Announces Proposed Public Offering Of Common Stock
Progenics Pharmaceuticals Inc announced that it is offering to sell, subject to market and other conditions, shares of its common stock pursuant to an effective registration statement in an underwritten public offering. Progenics also intends to grant the underwriter a 30-day option to purchase additional shares of common stock. All of the shares to be sold in the offering are to be sold by Progenics, with the proceeds to be used for research and development and general corporate purposes. Jefferies & Company, Inc. is acting as sole book-running manager for the proposed offering. Full Article
CytoDyn, Inc. Announces Entry Into Agreement With Progenics Pharmaceuticals, Inc. To Acquire PRO 140
CytoDyn Inc. announced that the Company and Progenics Pharmaceuticals, Inc. (Progenics) have entered into an asset purchase agreement, effective as of July 25, 2012 (the Agreement), pursuant to which the Company intends to acquire from Progenics humanized monoclonal antibody HIV viral-entry inhibitor drug candidate, PRO 140 (PRO 140). The terms of the Agreement provide for an initial payment by the Company to Progenics in the amount of $3.5 million and subsequent payments conditioned on continued clinical development of PRO 140 and a royalty payment to Progenics based on net sales upon commercialization following final FDA approval. The closing of this transaction is currently expected to take place in the next 90 days, but is subject to the satisfaction of a number of closing conditions, including, among other matters: Progenics having received all required authorizations, consents and approvals of government authorities, Progenics having entered into and delivered intellectual property assignments, the Company and Progenics having entered into a transition services agreement, the Company having obtained the financing and raising of capital it needs in order to consummate the transactions contemplated by the Agreement; and the Company having completed and been satisfied with its continuing due diligence investigation of PRO 140. Full Article
Salix Pharmaceuticals, Ltd. And Progenics Pharmaceuticals, Inc. Receive Complete Response Letter From FDA For RELISTOR sNDA
Salix Pharmaceuticals, Ltd. and Progenics Pharmaceuticals announced that they received at approximately 5:00 p.m. ET a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) following its review of a Supplemental New Drug Application (sNDA) for RELISTOR (methylnaltrexone bromide) injection for subcutaneous use for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. The CRL requests additional clinical data. Salix and Progenics intend to request an End-of-Review meeting with the Division of Gastroenterology and Inborn Errors Products to better understand the contents of the CRL. RELISTOR is a peripherally acting mu–opioid receptor antagonist specifically designed to block the constipating effects of opioid pain medications in the gastrointestinal tract. RELISTOR does not cross the blood-brain barrier, therefore relieving the distressing effects of the constipation while retaining the analgesic effect of the opioid. RELISTOR Subcutaneous Injection has been FDA approved since 2008 to treat constipation in patients with advanced illness and receiving palliative care, when response to laxative therapy has not been sufficient. Full Article
Salix Pharmaceuticals, Ltd. And Progenics Pharmaceuticals Announce FDA Extension Of RELISTOR sNDA Goal Date To July 27, 2012
Salix Pharmaceuticals, Ltd. and Progenics Pharmaceuticals announced that the Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for the Agency’s review of the Supplemental New Drug Application (sNDA) for RELISTOR (methylnaltrexone bromide) injection for subcutaneous use for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. The FDA has notified Salix that it requires additional time for a full review of the submission and has extended the April 27, 2012 goal date by the standard extension period of three months. The extended user fee goal date is July 27, 2012. The extension requested no additional studies. RELISTOR is a peripherally acting mu-opioid receptor antagonist that counteracts the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain. Full Article
Salix Pharmaceuticals And Progenics Pharmaceuticals, Inc. Announces Positive Results Of Oral Methylnaltrexone For Phase 3 Trial In Chronic, Non-Cancer Pain Subjects With Opioid-Induced Constipation
Salix Pharmaceuticals and Progenics Pharmaceuticals, Inc. announced the outcome of the Phase 3 trial to evaluate the efficacy and safety of oral methylnaltrexone for the treatment of opioid-induced constipation (OIC) in subjects with chronic, non-cancer pain. This trial, evaluating three once-daily oral methylnaltrexone dosing regimens (150, 300 and 450mg), demonstrated statistically results for the primary endpoint in two of the three treatment arms when compared to the placebo treatment arm. Both the 300 and 450 mg treatment arms demonstrated statistically improvements in rescue-free bowel movement (RFBM) within 4 hours of administration over 28 days of dosing when compared to placebo treatment. In addition, the 300 and 450 mg treatment arms demonstrated statistically improvements in RFBM within 4 hours of administration following the first dose when compared to placebo treatment. Statistically efficacy was also seen in both the 300 and 450 mg treatment groups for the two key secondary efficacy endpoints including one assessing response (responder/non-responder) to study drug during Weeks 1 to 4 where responder is defined as having 3 or more RFBMs per week, with an increase of at least one RFBM per week over baseline, for at least 3 out of the first 4 weeks. Overall, efficacy of oral methylnaltrexone in this study was comparable to that reported in clinical studies of subcutaneous methylnaltrexone in subjects with chronic, non-cancer pain. Full Article
Progenics Pharmaceuticals, Inc. Announces Strategic Focus On Oncology
Progenics Pharmaceuticals, Inc. 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. The Company will focus on oncology, building on its PSMA ADC clinical program and its multiplex kinase inhibitor research program. The Company plans 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, which licensed rights earlier this year. The Company 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. Full Article
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