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Mon, Oct. 20, 8:27 AM
- In two Phase 2a clinical trials, privately-held Genervon Biopharmaceuticals' drug candidate for Amyotrophic Lateral Sclerosis (ALS), GM6 (known as GM604 in the ALS trial and GM608 in a Parkinson's disease study), showed encouraging disease-modifying results albeit in a small number of patients.
- In the ALS study, GM604 significantly reduced the decline in ALSFRS-R versus the historical control (p=0.0047). Seven of eight patients has their ALS disease progression slowed or stopped at week 12 after six doses of GM604. Five of seven treated patients had their forced air capacity (FVC) disease progression slowed or reversed at week 12 compared to historical placebo (-11.5% compared to -4.7% after treatment).
- In the Parkinson's study, the difference in the treated patients' UPDRS scores versus historical placebo at week 12 were statistically significant (p=0.0085). Changes in secondary clinical outcomes measures at week 2 were statistically significant at the one-tailed 10% level for four of eight patients.
- Genervon has submitted these results to the FDA for guidance on how to make GM6 available for ALS and PD patients. GM604 for ALS has been designated Fast Track and an Orphan Drug by the FDA.
- ALS-related tickers:(NYSEMKT:CUR) (NASDAQ:BCLI) (NASDAQ:MNOV) (NASDAQ:BIIB) (NASDAQ:CYTK)
- PD-related tickers: (NASDAQ:ACOR) (Pending:CVTS) (NASDAQ:ACAD) (OTCQX:CYNAF) (NASDAQ:IPXL) (OTCQB:TTNP) (OTCQB:SGTH) (NYSE:TEVA) (NASDAQ:ADMS) (NASDAQ:PRAN) (NASDAQ:CHTP) (NASDAQ:PRTA) (NASDAQ:FOLD) (NASDAQ:AVNR) (NYSE:BSX) (NYSE:MRK)
Thu, Oct. 9, 12:46 PM
Thu, Oct. 9, 9:46 AM
- Impax Laboratories (IPXL +13.9%) acquires Tower Holdings, including operating subsidiaries CorePharma LLC and Amedra Pharmaceuticals LLC, and Lineage Therapeutics for $700M in cash. The privately-held companies specialize in the development, manufacture and commercialization of complex generic and branded pharmaceuticals.
- The transaction is expected to add $0.90 to Impax's 2015 EPS.
Tue, Oct. 7, 10:28 AM
Wed, Aug. 6, 10:31 AM
- Impax Laboratories (IPXL +1.3%) Q2 results: Revenues: $188.1M (+45.1%); Gross Profit: $109.8M (+86.4%); Operating Expenses: $55.8M (+5.1%); Operating Income: $53.9M (+829.3%); Net Income: $35.1M (+526.8%); EPS: $0.50 (+525.0%); Quick Assets: $413.0M; CF Ops: $12.4M (-92.7%).
- 2014 Guidance: Adjusted gross margins: upper 50% range versus mid-50% range; R&D expenses: $82M - 88M; SG&A expenses: $115M - 120M; CAPEX: $40M - 45M.
Wed, Aug. 6, 7:31 AM
Tue, Aug. 5, 5:30 PM
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Mon, Aug. 4, 8:47 AM
- The FDA reinspected Impax Laboratories' (NASDAQ:IPXL) Hayward, California manufacturing facility from June 16 to July 31, 2014. In its Form 483, it cited seven observations, two of which were repeat observations. When inspectors note a deficiency for a second time, it usually precipitates a warning letter.
- Impax shares were smacked down on July 29 after regulators inspected its Taiwan manufacturing facility and cited numerous GMP deficiencies.
Tue, Jul. 29, 3:53 PM
- Shares of Impax Laboratories (IPXL -14.6%) plunge on a 7x surge in volume after an FDA inspection of its Taiwan manufacturing facility. The site makes 12 products for U.S. distribution and will produce Ryatary, the firm's drug candidate for Parkinson's disease.
- The inspection notes contain numerous references to GMP violations. Investors perceive that the deficiencies could jeopardize the company's product supply.
Tue, Jul. 29, 12:47 PM
Mon, May. 5, 4:46 PM
- The U.S. District Court for the District of Delaware rules in favor of Avanir Pharmaceuticals (AVNR +1.5%) in its patent infringement case against Par Pharmaceuticals and Impax Laboratories (IPXL -1.3%) regarding their ANDAs for generic versions of Nuedexta.
- The judge upheld the validity of patents '282 and '484 and ruled the proposed formulations infringe on both of them.
- Nuedexta is the only FDA-approved product for the treatment of pseudobulbar effect. Based on the court's decision, the product has 12 years of market exclusivity remaining.
Thu, May. 1, 4:28 PM
Wed, Apr. 30, 5:35 PM
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Mon, Apr. 21, 5:24 PM
Wed, Apr. 16, 9:46 AM
- Impax Laboratories' (IPXL) +1.8%) Global Pharamaeuticals division launches its generic version of Genzyme's (SNY +0.2%) Renvela (sevelamer carbonate).
- The company will sell a specific allotment of bottles granted under a license from Genzyme. Impax's aNDA for the product is currently under regulatory review.
- The U.S. Renvela market is ~$900M.
Fri, Apr. 11, 7:46 AM
- Impax Pharmaceuticals (IPXL) resubmits its NDA for RYTARY (IPX066), an extended release formulation of carbidopa and levodopa for the treatment of Parkinson's disease. The resubmission includes updated information on the product's safety and stability.
- The FDA sent the company a CRL in January citing the need to re-inspect its manufacturing facility subsequent to a May 2011 warning letter.
- Consensus estimates for Q1 and Q2 are earnings of $0.04/share on revenues of $108.7M and earnings of $0.26/share on revenues of $145.5M, respectively.
- Consensus views for 2014 and 2015 are earnings of $0.68/share on revenues of $536.5M and $0.88/share on revenues of $566.5M, respectively.
- 350 mutual funds have positions, up from 315 a year ago.
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Impax Laboratories, Inc., is a technology-based, specialty pharmaceutical company focused on the development and commercialization of bioequivalent and brand-name pharmaceuticals, utilizing its controlled-release and other in-house development.
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