Mon, Nov. 7, 4:03 PM
Mon, Oct. 10, 12:45 PM
Mon, Sep. 12, 4:03 PM
Wed, Jul. 27, 9:23 AM
Mon, Jul. 18, 4:18 PM
- PSivida (NASDAQ:PSDV) announces that it is implementing a site consolidation plan whereby all of its R&D and product development will be conducted at a single location. It intends to close its Malvern, U.K. site and locate all of the functions at its Watertown, MA facility.
- The company says the move will save $900K a year in pre-tax operating expenses beginning in calendar Q4. It will book ~$680K in charges related to the plan.
Tue, Jul. 5, 11:16 AM
- Thinly traded micro cap pSivida (PSDV +5.4%) bucks the market's bearishness. Shares are up on average volume (only ~23K shares so far) in response to its announcement of positive results from preclinical animal studies assessing the effectiveness of a sustained-release insert based on its Durasert technology to deliver a tyrosine kinase inhibitor (TKI) for the treatment of wet age-related macular degeneration (wet AMD).
- The data showed the TKI insert was similar in efficacy to an injection of an FDA-approved AMD biologic in preventing choroidal neovascularization (formation of new blood vessels) and reducing vascular leakage.
- Based on the encouraging results, the company intends to advance the Durasert TKI insert into clinical development.
- TKIs are currently used to treat cancer, but some inhibit a growth factor called PDGF (platelet-derived growth factor) which plays a key role in blood vessel formation. The TKI used by pSivida inhibits both PDGF and VEGF (vascular endothelial growth factor). AMD meds Lucentis (ranibizumab) and Eylea (aflibercept) are both VEGF inhibitors. In cancer, TKIs are taken orally because systemic administration is too toxic. PSivida's approach aims to deliver a TKI dose directly to the retina that is 1,000 times less that the dose used to treat cancer.
- Related tickers: (OTCQX:RHHBY -1.5%)(REGN -0.5%)
Tue, May 31, 12:50 PM
Tue, May 31, 11:00 AM
Fri, May 27, 12:45 PM
Fri, May 27, 11:00 AM
Thu, May 5, 4:32 PM
- pSivida (NASDAQ:PSDV): FQ3 EPS of -$0.15 beats by $0.05.
- Revenue of $0.32M (-3.0% Y/Y) misses by $0.18M.
Mon, Feb. 8, 4:02 PM
- pSivida (NASDAQ:PSDV): FQ2 EPS of -$0.18 misses by $0.03.
- Revenue of $0.53M (+1.9% Y/Y) misses by $0.45M.
Thu, Jan. 7, 8:24 AM
- PSivida (NASDAQ:PSDV) prices its public offering of 4M shares of common stock at $4 per share. Underwriters over-allotment is an additional 440K shares. Closing date is January 12.
- Yesterday's close was $4.13.
Wed, Jan. 6, 6:28 PM
- Biotech pSivida Corp. (PSDV -7.8%) is compounding today's losses after hours, down another 6.8%, after news that it's planning a public offering of shares.
- The company had no further details about the underwritten offering, so size and terms are as yet unknown, as is when it might take place.
- Ladenburg Thalmann and Northland Securities are joint book-runners.
- The company specializes in developing sustained-release drug delivery products to address eye disease.
- Previously: Medidur marketing app in Europe accelerated, pSivida expects to file in H2; shares up 12% premarket (Dec. 28 2015)
Dec. 28, 2015, 7:44 AM
- PSivida (NASDAQ:PSDV) is up 12% premarket on light volume in response to its announcement that it plans to file its Marketing Authorization Application (MAA) in Europe in H2 2016 seeking clearance for Medidur for the treatment of posterior uveitis. The accelerated time line was enabled by the highly statistically significant results in the first Phase 3 trial reported last week.
- The UK Medicines and Healthcare Products Regulatory Agency (MHRA) advised the company that its application could be based on compelling results from one study as allowed under the Points to Consider of the European Agency for Evaluation of Medicinal Products. The MHRA provided its guidance in the formal minutes from an October 29 meeting with pSivida.
- Results from the trial showed that patients receiving Medidur experienced a significant reduction in the recurrence of posterior uveitis at six months compared to a sham injection (18.4% vs. 78.6%; p<0.00000001).
- Medidur is an injectable micro insert designed for the long-term treatment of posterior uveitis by providing sustained release flucinolone acetonide, a corticosteroid, for three years.
- Previously: Phase 3 study shows pSivida's Medidur effective in preventing recurrence of posterior uveitis; shares up 37% premarket (Dec. 22)
Dec. 22, 2015, 12:45 PM