Thu, Nov. 5, 10:32 AM
- Thinly-traded nano cap Eyegate Pharmaceuticals (EYEG +68.1%) rockets up on a 13x surge in volume, albeit on turnover of only 220K shares, in response to its announcement of interim data on the effects of iontophoretic delivery of its EGP-437 ophthalmic solution on patients with macular edema.
- The data from the ongoing Phase 1b/2a study show that iontophoresis, a non-invasive process that uses low-level electrical current to deliver the drug, can deliver EGP-437 to the back of the eye. This potentially represents a significant route-of-administration advantage over an injection into the eye (e.g. Regeneron's (REGN) EYLEA).
- CEO Stephen From says, "The interim results of the trial are highly promising and suggest the ability of the EyeGate II Delivery System to deliver drug to the posterior segment of the eye....We look forward to additional data from the extension of this trial, which we expect in mid-2016." The extension phase, set to commence in December, will recruit an additional 15 patients with a modified dosing regimen, three days at the same iontophoretic dose.
Mon, Oct. 12, 8:38 AM
- Eli Lilly (NYSE:LLY) is down 10% premarket on robust volume in response to its announcement that it has terminated the development of evacetrapib for the treatment of high-risk atherosclerotic cardiovascular disease due to lack of efficacy. Its decision was based on a review by the independent data monitoring committee.
- The move will result in a Q4 charge to R&D expense of up to $90M ($0.05 per share after tax). The company will incorporate the change in its 2015 guidance that it will provide during its earnings call on October 22.
- SVP and President of Lilly Bio-Medicines David Ricks says, "We're obviously disappointed in this outcome, as we hoped the evacetrapib would offer an advance in treatment for people with high-risk cardiovascular disease. We'll be working with investigators to appropriately conclude these trials. We remain confident in our pipeline as we prepare for launches in other therapeutics areas with significant unmet needs."
- Related tickers and status premarket: (NASDAQ:REGN) +4%; (NASDAQ:AMGN) +3%; (NASDAQ:ESPR) +14%; (NYSE:SNY) +1%.
Tue, Oct. 6, 6:44 PM
- Leading pharmacy benefits manager Express Scripts (ESRX -1%) has settled an investor debate about which pricey cholesterol drug it will cover -- by saying it will cover both of them.
- Praluent, from Regeneron (REGN -2.9%) and Sanofi (SNY -0.7%), and Repatha, from Amgen (AMGN -1.8%), will both be included on Express Scripts' formulary. Each of the PCSK9 inhibitors is at least $14,000/year, significantly higher than the cost of now-generic statins, though more effective.
- The drugs are injectables that dramatically lower LDL (the "bad cholesterol").
- Express Scripts has said that the drugs won't be "budget busters," and that most prescriptions are getting rejected because patients don't meet medical criteria.
- In after-hours action: ESRX flat; REGN +0.1%; SNY +0.8%; AMGN flat.
Wed, Sep. 30, 12:49 PM
- Bruised and battered biotech investors get some welcome buying today as bargain hunters open their wallets. The iShares Nasdaq Biotech Index Fund (IBB +2%) is up nicely, albeit on average volume.
- Key tickers: (AMGN +1.6%)(BIIB +2.5%)(GILD +1%)(CELG +0.7%)(DEPO +12.4%)(HZNP +8.6%)(NVO +0.7%)(AGN +4.9%)(VRX +6.4%)(REGN +0.9%)(TEVA +2%)(SHPG +2.6%)
Sun, Sep. 27, 8:59 AM
- The $8B iShares Nasdaq Biotechnology ETF (NASDAQ:IBB) fell 4.9% on Friday and 13% for the week - its worst weekly performance since the height of the financial panic seven years ago. Many biotech ETFs eat the same cooking - Gilead (NASDAQ:GILD), Amgen (NASDAQ:AMGN), Biogen (NASDAQ:BIIB), and Regeneron (NASDAQ:REGN) among the popular names - and FBT, XBI, and BBP fell in amounts similar to IBB.
- The news flow was relatively quiet late in the week, but Hilary Clinton's promise Monday to clamp down on drug prices set things in negative motion for the momo sector.
- Barron's Chris Dieterich reminds that a flood of biotech IPOs in recent years has filled the small cap universe with these highly speculative names, and biotech now makes up 7% of the iShares Russell 2000 Index (NYSEARCA:IWM). Indeed. The IWM fell 3.7% for the week, nearly tripling the decline of the S&P 500.
- ETFs: IWM, TZA, TNA, UWM, VB, VBK, URTY, SCHA, TWM, IWO, RWM, SRTY, VTWO, RCG, JKJ, VTWG, TWOK, FYX, JKK, EWRS, ZSML, FYC, SMLL, RYRSX
Mon, Aug. 31, 7:53 AM
- The Medicines Company (NASDAQ:MDCO) jumps 20% premarket on average volume in response to development partner Alnylam's (NASDAQ:ALNY) announcement that its investigational RNAi therapeutic, ALN-PCSsc, lowered LDL-C (bad cholesterol) up to 83% with a mean maximum reduction of up to 64% (+-5%) in an early stage study, results comparable to Amgen's (NASDAQ:AMGN) Repatha (evolocumab) and Sanofi (NYSE:SNY) and Regeneron's (NASDAQ:REGN) Praluent (alirocumab). The data were presented at the ESC Congress in London.
- What's notable in this case is the difference in dosing regimens. ALN-PCSsc was administered in one subcutaneous dose that was effective for over 140 days, giving it the potential for once per quarter or twice per year administration. Praluent is dosed once every two weeks and Repatha once every two weeks or once per month at a higher dose.
- ALN-PCSsc turns off PCSK9 synthesis in the liver. This is a different mechanism of action compared to Praluent and Repatha, both of which bind to PCSK9 in the blood.
- The Medicines Company will take the lead in developing ALN-PCSsc under the ORION Program. A Phase 2 study will commence by the end of the year and a Phase 3 trial is planned for 2017. The clinical development will include comparisons to the anti-PCSK9 monoclonal antibodies.
- The companies will host a conference call this morning at 9:30 am ET to discuss the results and their development plan.
Fri, Aug. 14, 7:16 AM
- Based on additional analyses of the data from a Phase 2a clinical trial in wet age-related macular degeneration, Avalanche Biotechnologies (NASDAQ:AAVL) decides not to proceed to Phase 2b with its lead product candidate AVA-101. Instead, it will conduct further preclinical studies to clarify the optimal dose and delivery of AVA-101 and AVA-201 compared to standard-of-care anti-VEGF protein therapy before advancing the best candidate back into the clinic. The process should be completed by the end of the year.
- The company's decision shouldn't be a surprise. The stock plummeted 40% in June after the company reported less-than-expected results from the Phase 2a study.
- The value proposition of AVA-101, a gene therapy that contains a gene that encodes a naturally occurring anti-VEGF protein, is a single subretinal injection compared intravitreal (inside the eye) injections as frequent as once per month for Regeneron's (NASDAQ:REGN) Eylea and Roche's (OTCQX:RHHBY) Lucentis.
- Shares are down 14% premarket on light volume.
- Previously: Avalanche Bio plummets 40% after hours on less-than-expected AVA-101 data; chances dim for pick up by Regeneron (June 15)
Tue, Aug. 4, 9:20 AM
Tue, Aug. 4, 6:31 AM
Fri, Jul. 24, 3:48 PM| Fri, Jul. 24, 3:48 PM | 8 Comments
Fri, Jul. 24, 2:31 PM
- Esperion Therapeutics (NASDAQ:ESPR) has taken a dive, -20.4%, as the FDA approves Praluent (alirocumab), the competing cholesterol-lowering drug developed by Regeneron (NASDAQ:REGN) and Sanofi (SNY +0.2%).
- Praluent is the first cholesterol-lowering treatment in the PCSK9 inhibitor class.
- Esperion fell sharply in June in response to a positive FDA AdComm vote for Praluent, which stands to compete against Esperion's ETC-1002 cholesterol drug candidate (provided it's approved).
- Regeneron shares remain halted.
Mon, Jun. 15, 6:52 PM
- Relatively recent IPO Avalanche Biotechnologies (NASDAQ:AAVL) craters 40% after hours on robust volume in response to its announcement of top-line results from a Phase 2a study assessing its lead product candidate, AVA-101, in patients with wet age-related macular degeneration (wet AMD). The primary endpoint of the trial was safety, but secondary efficacy measures have apparently disappointed investors despite the study not being powered to show statistical significance.
- The trial enrolled 32 wet AMD patients at least 55 years old. They were randomized to receive AVA-101 (n=21) or control (n=11). Both arms received two ranibizumab injections [Roche's (OTCQX:RHHBY) Lucentis] at day 0 and week 4. Almost all (n=29/32) had received prior anti-VEGF therapy with a median of 10 prior injections.
- The mean change in best corrected visual acuity (BCVA) from baseline in the AVA-101 cohort was +2.2 letters compared to -9.3 letters for control. In addition, 42.9% of patients (n=9/21) receiving AVA-101 improved or maintained stable vision with two or fewer rescue injections compared to 9.1% (n=1/11) for control. BCVA improvement of at least 10 letters with no more than two rescue injections occurred in 23.8% of the AVA-101 arm versus 0% in control.
- The modest average letter gain for the AVA-101 arm is substantially less than published studies of Eylea and Lucentis, which have demonstrated mean improvements in BCVA scores of 18.9 letters and 14.2 letters, respectively. If the difference persists in subsequent studies, then Regeneron will be less likely to take advantage of its right of first negotiation for the rights to AVA-101.
- The value proposition of AVA-101, a gene therapy that contains a gene that encodes a naturally occurring anti-VEGF protein, is a single subretinal injection compared intravitreal (inside the eye) injections as frequent as once per month for Regeneron's (NASDAQ:REGN) Eylea and Roche's Lucentis.
Wed, Jun. 10, 10:25 AM
- Esperion Therapeutics (ESPR -24%) drops on a 3x surge in volume as investors apparently perceive more modest prospects for the company's cholesterol-lowering drug candidate, ETC-1002, after yesterday's positive Ad Comm vote for Regeneron (REGN -4.9%) and Sanofi's (SNY +0.7%) Praluent (alirocumab), which is now poised for approval sometime this summer.
- UBS analyst Andrew Peters remains undeterred. He maintains his Buy rating and $140 price target.
- Previously: Esperion cholesterol-lowering drug candidate successful in Phase 2 study (March 17)
Wed, Jun. 10, 8:41 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) slumps 4% premarket on light volume in response to yesterday's Ad Comm vote on its cholesterol-lowering med Praluent (alirocumab), co-developed with Sanofi (NYSE:SNY).
- The committee voted 13-3 in favor of approval, but only in combination with a statin or as monotherapy in patients who cannot tolerate statins. Ideally, the vote would have supported the use of alirocumab as unconditional monotherapy.
- SNY is up a fraction premarket on modest volume.
Tue, Jun. 9, 6:51 PM
- Regeneron (NASDAQ:REGN) has reopened for trading, up 1.1% to $532, after an FDA Ad Comm ruling in favor of its and Sanofi's Praluent (alirocumab) cholesterol-lowering drug.
- Shares had been halted since just before 7 a.m.
- The vote was 13-3. On Wednesday, the committee turns its attention to Amgen's (NASDAQ:AMGN) drug evolocumab.
- Sanofi estimates that 11M Americans might qualify for the drugs, which could run up to $10K/year in cost. Amgen estimates that 8M Americans might qualify.
Wed, May 20, 1:14 PM
- Thinly traded nano cap Lpath (LPTN -79.5%) craters on a massive 78x surge in volume in response to its announcement that its lead product candidate, iSONEP, failed to achieve its primary and key secondary efficacy endpoints in a Phase 2 trial in patients with wet age-related macular degeneration (wet AMD) who had not responded adequately to anti-vascular endothelial growth factor (VEGF) therapies such as Roche's (OTCQX:RHHBY -0.4%) Lucentis (ranibuzumab) or Avastin (bevacizumab) or Regeneron's (REGN +1.4%) Eylea (aflibercept).
- Patients treated with iSONEP, either alone or as an adjunct, did not show any statistically significant improvement in visual acuity.
- SVP and Chief Development Officer Dario Paggiarino, M.D., says, "This trial was designed to evaluate the activity of iSONEP in wet AMD patients that had previously received at least three prior injections of an anti-VEGF agent and had not responded well. While the primary endpoint of the trial was not met, we will be conducting a complete analysis of the data, including additional anatomical endpoints, to better understand the results from each arm of the trial."
- iSONEP is a monoclonal antibody that binds to a bioactive lipid called sphingosine-1-phosphate, a major regulator of vascular systems.
- Final results will be presented in November at the American Academy of Ophthalmology meeting in Las Vegas, NV.
- Related ticker: (PFE +0.4%)
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