Today - Monday, July 6, 2015
- Newton, MA-based Chiasma (Pending:CHMA) is set for its IPO of 5.36M shares of common stock at $13 - 15.
- The late clinical stage biopharmaceutical firm develops oral forms of medications that are currently available only by injection through the leveraging of its proprietary Transient Permeability Enhancer (TPE) technology platform. Its lead product candidate is Orphan Drug-designated oral octreotide for the treatment of acromegaly, a condition where the body produces excess growth hormone. The company submitted its New Drug Application (NDA) to the FDA several weeks ago on June 15.
- 2014 Financials ($M): License Agreement Revenue: 13.2 (-82.0%); Operating Expenses: 15.0 (-56.6%); Net Loss: (2.9) (+45.6%); Cash Burn: (6.4) (-113.9%).
- In preparation for its uplisting to the Nasdaq Capital Market, BioRestorative Therapies (OTCQB:BRTX) reverse splits the number of it common shares 1:20 effective tomorrow. The stock symbol will be "BRTXD" for 20 days and then revert back to BRTX. The action will reduce the number of common shares from 54,387,963 to 2,719,399.
- Retrophin (NASDAQ:RTRX) closes the sale of its Rare Pediatric Disease Priority Review Voucher to Sanofi (NYSE:SNY) for $245M, payable via an upfront fee of $150M plus two additional payments of $47.5M, one in 2016 and the other in 2017.
- The voucher, which Retrophin acquired from Askepion Pharmaceuticals, can be sold or transferred an unlimited number of times. It shortens the FDA's review clock for a New Drug Application (NDA) from 10 months to six, clearly valuable to drug makers.
- Previously: Retrophin bags $245M from Sanofi for priority review voucher (May 27)
- San Carlos, CA-based BioCardia (BCDA) is set for its IPO of 3,846,154 shares of common stock at $12 - 14.
- The clinical stage regenerative medicine firm develops novel therapeutics to treat cardiovascular diseases. Its lead product candidate is the CardiAMP Cell Therapy System (CardiAMP), a comprehensive treatment that uses the patient's own cells to treat ischemic systolic heart failure, which is heart failure that develops after a heart attack. CardiAMP consists of a cell potency screening test, a point-of-care cell processing platform and a biotherapeutic delivery system. The entire process can be performed in 60 - 90 minutes and the patient can return home the same day.
- 2014 Financials ($M): Expenses: 7.2 (+3.1%); Net Loss: (10.2) (-84.8%); Cash Burn: (5.9) (-10.1%).
- In a regulatory filing, Zosano Pharma (NASDAQ:ZSAN) discloses that Novo Nordisk (NYSE:NVO) notified it that it will terminate their January 2014 collaboration to develop transdermal formulations of Novo's glucagon-like peptide (GLP-1) analogues. Novo's decision is based on its desire to focus on other priorities in its research portfolio. Once the agreement ends, all technology rights licensed to Novo will revert back to Zosano.
- There has been no after hours trading in ZSAN shares yet.
- Nano cap Oncolytics Biotech (ONCY +15%) is about to finish the session up nicely buoyed by an 8x surge in volume. Data were presented today at the ESMO World Congress on Gastrointestinal Cancer in Milan, Italy that showed treatment with Reolysin in combination with gemcitabine produced encouraging results in patients with pancreatic cancer when compared to treatment with gemcitabine alone.
- The Reolysin/gemcitabine regimen improved median progression-free survival, median overall survival as well as one-year and two-year survival rates compared to two earlier studies on gemcitabine as monotherapy. The overall disease control rate for the Reolysin group was ~83% (n=24/29).
- Vancouver, British Columbia, Canada-based ProNAi Therapeutics (Pending:DNAI) is set for its IPO of 6.7M shares of common stock at $14 - 16.
- The clinical stage biotech develops cancer therapeutics based on its proprietary DNA interference (DNAi) technology. Its lead product candidate is PNT2258, which targets an oncogene that plays a key role in programmed cell death (apoptosis) called BCL2. In a recent Phase 2 study, the disease control rate (DCR) in patients with relapsed/refractory non-Hodgkin's lymphoma who received PNT2258 was 85% (n=11/13). DCR includes complete responses, partial responses and stable (not progressing) disease). In addition, all four patients with diffuse large B-cell lymphoma who received PNT2258 experienced a clinical response, including three complete responses.
- 2014 Financials ($M): Operating Expenses: 22.6 (+463.7%); Net Loss: (73.7) (-487.7%); Cash Burn: (21.8) (-509.9%).
- Mesa Laboratories (MLAB -1.8%) acquires Markham, Ontario-based Infitrak for $12M CDN ($9.6M USD) plus a future contingent payment of up to $15M CDN ($12M USD). The deal will add ~$5.5M to Mesa's top line and will be accretive to earnings during the first 12 months.
- Infitrak focuses on "cold chain" services, a supply chain for temperature-sensitive products that provides an uninterrupted series of storage and distribution activities within a certain temperature range. Cold chains are used primarily in the pharmaceutical, healthcare and food industries.
- Aetna's (AET -5.7%) conference call this morning about its takeover of Humana (HUM +2.7%) apparently failed to excite investors. Shares are down on 4x higher volume.
- The market may perceive some antitrust risk in the deal. Humana is trading at $192 despite Aetna's bid of $230.
- Previously: Confirmed: Aetna to acquire Humana for $37B (July 3)
- Nano cap Enzon Pharmaceuticals (ENZN +17.4%) heads north on more than a 4x surge in volume. No particular news accounts for the action. Star investor Carl Icahn owns a stake, always a point of interest for coat-tailers.
- The company generates all of its revenues from royalties on seven marketed products that incorporate its Customized PEGylation Linker Technology: PegIntron, Sylatron, Macugen, CIMZIA, OMONTYS, Oncaspar and Adagen.
- Evercore ISI's Mark Schoenebaum says there is a 65% probability of success in the upcoming Phase 3 clinical trial evaluating Axovant Sciences' (AXON +0.7%) lead product candidate, RVT-101, in mild-to-moderate Alzheimer's disease (AD) patients. If successful, peak sales could reach $3.5B. If it fails, then AXON shares could lose 90% of their value. Just how Mr. Shoenebaum arrived at his precise prediction is unclear, but this is yet another superb example of the binary event nature of biotech investing. It's feast or famine.
- Axovant's story is interesting. It acquired RVT-101, a 5-HT6 inhibitor, from GlaxoSmithKline (GSK -1%) for a mere $5M. Fast forward to last month's IPO and the value of the company, based entirely on the potential of RVT-101, is almost $2B. This is a dramatic turnaround for a drug that failed four straight mid-stage trials about five years ago.
- The basis for the bullish outlook is the potential for RVT-101 to slow the rate of cognitive decline in AD patients. In an earlier study assessing the combination of RVT-101 and Pfizer's (PFE +0.2%) Aricept (donepezil), the rate of decline was lower than placebo. This is where Axovant will focus on its Phase 3 study, expected to yield results in H2 2017. Stoking the optimism are statements from the FDA that it will be more flexible in how it judges AD drugs in the future, after years of setbacks for drug developers.
- Related tickers: (OTCPK:ESALY) (OTC:ESALF)
10:49 AM| Comment!
- Thinly traded small cap Versartis (VSAR +19.5%) jumps on average volume in response to its announcement that the FDA removed the partial clinical hold on its 136-subject Phase 3 trial, called VELOCITY, assessing its lead product candidate, VRS-317, in pediatric patients with growth hormone deficiency. Patient recruitment can now proceed.
- Interim six-month height velocity data are expected by the end of 2016. Top-line data on 12-month mean height velocity are expected by mid-2017. If all goes well, FDA clearance could happen by late 2018.
- The primary endpoint of the study is non-inferiority of VRS-317 administered twice monthly to daily doses of Pfizer's (PFE +0.5%) Genotropin (somatropin [rDNA origin]) and Novo Nordisk's (NVO -0.3%) Norditropin (somatropin [rDNA origin]) as measured by 12-month mean height velocity.
- Believing the company's Medicare ops will outperform and that risk/reward is favorable, RBC has upgraded eHealth (NASDAQ:EHTH) to Outperform, and hiked its target by $2 to $16.
- The online health insurance provider is now up 49% from a March low of $8.81, albeit still down 76% from a March 2014 high of $54.91.
- An interim analysis of a Phase 2 study assessing ArQule's (ARQL -3.1%) lead product candidate, tivantinib, in combination with Erbitux (cetuximab), in patients with MET-High, KRAS wild-type metastatic colorectal cancer who recently progressed on anti-EGFR therapies showed a 52.4% disease control rate (DCR). The data were presented at the European Society of Medical Oncology World GI 2015 meeting in Milan, Italy.
- In 21 patients enrolled in the first stage of the trial, one experienced a complete response (CR), two experienced durable partial responses (PRs) and eight showed stable disease (SD). The DCR was, therefore, 52.4% (n=11/21). 20 additional patients were enrolled in the second stage.
- The primary endpoint of the trial is objective response rate (ORR) in the biomarker defined population. ORR frequently correlates with overall survival (OS) benefit.
- Final results from the complete 41-patient study are expected by the end of the year.
- Related tickers: (BMY +0.2%)(LLY -0.2%)
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