Tuesday, January 29, 2019
Stryker sees FY19 EPS $8.00-$8.20, consensus $8.01
https://thefly.com/landingPageNews.php?id=2855465
Conatus gains on publication of NASH med data
Conatus Pharmaceuticals (NASDAQ:CNAT) is up 6% premarket on light volume on the heels of the publication of results from three previously reported mid-stage studies of lead drug emirasan in NAFLD/NASH, portal hypertension and liver cirrhosis.
Three Phase 2b studies are in process with collaboration partner Novartis: ENCORE-NF (NASH) (topline data expected in H1); ENCORE-PH (portal hypertension) (clinical outcome data expected mid-year) and ENCORE-LF (liver function) (topline data expected mid-year).
OncoCyte gains on positive results of cancer detection test
OncoCyte Corp. OCX, +223.93% more than doubled in very active premarket trade Tuesday, after the developer of cancer detection tests reported positive results from its validation study of its DetermaVu liquid biopsy test for lung cancer. The stock ran up 104% on volume of about 820,000 shares, compared with the full-day average volume of about 30,350 shares. The company said the DetermaVu study demonstrated sensitivity of 90%, which is the percentage of malignant nodules that are correctly identified, and specificity of 75%, which is the percentage of benign nodules correctly identified. “These results show that DetermaVuTM significantly exceeds the critical parameters necessary for use in lung cancer diagnosis and that DetermaVu clearly outperforms reported results from competitors’ tests and other clinical models,” OncoCyte said in a statement. “DetermaVu™ has the potential to dramatically reduce U.S. healthcare costs by billions of dollars each year by eliminating unnecessary biopsies, which, according to a recent Medicare study, cost on average $14,634 each.” The company expects DetermaVu to be commercially available in the second half of 2019. The stock has tumbled 54% over the past 12 months through Monday, while the S&P 500 SPX, -0.15% has lost 7.4%.
Zynerba gains on data
Cannabinoid therapeutics developer Zynerba Pharmaceuticals (ZYNE+37.5%) is up on more than a 7x surge in volume in early trade as shares break out from near-term consolidation.
Topline data from its Phase 2/3 CONNECT-FX study evaluating ZYN002, a cannabinoid transdermal gel, in patients with Fragile X syndrome should be available in H2 (corp. presentation, slide #4).
On the working capital front, at the end of September 2018, it had $66.2M in cash and equivalents while operations consumed $26.2M during the first three quarters of the year.
Neurocrine and Voyager Team on Huge Deal for Gene Therapy in Parkinson’s
Shares of Voyager Therapeutics have skyrocketed more than 43 percent in premarket trading after the company announced it had forged a collaborative deal to develop a gene therapy treatment for Parkinson’s disease with San Diego-based Neurocrine Biosciences.
Neurocrine’s R&D deal covers Voyager’s gene therapy programs, VY-AADC for Parkinson’s disease and VY-FXN01 for Friedreich’s ataxia, as well as rights to two programs that have yet to be determined. The collaboration will combined Neurocrine Biosciences’ expertise in neuroscience, drug development and commercialization with Voyager’s innovative gene therapy programs targeting severe neurological diseases.
Kevin Gorman, chief executive officer of Neurocrine, said the collaboration with Voyager has the potential to develop beneficial therapeutics for people with serious neurological disorders.
“The partnership with Voyager allows us to expand our clinical development pipeline addressing neurological disorders, leverage Voyager’s expertise in CNS-focused gene therapy, and develop potential treatments for diseases, such as Parkinson’s disease and Friedreich’s ataxia, which have significant unmet clinical needs,” Gorman said in a statement.
Andre Turenne, president and CEO of Voyager, said Neurocrine is an ideal partner and has “proven expertise” in the development of therapies for people with movement disorders and other neurological diseases. The collaboration with Neurocrine will enhance the company’s efforts to become the leading “fully-integrated gene therapy company focused on severe neurological diseases,” he added.
Under terms of the agreement, Neurocrine provided Voyager with $165 million in an upfront payment, along with funding for ongoing development of each program. If developmental, regulatory and commercial milestones are hit, Voyager could snag up to $1.7 billion.
The collaborative deal primarily focuses on two assets. VY-AADC is an investigational gene therapy product. According to Voyager, the therapy is designed to deliver the AADC gene directly into neurons of the putamen where dopamine receptors are located. This bypasses the substantia nigra neurons and enables the neurons of the putamen to produce the AADC enzyme to convert levodopa into dopamine. Voyager said this approach provides the potential to “durably enhance the conversion of levodopa to dopamine and provide clinically meaningful improvements by restoring motor function in patients and improving symptoms following a single administration.”
After the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation for VY-AADC for the treatment of Parkinson’s disease in patients with motor fluctuations who are refractory to medical management, Voyager initiated a Phase II trial. The mid-stage RESTORE-1 trial is aimed at patients who have been diagnosed with Parkinson’s disease for at least four years, are not responding adequately to oral medications, and have at least three hours of OFF time during the day.
As part of the deal, Neurocrine will fund the clinical development of the Phase II and III VY-AADC program. After the data readout of the RESTORE-1 trial, Voyager has the option to either co-commercialize VY-AADC with Neurocrine Biosciences in the U.S., or grant Neurocrine full global commercial rights in exchange for milestone payments and royalties based on global sales.
Neurocrine will also fund Phase I development of the gene therapy treatment for Friedreich’s ataxia, a rare inherited neurological disease caused by mutations in the frataxin gene, which results in severe sensory impairment, progressive loss of the ability to walk, generalized weakness, and loss of sensation, as well as severe and potentially fatal cardiomyopathy.
Thermo Fisher to sell Anatomical Pathology line to PHC Holdings for $1.14B
PHC Holdings Corporation announced that it has signed a definitive agreement with Thermo Fisher Scientific to acquire Thermo Fisher’s Anatomical Pathology business for approximately $1.14B. Thermo Fisher’s Anatomical Pathology business is one of the leading providers of microscope slides, instruments and consumables in the industry and is part of Thermo Fisher’s Specialty Diagnostics Segment, operating in the US, Europe and China with approximately 1,200 employees. PHCHD currently expects to close the transaction in the second quarter of 2019, subject to customary closing conditions and the receipt of applicable regulatory approvals. Thermo Fisher expects the net dilution to 2019 adjusted earnings per share to be approximately 10c, which will be incorporated into its 2019 financial guidance that will be provided on the January 30 earnings conference call.
Seattle Genetics label expansion likely to drive Q4 beat, says Piper Jaffray
Piper Jaffray analyst Joseph Catanzaro says the question of whether Q4 is an easy beat for Seattle Genetics’ Adcetris has been raised after the drug received a label expansion in mid-November to include the E-2 first-line peripheral T-cell lymphoma setting. The analyst expects the new label to contribute to a Q4 Adcetris beat as consensus estimates are largely unchanged since the news. However, how much and where 2019 guidance falls will point to expectations for E-2 moving forward, Catanzaro tells investors in a research note. He believes $137M-plus in Q4 sales and 2019 guidance of $660M-plus “would be very positive numbers” for Adcetris. The analyst keeps a Neutral rating on Seattle Genetics with a $66 price target.
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