Healthcare News

  • Today - Friday, January 18, 2019
    • Immunomedics (IMMU -26.4%) is currently trading ~16% above the intraday low of $11.57 as bargain hunters move in after shares plummeted in reaction to the FDA's rejection of its marketing application seeking approval for antibody-drug conjugate (ADC) sacituzumab govitecan for triple-negative breast cancer (TNBC).
    • The company says the CRL cited issues with Chemistry, Manufacturing and Controls (CMC), adding that no additional clinical or preclinical data are needed. It plans to meet with the agency as soon as possible to clarify what needs to be done to support a refiling.
    • Uber-bull H.C. Wainwright (BUY/$10) says today's drop in Thyme Technologies (TYME -37.5%) is a "buying opportunity." Shares dropped as much as 46% after the company announced mid-stage SM-88 survival data in advanced pancreatic cancer that failed to withstand scrutiny.
    • Bargain hunters have moved in, though. Shares are currently exchanging hands at ~17% above the intraday low of $2.00. Volume is six times normal.
    • A study just published in JAMA Open Network conducted by researchers at Brown University found a strong link between the amount spent on marketing by opioid manufacturers and the number of prescriptions written by doctors, leading to a rise in opioid overdose deaths.
    • Specifically, when drug makers increased their marketing spend by $5.29/1,000 population the number of opioid prescriptions jumped 82% which led to a 9% rise in opioid-related deaths a year later (time period analyzed: August 1, 2013 - December 31, 2015).
    • The DEA's Jordan Trecki cautions that prescription opioids are only part of the opioid crisis since many deaths result from the abuse of illegal drugs like heroin and illicitly produced fentanyl. FDA-approved painkillers account for ~40% of opioid overdoses.
    • Selected tickers: ENDP, MNK, OTCPK:INVVY, OTCPK:RBGLY, JNJ, INSY, OTCQB:ELTP, OPNT, AGN, TEVA, ABBV, ALKS, AMPH, COLL, PTIE, OTC:ACUR, PTX, ACRX, IPCI, KMPH, TRVN, CXW, BDSI, MYL, PRGO, ASRT, NKTR, XLV
    • Thinly traded Kura Oncology (KURA +3.4%) is up on light volume following its announcement that lead candidate tipifarnib may be effective in treating certain pancreatic cancer patients based on a retrospective analysis of a previously conducted Phase 3 study called INT-11. Specifically, patients with lymph node or liver metastases and those with no abdominal pain appear most likely to benefit. The data are being presented at the ASCO GI Cancers Symposium in San Francisco.
    • INT-11 enrolled 688 pancreatic cancer patients. Its primary objective was evaluating the effectiveness of tipifarnib + chemo agent gemcitabine compared to gemcitabine + placebo. Treatment with tipifarnib failed to show enough of an effect on overall survival (OS) in the overall population but did demonstrate longer median OS in patients with no abdominal pain (n=155) with 48% less risk of death (10.2 months vs. 5.9 months; hazard ratio = 0.52; p<0.0001). The company says the absence of abdominal pain may serve as a surrogate of clinical benefit in these patients.
    • Tipifarnib also showed a treatment effect in patients (n=67) with nodal or distant (liver only) metastases. Median OS in the nodal group was 12.8 months vs. 8.2 months in the gemcitabine + placebo arm with 54% less risk of death (hazard ratio = 0.46; p=0.01) and 10.2 months vs. 5.9 months with 30% less risk of death (hazard ratio - 0.70; p=0.02) in the liver metastases group. The cancer in both groups expressed high levels of a gene called CXCL12 which the company says tipifarnib downregulates.
    • Tipifarnib inhibits an enzyme called farnesyl transferase. Interfering with its function inhibits protein farnesylation, a key signaling process in cancer initiation and development. Farnesyl transferase inhibitors have shown particular promise in blocking HRAS (an oncogene) farnesylation.
    • Gainers: Cellectar Biosciences (NASDAQ:CLRB+13%. Rafael Holdings (NYSEMKT:RFL) +11%. EDAP TMS (NASDAQ:EDAP+9%. 22nd Century Group (NYSEMKT:XXII) +9%. Tocagen (NASDAQ:TOCA) +9%.
    • Losers: Tyme Technologies (NASDAQ:TYME) -35%. Immunomedics (NASDAQ:IMMU) -29%. Lexicon Pharmaceuticals (NASDAQ:LXRX) -22%. Biocept (NASDAQ:BIOC) -18%. Microbot Medical (NASDAQ:MBOT) -10%.
    • Eli Lilly (LLY -3%) has stopped promoting LARTRUVO (olaratumab) for the treatment of soft tissue sarcoma after a Phase 3 clinical trial failed to demonstrate a treatment benefit over standard-of-care chemo.
    • It will book a pretax charge of $70M - 90M this quarter as it works through what to do next. The action will trim EPS this year by ~$0.17.
    • The FDA approved the med over two years under accelerated review status based on Phase 2 data that showed a positive effect.
    • Zimmer Biomet Holdings (ZBH -1%) is under modest pressure in early trade in apparent response to a cautious report at independent equity research shop Cleveland Research.
    • Kindred Biosciences (KIN -8.2%) is down on almost double normal in early trade in response to its public offering of 4.215M shares of common stock at $9.50 per share. Underwriters over-allotment is an additional ~632K shares. Closing date is January 23.
    • Yesterday's close was $10.71.
    • Biocept (NASDAQ:BIOC) has entered into a securities purchase agreement to sell ~990K common shares a price of $2.25 in a registered direct offering.
    • Expected gross proceeds are ~$2.2M.
    • Closing date is January 23.
    • Shares are down 25% premarket.
    • Thinly traded nano cap EDAP TMS SA (NASDAQ:EDAP) is up 13% premarket on light volume following its announcement that it has sold a Focal One HIFU device to the Maimonides Medical Center in Brooklyn, NY. The product is used to treat prostate cancer.
    • Precision Therapeutics (NASDAQ:AIPT) CEO and Director Carl Schwartz has invested an additional $1M in the company, a $950K loan and the purchase of 78,125 common shares at $0.64 per share.
    • He also received additional warrants to purchase common stock.
    • Shares are up 3% premarket.
    • Can-Fite BioPharma (NYSEMKT:CANF) is down 8% premarket in response to its direct sale of 2,238,096 ADSs at $1.05/ADS to an institutional investor.
    • The investor will also receive 5 1/2-year warrants to purchase up to the same number of ADSs at $1.30.
    • Closing date is January 23.
    • Tyme Technologies (NASDAQ:TYME) slumps 48% premarket on light volume (so far) following its release of mid-stage data on SM-88 in patients with end-stage pancreatic cancer.
    • The company reported a survival benefit in a third-line setting but investors aren't buying it.
    • STATnews' Adam Feuerstein calls the company's press release "totally irresponsible," adding that the trial failed to show said survival benefit.
    • Results from an open-label Phase 2 clinical trial evaluating Tyme Technologies' (NASDAQ:TYME) SM-88 in patients with end-stage pancreatic cancer showed a treatment benefit. The data are being presented today at the ASCO GI Cancers Symposium in San Francisco.
    • Specifically, 68% (n=19/28) of evaluable patients with actively progressing end-stage pancreatic cancer who received SM-88 alone remain alive after median follow-up of 4.3 months.
    • 79% (n=11/14) of patients receiving SM-88 in a third-line setting remain alive after median follow-up of 4.7 months, more than twice as long as historical results.
    • The company plans pursue regulatory approval for third-line use.
    • SM-88 is a combination therapy that uses a proprietary dysfunctional tyrosine derivative to interrupt the metabolic processes of cancer cells, breaking down their defenses and making them vulnerable to oxidative stress and death.
    • Management will host a conference call this morning at 9:00 am ET to discuss the data.
    • Shares, currently halted, will resume trading at 8:30 am ET.
    • Previously: Tyme Tech up 16% ahead of data readout on SM-88 in pancreatic cancer (Nov. 26, 2018)
    • Bio-Path Holdings (NASDAQ:BPTH) executed a 1:20 reverse stock split after the close yesterday. Post-split trading commences today.
    • Update: Shares are up 15% premarket on modestly higher volume.
    • Aimmune Therapeutics (NASDAQ:AIMT) appoints Andrew Oxtoby as Chief Commercial Officer (CCO), effective, January 22.
    • Mr. Oxtoby joins Aimmune from Eli Lilly and Company, where he most recently had responsibility for its U.S. insulin business.
    • Nasdaq has suspended trading in Tyme Technologies (NASDAQ:TYME) pending the release of news. Shares were down 2% premarket when halted.
    • Lexicon Pharmaceuticals (NASDAQ:LXRX) slumps 23% premarket on light volume in reaction to yesterday's 8-8 split vote from a FDA advisory committee on sotagliflozin, making FDA approval highly uncertain.
    • Collaboration partner Sanofi (NASDAQ:SNY) is down 1% premarket.
    • CVS Health (NYSE:CVS) and Walmart (NYSE:WMT) have inked a new multi-year agreement under which latter will continue participating in the CVS Caremark pharmacy benefit management commercial and Managed Medicaid retail pharmacy networks.
    • Financial terms are not disclosed.
    • CVS is up 2% premarket.
    • Celgene (NASDAQ:CELG) inks a collaboration agreement with privately held Kyn Therapeutics aimed at developing treatments that target immunosuppressive metabolites, molecules that are upregulated in cancer.
    • Under the terms of the partnership, Kyn will receive $80M upfront, an equity investment from CELG, milestones and royalties on net sales. Kyn will be responsible for early-stage development through Phase 1b studies at which point CELG can opt in to lead subsequent development and commercialization.
    • Initially, CELG will have exclusive options to in-license Kyn's hydrocarbon receptor antagonist and kynurenine-degrading enzyme programs.
    • Aurora Cannabis (NYSE:ACBprices its 5.5% convertible senior notes due 2024 at par. The Company will issue $300M aggregate principal amount of notes, or $345M if the initial purchasers' over-allotment option is exercised in full.
    • The initial conversion rate will be 138.37 common shares per $1,000 principal amount of notes (~$7.23/share).
    • Net proceeds will be used to support its Canadian and international expansion initiatives, for general corporate purposes and working capital.
    • Closing date is January 24.
    • Shares are up 3% premarket.
    • Celgene (NASDAQ:CELG) will collaborate with privately held Obsidian Therapeutics on the discovery and development of cell therapies based on the latter's Destabilizing Domain (DD) technology.
    • Under the terms of the multiyear agreement, CELG will have the exclusive option to in-license global rights to the DD-based cell therapy candidates in oncology. Obsidian will receive an upfront payment, milestones and royalties on net sales. Specific financial terms are not disclosed.
    • Obsidian says its DD technology regulates the expression of the proteins interleukin-12 (IL-12) and CD40L which enables precise pharmacologic control of the safety and efficacy of the cell therapies.
    • AVROBIO (NASDAQ:AVRO) will begin a Phase 1/2 clinical trial for AVR-RD-04, for the treatment of cystinosis, following IND acceptance by FDA.
    • AVR‑RD-04 is designed as one-time gene therapy for the treatment of cystinosis by inserting the functional gene for human cystinosin (CTNS).
    • Cystinosis is a rare, genetic, lysosomal storage disease caused by the accumulation of the amino acid cystine which can lead to organ and tissue damage.
    • Update: Shares are up 11% premarket albeit on only 70 shares.
    • Noteworthy events during the week of January 20 - 26 for healthcare investors.
    • Sunday (1/20): Keystone Symposia on Integrated Pathways in NASH and NAFLD, Santa Fe, NM (5 days). Lipocine (NASDAQ:LPCN): LPCN 1144 data. Cue Biopharma (NASDAQ:CUE): Preclinical data on lead candidate CUE-101.
    • TUESDAY (1/22): Johnson & Johnson (NYSE:JNJ) Q4 earnings release. (Kicks off the earnings season for Big Biopharma and biotechs).
    • World Stem Cell Summit, Miami, FL (4 days). Marker Therapeutics (NASDAQ:MRKR): Corporate overview by CEO.
    • Annual Meeting of the Leipzig Interventional Course, Leipzig, Germany (4 days). Teleflex (NYSE:TFX): Showcase Manta Vascular Closure Device. InspireMD (NYSEMKT:NSPR): Showcase CGuard Carotid Embolic Prevention System.
    • THURSDAY (1/24): Anixa Biosciences (NASDAQ:ANIX): Conference call on 2019 plan including its Cchek cancer test.
    • Eli Lilly's (NYSE:LLY) LARTRUVO (olaratumab), combined with the chemo agent doxorubicin, failed to demonstrate a treatment benefit compared to doxorubicin alone in a Phase 3 clinical trial, ANNOUNCE, in patients with advanced/metastatic soft tissue sarcoma (STS).
    • Specifically, the study did not meet the primary endpoint of overall survival (OS) in the full study population nor in the leiomyosarcoma sub-population. No difference in survival was observed between the study arms for either group.
    • Detailed results will be submitted for presentation at a future medica conference and for publication.
    • The FDA granted accelerated approval for LARTRUVO for STS in October 2016.
    • The company says the negative outcome will shave ~$0.17 off of its 2019 EPS guidance. Its minimum 2020 outlook will remain as is.
    • Eli Lilly's (NYSE:LLY) IND filing seeking FDA sign-off to start clinical development of an immuno-oncology bispecific antibody based on Zymeworks' Azymetric platform triggers an $8M milestone payment to the latter under their 2014 license and collaboration agreement.
    • Lilly's submission is the second in the past six months.
    • ProPhase Labs (NASDAQ:PRPH) promotes Monica Brady to the position of Chief Financial Officer.
    • Ms. Brady has served as the Company’s Chief Accounting Officer since September 2017 and previously as Director of Finance since 2009.
    • Immunomedics (NASDAQ:IMMU) has received a Complete Response Letter (CRL) from the FDA for its BLA seeking accelerated approval for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.
    • The Company will host a conference call today at 8:00 am ET to discuss the rejection.
    • Shares, currently halted, will resume trading at 9:10 am ET.
    • Update: Shares are down 35% premarket.
    • Aratana Therapeutics (NASDAQ:PETX) appoints Craig Tooman as President and Chief Executive Officer (CEO), and also elected him to the Board of Directors.
    • He was the Chair of the Audit Committee before transitioning to CFO in November 2013.
    • Former President & CEO Steven St. Peter, M.D. resigned yesterday.
    • Sunesis Pharmaceuticals (NASDAQ:SNSS) prices public offerings of (i) 23M common stock at a price of $0.50 per share and (ii) 17,000 shares of Series E Convertible Preferred Stock at $500 per share, for expected gross proceeds of ~$20M.
    • Underwriters over-allotment is an additional 3.45M shares.
    • Net proceeds will be used to fund ongoing R&D and general corporate purposes.
    • Closing date is January 23.
    • Previously: Sunesis readies equity offering; shares down 10% after hours (Jan. 17)
  • Thursday, January 17, 2019
    • MorphoSys (NASDAQ:MOR) announces that licensee Janssen Research & Development, LLC, a unit of Johnson & Johnson (NYSE:JNJ), has initiated a Phase 2a proof-of-concept study evaluating Tremfya (guselkumab) in patients with moderately to severely active ulcerative colitis.
    • The FDA approved Tremfya in July 2017 for plaque psoriasis.
    • An FDA advisory committee voted 8 - 8 that the benefits of Sanofi (NASDAQ:SNY) and Lexicon Pharmaceuticals' (NASDAQ:LXRX) sotagliflozin outweigh the risks as an adjunct to insulin to improve glycemic control in adults with type 1 diabetes.
    • Bio-Path Holdings (NASDAQ:BPTH) has closed its public offering of ~8.6M common shares at $0.13 per share yielding gross proceeds of ~$1.1M.
    • Shares are up 5% after hours.
    • Sunesis Pharmaceuticals (NASDAQ:SNSS) launches a public offering of common and preferred stock. Prices, volumes and terms have yet to be announced.
    • Shares are down 10% after hours.
    • Alder BioPharmaceuticals (NASDAQ:ALDR) appoints Paul Streck, M.D. as Chief Medical Officer effective January 21. He joins the firm from Insmed where he was also CMO.
    • Kindred Biosciences (NASDAQ:KIN) slips 3% after hours in response to its announced stock offering. Price, volume and terms have yet to be announced.
    • Five Prime Therapeutics (FPRX +7%) is up on average volume following its announcement of Phase 1 data on bemarituzumab + the chemo regimen mFOLFOX6 in heavily pretreated patients with metastatic gastric cancer whose tumors overexpress an oncogene called FGFR2b (~35% of gastric cancer cases). The results were presented at the ASCO GI Cancers Symposium in San Francisco.
    • The overall response rate (ORR) was 19% (n=4/21), all partials. The disease control rate (responders + stable cancer) was 57% (n=12/21). Median duration of response was 15.4 weeks.
    • On the safety front, bemarituzumab, an FGFR2b inhibitor, was well-tolerated with no dose-limiting toxicities. The maximum tolerated dose was not reached during dose escalation.
    • A Phase 3 study is next up.
    • Prompted by a recent meta-analysis of randomized studies, the FDA is evaluating possible increased mortality in patients receiving paclitaxel-coated balloons and paclitaxel-eluting stents for their peripheral artery disease (PAD).
    • In the meantime, the agency recommends continued surveillance by healthcare providers and reporting of adverse events through the usual channels.
    • Related tickers: (MDT +0.1%)(ABT +0.9%)(BSX +0.9%)
    • Thinly traded nano cap PLx Pharma (PLXP +26.3%) is up on more than a 7x surge in volume, albeit on turnover of only 274K shares. The stock is up over five-fold since touching $1.00 on December 27, 2018.
    • Last week, it filed a proxy statement for its February 14 shareholders meeting. Management is seeking a thumbs-up from investors on two items, one of which is the issuance of stock representing over 20% of its outstanding shares to certain investors.
    • At the end of September, it had $16.5M in cash and equivalents while operations consumed $7.2M during the first three quarters of the year.
    • Cannabis outfit Invictus MD (OTCQX:IVITF -11.5%) has applied for listing on the Nasdaq Capital Market. Concurrently, it will also consolidate the number of issued and outstanding common  shares.
    • INSYS Therapeutics (INSY +5.1%) is up on below-average volume in apparent reaction to a statement from FDA Commissioner Scott Gottlieb, M.D. supporting over-the-counter access for opioid overdose med naloxone, currently prescription-only.
    • The agency has taken the added step of developing a model Drug Facts Label (DFL) to aid developers in their regulatory submissions.  A DFL is a set of instructions for consumers detailing the safe use of the product without the supervision of a healthcare professional.
    • Related tickers: (EBS)(ADMP +4.9%)
    • Gainers: Lipocine (NASDAQ:LPCN) +59%. Correvio Pharma (NASDAQ:CORV) +34%. PLx Pharma (NASDAQ:PLXP) +20%. Titan Medical (NASDAQ:TMDI) +16%. Biocept (NASDAQ:BIOC) +16%.
    • Losers: CHF Solutions (NASDAQ:CHFS) -11%. Aileron Therapeutics (NASDAQ:ALRN) -10%. Therapix Biosciences (NASDAQ:TRPX) -7%. Kala Pharmaceuticals (NASDAQ:KALA) -6%. Altimmune (NASDAQ:ALT) -5%.
    • Following a meeting with the FDA, Omeros (OMER +1.1%) has changed the primary endpoint of assessment of proteinuria (protein in urine) to 36 weeks from 24 weeks in its Phase 3 clinical trial, ARTEMIS-IGAN, evaluating OMS721 in patients with immunoglobulin A nephropathy (IgAN) to allow for additional dosing. Also, high-risk patients in the control group will be allowed open-label treatment after one year of blinded therapy.
    • Additional Phase 2 data from eight IgAN patients showed a median reduction in proteinuria of 61% from baseline (assessed 31 - 54 weeks post-baseline).
    • OMS721 is a human monoclonal antibody that binds to an enzyme called mannan-binding lectin-associated serine protease-2 (MASP-2) that plays a key role in the lectin pathway of the complement system which is believed to contribute to significant tissue injury. It is also in Phase 3 development for atypical hemolytic uremic syndrome (aHUS) and hematopoietic stem cell transplant-associated thrombotic microangiopathy.
    • Thinly traded micro cap Correvio Pharma (CORV +23.7%) is up on more than 50% higher volume in early trade. This morning, it announced the completion of its at-the-market stock sales agreement with B. Riley FBR that netted $11.5M. It has no current plans to enter into another agreement.
    • Dosing is underway in a 100-subject post-market study evaluating Medtronic's (MDT +0.2%) SynchroMed intrathecal drug delivery system (its "pain pump") as an alternative to oral opioids in patients with chronic intractable non-malignant primary back pain with or without leg pain. Participants will be followed for 12 months.
    • The company says the device provides effective pain relief at a fraction of the oral dose with fewer side effects.
    • Johnson & Johnson (NYSE:JNJ) will collaborate with Apple on a clinical study evaluating the effect of an Apple Watch-based ECG app together with irregular heart rhythm notifications on outcomes in atrial fibrillation (AF) patients. Specifically, the study will assess the impact of Apple Watch on the early detection and diagnosis of AF and the potential to improve outcomes, including the prevention of stroke.
    • A multiyear U.S.-based research program will be launched later this year in people at least 65 years old.
    • Microbot Medical (NASDAQ:MBOT) is up 11% premarket on increased volume, poised to add to its torrid pace. Shares have jumped four-fold this week on the news of a new European patent covering its ViRob platform.
    • This morning, the company announced that it demonstrated an activated Self-Cleaning Shunt during investor/analyst meetings last week in San Francisco. It is developing the device for preventing occlusion (blockage) in shunts for hydrocephalus (buildup of fluid in the brain).
    • HCA Healthcare's (NYSE:HCA) wholly owned subsidiary, HCA Inc., offers $1B aggregate principal amount of senior notes.
    • Price, volume and actual terms have yet to be released. Net proceeds will be used for general corporate purposes.
    • CorMedix (NYSEMKT:CRMD) is up 16% premarket on above-average volume following its announcement of positive results from a Phase 3 clinical trial, LOCK-IT-100, evaluating its Neutrolin catheter lock solution in hemodialysis patients.
    • Patients in the Neutrolin arm experienced 72% less risk of catheter-related bloodstream infections compared to the heparin control arm, well above the 55% assumed treatment effect. The separation from control was statistically significant (p=0.0034).
    • The study was stopped early since efficacy was demonstrated after an interim analysis. No safety signals were observed.
    • Management will host a conference call today at 4:30 pm ET to discuss the results.
    • AMAG Pharmaceuticals (NASDAQ:AMAG) has completed the acquisition of Perosphere Pharmaceuticals, a private biopharmaceutical company.
    • At closing, AMAG paid the Perosphere equityholders $40M in cash consideration. AMAG also repaid $12M of Perosphere’s term loan indebtedness and assumed $6.2M of other liabilities.
    • Perosphere equityholders will be eligible to receive regulatory and commercial sales milestones payments of up to $140M and $225M, respectively.
    • Viking Therapeutics (NASDAQ:VKTX) is up 2% premarket on modest volume following yesterday's 6% drop related to a bearish Citron Research report on licensor Ligand Pharmaceuticals.
    • Bull supporter Raymond James (OUTPERFORM/$43) calls the report "ridiculous."
    • Nobilis Health (NYSEMKT:HLTH) has named current SVP of Finance, Brandon Moreno, as the Company's CFO, effective immediately.
    • Mr. Moreno has been with Nobilis for over 4 years.
    • Shares are down 35% premarket.
    • The USPTO issues Notice of Allowance to RedHill Biopharma (NASDAQ:RDHL) for a new patent covering TALICIA (RHB-105),for H. pylori Infection. The patent will be valid until at least 2034.
    • Once granted, this will be the fifth patent covering TALICIA in U.S.
    • Shares are up 4% premarket.
    • AmerisourceBergen (NYSE:ABC) initiated with Buy rating and $89 (15% upside) price target at UBS.
    • Align Technology (NASDAQ:ALGN) initiated with Buy rating and $230 (11% upside) price target at UBS.
    • Cardinal Health (NYSE:CAH) initiated with Neutral rating and $51 (5% upside) price target at UBS.
    • CVS Health (NYSE:CVS) initiated with Buy rating and $75 (17% upside) price target at UBS. Shares down a fraction premarket.
    • Quest Diagnostics (NYSE:DGX) initiated with Neutral rating and $90 (7% upside) price target at UBS.
    • Henry Schein (NASDAQ:HSIC) initiated with Sell rating and and $73 (9% downside risk) price target at UBS.
    • Labcorp (NYSE:LH) initiated with Buy rating and $169 (28% upside) price target at UBS.
    • McKesson (NYSE:MCK) initiated with Neutral rating and $134 (8% upside) at UBS.
    • Owens & Minor (NYSE:OMI) initiated with Neutral rating and $8 (5% upside) price target at UBS. Shares up 1% premarket.
    • Patterson Companies (NASDAQ:PDCO) initiated with Neutral rating and $23 (4% upside) price target at UBS.
    • Premier (NASDAQ:PINC) initiated with Buy rating and $45 (13% upside) price target at UBS.
    • Walgreens Boots Alliance (NASDAQ:WBA) initiated with Sell rating and $70 (3% downside risk) price target at UBS. Shares down 1% premarket.
    • DENTSPLY SIRONA (NASDAQ:XRAY) initiated with Neutral rating and $42 (5% upside) price target at UBS.
    • Amicus Therapeutics (NASDAQ:FOLD) upgraded to Buy with a $16 (32% upside) at Citigroup citing upside with Galafold. Shares up 3% premarket.
    • Savaria (SIS) (TSE) upgraded to Outperform with a C$17 (16% upside) price target at National Bank.
    • Five Prime Therapeutics (NASDAQ:FPRX) upgraded to Outperform with a $16 (60% upside) price target at Wedbush.
    • Insmed (NASDAQ:INSM) upgraded to Buy with a $35 (51% upside) price target at Goldman Sachs citing upside with Arikayce. Shares up 3% premarket.
    • Aptinyx (NASDAQ:APTX) downgraded to Neutral with an $8 (33% upside) after its NYX-2925 flop. Shares down 5% premarket.
    • MANF Therapeutics, a wholly-owned subsidiary of Amarantus Bioscience Holdings (OTCPK:AMBS) has received a notice of allowance from the European and Japanese Patent Office covering the use of MANF as a treatment for various neurodegenerative disorders, including Parkinson’s disease and as a treatment for diabetes and other beta-cell disorders, respectively.
    • Aerpio Pharmaceuticals (OTCQB:ARPO) has completed patient dosing in TIME-2b study, a Phase 2b clinical trial designed to assess the efficacy and safety of AKB-9778, for patients with moderate to severe non-proliferative diabetic retinopathy.
    • Top-line results are expected in March 2019.
    • The primary endpoint is the percentage of patients who improve by 2 or more steps in diabetic retinopathy severity score in the study eye.
    • IMV (IMV) doses first patient in the Phase 1 trial evaluating neoepitopes formulated in DPX delivery platform in patients with ovarian cancer.
    • The study will enroll up to 15 patients.
    • Spectrum Pharmaceuticals (NASDAQ:SPPI) has agreed to sell its line-up of seven FDA-approved hematology/oncology products to Aurobindo Pharma USA subsidiary Acrotech Biopharma, LLC for $160M in upfront cash plus up to $140M in regulatory and sales milestones.
    • The company will downsize by ~40% with most employees transitioning to Acrotech. It will retain a core commercial group to launch ROLONTIS (eflapegrastim) and poziotinib.
    • Management will host a conference call this morning at 8:30 am ET.
    • Shares are up 1% premarket.
    • Premier Health Group (OTCPK:PHGRF) has entered into a strategic partnership with China's 360 Health, a subsidiary of 360 Security Technology.
    • As part of the collaboration, Premier and 360 Health will implement an infrastructure whereby Premier will provide second opinion by connecting 360 Health's patients in China with doctors in Canada both remotely and in person.
    • Additional updates will provided in coming months.
    • Thinly traded nano cap Lipocine (NASDAQ:LPCN) is up 125% premarket on robust volume following its announcement of encouraging data from an open-label single-arm study evaluating NASH candidate LPCN 1144 in 36 hypogonadal males with at least 10% baseline liver fat.
    • Interim data on seven patients with average baseline liver fat of 21% showed an absolute reduction from baseline of 7.6% and a 38% relative reduction. The responder rate was 86% (n=6/7) (defined as at least a 4.1% absolute reduction in liver fat) and 71% (n=5/7) with a 29% absolute reduction criterion.
    • No new safety signals were observed.
    • 16-week data should be available later this quarter.
    • LPCN 1144 is an oral prodrug of what the company says is "bioidentical" testosterone.
    • Zafgen (NASDAQ:ZFGN) announces positive results from the second cohort in its Phase 2 clinical trial evaluating MetAP2 inhibitor ZGN-1061 in patients with type 2 diabetes (T2D).
    • Results at week 12 showed that treatment with the 1.8 mg dose substantially improved A1C levels compared to the 0.9 mg dose with notable weight loss.
    • The reductions in A1C were statistically significant for both doses compared to placebo.
    • No new safety signals were observed.
    • Complete results from cohort 2 will be submitted for presentation at a future medical conference.
    • Shares are up 26% premarket on light volume.
    • Becton, Dickinson (NYSE:BDX) reports preliminary fiscal Q1 2019 results for the quarter ended December 31, 2018.
    • FQ1 revenues of $4.16B.
    • GAAP EPS of ~$2.05; Non-GAAP EPS of ~$2.70.
    • The company reaffirms previously issued fiscal 2019 guidance.
    • The Company will release FQ1 results on February 5, at 8:00 a.m. ET.
    • Adamis Pharmaceuticals (NASDAQ:ADMP) is up 14% premarket on light volume in reaction to commercialization partner Sandoz's U.S. launch of Symjepi (epinephrine).
    • Nasdaq has suspended trading in Lexicon Pharmaceuticals (NASDAQ:LXRX) ahead of today's FDA advisory committee review of development partner Sanofi's marketing application seeking approval for sotagliflozin as an adjunct to insulin to improve glycemic control in adults with type 1 diabetes.
    • Revance Therapeutics (NASDAQ:RVNC) prices its public offering of 5,882,353 common stock at a price of $17.00 per share, for expected gross proceeds of ~$100M.
    • Underwriters over-allotment is an additional 882,352 shares
    • Net proceeds will be used for working capital, general corporate purposes and capital investments.
    • Closing date is January 22.
    • Shares are down 1% premarket.
    • The FDA has accepted Aerie Pharmaceuticals' (NASDAQ:AERI) IND application for AR-1105 (dexamethasone intravitreal implant) for the treatment of macular edema due to retinal vein occlusion. A Phase 2 clinical study is expected to begin later in Q1 2019.
    • AR-1105 is a bio-erodible implant designed to release the steroid dexamethasone over a six-month sustained period.
    • Cellular Biomedicine Group's (NASDAQ:CBMG) AlloJoin therapy for Knee Osteoarthritis (KOA) has been approved as the first stem cell KOA drug application in China for a Phase II clinical trial, following a 60-day priority review period.
    • FDA accepts Genentech, a member of the Roche Group's (OTCQX:RHHBY), supplemental Biologics License Application (sBLA) for Tecentriq (atezolizumab) in combination with Abraxane and carboplatin for the first-line treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumor aberrations. The FDA approval is expected by September 2.
    • Abraxane is a registered trademark of Abraxis Bioscience, LLC, a wholly owned subsidiary of Celgene Corporation.
    • Mirati Therapeutics (NASDAQ:MRTX) prices public offering of 1,612,903 common stock at a price of $62.00 per share, for expected gross proceeds of ~$100M.
    • Underwriters over-allotment is an additional 241,935 shares.
    • Net proceeds will be used for general corporate purposes, clinical development of preclinical programs & products, and for working capital.
    • Closing date is January 22.
  • Wednesday, January 16, 2019
    • Nanocap firm Cancer Genetics (NASDAQ:CGIX) has jumped 16.2% on very heavy postmarket volume after filing about a forbearance agreement with its lenders.
    • The loan amendment with Silicon Valley Bank changes the interest rate to WSJ Prime plus 2.25 percentage points (making it 6.75% at Sept. 30, 2018); sets up milestone in connection with a potential strategic transaction satisfactory to the bank; and extends the revolving line maturity to April 15, among other items.
    • A modification with Partners for Growth also sets milestones for a potential strategic transaction. That loan is an interest-only term loan of $6M bearing interest at 11.5%, maturing March 22, 2020.
    • Amicus Therapeutics (NASDAQ:FOLD) is up 2.7% after hours following an upgrade at Citi to Buy.
    • Analyst Mohit Bansal is focused on the company's Fabry disease therapy Galafold, where early indications back up a peak sales view of $1B. Some 20% of patients are starting on the capsules without switching from an existing therapy, which Bansal sees as a "major upside" to estimates. (h/t Bloomberg)
    • Bansal's boosted the firm's price target to $16 from $12, implying 31.6% upside from today's close.
    • Shares had closed up 1.4% to near a three-month high during the regular session.
    • HTG Molecular (NASDAQ:HTGM) is up 6.2% postmarket after announcing a new software product, HTG EdgeSeq Reveal.
    • It's designed to streamline analysis of biomarket data from samples analyzed using the company's EdgeSeq Precision Immuno-Oncology Panel.
    • The software enables applications including immunophenotyping of tumor infiltrating lymphocytes; monitoring of immunotherapy response biomarkers; and the elucidation of immune-escape mechanisms known to drive disease progression, the company says.