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.
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.
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.
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.
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.
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.
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:ACB) prices 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.
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.
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.
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.
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.
Florida Governor Ron DeSantis, who took control on Jan. 8, is paving the way to end legal wrangling over smokable medical marijuana.
Patients can currently only use oils, sprays, edibles and vaping due to concerns about a slippery slope toward recreational use, but if the Florida legislature does not change the law by mid-March, DeSantis said he'll drop the state's appeal in the case.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.