BioShares Biotechnology Clinical Trials (BBC): $22.89, -$0.16, -21.2% YTD
BioShares Biotechnology Products (BBP): $33.97, -$0.41, +10.2% YTD
Following the first U.S. presidential debate where investors awarded the debate to Democrat Hillary Clinton over Republican Donald Trump, U.S. stock index futures were higher. On the economic calendar, building permits, CaseShiller’s composite indexes, Markit’s composite purchasing manager index and consumer confidence are expected. Nike is expected to report first quarter results after the closing bell. European markets were in the red as weakness in banks, led by another drop to record lows for Deutsche Bank, once again weighed on markets. Asian shares closed mixed, recovering from an early bout of nerves. The Mexican peso surged and the greenback advanced against the yen, while gold weakened. Crude futures fell as optimism faded for an output-limiting deal during an oil producer meeting in Algeria.
Prothena Corporation plc announced that its President and Chief Executive Officer Dale Schenk, PhD, who announced in December 2014 that he had been diagnosed with and was undergoing treatment for pancreatic cancer, is taking a medical leave of absence in order to focus full time on his health. Dr. Schenk will continue serving on Prothena`s Board of Directors. During the period of Dr. Schenk`s leave, the Company will be led by Gene Kinney, PhD, Prothena`s Chief Operating Officer. Dr. Kinney has been with Prothena since it was established in 2012 and is responsible for the integrated research, development and commercial organization, as well as several additional key functions within the Company.
Achaogen announced that on September 23, 2016, the compensation committee of the Company’s board of directors granted six new employees options to purchase an aggregate of 72,750 shares of the Company’s common stock and 23,625 restricted stock units. Each stock option has an exercise price per share equal to $4.34, which was the closing trading price on the date of the grant. The stock options and restricted stock units were granted pursuant to the Company’s 2014 Employment Commencement Incentive Plan, which was approved by the Company’s board of directors in December 2014 under Rule 5635(c)(4) of The Nasdaq Global Market for equity grants to induce new employees to enter into employment with the Company.
VBI Vaccines announced the voting results from its annual general and special meeting held on September 23, 2016. A total of 26,558,396 shares were represented at the Meeting, being 73.50% of the Company’s issued and outstanding common shares. The shareholders voted on and approved all matters brought before the Meeting, including the appointment of EisnerAmper LLP, Chartered Accountants as auditors of the Company and to authorize the directors to fix their remuneration, the election of the directors of the Company, and an advisory resolution to approve the Company’s approach to executive compensation.
Bristol-Myers Squibb and Nektar Therapeutics announced a new clinical collaboration to evaluate Bristol-Myers Squibb’s Opdivo (nivolumab) with Nektar’s investigational medicine, NKTR-214, as a potential combination treatment regimen in five tumor types and seven potential indications. Opdivo is a PD-1 immune checkpoint inhibitor designed to overcome immune suppression. NKTR-214 is an investigational immuno-stimulatory therapy designed to expand specific cancer-fighting T cells and natural killer (NK) cells directly in the tumor micro-environment and increase expression of PD-1 on these immune cells.
Kite Pharma announced positive topline results from a pre-planned interim analysis of ZUMA-1 for its lead product candidate, KTE-C19, in patients with chemorefractory diffuse large B-cell lymphoma (DLBCL). KTE-C19 met the primary endpoint of objective response rate (ORR), p<0.0001, with ORR of 76 percent, including 47 percent complete remissions (CR). Following the news, SunTrust analyst Peter Lawson increased his price target to $90 from $80; Barclays analyst Jonathan Eckard increased his price target to $65 from $60.
Amgen announced top-line results of the Phase III CLARION trial, which evaluated an investigational regimen of KYPROLIS (carfilzomib), melphalan and prednisone (KMP) versus Velcade (bortezomib), melphalan and prednisone (VMP) for 54 weeks in patients with newly diagnosed multiple myeloma who were ineligible for hematopoietic stem-cell transplant. The trial did not meet the primary endpoint of superiority in progression-free survival (PFS) (median PFS 22.3 months for KMP versus 22.1 months for VMP, HR = 0.91, 95 percent CI, 0.75 – 1.10). While the data for overall survival, a secondary endpoint, are not yet mature, the observed hazard ratio (KMP versus VMP) was 1.21 (95 percent CI, 0.90 – 1.64). Neither result was statistically significant.
CEL-SCI Corporation announced that it has received verbal notice from the FDA that its Multikine (Leukocyte Interleukin Injection) Phase III clinical trial in advanced primary head and neck cancer has been placed on clinical hold. Pursuant to this communication from FDA, patients currently receiving study treatments can continue to receive treatment, and patients already enrolled in the study will continue to be followed. CEL-SCI was also told to expect a formal letter from the FDA within 30 days and will work diligently with the FDA to obtain the release of the clinical hold. The study currently has about 926 patients enrolled.
Amgen and UCB announced that the FDA has accepted for review the BLA for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. Romosozumab works by binding and inhibiting the activity of the protein sclerostin, a protein naturally occurring in the bone, thereby increasing bone formation and decreasing bone resorption.
ProNAi Therapeutics announced that it has obtained an exclusive license from the CRT Pioneer Fund LP for worldwide rights to develop and commercialize PNT737 (formerly CCT245737), a highly selective, orally available, small molecule inhibitor of Checkpoint kinase 1 (Chk1). PNT737 is being investigated in two recently initiated Phase I clinical trials, currently sponsored and managed by the Cancer Research UK Centre for Drug Development, led by The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust.
Incyte announced that its first-in-class JAK1/JAK2 inhibitor, Jakafi (ruxolitinib), has been included as a recommended treatment in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for myelofibrosis.
Summit Therapeutics received Rare Pediatric Disease designation from the FDA for ezutromid in the treatment of DMD. As a utrophin modulator, ezutromid has potential as a disease-modifying treatment for all patients with the fatal muscle wasting disease DMD, regardless of their underlying dystrophin gene mutation.
Infinity Pharmaceuticals announced initial clinical and new preclinical data for IPI-549, an orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. Preliminary Phase I results from nine patients with advanced solid tumors show that the safety, pharmacokinetics and pharmacodynamics of IPI-549 monotherapy treatment appear favorable. Additionally, new preclinical data demonstrate that IPI-549 can reverse tumor resistance to checkpoint inhibitors, providing additional rationale for the planned evaluation of IPI-549 in combination with a checkpoint inhibitor in the ongoing Phase I study. These data are being presented in a poster session at the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival taking place in New York City.
MyoKardia announced that it has commenced an underwritten public offering of 3,800,000 shares of its common stock. In addition, MyoKardia expects to grant the underwriters a 30-day option to purchase up to an additional 570,000 shares of common stock at the public offering price, less the underwriting discount. Credit Suisse Securities and Cowen and Company are acting as joint lead book-running managers for the offering. BMO Capital Markets Corp. is acting as book-running manager. Wedbush Securities is acting as co-manager.
Jazz Pharmaceuticals announced that patient enrollment has been completed for its two Phase III studies evaluating JZP-110 in excessive sleepiness (ES) associated with obstructive sleep apnea (OSA).
Sage Therapeutics announced positive results on secondary endpoints from its Phase II clinical trial of SAGE-547 for the treatment of severe postpartum depression (PPD) at The Marcé Society for Perinatal Mental Health held September 26 — 28, 2016 in Melbourne, Australia. Secondary endpoints in the study, including the Edinburgh Perinatal Depression Scale (EPDS) and the Patient Health Questionnaire (PHQ-9) showed improvement through 30 days in the SAGE-547-treated group compared to the placebo group, demonstrating a strong durability of effect from SAGE-547 for over three weeks following the end of treatment. These data are consistent with previously reported top-line results showing SAGE-547 achieved the primary endpoint with a statistically significant reduction in the Hamilton Rating Scale for Depression (HAM-D) compared to placebo at 60 hours and maintained at similar magnitude through the 30-day follow-up. A similar statistically significant response was observed on other secondary endpoints including the Montgomery-Åsberg Depression Rating Scale (MADRS) and Remission from depression, as determined by a HAM-D of less than 7. The company is pursuing publication of a comprehensive dataset from the Phase 2 trial in severe PPD in a peer-reviewed journal. The FDA granted Breakthrough Therapy Designation to SAGE-547 for the treatment of postpartum depression (PPD). There are no approved therapies specifically for PPD.
Idera Pharmaceuticals reported initial clinical data from its ongoing Phase I/II clinical trial of intra-tumoral IMO-2125, a Toll-like receptor (TLR) 9 agonist. In this arm of the Phase I portion of the trial, IMO-2125 is being evaluated in combination with ipilimumab for treatment of patients with metastatic melanoma who have failed prior PD-1 therapy. These early results indicate that IMO-2125 is demonstrating promising clinical activity and is being well tolerated in a patient population with minimal options and low expectation of clinical response with ipilimumab treatment alone.
Actinium Pharmaceuticals has initiated a Phase II clinical trial of Actimab-A in patients newly diagnosed with Acute Myeloid Leukemia (AML) who are over the age of 60. Actimab-A, Actinium’s most advanced alpha particle immunotherapy (APIT) program consists of the CD33 targeting monoclonal antibody, HuM195, and the alpha-emitting radioisotope, actinium-225.
Pieris Pharmaceuticals announced that it presented new preclinical data demonstrating in vivo efficacy of its lead 4-1BB (CD137)-based bispecific cancer immunotherapeutic drug candidate, PRS-343, at the 2016 CRI-CIMT-AACR International Cancer Immunotherapy Conference – Translating Science into Survival, taking place in New York City.
Asterias Biotherapeutics announced that the first patient with incomplete AIS-B cervical spinal cord injury was successfully dosed with 10 million cells of AST-OPC1 (oligodendrocyte progenitor cells) in the SCiSTAR clinical trial at Shepherd Center in Atlanta. The company recently received FDA clearance to expand the study into this additional patient population based on the continued favorable safety profile observed in the ongoing clinical study. A total of 5-8 AIS-B patients are expected to be enrolled and dosed with 10 million cells in the study. Asterias recently reported positive early efficacy data for AST-OPC1 in AIS-A patients, or those with complete cervical spinal cord injuries.
AcelRx Pharmaceuticals announced the initiation of the Phase III IAP312 study of Zalviso (sufentanil sublingual tablet system), an investigational product candidate being developed for the management of moderate-to-severe acute pain in adult patients in a hospital setting. IAP312 is a multicenter, open-label study designed at the request of the Division of Anesthesia, Analgesia and Addiction Products of the FDA. The IAP312 study will enroll approximately 315 hospitalized, post-operative patients who will use Zalviso to self-administer sublingually tablets containing 15 micrograms of sufentanil as often as once every 20 minutes for 24–to-72 hours to manage their moderate-to-severe acute pain. In addition to safety and efficacy measures, IAP312 will collect information on device usability, including any incidence of Zalviso’s failure to dispense medication as well as the incidence of misplaced or dropped tablets.
MiNA Therapeutics announced the presentation of data supporting the on-target mechanism of action of drug candidate MTL-CEBPA. MTL-CEBPA is the first development candidate to emerge from MiNA’s RNA activation platform and is currently being evaluated in a Phase I clinical study in patients with liver cancer. The data were presented at the 2016 Annual Meeting of the Oligonucleotide Therapeutics Society on September 26 in Montreal, Canada, in a poster titled “Development and mechanism of a small activating RNA targeting CEBPA, a novel therapeutic in clinical trials for patients with liver cancer”.
Aduro Biotech highlighted two posters presented at the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CRI-AACR) in New York. The preclinical data demonstrate positive changes in the tumor microenvironment and induction of a tumor-specific immune response by Aduro’s LADD (listeria-based immunotherapy construct) and STING (Stimulator of Interferon Genes) Pathway Activator immunotherapy platform technologies. Importantly, adding a PD-1 blockade to either immunotherapy regimen significantly bolstered antitumor efficacy.
Momenta Pharmaceuticals announced that Shire has exercised its right to terminate its collaboration agreement with the Company to develop and commercialize M923, a proposed biosimilar of HUMIRA (adalimumab), based on a comprehensive portfolio assessment following the acquisition of Baxalta. Under the terms of the 2011 collaboration agreement, the agreement will terminate twelve months following the notice and Shire will continue to be obligated to fund the M923 program until termination. Shire will begin to work to transfer all ongoing clinical, regulatory and commercialization activities to Momenta.
Biothera Pharmaceuticals announced the presentation of clinical data demonstrating the mechanism of action of Imprime PGG, the Company’s Phase II cancer immunotherapy drug, in healthy human volunteers. These are the first data to show that when administered intravenously to healthy human subjects, Imprime PGG drives the immunopharmacodynamic (IPD) responses observed in ex vivo human and in vivo mouse studies. Specifically, the study demonstrated that formation of an immune complex between Imprime PGG and endogenous anti-beta glucan antibodies (ABA) was critical to elicit Imprime-induced immune activating events in humans. These findings provide additional evidence that ABA levels may be a particularly useful biomarker for selecting patients most likely to respond to Imprime-based therapy.
Peregrine Pharmaceuticals announced the presentation of preclinical study data demonstrating that phosphatidylserine (PS)-targeting antibodies similar to bavituximab are able to enhance the anti-tumor activity of multiple checkpoint targeting agents including anti-PD-1 and anti-LAG3 therapies in a model of triple negative breast cancer (TNBC). Data showed that eight of the ten (80%) animals receiving the preclinical bavituximab equivalent (ch1N11) combined with anti-PD-1 and anti-LAG3 therapies ("Triple Combination") experienced complete tumor regressions, whereas there were no animals (0/10) in the anti-PD-1 and anti-LAG3 combination treatment arm that had a complete regression.
Provectus Biopharmaceuticals announced that the Society for Immunotherapy of Cancer has accepted an abstract for a poster presentation related to the use of PV-10, an investigational ablative immunotherapy under development by Provectus for solid tumor cancers, in the treatment of pancreatic cancer.
Ansun BioPharma announced the publication of two reports by researchers showing potent inhibitory effect of DAS181 on respiratory syncytial virus (RSV) and human metapneumovirus (hMPV).
IsoRay announced that on September 23, 2016, it entered into a Stipulation of Settlement (the "Settlement"), pursuant to which IsoRay and IsoRay’s former CEO (together, the "Defendants") have, subject to certain conditions and approvals, agreed to settle the previously-disclosed consolidated securities class action litigation, In re IsoRay, Inc. Securities Litigation, Case No. 4:15-cv-05046-LRS (the "Litigation"), pending in the U.S. District Court for the Eastern District of Washington.
MDxHealth SA announced that Independence Blue Cross has issued a positive medical coverage policy decision for the ConfirmMDx for Prostate Cancer test.
Galderma announced that it has received a Positive Opinion from 16 concerned European regulatory agencies for the market approval of EPIDUO 0.3% / 2.5% gel (adapalene/ benzoyl peroxide), for the cutaneous treatment of acne vulgaris, when comedones, numerous papules and pustules are present.
Coherus BioSciences announced that it has regained from Shire all development and commercial rights previously licensed for CHS-0214 etanercept, a biosimilar candidate to Enbrel, for Europe, Canada, Brazil, the Middle East and other territories. Reconveyance of CHS-0214 rights to Coherus results from Shire’s strategic portfolio review, following its June 2016 acquisition of Baxalta Incorporated, and includes no present or future payments from Coherus.
Perrigo Company announced an exclusive licensing agreement with Highland Pharmaceuticals, for its Tarex methamphetamine ("meth") blocking technology and the distribution rights of Zephrex-D(R) (pseudoephedrine HCI 30 mg). Zephrex-D(R) was developed using the Tarex(R) technology and has been proven to be more than 98% effective at blocking one of the more common domestic methods of illegal meth production.
Nano Dimension announced the pricing of its public offering of 1,850,000 American Depository Shares (ADSs) at a price of $6.50 per ADS. In addition, Nano Dimension has granted the underwriters a 45-day over-allotment option to purchase up to 277,500 additional ADSs at the public offering price. All of the ADSs are being offered by the Company.
ANI Pharmaceuticals announced the launch of Erythromycin Ethylsuccinate for Oral Suspension 200mg/5mL indicated as a treatment for various infections.
Immunicum announced the appointment of Carlos de Sousa as Immunicum’s Chief Executive Officer effective on October 1, 2016. Mr. de Sousa brings more than 25 years of relevant experience in the international pharmaceutical and biotech industries, including senior positions at Nycomed/Takeda, Pfizer, Novartis, BBB Therapeutics, Newron Pharmaceuticals and, most recently, as Chief Business Officer at Zealand Pharma in Denmark.
Fortis Therapeutics announced the close of an $18 million Series A financing. The investment was led by Avalon Ventures and was joined by Bregua Corporation, Lilly Asia Ventures, Osage University Partners, and Vivo Capital. The company was founded on technology from Bin Liu, Ph.D., a professor in the Department of Anesthesia at UC San Francisco, and is focused on developing new antibody drug conjugate therapies for late-stage metastatic castrate-resistant prostate cancer and multiple myeloma.
Navidea Biopharmaceuticals announced that its Board of Directors has appointed Michael M. Goldberg, M.D. as President and Chief Executive Officer effective September 22, 2016. The Board of Directors has also appointed Eric K. Rowinsky M.D., a Navidea board member since 2010, as Chairman of Navidea’s Board, a position previously held by Dr. Goldberg, who will remain a board member.
Insmed announced the appointment of Roger Adsett as chief commercial officer. Mr. Adsett was most recently senior vice president, head of the gastrointestinal and internal medicine business unit at Shire.
OPKO Health announced the appointment of Benjamin D. Solomon, M.D. as Managing Director of GeneDx, effective as of October 3, 2016. GeneDx, part of OPKO’s BioReference Laboratories subsidiary, specializes in genetic testing for rare hereditary disorders.
Morgan Stanley analyst David Risinger increased his price target of Alkermes to $45 from $41, citing strong Vivitrol growth prospects were detailed by management; Citi analyst Liav Abraham increased her price target to $53 from $44, citing an updated model to reflect higher Vivitrol estimates.
Leerink analyst Geoffrey Porges downgraded Gilead to “market perform” from “outperform” and decreased his price target to $94 from $112, citing HCV revenues will decline faster, and farther, than previously estimated, and than consensus currently forecasts.
Goldman Sachs analyst Jami Rubin upgraded Eli Lilly to “buy” from “neutral” and increased her price target to $95 from $89, citing the company is the least exposed to above-CPI price increases, which leaves it less vulnerable to potential future pressure.
Goldman Sachs analyst Terence Flynn revised his price target on the following companies: Amgen increased to $206 from $204; Jazz Pharmaceuticals decreased to $187 from $195.
Cowen analyst Ritu Baral downgraded Mast Therapeutics to “market perform” from “outperform,” citing lack of clarity on a path forward after ‘188 missed in its PhIII trial for sickle cell and the program was discontinued.
Goldman Sachs analyst Stephan Stewart revised his rating and price target of the following companies: Impax Laboratories upgraded to “neutral” from “sell” and increased his price target to $26 from $25; Concordia decreased to $4 from $13.
Rodman & Renshaw analyst Raghuram Selvaraju decreased his price target of DURECT Corporation to $3.50 from $4, citing Pain Therapeutics, the licensee of REMOXY from DURECT Corporation, announced that it had received a complete response letter for the resubmitted NDA of REMOXY® from the FDA, stating that this long-acting gelatin capsule formulation of oxycodone cannot be approved in the present form.