BioShares Biotechnology Clinical Trials (BBC): $22.20, -$0.99, -23.6% YTD
BioShares Biotechnology Products (BBP): $32.75, -$1.04, +6.3% YTD
Weak economic data from China and Japan coupled with lower oil prices a day after OPEC members agreed to reduce output, weighed on investor sentiment and pushed global markets down. Troubles at Deutsche Bank, whose U.S. shares took a hammering on reports some hedge funds had reduced financial exposure to Germany’s largest lender, also weighed on sentiment. Personal consumption, Chicago PMI, and U-Mich sentiment figures are expected amongst others on the economic calendar. Markets will watch for important economic data releases next week, including payrolls and non-manufacturing indexes, which will give help gauge strength of the economy vis-a-vis a rate hike in December. Safe haven gold rose, but a stronger greenback limited gains.
Foamix Pharmaceuticals announced the pricing of an underwritten public offering of 6,000,000 ordinary shares at a price to the public of $9.50 per share. Of the ordinary shares, 5,700,000 shares will be sold by Foamix and 300,000 shares will be sold by certain selling shareholders. In addition, Foamix has granted the underwriters a 30-day option to purchase up to 900,000 additional ordinary shares.
BIOPHYTIS reported its consolidated half-year financials as of June 30, 2016. The company reported a first half loss of €3.7 million, compared to a net loss of €1.7 million in the same period of 2015. The available cash at June 30, 2016 was €6.9 million.
Zealand Pharma completed a private placement of 1.48M shares at DKK 96.90/share. The offering raised DKK 143M ($22M) and approximately 2/3 of the Offering was subscribed by U.S. investors and the rest by European investors. Bryan, Garnier & Co. acted as the Sole Global Coordinator and Sole Bookrunner.
GeNeuro reported its half-year financial results for the period ending June 30, 2016. The Company recorded a net loss of K€6,815. Cash and cash equivalents at June 30, 2016 amounted to K€42,408 vs. K€19,560 at 31 December 2015.
Aurinia Pharmaceuticals announced that in addition to voclosporin (23.7 mg BID) achieving its primary endpoint of Complete Remission (CR) at 24 weeks, both doses of voclosporin when added to the current standard of care of Mycophenolate Mofetil (MMF) and a forced oral corticosteroid taper have met all 24-week pre-specified secondary endpoints vs the control group. These pre-specified endpoints include: Partial Remission (PR), which is measured by a ≥50% reduction in UPCR with no concomitant use of rescue medication; time to CR and PR; reduction in Systemic Lupus Erythematosus Disease Activity Index or SLEDAI score; and reduction in UPCR over the 24-week treatment period.
Prothena Corporation provided an outline of the Phase 2 development strategy for PRX003. Prothena plans to advance a Phase 2 clinical study of PRX003 for the treatment of psoriatic arthritis, a Th17-mediated disease where multiple cytokines contribute to pathology. Should the interim analysis of the ongoing Phase 1b multiple ascending dose proof-of-biology study in patients with psoriasis meet certain pre-specified criteria, Prothena will begin preparation for a Phase 2 study in patients with psoriatic arthritis. The interim analysis is expected by mid-2017.
BioDelivery Sciences International reported that according to the Substance Abuse and Mental Health Services Administration (SAMHSA), 1,665 clinicians have applied for and were granted waivers to prescribe buprenorphine for the treatment of opioid dependence at the increased limit of 275 from the previous 100.
OncoSec Medical Incorporated will host its fiscal fourth quarter and fiscal year end 2016 financial results conference call on Thursday, October 13.
Threshold Pharmaceuticals announced interim data from its two Phase 2 proof-of-concept clinical trials of tarloxotinib and outlined its plans to focus company resources on the more clinically-advanced evofosfamide program as well as an earlier-stage anticancer candidate, TH-3424.
Dermata Therapeutics announced positive findings from their 28-day Phase 1 Pharmacokinetic Study in Acne Rosacea patients with their lead compound, DMT210. The results from the Phase 1 study show that DMT210 has minimal systemic exposure, an acceptable safety profile and appears well tolerated by patients, with most reported local skin reactions as mild.
AbbVie announced that the FDA has granted Breakthrough Therapy Designation for the investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of patients with chronic HCV who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1, including therapy with an NS5A inhibitor and/or protease inhibitor.
Regeneron Pharmaceuticals announced topline results from the Phase II CAPELLA study evaluating aflibercept co-formulated with rinucumab, an anti-platelet-derived growth factor receptor beta (anti-PDGFR-beta) antibody, in patients with neovascular age-related macular degeneration (wet AMD). The combination therapy did not demonstrate an improvement in best corrected visual acuity (BCVA) compared to intravitreal aflibercept injection monotherapy at 12 weeks, the primary endpoint of the study. At 12 weeks, patients in both combination aflibercept/rinucumab groups showed a 5.8 letter improvement in BCVA. Patients treated with aflibercept alone showed a 7.5 letter improvement in BCVA.
Arbutus Biopharma reported interim results from the first two cohorts of the ongoing ARB-1467 Phase II multi-dose clinical trial in chronically infected HBV patients. The first two cohorts enrolled patients with hepatitis B e-antigen (HBeAg) negative chronic HBV infection. At this time, serum HBsAg data are available following single doses for both Cohort 1 and Cohort 2 and following multiple doses for Cohort 1. Single dose ARB-1467 results for Cohorts 1 and 2 demonstrate significant reductions in serum HBsAg levels. Importantly, multiple dose results from Cohort 1 show a step-wise, additive reduction in serum HBsAg. These multiple dose results are the first of their kind for an RNAi product candidate in patients with chronic HBV infection. Treatment with ARB-1467 has been generally well tolerated to date.
Emergent BioSolutions announced that it has signed a multi-year contract with the Biomedical Advanced Research and Development Authority (BARDA), which is a division of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, for the advanced development and delivery of NuThrax (anthrax vaccine adsorbed with CPG 7909 adjuvant), also known as AV7909, the company’s next generation anthrax vaccine candidate. The contract, valued at up to approximately $1.6 billion, consists of a five-year base period of performance valued at approximately $200 million to develop NuThrax for post-exposure prophylaxis of anthrax disease and to deliver to the Strategic National Stockpile (SNS) an initial two million doses following Emergency Use Authorization (EUA) pre-approval by the FDA. The company anticipates that FDA could authorize NuThrax for emergency use as early as 2018, triggering deliveries of NuThrax to the SNS in 2019. The contract also includes procurement options for the delivery of an additional 7.5 million to 50 million doses of NuThrax to the SNS, valued from approximately $255 million to up to $1.4 billion, respectively, and options for an additional clinical study and post-marketing commitments valued at $48 million, which if both were to be exercised in full, would increase the total contract value to up to $1.6 billion.
Endo Pharmaceuticals Inc., a subsidiary of Endo International, announced new data to be presented evaluating the safety and efficacy of XIAFLEX (collagenase clostridium histolyticum) (or CCH) injection under investigation for the treatment of palmar Dupuytren’s disease nodules. The findings will be presented during a podium presentation on Saturday, October 1, 2016 at 10:40 a.m. CDT at the annual meeting of the American Society for Surgery of the Hand (ASSH) held from September 29 to October 1, 2016 in Austin, Texas. In a Phase II, randomized, double-blind, placebo-controlled, dose-ranging study, in 75 adult study participants with Dupuytren’s disease and at least 1 nodule who received a single injection of CCH 0.40 mg or 0.60 mg, a statistically significant decrease was shown from baseline in the mean nodule surface area (P<=0.001), consistency score (P<0.001) and hardness score (P<=0.01) at week 8 versus study participants receiving placebo. The safety profile of those treated with CCH was generally well tolerated. Adverse events included extremity pain, axillary pain, injection site-related adverse events and pruritus. One adverse event was reported as severe (injection site pain with CCH 0.60 mg). No patients were discontinued from the study because of an adverse event.
Teva Pharmaceutical announced that it has received EU Marketing Authorization for Aerivio Spiromax (fluticasone/salmeterol 500/50) as a maintenance bronchodilator treatment for adult patients with severe asthma and chronic obstructive pulmonary disease (COPD). Aerivio Spiromax contains a fixed dose combination of fluticasone propionate, an inhaled corticosteroid to treat the underlying inflammation in asthma and COPD, and salmeterol xinafoate, a long-acting beta-agonist, being delivered via the award-winning Spiromax inhaler.
Cempra announced interim results showing anti-NASH effects in the first six nonalcoholic steatohepatitis (NASH) patients dosed with solithromycin in a Phase II study. Compared with baseline values, after 90 days of solithromycin treatment, all six NASH patients had a reduction in their nonalcoholic fatty liver disease (NAFLD) activity score (NAS) (mean reduction, 1.3) and their alanine aminotransferase (ALT) (mean reduction, 17.8 U/L). Five of six patients had a reduction in their aspartate aminotransferase (AST), and the sixth patient had an AST that was unchanged and normal (mean reduction for the six patients, 10.1 U/L). There were also mean reductions in ballooning hepatocyte degeneration and inflammation, both of which are histological signs of NASH. Solithromycin has been well tolerated in this study.
ImmunoGen announced the completion of a strategic review of its operations. As a result of this initiative, the company will reduce its workforce by 17% and seek to partner its non-core B-cell lymphoma programs, creating a stronger organization focused on delivering innovative ADC therapies that meaningfully improve the lives of cancer patients.
Enanta Pharmaceuticals announced that a poster presentation on one of the lead compounds in its RSV program was presented at the 10th Annual Respiratory Syncytial Virus conference taking place in Patagonia, Argentina. Data presented in a poster titled, EP-023938, A Novel Non-Fusion Replication Inhibitor of Respiratory Syncytial Virus (RSV), M.H. J. Rhodin, et al., demonstrated that EP-023938 is a potent inhibitor of both RSV-A and RSV-B activity, maintaining antiviral activity post-infection while presenting a high barrier to resistance. Further, EP-023938 maintained antiviral potency across all clinical isolates tested as well as virus that was resistant to fusion inhibitors. Given this favorable preclinical profile, along with demonstrated synergy with inhibitors of other mechanisms, Enanta plans to continue evaluation of EP-023938 as a potential development candidate for RSV.
Grünenthal presented data for the first time of its compound cebranopadol in patients with cancer-related pain. The cebranopadol data is from a Phase III randomized, double-blind, double-dummy, active-controlled multiple dose study with patients randomized to either once-daily cebranopadol or twice-daily morphine sulfate PR (prolonged release). Results reached statistical significance for non-inferiority and even superiority for the primary endpoint (average amount of daily rescue medication intake over the last two weeks of the maintenance phase in the trial, p<0.05). Cebranopadol was well tolerated, with side effects comparable to morphine sulfate PR. Enrollment in this trial, which is one of the largest trials conducted in cancer pain to date, was stopped for strategic reasons. Cebranopadol, a novel first-in-class analgesic, discovered and developed by Grünenthal, has previously demonstrated strong efficacy in moderate to severe, chronic neuropathic pain and musculoskeletal pain. Grünenthal is actively seeking for development and commercialization partners to make cebranopadol available for patients in Asia.
CANCER RESEARCH UK has announced its first cross-company deal as part of its Experimental Cancer Medicine Centre (ECMC) Combinations Alliance. MSD, Verastem, and Cancer Research UK will trial a new combination of immunotherapy drugs in mesothelioma, non small cell lung and pancreatic cancers. The trial will run through the ECMC network at centres in Edinburgh-Dundee, Southampton, Glasgow, Leicester and Belfast. The phase Ib/IIa trial will investigate whether a focal adhesion kinase (FAK) inhibitor drug from Verastem called VS-6063 (defactinib) can boost the effectiveness of a PD-1 immunotherapy drug from MSD called Keytruda (pembrolizumab).
Daiichi Sankyo Europe GmbH announced data from a new analysis of the phase III Hokusai-VTE study, which showed that a reduced dose of LIXIANA (edoxaban, once-daily 30 mg) was as effective and well-tolerated in preventing recurrent VTE episodes as the standard 60 mg edoxaban treatment regimen, and safer than warfarin in preventing bleeding events in patients meeting the criteria for dose reduction.
Sernova announced the appointment of Scott Langille as Chief Financial Officer.
Nanobiomed announced its leading-edge development of a new molecule for use in tissue and cancer diagnostics.
Eisai Co. announced the initiation of a global Phase III Clinical Study (Study 307, CLEAR Study) of its in-house developed multiple receptor tyrosine kinase inhibitor lenvatinib mesylate (lenvatinib) in respective combination regimens with the anticancer agent everolimus and the anti-PD-1 antibody pembrolizumab as a potential first-line treatment for advanced renal cell carcinoma.
Kindred Biosciences announced the submission to FDA of the Safety technical section of the New Animal Drug Application (NADA) for Mirataz (mirtazapine 2% transdermal ointment, KIND-010). This is the final major technical section to be submitted for Mirataz. The Chemistry, Manufacturing, and Controls technical section was submitted in May 2016 and the Effectiveness technical section was submitted in August 2016.
Teligent announced that its Estonian subsidiary, Teligent OÜ, has received approval from Health Canada’s Therapeutic Products Directorate for Lidocaine Hydrochloride Topical Solution USP. This is the fifth approval for Teligent OÜ this calendar year and will be distributed by Teligent’s business in Canada.
SQZ Biotech announced the closing of a $16 million Series B financing round led by NanoDimension and Polaris Partners, with participation from other existing and new investors. Using its breakthrough cell engineering technology, SQZ Biotech is developing a new generation of cell therapies that harness the body’s natural immune system to combat disease. SQZ will utilize the funds to advance its preclinical immuno-therapy programs in oncology and other serious diseases.
Delcath Systems announced that it intends to offer shares of its common stock and warrants to purchase shares of common stock in an underwritten public offering. Roth Capital Partners is acting as the sole manager for the offering. The Company intends to use the net proceeds from the offering (including any resulting from the exercise of the warrants, if any) for general corporate purposes, including, but not limited to, funding of its clinical trials, commercialization of its products, obtaining regulatory approvals, research, capital expenditures and working capital.
Sequenom, a wholly-owned subsidiary of Laboratory Corporation of America Holdings, announced the results, as of 5:00 p.m., New York City time, on September 29, 2016 (the “Early Tender and Consent Payment Deadline”), of (A) the cash tender offers (the “Tender Offers”) for any and all of the outstanding 5% Convertible Senior Notes Due 2017 and 5% Convertible Senior Exchange Notes Due 2018 issued by Sequenom, and (B) the solicitations of consents of the holders of Notes to enact certain proposed amendments to the indentures governing the Notes to eliminate various reporting obligations and restrictive provisions related to the incurrence of indebtedness, as well as make certain other changes in the indentures. The Tender Offers will expire at 5:00 p.m., Eastern Time, on Monday, October 17, 2016, unless extended or terminated.
Dynatronics announced the appointment of David A. Wirthlin as CFO, effective October 11, 2016. Wirthlin will succeed Terry M. Atkinson and will report to Dynatronics’ CEO Kelvyn H. Cullimore, Jr. Mr. Atkinson will continue with Dynatronics as Director of Accounting.
Piper Jaffray analyst Charles Duncan downgraded Alcobra to “neutral” from “overweight” and decreased his price target to $3 from $10, citing Metadoxine XR program was placed on full clinical hold by the FDA.
JMP analyst Donald Ellis initiated coverage of Aclaris Therapeutics with a “market outperform” rating and $34 price target, citing the company’s lead asset, A-101, is currently in Phase III clinical trials for seborrheic keratosis and a Phase II trial for common warts.
Wells Fargo analyst Jim Birchenough initiated coverage of Global Blood Therapeutics with an “outperform” rating and $75-$81 valuation range, citing a positive outlook for the company’s hemoglobin modifier GBT440 in Sickle Cell Disease (SCD) and prospects for successful Phase III development and commercialization.
Brean Capital analyst Difei Yang assumed coverage of Alder Biopharmaceuticals with a “buy” rating and a $45 price target, citing the company’s lead product candidate, ALD403, a novel monoclonal antibody delivered intravenously and indicated for migraine prevention, is entering two Phase III trials for frequent episodic migraines and chronic migraines.
Brean Capital analyst Difei Yang assumed coverage of Nektar Therapeutics with a “buy” rating and increased her price target to $23 from $18, citing Nektar’s products from recent/future launches that are likely to generate the most upside are: Movantik, Adynovate and Amikacin Inhale product.
Following ImmunoGen’s announcement of a restructuring, Cantor Fitzgerald analyst Mara Goldstein decreased her price target to $5 from $9; Canaccord analyst John Newman decreased his price target to $6 from $20.
Leerink analyst Jason Gerberry decreased his price target of Mylan to $45 from $55, citing lower EpiPen sales forecast.
Raymond James analyst Reni Benjamin initiated coverage of Adaptimmune with an “outperform” rating and $16 price target, citing a buying opportunity for risk-tolerant investors with the value of ADAP’s TCR platform, multiple trial initiations and data readouts expected within the next 12 months, the experience and knowledge to design first-in-class TCR products, and a cash position of $187.5 million.