BioShares Biotechnology Clinical Trials (BBC): $22.51, -$0.14, -22.5% YTD
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U.S. stock index futures edged up, boosted by upbeat U.S. manufacturing data in the previous session, which propped up expectations for an interest rate hike in December. Micron Technology is expected to report fourth-quarter results after the closing bell. European shares rallied, with Germany’s Deutsche Bank hitting a two-week high and Pearson gaining after encouraging comments by Morgan Stanley. Asian shares finished higher with Japan’s Nikkei leading the way. Britain’s pound slumped to its weakest level in more than three-decades, as Brexit worries were compounded by a revitalized dollar. Gold edged lower. Crude futures took a breather after news that Iran and Libya have continued to increase production.
Paratek Pharmaceuticals will ring the closing bell at Nasdaq to mark the company’s 20th anniversary of working to develop new antibiotics.
Rockwell Medical announced that the Triferic Phase-1 Healthy Volunteer Intravenous (IV) Pharmacokinetic Study has been published in the Journal of Clinical Pharmacology.
Santhera Pharmaceuticals announced the appointment of Kristina Timdahl, MD, as Chief Medical Officer and Head of Development and Member of the Executive Management with effect from January 1, 2017. Kristina Timdahl will replace Nick Coppard, PhD, who will retire in January 2017.
Rexahn Pharmaceuticals announced it will present the preliminary Phase Ib/IIa efficacy data for RX-3117 in metastatic pancreatic cancer and an update on the Supinoxin™ Phase I clinical trial at the 2016 European Society for Medical Oncology (ESMO) Congress, which will take place October 7th – 11th in Copenhagen, Denmark.
Sarepta Therapeutics and Summit Therapeutics announced that they have entered into an exclusive license and collaboration agreement granting Sarepta rights in Europe, as well as in Turkey and the Commonwealth of Independent States (‘the licensed territory’), to Summit’s utrophin modulator pipeline, including its lead clinical candidate, ezutromid, for the treatment of Duchenne muscular dystrophy (‘DMD’). As part of the agreement, Sarepta also obtains an option to license Latin American rights to Summit’s utrophin modulator pipeline. Summit retains commercialization rights in all other countries. Under the terms of the agreement, Summit will receive an upfront fee of $40 million. In addition, Summit will be eligible for future ezutromid related development, regulatory and sales milestone payments totalling up to $522 million, including a $22 million milestone upon the first dosing of the last patient in Summit’s PhaseOut DMD trial, and escalating royalties ranging from a low to high teens percentage of net sales in the licensed territory. Summit will also be eligible to receive development and regulatory milestones related to its next-generation utrophin modulators. Sarepta and Summit will share specified utrophin modulator-related research and development costs at a 45%/55% split, respectively, beginning in 2018. If Sarepta elects to exercise its option for Latin American rights, Summit would be entitled to additional fees, milestones and royalties.
Aralez Pharmaceuticals announced it will acquire the U.S. rights to Toprol-XL (metoprolol succinate) and its Authorized Generic (AG) pursuant to an agreement entered into between AstraZeneca and Aralez Pharmaceuticals Trading DAC, a subsidiary of Aralez. Toprol-XL is a cardioselective beta-blocker indicated for the treatment of hypertension, alone or in combination with other antihypertensives; the long term treatment of angina pectoris and treatment of stable, symptomatic (NYHA class II or III) heart failure of specific origins. The agreement includes an initial upfront payment of $175 million, which will be financed through a previously committed senior secured debt facility with Deerfield Management. At closing, Aralez will also borrow funds under this credit facility to replenish $25 million that was paid from cash on hand in connection with the recently announced ZONTIVITY acquisition. In addition, Deerfield has agreed to provide Aralez access to up to an additional $250 million in capital to fund future mutually agreeable acquisitions. The transaction with AstraZeneca also includes mid-teen percentage royalties and up to $48 million of potential contingent milestone payments.
Viking Therapeutics announced that the first patient has been dosed in the company’s Phase II clinical trial of VK2809 in patients with primary hypercholesterolemia and non-alcoholic fatty liver disease. VK2809 is a novel, orally available small molecule thyroid receptor agonist that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promising therapeutic potential in this patient population.
Amgen announced that the Journal of Clinical Oncology (JCO) published results from the Phase I/II ‘205 single-arm trial evaluating BLINCYTO (blinatumomab) in pediatric patients with Philadelphia chromosome‑negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Based on data from an exploratory pooled analysis of 70 patients who received the recommended dose of BLINCYTO in the Phase I or Phase II portions of the study, 27 patients (39 percent, 95 percent confidence interval [CI], 27–51 percent) achieved complete remission within the first two cycles. The most frequent grade ≥3 adverse events (AEs) among the patients who received the recommended dose were anemia (36 percent), thrombocytopenia (21 percent), febrile neutropenia (17 percent), hypokalemia (17 percent) and neutropenia (17 percent). The most common AEs overall were pyrexia (80 percent), anemia (41 percent), nausea (33 percent) and headache (30 percent).
Samsung Bioepis announced that the EMA has accepted for review the company’s MAA for SB3, a biosimilar candidate referencing Herceptin (trastuzumab). Herceptin is a monoclonal antibody (mAb) indicated for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer. The MAA for SB3 was submitted in August 2016.
Genentech, a member of the Roche Group, announced that it has received a second Breakthrough Therapy Designation (BTD) from the FDA for its anaplastic lymphoma kinase (ALK) inhibitor, Alecensa (alectinib). The latest BTD was granted for the treatment of adult patients with advanced ALK-positive non-small cell lung cancer (NSCLC) who have not received prior treatment with an ALK inhibitor.
Nuevolution announced that Amgen and Nuevolution have entered into a multiple target research collaboration to develop and commercialize novel therapeutics in the areas of oncology and neuroscience. Nuevolution will apply its Chemetics drug discovery platform to discover and advance potential therapeutics of interest to Amgen. The research collaboration brings together Nuevolution’s proprietary drug discovery platform with Amgen’s disease expertise and drug development capabilities. Under the terms of the agreement, Amgen has an exclusive option to obtain all rights to successfully developed programs. Nuevolution is eligible to receive a license fee payment upon option exercise and milestone payments upon achievement of specified research, development and commercial milestones, amounting up to USD 410 million per target. Nuevolution would also be entitled to receive royalties on future sales. Additional financial details are not being disclosed.
Reuters reported that AstraZeneca said its heart drug Brilinta failed to show any benefit over an existing medicine in treating peripheral artery disease (PAD) in a large-scale clinical trial. The company said it was disappointed that the drug, which is used to treat heart attack patients, had not been successful for PAD sufferers.
Otonomy announced the successful completion of a Phase II clinical trial that evaluated a single administration of OTIPRIO (ciprofloxacin otic suspension) for the treatment of pediatric patients with acute otitis media with tympanostomy tubes (AOMT). The Phase II trial was designed to evaluate the safety and tolerability of two dose levels of OTIPRIO, 6 mg (0.1 mL) and 12 mg (0.2 mL), administered in pediatric patients with AOMT and to determine the most appropriate dose for further development in this indication. The trial demonstrated that both OTIPRIO doses were well-tolerated, achieved higher and statistically significant clinical cure rates over sham (no treatment), with the highest clinical cure rate observed in the 12 mg dose group. Additional results from this trial will be presented at the Otonomy Investor and Analyst Day on October 7 and will be presented at an upcoming medical conference.
Ampio Pharmaceuticals announced that a manuscript titled: "Potential Beneficial Effect of Low Dose Danazol in Combination With Renin Angiotensin Inhibitors in Diabetic Macular Edema" was accepted for publication in Acta Ophthalmologica, an international peer-reviewed journal in the field of ophthalmology.
Cellectar Biosciences announced that the USPTO has issued a formal patent allowance for CLR 1603, which covers method of use for the treatment of a variety of solid tumors and associated cancer stem cells using the company’s phospholipid drug conjugate ("PDC") delivery platform technology with paclitaxel. This patent allowance follows the May 2016 issuance of the composition of matter patent for the same compound.
Tetra Bio-Pharma, through its subsidiary, PhytoPain Pharma, announced that it received a PRE-IND Acknowledgement and Meeting Request Granted letter from the FDA.
Dipexium Pharmaceuticals announced that it has been granted Small and Medium Enterprise (SME) designation by the EMA. The Company recently completed its pivotal Phase III clinical trials (OneStep-1 and OneStep-2) with Locilex in mild infections of diabetic foot ulcers in the U.S. under a Special Protocol Assessment (SPA) agreement from FDA. Dipexium expects to have top-line data from these trials available for release shortly as its scientific advisory team is finalizing the database, which currently remains blinded.
Dimension Therapeutics announced that the FDA granted orphan drug designation for the Company’s product candidate, DTX401, the first AAV gene therapy to enter IND-enabling studies for the treatment of GSDIa. Designed to address the underlying genetic defect, DTX401 delivers stable expression and activity of the enzyme glucose-6-phosphatase (G6Pase). DTX401 has been shown to improve G6Pase activity and reduce hepatic glycogen levels, a well-described biomarker of disease progression, in multiple in vivo preclinical models.
Catabasis Pharmaceuticals announced that target enrollment of 30 patients has been reached for Part B of the MoveDMD trial, a 12-week trial to assess the safety and efficacy of edasalonexent (CAT-1004) in Duchenne muscular dystrophy (DMD). Edasalonexent is an oral small molecule that the Company believes has the potential to be a disease-modifying therapy for DMD patients, regardless of their underlying dystrophin mutation. Catabasis has previously reported positive safety, tolerability, pharmacokinetics and biomarker results from Part A of the trial. Based on scheduling of the enrolled patients as of September 30, 2016, the Company expects to report top-line safety and efficacy results from this Phase II trial in the first half of Q1 2017.
PTC Therapeutics announced that the Proceedings of the National Academy of Sciences (PNAS) has published new results further validating Translarna’s (ataluren) mechanism of action to promote readthrough of premature stop codons resulting from nonsense mutations in genetic disorders. The results reported in PNAS establish ataluren’s ability to alter the protein production process at premature stop codons and to promote the insertion of specific amino acids and restore the production of a full-length functional protein.
Daiichi Sankyo announced that it has entered into a strategic collaboration with AgonOx, a privately held biotechnology company developing a pipeline of novel immunotherapy drugs targeting key regulators of the immune response to cancer, to develop an undisclosed immuno-oncology target. Under terms of the agreement, Daiichi Sankyo and AgonOx will collaborate on preclinical development of the program. Following preclinical assessment, Daiichi Sankyo has an exclusive option to research, develop, manufacture and commercialize the program worldwide. Financial terms of the agreement were not disclosed.
Theravance Biopharma announced dosing of the first patient in a Phase Ib clinical trial of TD-1473 in patients with moderate to severe ulcerative colitis. TD-1473 is a novel, potent, orally administered and intestinally restricted pan-Janus kinase (JAK) inhibitor in clinical development, with the potential to treat a range of inflammatory intestinal diseases. Importantly, TD-1473 is specifically designed to act directly at the site of inflammation in the intestinal wall with minimal systemic exposure.
pSivida announced that its second Phase III trial of Medidur in chronic, non-infectious posterior segment uveitis met its target enrollment of 150 patients. The trial is being conducted in clinical sites in India, with the same study design and endpoints as the first Phase III trial conducted in the US, EU and India. The results of both Phase III trials will support US product registration, with NDA submission planned for the second half of 2017. Filing for EU registration remains on track for the first calendar quarter of 2017.
Axsome Therapeutics announced the publication of data showing that AXS-02 (oral zoledronate) inhibits pain in a well-validated animal model of complex regional pain syndrome (CRPS).
Five Prime Therapeutics announced that it has initiated the Phase Ib portion of the clinical trial evaluating the immunotherapy combination of cabiralizumab (FPA008), Five Prime’s investigational monoclonal antibody that inhibits colony stimulating factor-1 receptor (CSF1R), with OPDIVO (nivolumab), Bristol-Myers Squibb‘s PD-1 immune checkpoint inhibitor, in multiple tumor types.
Halozyme Therapeutics announced that its investigational drug, PEGPH20, and a companion diagnostic assay for assessment of hyaluronan (HA) under development by Ventana Medical Systemswill be included in a groundbreaking pancreatic cancer clinical trial initiative called Precision Promise.
PharmaMar announced a licensing agreement with Boryung Pharm to commercialize the marine-derived anticancer drug Aplidin (plitidepsin) in South Korea. Under the terms of the agreement, PharmaMar will receive an upfront payment along with royalties and additional remunerations upon achieving regulatory milestones with Aplidin. PharmaMar will retain exclusive production rights and will supply the finished product to Boryung Pharm for commercial use.
EUSA Pharma announced the acquisition of exclusive global commercialization rights to the oncology product Isqette (dinutuximab beta) from Apeiron Biologics. Dinutuximab beta is currently used as part of the regimen for the treatment of high risk neuroblastoma in Europe and is available under a managed access program. The immunotherapy has orphan drug designation in the US and EU and is currently under review for marketing authorization by the EMA. EUSA expects to file the product for registration in the US and Japan in 2017.
Infirst Healthcare announced top line results from its Phase III study IFH-2014-002, investigating the effectiveness of a low dose (1200 mg total daily dose) of lipid formulated ibuprofen capsule in comparison with a low dose (1200 mg total daily dose) and high dose (2400 mg total daily dose) standard soft gel ibuprofen capsules.
Eisai Co. announced that its research subsidiary Morphotek has signed an exclusive licensing agreement with Eurofarma Laboratorios S.A. to develop and commercialize the monoclonal antibody farletuzumab (development code: MORAb-003) as a potential anticancer agent in Latin America. Under the terms of the agreement, Morphotek will receive from Eurofarma an upfront payment as well as scheduled development and sales milestone payments. Additionally, Morphotek will receive royalties from commercial sales of farletuzumab in Latin America. Morphotek will supply Eurofarma with clinical and commercial materials while Eurofarma has the option to assume responsibility for filling and packaging farletuzumab vials. Morphotek retains all rights to develop and commercialize farletuzumab in regions outside of Latin America.
Merck announced the launch of two innovative fertility technologies, Gavi oocyte protocol and Geri medium. Both products help to improve key steps of assisted reproductive treatment (ART) – an area where laboratory technologies play a vital role for treatment success.
Ajinomoto Althea announced that a biologics candidate developed by a Japanese global pharmaceutical company and manufactured at Ajinomoto Althea using CORYNEX Protein Expression System, has entered phase I clinical trials.
Turing Pharmaceuticals announced a sponsored research agreement with Washington University in St. Louis (WUSL) to investigate novel treatments for toxoplasmosis.
Acorda Therapeutics announced that Chief Financial Officer Michael Rogers has left the company. David Lawrence, Acorda’s Chief of Business Operations, has assumed the role of Chief, Business Operations and Principal Accounting Officer. Andrew Hindman, Acorda’s Chief Business Development Officer, has assumed responsibility for Financial Planning and Analysis and Investor Relations. Mr. Rogers will serve as a consultant to the Company through the end of the year as part of this transition.
Cytovance Biologics announced the appointment of Jenny Chen to Chief Financial Officer.
Immune Design announced the appointment of Sergey Yurasov, M.D., Ph.D. as Senior Vice President of Clinical Development and Chief Medical Officer.
Seattle Genetics announced two executive promotions and an executive appointment to the company’s clinical development leadership team. Vaughn B. Himes, Ph.D., has been promoted to Chief Technical Officer. Dennis Benjamin, Ph.D., has been promoted to Senior Vice President, Translational Research. Dr. Benjamin will be responsible for preclinical research, nonclinical sciences and experimental pharmacology. Seattle Genetics also named Robert J. Lechleider, M.D., as Senior Vice President, Clinical Development.
Mirati Therapeutics announced the appointment of Chris LeMasters to the newly created position of Executive Vice President and Chief Business Officer, effective September 30, 2016.
MyoKardia announced the closing of its previously announced underwritten public offering of 4,370,000 shares of common stock, at the public offering price of $15.00 per share, which included 570,000 shares sold pursuant to the full exercise by the underwriters of their option to purchase additional shares. MyoKardia estimates net proceeds from the offering to be approximately $61.0 million, after deducting underwriting discounts and commissions and estimated offering expenses. Credit Suisse Securities and Cowen acted as joint lead book-running managers for the offering. BMO Capital Markets acted as book-running manager. Wedbush PacGrow acted as co-manager.
Brean analyst Jason Wittes assumed coverage of the following companies: Alexion with a “buy” rating and $221 price target; Celldex with a “buy” rating and $16 price target; Neuralstem with a “buy” rating and $4 price target; Heron with a “buy” rating and decreased his price target to $41 from $55; Inovio with a “buy” rating and $18 price target; Progenics with a “buy” rating and decreased his price target to $11 from $14; Ohr with a “hold” rating.
Leerink analyst Paul Matteis resumed coverage of the following companies: Alkermes with an “outperform” rating and $57 price target; Aquinox with an “outperform” rating and increased his price target to $24 from $21; GW Pharmaceuticals with an “outperform” rating and increased his price target to$162 from $138; Neurocrine with an “outperform “rating and $70 price target; Sage Therapeutics with an “outperform” rating and increased his price target to $68 from $66; Zogenix with an “outperform” rating and decreased his price target to $17 from $19; Acorda with a “market perform” rating and $25 price target; Acadia Pharmaceuticals with a “market perform” rating and decreased his price target to $34 from $35.
Piper Jaffray analyst Joshua Schimmer increased his price target of Clovis to $42 from $14, citing a positive on the uptake of PARPi’s more broadly in ovarian cancer.
JP Morgan analyst Chris Schott revised his price targets of the following companies: Akorn decreased to $42 from $45; Coherus increased to $38 from $35; Impax decreased to $28 from $30; Mylan decreased to $52 from $62; Teva decreased to $65 from $75; Zoetis increased to $53 from $50.
Mizuho analyst Irina Koffler downgraded Depomed to “neutral” from “buy,” citing a likely take out at $29 and lack of upside.
Piper Jaffray analyst Edward Tenthoff initiated coverage of Xenocor with an “overweight” rating and $35 price target, citing Xencor is developing next-gen and bispecific antibodies utilizing the company’s proprietary XmAb technology.
Janney analyst Debjit Chattopadhyay increased his fair value estimate of Summit Therapeutics to $18 from $13, citing Summit licensed the European rights of its lead investigational candidate ezutromid to Sarepta and in exchange will receive $40M upfront.
Piper Jaffray analyst Edward Tenthoff initiated coverage of Versartis with an “overweight” rating and $22 price target, citing Versartis is developing somavaratan, a long-acting recombinant Human Growth Hormone to treat growth hormone deficiency.
JP Morgan analyst Anupam Rama increased his price target of Ophthotech to $110 from $95, citing the current weakness as a buying opportunity because there are important mechanistic differences between Fovista versus REGN2176-3, early phase 1 data for Fovista are comparatively more compelling, the Fovista phase 3 readout will now be viewed as an independent binary catalyst, the bar for phase 3 success has potentially been reset, and a key intermediate / longterm debate around co-formulation versus co-administration has now been eliminated.