Join Now - it is FREE

Basic level includes our interactive biotech chatroom, forum, biotech stock screener; you also receive the biotech digest in your email everyday.

Sarepta Therapeutics $SRPT inked a deal with Summit Therapeutics $SMMT for its Duchenne pipeline candidates. $SMMT soared in response to the news. Under the terms of the deal, $SMMT will grant an exclusive license to its utrophin modulator pipeline, including lead product candidate ezutromid, for the treatment of Duchenne muscular dystrophy (DMD). Sarepta's licensed territory includes Europe, Turkey and the Commonwealth of Independent States (Russia and eight former members of the Soviet bloc). It also has an option to the rights in Latin America. Summit holds commercialization rights in all other countries. Summit will get an upfront payment of $40mn and up to $522mn in milestone payments and escalating low-to-high-teens royalties on net sales. Sarepta and Summit will share utrophin modulator-related R&D costs on a 45%/55% basis starting in 2018. If Sarepta exercises its option on Latin America, Summit will be eligible for additional fees, milestones and royalties.

Catabasis Pharmaceuticals $CATB reached its enrollment target in its second part of mid-stage study of edasalonexent (CAT-1004) for the treatment of Duchenne muscular dystrophy (DMD). The study enrolled 30 participants. The primary endpoints are safety and tolerability over 12 weeks and muscle composition and inflammation as measured by MRI at Week 12. The topline data should be available in Q1 2017.

Cascadian Therapeutics Plans reverse stock split-The board of Cascadian Therapeutics $CASC approved a plan for a reverse stock split of the company’s common stock at a ratio between 1:4 and 1:10, inclusive. The company plans to hold a special meeting on November 18 to get shareholders’ approval for the proposed action.

Trovagene’s Trovera liquid biopsy to be a part of pancreatic cancer Clinical Trial-Trovagene $TROV announced on Thursday that its Trovera liquid biopsy will participate in a pancreatic cancer study dubbed as Precision Promise, a large scale trial designed to find out the use of precision medicine to improve patients recovery. The non-for-profit organization, the Pancreatic Cancer Action will make an initial investment of $35mn to begin the study. As the company is a founding member of the initial Precision Promise Industry Working Group has not come as a surprise to see the inclusion of its liquid biopsy in the study.

Roche's Alecensa Gets BTD by FDA for ALK-positive non-small cell lung cancer-Roche $RHHBY was granted a second Breakthrough Therapy Designation (BTD) from the FDA for its ALK inhibitor, Alecensa (alectinib), intended for the treatment of adult patients with advanced anaplastic lymphoma Kinase (ALK) positive non-small cell lung cancer, who not received prior treatment with an ALK inhibitor. Alecensa is currently approved in the U.S. for ALK positive NSCLC patients who have shown progress or are intolerant to crizotinib, the treatment’s first BTD tag.

AstraZeneca’s Brilinta Flunks to Better Plavix in Large-scale CV outcome study-Phase 3 clinical trial, EUCLID, assessing AstraZeneca’s $AZN Brilinta (ticagrelor) against Bristol-Myers Squibb $BMY and Sanofi's $SNY Plavix (clopidogrel) for the prevention of atherothrombotic events (a composite of cardiovascular death, heart attack (MI) or ischemic stroke) in patients with symptomatic peripheral artery disease (PAD) failed to meet its primary endpoint.

Bayer Concludes EU Registration Process for Contraceptive Candidate-Bayer $BAYRY completed its European registration process to gain EU-wide marketing authorization for its new low dose levonorgestel-releasing intrauterine system (LNG-IUS) for the long-term prevention of pregnancy. Based on the positive outcome, the Health Authorities of the EU member nations will grant national marketing authorizations in the coming weeks and months. The drug-maker intends to introduce the new five year contraceptive under the brand name Kyleena, subject to the approval.

Ocular's late-stage Trial of OTX-TP in glaucoma and ocular hypertension starts-The enrollment process for Phase 3 clinical trial, evaluating Ocular Therapeutix’s $OCUL OTX-TP (sustained released travoprost) for the treatment of glaucoma and ocular hypertension. The trial is the first two planned that will support regulatory applications, subject to its success. The trial includes two arms, the study drug and a comparator arm using a non-drug-eluting hydrogel-based intracanalicular insert. It will not include a timolol comparator arm nor active or placebo eye drops in either arm. The primary endpoint is the reduction in intraocular pressure from baseline to Weeks 2, 6 and 12 following insertion. The topline data are expected in H1 2018.

Samsung Bioepis' Herceptin biosimilar under review in Europe-Samsung Bioepis, a joint venture between Samsung BioLogics and Bioge, announced that the European Medicines Agency (EMA) has agreed to review the company’s Marketing Authorization Application (MAA) for SB3, a biosimilar to Roche’s Herceptin (trastuzumab). Herceptin is a monoclonal antibody indicated for the treatment of breast cancer and gastric cancer. The MAA got submitted in August. Merck $MRK will distribute and market SB3 in Europe, if it is approved.

Viking's mid-stage study of VK2809 in high cholesterol and fatty liver disease Commences-The first patient got dosed in Viking Therapeutics’ $VKTX Phase 2 study evaluating VK2809 for the treatment of patients with primary hypercholesterolemia and non-alcoholic fatty liver disease. The subjects will receive once-a-day oral doses of VK2809 or placebo for 12 weeks followed by a four weej off-drug phase. The primary endpoint of the 80-subject, randomized, double-blind, placebo-controlled, parallel group study is the effect of VK2809 on LDL-C from baseline to Week 12 compared to placebo. Secondary endpoints will evaluate changes in liver fat content, triglycerides and inflammatory biomarkers. The topline data is expected in Q1.

No approvals to report.

No patents to report.

Aralez Pharmaceuticals $ARLZ, through its subsidiary Aralez Pharmaceuticals Trading DAC signed an agreement with AstraZeneca $AZN for the commercial rights of branded and authorized generic Toprol-XL (metoprolol succinate), a beta broker, for the control of high blood pressure, chest pain, and heart failure. As per the terms of the deal, $AZN will be paid $175mn for granting rights to the branded product and the authorized generic version marketed by Par Pharmaceuticals. In addition, AZN will also receive up to $48mn in milestone payments and mid-teen royalties on net sales. The transaction is expected to close this quarter.

No secondary offerings to report.

No IPOs to report.

Micro cap stock, IRADIMED $IRMD slumped on Wednesday amid heavy trading volume in response to its announcement that it has lowered its sales and earnings forecast for Q3 and FY2016. For the Q3, the company expects revenue of $7.5 to $7.6mn, down from its earlier outlook of $9.9mn to $10mn. Non-GAAP EPS guidance is now of $0.11-$012, down from earlier forecast of $0.23-$0.24. GAAP EPS is expected at $0.09 to $0.10. For 2016, non-GAAP EPS forecast if at $0.60-$0.63, down from $0.91 to $0.93 and revenue expectations trimmed to $$33.2mn from $39 0$40mn. CEO Roger Susi says the underperformance is due to a combination of underestimating sales cycle times resulting from the company's new sales strategy and the focus on reducing backlog, a long-stated objective.

Theratechnologies Inc. $THERF today reported its fiscal third quarter results (for the quarter ended August 31) on Tuesday. For the quarter, net sales were $8,925,000. Adjusted EBITDA was $1,297,000. Net profit came at $888,000. Commenting about the results, Theratechnologies’ President and CEO, Luc Tanguay, said, “In the third quarter, Theratechnologies continued to progress in accordance with its business plan and guidance for 2016. Sales are on track, we are managing expenses carefully and operations are consistently generating positive EBITDA. At the same time, the ibalizumab phase III trial is proceeding on schedule and we have started preparing for the anticipated launch in the United States in 2017.”