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Capricor Therapeutics $CAPR announced the completion of Phase 2 enrollment for clinical trial, ALLSTAR, which is assessing CAP-1002 (allogeneic cardiosphere-derived cells, or CDCs) in adults with cardiac dysfunction following a large heart attack (myocardial infarction, or MI).
The randomized, double-blind, placebo-controlled clinical trial has enrolled adults with a history of MI within the prior 12 months that resulted in scar tissue replacing at least 15% of total left ventricular mass. The primary endpoint is infarc size as measured by MRI. ALLSTAR will also explore additional efficacy parameters, such as ejection fraction and cardiac volumes, as well as evaluate the safety and tolerability of CAP-1002. The expected clinical trial completion date is September 2021.

Gilead $GILD to initiate Trials of filgotinib in Crohn’s and Ulcerative colitis with Galapagos- Galapagos N.V. $GLPG announced that it has successfully concluded negotiations with the both the American and European regulatory authorities that paves the way to initiate Phase 3 study, DIVERSITY, evaluating filgotinib for the treatment of Crohn’s disease and a Phase 2 b/3, SELECTION, in ulcerative colitis. Both studies will enroll about 1,300 participants at sites spread across the world. Gilead Sciences $GILB, a collaborative partner will lead the effort.

Alnylam Terminates revusiran development-Alnylam $ALNY shares nosedived in afterhours trading on Wednesday amid heavy volume trading in response to news that it has decided to terminate development of revusiran, an RNAi therapeutic for the potential treatment of hereditary ATTR amyloidosis (hATTR) with cardiomyopathy, an Orphan Drug Designation. The company also communicated its decision to regulatory authorities, study sites, and investigators.

Global Blood Falls Sharply ahead of Key sickle cell conference in London-Global Blood Therapeutics fell more than 10% on Wednesday amid four-fold increase in trading volume as investors remained anxious ahead of a key sickle cell meeting. The 2016 Sickle Cell Thalassemia Conference (ASCAT) got underway in London on Wednesday. Investors are edgy about the company’s lead product candidate, GBT440, in mid-stage development for sickle cell disease (SCD), particularly, a possibility that the efficacy period will be extended from 28 days to six months. At a Cowen panel today, doctors were unconvinced about GBT440's mechanism of action, adding to the bearish sentiment.GBT440 is an oral, once-daily SCD therapy that works by increasing hemoglobin's affinity for oxygen.

RedHill BioPharma Commences Mid-Stage Trial with YELIVA-RedHill BioPharma $RDHL announced that it has begun a Phase 2 clinical trial assessing YELIVA (ABC294640) in patients with advanced hepatocellular carcinoma (HCC). The study will be conducted at the Medical University of South Carolina Hollings Center, including several clinical centers in the U.S. It is supported by a $1.8mn grant from the National Cancer Institute. Enrollment for the study would commence soon. The trial will evaluate YELIVA as second-line monotherapy in up to 39 participants with advanced HCC who have experienced tumor progression following treatment with first line single agent sorafenib (Bayer’s Nexavar).

FDA cautions of risk of HBV reactivation in patients taking HCV meds-The FDA notified that it now requires a black box warning in the labels of at least nine brand name direct acting antiviral drugs for the treatment of hepatitis C virus (HCV) infection due to the risk of reactivation of hepatitis B in patients who previously had the disease. The authority said that it has observed 24 cases of such reactivation from November 22, 2013 to July 18, 2016. The revised labeling applies to Gilead Sciences $GILD Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir), AbbVie's $ABBV Viekira Pak (ombitasvir/paritaprevir/ritonavir, dasabuvir) and Merck's $MRK Zepatier (elbasvir and grazoprevir).

Hurricane Matthew Might Spread Zika Virus-Officials in Florida have warned that hurricane Matthew could make controlling Zika a difficult task by interrupting mosquito-spraying efforts and boosting numbers of the biting bugs that spread the virus. The warnings come just after the authorities revealed six new suspected non-travel Zika cases in Miami Beach and Miami-Dade County, adding the number of cases where local mosquitoes are believed to have caused infections to 139. Zika treatment related tickers are: $SNY, $ABT, $INO, $AEMD, $XON, $CEMI, $BCRX, $TMO, $OSUR.

The European Medicines Agency has accepted the Marketing Authorization Approval (MAA) of Repros Therapeutics $RPRX, seeking approval of enclomiphene cirate for the treatment of secondary hypogonadism. The maximum time limit for an opinion to be issued by the advisory Committee for Medicinal Products for Human Use (CHMP) is 210 days. If encouraging, a final decision from the European Commission is announced in about 60 days. Its U.S. application was rejected by the FDA in December 2015 citing the need for more supporting data, i.e., a new Phase 3 study will be needed to support the filing.

The FDA labelled Roche’s $RHHBY Actemra/RoActemra (tocilizumab) a Breakthrough Therapy for the treatment of giant cell arteritis (GCA), a chronic potentially life-threatening autoimmune condition characterized by the inflammation of the large and medium-sized arteries. If a drug candidate receives as Breakthrough Therapy Status by the FDA then the company which is developing the treatment gets intensive guidance from the regulator’s review team, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).

No patents to report.

In order to get the European Commission's nod to its $35B acquisition of Actavis Generics, Teva Pharmaceutical Industries $TEVA sold Actavis' UK and Ireland assets and operations to Intas Pharmaceuticals unit Accord Healthcare Limited for ₤603M ($766M). The deal includes a portfolio of generic medicines and a manufacturing plant in Barnstaple, England. Teva, however, will continue to retain some non-overlapping generics, specialty medicines and OTC products. The deal is expected to close in next three months.

Insmed $INSM inked a deal with AstraZeneca $AZN, which gives the former rights to $AZN’s AZD7686, an oral inhibitor of enzymes called dipeptidyl peptidase 1 (DPP1). It plays a vital role in the activation of neutrophil serine proteases, enzymes that mediate innate immune responses and play an important role in certain pulmonary diseases like non-cystic fibrosis bronchiectasis, chronic bronchial inflammation that can lead to respiratory failure. According to the terms of the deal, $AZN will receive an upfront payment of $30mn, up to $120mn in milestones and tiered high-single-to-med-teens royalties on net sales.
Under the terms of the agreement, AstraZeneca will receive an upfront payment of $30M, up to $120M in milestones and tiered high-single-digit-to-med-teens royalties on net sales. In addition, AZN also has the option to negotiate a future agreement for commercializing AZD7986/INS1007 in chronic obstructive pulmonary disease or asthma.

Concordia International $CXRX announced on Wednesday that it began an offering of new 5 ½ year Senior Secured First Lien notes. However, its board hasn’t announced on the interest rate, principal amount and maturity of notes. Net proceeds from the offering will be utilized to support its development pipeline and improve its liquidity position.

No IPOs to report.

Acorda Therapeutics $ACOR CFO, Michael Rogers has left the company, seemingly due to the demand of traveling from Boston. David Lawrence, meanwhile, has taken up the role of Principal Accounting Officer. He was serving as Chief of Business Operations. Andrew Hindman, who is serving as Chief Business Development Officer, will be having added responsibilities of Financial Planning and Analysis and Investor Relations. Mr. Rogers will now serve as a consultant through the end of the year to assist the transition.