Premarket Biotech Digest – RDHL Initiates Two Products. BMY Starts Recall, PULM Inks New Deal
Top Pick of the Day: RDHL
RedHill Biopharma (RDHL) stock perked up as the company announced starting two GI-focused products in the U.S. These products are Donnatal, to be used for the adjunctive treatment of irritable bowel syndrome and EnteraGam, designed for the dietary management of chronic diarrhea and loose stools. The company has inked an exclusive co-promotion agreement with Concordia International for Donnatal. The agreement allows for the revenue sharing between the companies. It has also exclusively licensed EnteraGam from Entera Health. The company will pay royalties on net sales.
RedHill stock is currently 9 percent down on YTD basis. The company is focused on the development and commercialization of clinical-stage, orally-administered, small molecule drugs.
Focus Ticker: APTO
Aptose Biosciences (APTO) stock is on rally as the company announced updates for its pipeline candidates CG'806 and APTO-253. The company plans to continue with its study of APTO-253, a c-Myc oncogene inhibitor. The company aims to find the root cause of recent manufacturing setbacks related to the intravenous formulation, it also plans to restore the molecule to an appropriate state for clinical trials and partnering. CG’806 is a pan-FLT3/BTK inhibitor, showed superiority over other agents in a cellular model of FLT3-positive AML. It successfully eliminated AML FLT3-ITD tumors without toxicity in a mouse model.
The company stock gained over 21 percent in its previous trading session, taking its YTD gain to 12.23 percent. The stock is down 47 percent on 12 months basis.
Sector News
Endo International (ENDP) President & CEO Paul Campanelli said the company will work with the FDA over the issue of OPANA ER availability. He claimed that OPANA ER is prescribed nearly 50,000 times each month. He also added that the company will no longer promote pain products.
Bristol-Myers Squibb (BMY) announced voluntarily recalling a single lot of blood thinner Eliquis (apixaban) that was distributed to wholesalers and retail pharmacies in February.The decision has been taken pursuant to a complaint that a bottle labeled as 5 mg tablets was found to contain 2.5 mg tablets.
Approvals
Pfizer (PFE) announced that its Phase 3-stage tanezumab has been designated for Fast Track review by the FDA for the treatment of chronic pain in patients with osteoarthritis and chronic back pain. The company is collaborating with Eli Lilly for this purpose.
NeuroMetrix (NURO) announced that it has been issued U.S. Patent No. 9,675,801 by the USPTO covering novel mechanisms to help Quell users safely obtain pain relief therapy over extended periods of time
Deals and Collaborations
Pulmatrix (PULM) announced inking a new deal with Janssen Biotech subsidiary RespiVert Ltd. for exclusive global rights to a portfolio of kinase inhibitors that it intends to develop for inhaled formulations based on its iSPERSE technology. The companies did not disclose the financial terms of the contract.
AbbVie (ABBV) announced inking a collaboration with privately held Principia Biopharma for developing oral immunoproteasome inhibitors for the potential treatment of autoimmune and inflammatory disorders. AbbVie will be responsible for ongoing clinical development and commercialization of compounds resulting from the partnership.
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