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Calithera Biosciences ($CALA) stock jumped in the premarket session as the company announced its new global collaboration and license agreement with Incyte Corporation. The agreement deals with research, development and commercialization of Calithera’s first-in-class, small molecule arginase inhibitor CB-1158 in hematology and oncology.
The deal will involve up-front payment of $45 million to Calithera. The company will also receive $8 million through the purchase of shares at a price of $4.65 per share. In return, Incyte will receive worldwide rights to develop and commercialize CB-1158 in hematology and oncology. Calithera will keep certain rights pertaining to research, develop and commercialize certain other arginase inhibitors in certain orphan indications.
The stock recorded 27.17% increase in its premarket trading session.

Rexahn Pharmaceuticals Inc. ($RNN) stock showed a strong performance this year, wiping out some of the steep losses it had incurred previous year. The stock is up 26 percent this year so far. The company had recently provided updates about the current Phase IIa clinical trial of RX-3117 in metastatic pancreatic cancer. Rexahn is upbeat about the results as it reported that 20% of patients exhibiting progression free survival of greater than 5.6 months including one patient having progression free survival of 7.2 months.
The company had closed its third quarter with $21.8 million in cash and investments. The main outflow of the cash was related to operating activities. Rexahn is confident that its current liquidity situation is sufficient to see it into the first half of 2018. With strong data on its lead drug candidate, the stock price is expected to show strength.

 

• Regulus Therapeutics ($RGLS) announced that the FDA has extended the clinical hold on its lead product candidate RG-101. The hold was first instituted in June, 2016 and will remain in place until more safety data are available. The FDA is mainly interested in reviewing final safety and efficacy data from the current clinical and preclinical studies. The required data is expected to be available in the fourth quarter.
• Aurinia Pharmaceuticals ($AUPH) announced that it has selected clinical research outfit Worldwide Clinical Trials to run its AURORA Phase 3 study for the evaluation of its lead product candidate voclosporin for treating lupus nephritis. The pivotal trial is expected to commence in the second quarter.
The study will involve randomized 320 subjects. The primary endpoint of the study is the number of participants achieving renal response (complete remission) at week 24. The study is expected to be completed by March, 2020 while the estimated final data collection date for the primary objective is December 2019.

• uniQure ($QURE) announced receiving Breakthrough Therapy for the treatment of severe hemophilia B for its Phase 1/2-stage gene therapy AMT-060. The designation will provide the company with many benefits including more intensive guidance from the FDA, the involvement of more senior agency personnel and a rolling review of the marketing application.
• Ironwood Pharmaceuticals ($IRWD) announced positive top-line results from a Phase 3 clinical trial assessing linaclotide in Japanese patients with chronic constipation. The final results will be used for supporting a regulatory application in Japan. The drug is currently approved in Japan to treat irritable bowel syndrome with constipation.

 
• Mallinckrodt ($MNK) announced that it has completed the divestment of its nuclear imaging unit to radiopharmacy outfit IBA Molecular, before tax, including up-front and contingent considerations and the assumption of long-term obligations. The deal is priced at $690 million. It was first announced in August, 2016.
The company’s Nuclear Imaging operations encompass two manufacturing facilities. The company is now looking to transform its portfolio with durable and innovative specialty pharmaceutical assets. Mallinckrodt will pay $574 million in up-front consideration, assume approximately $39 million of long-term obligations, and approximately $77 million of contingent consideration.

 

• Hill-Rom Holdings ($HRC) reported its first quarter revenue at $637.4 million, down 3.6 percent. Its net income for the quarter stood at $23.8 million. The company expects its FY2017 non-GAAP EPS to be in the range of $3.74 to $3.82.

• Humana ($HUM) receives Buy rating from Bank of America Merrill Lynch. The price target for the stock has been set at $250.
• Clovis Oncology ($CLVS) receives Buy rating from Bank of America Merrill Lynch. The price target for the stock has been set at $74.

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