CALA Surges On BMY Deal, OVAS Hands Pink Slips, MACK Halts Breast Cancer Study

(RTTNews) - The FDA has turned down Advanced Accelerator Applications S.A.'s (AAAP) New Drug Application for Lutathera for the treatment of gastroenteropancreatic neuroendocrine tumors in adults.

In its complete response Letter issued to the company, the FDA has questioned the format, traceability, uniformity, and completeness relating to the clinical datasets, and has also sought for subgroup analyses for gender, age and racial subgroups, as well as other stratification factors and important disease characteristics.

AAAP closed Wednesday's trading at $24.68, down 5.84%.

Alexion Pharmaceuticals Inc.'s (ALXN) phase 2/3 registration trial of Soliris for the prevention of delayed graft function after kidney transplantation in adult recipients of a deceased donor kidney has failed to meet the primary endpoint.

In the trial, dubbed PROTECT, the incidence of delayed graft function, or DGF, with a two-dose regimen of Soliris was set as the primary goal, and it did not reach statistical significance. The primary endpoint also included incidence of death, graft loss, and loss to follow-up, including discontinuation.

DGF is an early and serious complication of organ transplantation in which the transplanted organ fails to function normally immediately following transplantation.

Soliris is approved by the FDA to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare type of blood disorder that can lead to disability and premature death, and to treat atypical Hemolytic Uremic Syndrome (aHUS), a rare and chronic blood disease that can lead to kidney (renal) failure and is also associated with increased risk of death and stroke.

The drug's net product sales in Q3, 2016, were $729 million compared to $665 million in Q3 2015. For full year 2016, the company anticipates the drug to bring home sales of $2.84 billion to $2.88 billion.

ALXN closed Wednesday's trading at $118.99, up 1.94%.

Shares of Calithera Biosciences Inc. (CALA) rose more than 39% on Wednesday after announcing a clinical trial collaboration with Bristol-Myers Squibb Co. (BMY).

The collaboration aims to evaluate Bristol-Myers Squibb's Opdivo in combination with Calithera's CB-839 in patients with clear cell renal cell carcinoma (ccRCC). CB-839 is an orally administered glutaminase inhibitor currently in Phase 1/2 clinical studies.

CALA closed Wednesday's trading at $3.65, up 19.67%.

Concert Pharmaceuticals Inc. (CNCE) has initiated a phase II clinical trial of CTP-656 for the treatment of cystic fibrosis.

The trial is designed to enroll about 30-40 patients, and topline results are expected by year-end 2017.

CNCE closed Wednesday's trading at $9.37, up 3.08%.

Seeking to improve cost structure, OvaScience (OVAS) is reducing its workforce by approximately 30 percent and will slow the commercial expansion of its fertility treatment AUGMENT.

The AUGMENT treatment is available in certain IVF clinics in Canada and Japan, and the company will limit the growth of its commercial infrastructure in those countries.

The cost cutting measures are expected to extend the cash runway into the first quarter of 2019.

OvaScience is also exploring the potential entry into the U.S. market.

OVAS closed Wednesday's trading at $2.97, down 0.67%. In after-hours, the stock was down another 27.61% to $2.15.

Shares of Merus B.V. (MRUS) touched a new high on Wednesday, rising as much as 57%, following global strategic research collaboration with Incyte Corp. (INCY) to discover and develop bispecific antibodies.

The Collaboration and License Agreement grants Incyte the exclusive rights for up to eleven bispecific antibody research programs, including two of Merus' current preclinical immuno-oncology discovery programs.

As part of the agreement terms, Incyte will make an up-front payment of $120 million and purchase 3.2 million shares of Merus stock at $25 per share, for a total equity investment of $80 million. Merus is also entitled to receive potential development, regulatory and commercial milestones and sales royalties.

The transaction, subject to customary conditions, is expected to close in the first quarter of 2017.

MRUS touched a new high of $22.18 on Wednesday, before closing the day's trading at $20.22, up 42.90%.

Shares of Merrimack Pharmaceuticals Inc. (MACK) dropped to a new 52-week low on Wednesday after the company announced that it has pulled the plug on its phase II study of MM-302 in HER2-positive metastatic breast cancer patients, dubbed HERMIONE.

The decision to stop the trial was based on the opinion of Data and Safety Monitoring Board that the study is unlikely to demonstrate benefit over the comparator treatments.

MACK touched a new 52-week low of $4.35 on Wednesday before closing the day's trading at $4.38, down 18.44%.