FDA Snubs AMAG, Bright Pathway For STEM, AVXL Surges, Be All Ears For OTIC

(RTTNews) - Aduro Biotech Inc. (ADRO) has submitted an Investigational New Drug Application to the FDA for ADU-741, a LADD immunotherapy product candidate for the treatment of prostate cancer, paving way for the company's license partner Janssen to initiate a phase I study.

Aduro has an agreement with Janssen for certain product candidates specifically engineered for the treatment of prostate cancer based on Aduro's novel LADD immunotherapy platform, valued at over $346 million.

Following the IND submission, Aduro has received a milestone payment from Janssen.

ADRO closed Wednesday's trading at $28.73, down 0.48%.

AMAG Pharmaceuticals Inc's. (AMAG) manufacturing supplement seeking approval for a single-dose vial of Makena to reduce the risk of preterm birth in certain at-risk patients has been turned down again by the FDA.

Makena, the only FDA-approved treatment indicated to reduce the risk of preterm birth in women who are pregnant with one baby and who have spontaneously delivered one preterm baby in the past, is currently marketed in a multi-dose vial, containing five weekly injections.

Makena came under AMAG pharma's fold following the acquisition of Lumara Health last September. The company's manufacturing supplement seeking approval for a single-dose vial of Makena was sent back to the drawing board in May of this year too.

In the complete response letter issued to AMAG Pharma yesterday, the FDA has requested additional information, and the company is working with its manufacturer to submit a response addressing the issues raised by the regulatory agency.

Looking ahead to full year 2015, the company expects Makena net sales to range between $245 million and $270 million.

AMAG closed Wednesday's trading at $29.06, down 1.66%. In after hours, the stock fell 12.94% to $25.30.

Shares of Anavex Life Sciences Corp. (AVXL), which surged over 63% on Wednesday, continued its hot streak in extended trade too, following the company's decision to advance its drug candidate ANAVEX 2-73 for the treatment of Alzheimer's disease in a larger double-blinded, randomized, placebo-controlled phase 2/3 trial.

Christopher Missling, President and CEO of the company said, "By implementing a different, innovative trial design for ANAVEX 2-73 in Alzheimer's treatment, it is believed that this is more efficient than a conventional Phase 2 study since it is designed to reduce the risk of a Phase 3 trial failure, as well as receiving the best quality information we can about ANAVEX 2-73."

AVXL closed Wednesday's trading at $5.30, up 63.58. In after hours, the stock was up another 15.47% at $6.12.

Bristol-Myers Squibb Co.'s (BMY) cancer drug Opdivo, as a single agent, continued to demonstrate superior overall survival in treatment-naïve BRAF wild-type advanced melanoma patients - with 57.7% of patients alive at two years compared to 26.7% of patients treated with gold standard for treatment Dacarbazine in a phase III trial, dubbed CheckMate -066.

The company's supplemental Biologics License Application for Opdivo for the treatment of patients with previously untreated advanced melanoma is under FDA review, with a decision slated for November 27, 2015.

In the U.S., the FDA granted its first approval for Opdivo for the treatment of patients with unresectable or metastatic melanoma who no longer respond to other drugs last December.

In related news, a follow up of a phase 1b multidose, dose-finding study of Opdivo, in combination with Yervoy, in patients with unresectable or metastatic melanoma has shown three year overall survival rate of 68% across the dosing cohorts.

Last month, Opdivo in combination with Yervoy was granted accelerated approval for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

BMY closed Wednesday's trading at $67.61, up 2.86%.

Otonomy Inc. (OTIC) has commenced enrollment in the U.S. phase 3 clinical trial of OTO-104 in Ménière's disease. A second phase III trial is expected to be initiated in the EU in the first quarter of 2016.

Ménière's disease is a chronic condition characterized by acute vertigo attacks, tinnitus, fluctuating hearing loss and a feeling of aural fullness.

The company anticipates reporting phase III results in the second half of 2017.

OTIC closed Wednesday's trading at $29.02, up 1.50%.

StemCells Inc.'s (STEM) proprietary human neural stem cells administered into patients with traumatic injury in the cervical region of the spinal cord have demonstrated motor improvements in both strength and function, according to interim results from the first cohort of the ongoing phase II Pathway Study.

The first cohort of the Pathway Study evaluated the safety and preliminary signs of efficacy, of cell administration into the cervical cord and is used to select the dose level for the 40-patient second cohort, a randomized, controlled and single-blinded arm of the trial, which is already underway.

STEM closed Wednesday's trading at $0.45, up 1.11%. In after hours, the stock was up 49.45% at $0.68.

Shares of Vitae Pharmaceuticals Inc. (VTAE) were up over 23% in extended trading on Wednesday, following positive top-line results from the healthy human volunteer part of the multiple ascending dose phase I clinical trial of VTP-43742, a drug candidate for the treatment of multiple autoimmune disorders, including psoriasis.

The part of the study, which examined the safety, tolerability, pharmacokinetic and pharmacodynamic profile of multiple oral doses of VTP-43742 in 40 healthy human volunteers, has shown VTP-43742 to be safe and generally well tolerated at all dose levels. No serious adverse events were reported, and all study subjects completed the full 10 days of dosing, according to the company.

The top-line clinical efficacy results from the second part of the phase I trial, which is a proof-of-concept trial in patients with moderate to severe psoriasis, are expected in the first quarter of 2016.

VTAE closed Wednesday's trading at $12.98, down 3.64%. In after hours, the stock was up 23.27% at $16.00.