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EIGR Soars On Progeria Deal, BOLD Investors Emboldened, BDSI's Cash Strengthens

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The following are some of today's top gainers in the pharma/biotech sector.

1. Eiger Pharmaceutical Inc. (EIGR)

Gained 41.77% to close Thursday's (May 17) trading at $16.80.

News: The Company has expanded its licensing agreement with Merck to include rights to develop experimental drug Lonafarnib for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria), a rare and fatal genetic condition characterized by accelerated aging in children.

Lonafarnib has been dosed in over 80 children with Progeria at Boston's Children Hospital in multiple Phase 1/2 and Phase 2 studies.

The expanded agreement provides Eiger with commercial and distribution rights to Lonafarnib across the licensed and approved indications in the future.

Concurrently, Eiger announced that it has completed a collaboration agreement with The Progeria Research Foundation (PRF). Eiger, at its sole cost and expense, will provide Lonafarnib for ongoing clinical trials and expanded access in Progeria and be responsible for any potential filing of an NDA for the Progeria indication based on PRF data. Eiger plans to seek FDA guidance regarding a potential regulatory approval for Lonafarnib in Progeria.

2. Audentes Therapeutics Inc. (BOLD)

Gained 21.91% to close Thursday's trading at $41.39.

News: The Company announced continuing positive data from the first dose cohort of ASPIRO, a Phase 1/2 clinical trial of AT132 in patients with X-Linked Myotubular Myopathy (XLMTM).

XLMTM is a rare monogenic disease characterized by extreme muscle weakness, respiratory failure and early death, with an estimated 50% mortality rate by 18 months of age.

According to the Company, there were significant improvements in neuromuscular and respiratory function at 24-week timepoint, and encouraging initial efficacy was observed at four-week timepoint in Cohort 1 expansion patients.

The earliest treated patient has now been ventilator independent for over eight weeks, according to the Company.

3. Evolus Inc. (EOLS)

Gained 20.93% to close Thursday's trading at $12.94.

News: No news

Recent event :

On May 16, 2018, the FDA rejected the Company's Biologics License Application for DWP-450 for the treatment of glabellar lines, also known as frown lines, in adult patients.

There were deficiencies in items related to Chemistry, Manufacturing, and Controls ("CMC") processes that led to the rejection. However, no deficiencies were related to clinical or non-clinical matters.

The Company also announced a good news related to favorable completion of FDA's pre-approval inspection of Daewoong's manufacturing facility in South Korea which was purpose built for production of DWP-450.

4. Loxo Oncology Inc. (LOXO)

Gained 20.09% to close Thursday's trading at $167.53.

News: The Company announced that it will present updated interim data from the ongoing phase I clinical trial for LOXO-292 in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase at the ASCO Annual Meeting on June 2, 2018.

RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary thyroid cancer, and a subset of colon and other cancers.

5. BioDelivery Sciences International Inc. (BDSI)

Gained 17.95% to close Thursday's trading at $2.30.

News: The Company announced that it has entered into definitive agreements with existing institutional and other accredited investors to purchase an aggregate of approximately $50 million worth of BDSI's newly designated Series B Non-Voting Convertible Preferred Stock (Series B Stock) in a registered direct offering.

The Company also announced a $50 million equity financing led By Broadfin.

The agreements are meant to significantly strengthen BDSI's financial position and extend its cash runway through 2020.

6. Minerva Neurosciences Inc. (NERV)

Gained 13.85% to close Thursday's trading at $7.40.

News: The Company announced that the Journal of Clinical Psychiatry has published positive results of cognitive performance from its phase IIb trial of Roluperidone in patients with schizophrenia and negative symptoms.

Results presented in this publication suggest a benefit of Roluperidone on cognitive performance in schizophrenia patients with stable positive symptoms and moderate to severe negative symptoms.

Roluperidone ((MIN-101) is currently under a pivotal phase III clinical trial as monotherapy for negative symptoms in patients diagnosed with schizophrenia.

by RTTNews Staff Writer

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