Gainers & Losers Of Apr.10: CYTX, AXON, GERN, OMED, TXMD...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of April 10, 2017.

GAINERS

1. Cytori Therapeutics Inc. (CYTX)

Gained 25.55% to close Monday's (Apr.10) trading at $1.72.

News: The Company received approval from the FDA to conduct a pilot clinical trial to evaluate Cytori Cell Therapy in patients with thermal burn injury.

The initiation of the trial, dubbed RELIEF, is dependent upon execution of a contract option by the Biomedical Advanced Research and Development Authority (BARDA) to provide the necessary funds.

In after-hours, the stock plunged over 23%, following a proposed public offering announced by the Company.

2. Axovant Sciences Ltd. (AXON)

Gained 22.54% to close Monday's trading at $18.54.

News: The Company has appointed David Hung as its CEO.

Hung was the co-founder, President, and Chief Executive Officer of Medivation, which was acquired by Pfizer for approximately $14 billion in September 2016.

A SEC filing reveals that Hung will purchase at least $10 million of Axovant's securities in its next financing event.

Near-term catalysts:

The Company's investigational drugs are Intepirdine, Nelotanserin, RVT-103 and RVT-104.

-- A phase III study of Intepirdine in patients with mild-to-moderate Alzheimer's disease, dubbed MINDSET, is underway - with top-line results expected in late September 2017. -- Results from a phase 2b study of Intepirdine in patients with dementia with Lewy bodies, known as HEADWAY-DLB, are anticipated in the fourth quarter of 2017. -- Results from a phase 2 study of Nelotanserin for treatment of REM Behavior Disorder (RBD) in patients with DLB are expected in the second half of 2017. -- Proof of concept study results of RVT-103 are anticipated in the first half of this year.

3. Geron Corp. (GERN)

Gained 19.53% to close Monday's trading at $2.57.

News: The second internal data reviews of phase II/III trial of Imetelstat in myelodysplastic syndromes, dubbed IMerge, and phase II trial of Imetelstat in myelofibrosis, known as IMbark, have been completed. Imetelstat, discovered by Geron, is licensed to Janssen, a unit of Johnson & Johnson.

For IMerge, the benefit/risk profile of Imetelstat in the treated patients supports continued development in lower risk myelodysplastic syndromes. A data package and proposed trial design refinements are planned to be provided to the FDA.

For IMbark, the current results suggest clinical benefit and a potential overall survival benefit associated with Imetelstat treatment in relapsed or refractory myelofibrosis; the trial will continue unchanged to evaluate maturing efficacy and safety data, including an assessment of overall survival, Geron noted.

4. Windtree Therapeutics Inc. (WINT)

Gained 13.76% to close Monday's trading at $1.24.

News: No news

Near-term catalysts:

Windtree's lead product candidate is AEROSURF, a novel, investigational combination drug/device product to potentially reduce or eliminate the need for endotracheal intubation and mechanical ventilation in the treatment of premature infants with respiratory distress syndrome (RDS).

-- Top line data from phase 2b clinical trial of AEROSURF administered to premature infants 28 to 32 week gestational age is expected in mid-2017. -- Top line data from the third dose groups in its phase 2a trial of AEROSURF in 48 premature infants 26 to 28 week gestational age is expected in mid-second quarter of 2017.

5. Zynerba Pharmaceuticals Inc. (ZYNE)

Gained 12.18% to close Monday's trading at $24.78.

News: No news

The Company's lead product candidate is ZYN002 CBD Gel.

A phase II study of ZYN002 cannabidiol (CBD) gel in adult epilepsy patients with refractory focal seizures, dubbed STAR 1; a phase II open-label extension trial for ZYN002 CBD Gel in adult epilepsy patients, known as STAR 2; a phase II study of ZYN002 CBD gel for the treatment of osteoarthritis, dubbed STOP, and a phase II trial of ZYN002 CBD Gel in pediatric Fragile X Syndrome patients, called FAB-C, are ongoing.

Near-term catalysts:

-- Top-line data from the STAR 1 and STOP trials are expected in July/August of this year. -- Top-line data from the FAB-C trial are expected to be available in the third quarter of 2017.

LOSERS

1. OncoMed Pharmaceuticals Inc. (OMED)

Lost 36.64% to close Monday's trading at $5.55.

News: The Company's phase II trial of Demcizumab in pancreatic cancer missed primary endpoint.

The phase II trial, dubbed "YOSEMITE", designed to assess the efficacy and safety of Demcizumab plus standard-of-care chemotherapy in first-line metastatic pancreatic cancer did not meet the primary endpoint of progression-free survival.

The other bad news was Bayer's decision of not to exercise its option to license OncoMed's the first-in-class Wnt pathway inhibitors Vantictumab and Ipafricept for strategic reasons.

A phase Ib combination trial of Vantictumab and paclitaxel in HER2-negative breast cancer and a phase Ib combination trial of Vantictumab plus gemcitabine and Abraxane in advanced pancreatic cancer are underway.

A phase Ib combination clinical trial of Ipafricept plus carboplatin and paclitaxel in ovarian cancer and a phase Ib Phase combination clinical trial of Ipafricept plus gemcitabine and Abraxane in pancreatic cancer are ongoing.

Now that Bayer has walked out, OncoMed retains worldwide rights to both the Wnt pathway inhibitors.

2. TherapeuticsMD Inc. (TXMD)

Lost 19.48% to close Monday's trading at $6.20, down 19.48%.

News: The FDA has identified certain deficiencies in the proposed labeling and/or postmarketing requirements/commitments for TX-004HR, the Company's drug candidate for the treatment of moderate-to-severe vaginal pain during sexual intercourse in post-menopausal women.

The NDA for TX-004HR (Yuvvexy) is under FDA review with a decision date set for May 7, 2017. In the wake of the recent development, it remains to be seen if the FDA decision will be announced in the said time.

3. Ritter Pharmaceuticals Inc. (RTTR)

Lost 8.77% to close Monday's trading at $1.40, continuing its slide for the second day.

News: No news

Recent event: On March 29th, the Company reported positive results from its phase 2b/3 study of RP-G28 in subjects with lactose intolerance. However, there were irregularities at one study center, and the data from this center were excluded from the primary analysis population.

The primary endpoint of the trial, i.e., a clinically meaningful benefit to patients suffering from lactose intolerance, met statistical significance, and no significant adverse events (SAEs) were reported from treatment, said the Company.

Based on the trial results, Ritter believes that the successful completion of a confirmatory phase III program could be adequate to support a New Drug Application submission and therefore has requested an end-of-Phase II meeting with the FDA.