MRNS Soars On Epilepsy Trial Data, SMMT Climbing Up, ACHN Takes A Hit

Pharma Sep11 091117

The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of September 11, 2017.


1. Marinus Pharmaceuticals Inc. (MRNS)

Gained 33.01% to close Monday's (Sep.11) trading at $4.15.

News: The Company announced positive results from its phase II study of Ganaxolone in children with CDKL5 disorder, a severe, rare genetic epilepsy that results in early-onset, treatment-refractory seizures, pervasive neuro-developmental delay and disabling behavioral issues.

According to the trial results, patients treated with Ganaxolone showed a sizeable decrease in seizure frequency and increase in attention associated with a calmer demeanor.

Following encouraging data, the Company has prioritized CDKL5 disorder as its lead pediatric orphan program for advancement into later stage clinical development.

2. Summit Therapeutics plc (SMMT)

Gained 11.19% to close Monday's trading at $16.00.

News: The Company has been awarded a contract worth up to $62 million by the Biomedical Advanced Research and Development Authority ('BARDA'), an agency of the US government's Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response.

The funds are intended to support the clinical and regulatory development of the Company's Ridinilazole for the treatment of C. difficile infection, including its planned Phase 3 development program.

In a Phase 2 proof of concept clinical trial conducted in North America, Ridinilazole was shown to be highly preserving of the microbiome of patients compared with the standard of care, Vancomycin, and achieved a substantial reduction in rates of recurrent disease.

3. Arrowhead Pharmaceuticals Inc. (ARWR)

Gained 10.29% to close Monday's trading at $3.43.

News: No news

Upcoming event:

The analyst R&D day is scheduled for Thursday, September 14th in New York City, during when the Company is expected to provide a comprehensive update about its new technology called TRMs, or Targeted RNA Molecules, and lead programs.

According to the Company, TRMs are proving capable of efficient delivery and knockdown of target genes not just in the liver, but also in tissues outside the liver without the need for an engineered endosomal escape component.

4. T2 Biosystems Inc. (TTOO)

Gained 9.49% to close Monday's trading at $5.19.

News: The Company has filed a 510(k) premarket submission for the T2Bacteria Panel with the FDA.

The T2Bacteria Panel is designed to run on the FDA-cleared T2Dx Instrument. The T2Bacteria Panel, once FDA cleared, combined with the commercially available T2Candida Panel is designed to be the first comprehensive rapid diagnostic solution on the market that identifies pathogens associated with sepsis within hours instead of days, potentially enabling 95% of patients with bloodstream infections to receive targeted therapy within 8 hours of blood draw.

TTOO was trading around $2.96 when we alerted our premium subscribers to this stock on August 8, 2017.

5. Fulgent Genetics Inc. (FLGT)

Gained 9.24% to close Monday's trading at $5.91.

News: No news

Recent event:

The Company reported Q2, 2017 financial results on August 7, 2017.

Non-GAAP income for the recent second quarter was $284,000, or $0.02 per share on revenue of $4.6 million.

For the third quarter of 2017, the Company expects revenue to be between $5.5 million and $6 million. Looking ahead to full year 2017, the Company anticipates revenue in the range of $24 million to $25 million.

6. Depomed Inc. (DEPO)

Gained 9.15% to close Monday's trading at $6.68.

News: The Company is slated to make a presentation at the Morgan Stanley Global Healthcare Conference on September 12, 2017 in New York.

7. Natus Medical Incorporated (BABY)

Gained 8.51% to close Monday's trading at $35.70.

News: The Company has agreed to acquire certain neurosurgery business assets from Integra LifeSciences Holdings Corporation (IART) for $47.5 million in cash.

The acquired assets include Camino intracranial pressure monitoring system product line and associated products. The acquisition expands Natus' product offering into neurosurgery market, and is expected to be immediately accretive to non-GAAP earnings.


1. Achillion Pharmaceuticals Inc. (ACHN)

Lost 22.09% to close Monday's trading at $3.82.

News: The worldwide license and collaboration arrangement on hepatitis C with Johnson & Johnson subsidiary Janssen Pharmaceuticals Inc. has been terminated, upon request by Janssen.

The Companies entered into collaboration in 2015 to develop and commercialize one or more of Achillion's lead hepatitis C virus (HCV) assets which include ACH-3102, ACH-3422, and sovaprevir.

2. Aileron Therapeutics Inc. (ALRN)

Lost 11.57% to close Monday's trading at $12.38.

News: No news

Recent event:

Aileron's common stock made its debut on the NASDAQ Global Market on June 29, 2017 $15.00 per share.


The Company's lead product candidate is ALRN-6924. Multiple clinical studies of ALRN-6924 are underway, including a Phase 1 All-comers trial in advanced solid tumors or lymphomas, a Phase 2a trial in peripheral T-cell lymphoma (PTCL), a Phase 1 trial in acute myeloid leukemia (AML) and advanced myelodysplastic syndrome (MDS) as a monotherapy, and a Phase 1b trial in AML/MDS in combination with cytosine arabinoside (Ara-C).

3. Foamix Pharmaceuticals Ltd. (FOMX)

Lost 9.31% to close Monday's trading at $5.16.

News: No news

Near-term catalysts:

-- Top-line results from third phase III Acne clinical trial for Minocycline Foam FMX101 expected by mid-2018.
-- Top-line results from blinded phase of Phase 3 program of topical Minocycline Foam 1.5%, FMX103 for the treatment of moderate-to-severe acne anticipated by mid-2018.

4. Apollo Endosurgery Inc. (APEN)

Lost 8.74% to close Monday's trading at $3.97.

News: No news

Recent event:

On August 10, 2017, the FDA alerted health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity.

Four reports involve the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery.

The following were the clarifications provided by the Company pertaining to the FDA's alert.

ORBERA, which assists adult patients suffering from obesity with a body mass index of 30 to 40 in losing and maintaining weight, was approved by the FDA in August of 2015. "Since its approval, there have been 5 reported deaths of patients who had received the ORBERA intragastric balloon in four different countries, and they were all self reported by the Company. The incident rate remains less than 0.01% and there have been no product liability-related claims in connection with the five cases".

5. Edge Therapeutics Inc. (EDGE)

Lost 7.90% to close Monday's trading at $9.67.

News: No news

Near-term catalysts:

-- A pre-planned futility analysis of phase III study of EG-1962 as a treatment for aneurysmal subarachnoid hemorrhage (aSAH) delivered via external ventricular drain, dubbed NEWTON 2, is expected in late-2017.
-- Top-line efficacy results from the interim analysis of NEWTON 2 study are anticipated in the first quarter of 2018.

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