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MYND Excited, STDY Steadying Up, SELB Awaits Data In Q3, EYPT Catches Eyes

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

1. MYnd Analytics Inc. (MYND)

Gained 32.21% to close Thursday's (Apr.12) trading at $1.97.

News: No news

MYnd is a predictive analytics company that has developed a decision support tool to help physicians reduce trial and error treatment in mental health and provide more personalized care to patients.

Recent events:

-- On March 29, 2018, the Company completed a private placement for gross proceeds of $2.1 million.
-- Last November, the Company acquired revenue-generating Arcadian Telepsychiatry Services which is anticipated to generate rapid growth and benefits from cross-selling going forward.
-- The Company ended the fiscal year-end on September 30, 2017 with no long-term debt and over $5 million cash.

2. SteadyMed Ltd. (STDY)

Gained 22.03% to close Thursday's trading at $3.60.

News: No news

Recent events:

-- On August 31, 2017, the FDA refused to even accept the Company's New Drug Application for Trevyent for the treatment of Pulmonary Arterial Hypertension.

Trevyent is a PatchPump wearable injector prefilled with a therapeutic drug, Treprostinil. The active pharmaceutical ingredient used in United Therapeutics' approved PAH drug Remodulin is also Treprostinil.

In its Refusal to File Letter, the FDA had concluded that the application was not sufficiently complete to permit a substantive review.

-- On November 1, 2017, the Company formally met with the FDA to discuss the issuance of the refuse-to-file letter, and it was informed that no clinical trials are required for NDA resubmission.

The Company was told by the FDA that a repeat of in vitro Design Verification (DV) testing on Trevyent, supported by pharmacokinetic modeling and Process Validation, are sufficient for the resubmission and acceptance of the NDA.

As of December 31, 2017, SteadyMed had cash and cash equivalents of $32.5 million.

Near-term Catalysts:

-- Trevyent performance data are expected to be available around mid 2018.
-- Resubmission of Trevyent NDA is expected to occur before the end of 2018.

3. Geron Corporation (GERN)

Gained 20.54% to close Thursday's trading at $3.99.

News: No news

Pipeline:

The Company's lead drug candidate is Imetelstat, which is being developed for the potential treatment of hematologic myeloid malignancies. Geron has a deal in place with Janssen, under which Janssen is wholly responsible for the development, manufacturing, seeking regulatory approval for and commercialization of imetelstat worldwide.

-- A phase 2/3 clinical trial of Imetelstat, dubbed IMerge, in transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent, is underway.
-- A phase II clinical trial evaluating two doses of Imetelstat in intermediate-2 or high-risk myelofibrosis (MF) patients who are refractory to or have relapsed after treatment with a JAK inhibitor, dubbed IMbark, is ongoing.

Near-term Catalysts:

-- A protocol-specified primary analysis, which includes an assessment of overall survival, for the IMbark study will begin by the end of the second quarter of 2018.
-- Based on the primary analysis, Janssen will decide whether or not to maintain the license rights and continue the development of Imetelstat in any indication. The decision of Janssen will be known by the end of the third quarter of 2018.

If Janssen takes a positive decision, Geron would receive a $65 million milestone payment at the time of an affirmative Continuation Decision, and would be eligible to receive potential payments of up to $470 million for the achievement of certain development and regulatory milestones, up to $350 million for the achievement of certain sales milestones, and tiered royalties ranging from a mid-teens up to low twenties percentage rate on worldwide net sales of Imetelstat.

4. Bellicum Pharmaceuticals Inc. (BLCM)

Gained 20.29% to close Thursday's trading at $8.24.

News: The FDA has lifted the clinical hold on BPX-501 studies in the U.S.

On January 31, 2018, the FDA had imposed clinical hold on the Company's U.S. studies of BPX-501 due to three cases of encephalopathy deemed as possibly related to the drug candidate, which sent the shares down as much as 38% to $5.02 that day.

BPX-501 is under multiple phase 1/2 clinical trials in adults and pediatric patients with leukemias, lymphomas, and genetic blood diseases in the U.S. and Europe.

5. Selecta Biosciences Inc. (SELB)

Gained 19.68% to close Thursday's trading at $12.04.

News: No news

Recent event:

-- On April 10, 2018, the Company presented new data from its ongoing phase II trial of SEL-212 for the treatment of chronic severe gout.

The data reported consisted of patients that received three monthly doses of SEL-212. The 3 month, phase II data indicated that SEL-212 product profile may provide better and more sustained serum uric acid control, fewer flares, and less frequent dosing compared with recent data reported with the current FDA-approved uricase therapy.

Near-term Catalyst:

-- Data from patients receiving five doses of SEL-212 in the phase II trial are expected to be presented at Q3 medical conference.

6. Rigel Pharmaceuticals Inc. (RIGL)

Gained 16.72% to close Thursday's trading at $3.91.

News: No news

Near-term Catalyst:

-- The Company's oral drug candidate Tavalisse, proposed for the treatment of adult patients with chronic immune thrombocytopenia, is under FDA review - with a decision expected on April 17, 2018.

If approved, analysts expect Tavalisse to rake in peak sales of $360 million.

7. EyePoint Pharmaceuticals Inc. (EYPT)

Gained 15.87% to close Thursday's trading at $1.46. The stock is up 28% in the last 2 days.

News: No news

Recent event:

-- On March 28, 2018, pSivida Corp. (PSDV) acquired specialty biopharmaceutical company Icon Bioscience Inc.
-- pSivida Corp. rebranded and changed its name to EyePoint Pharmaceuticals Inc., with ticker EYPT, effective April 2, 2018.

Near-term Catalysts:

-- DEXYCU, a dropless, long-acting therapeutic, which was approved by the FDA for the treatment of inflammation in post cataract surgery on February 9, 2018, is expected to be launched in the U.S. in the first half of 2019 following the successful scale up of commercial supplies.
-- The NDA for Durasert micro-insert, proposed for treatment of non-infectious posterior segment uveitis, is under FDA review - with a decision expected on November 5, 2018.

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

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