CASI Makes Case For Hope, MYND On Track, URGN Sprints, No Stopping INNT

pharma 040218

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

1. CASI Pharmaceuticals Inc. (CASI)

Gained 47.54% to close Tuesday's (Apr.3) trading at $6.30.

News: No news

Recent events:

-- On January 26, 2018, the Company acquired from Sandoz Inc. a portfolio of 25 U.S. FDA-approved abbreviated new drug applications (ANDAs), one ANDA that FDA tentatively approved, and three ANDAs that are pending FDA approval.

On March 20, 2018, the Company announced $50 million private placement to new and existing investors. As of December 31, 2017, CASI had cash and cash equivalents of approximately $43.5 million.

On March 29, 2018, the Company announced Q4 and full-year 2017 financial results.

The net loss for the recent fourth quarter widened to $5.0 million or $0.08 per share from $2.7 million or $0.05 per share for the fourth quarter of 2016.

Near-term Catalysts:

-- The Company is slated to make a presentation at the H.C. Wainwright Global Life Sciences Conference on April 10, 2018.
-- The Company looks forward to launch certain products that it acquired from the Sandoz portfolio in China, along with its launch of EVOMELA, MARQIBO and ZEVALIN all of which are in various stages of CFDA review.

2. Innovate Biopharmaceuticals Inc. (INNT)

Gained 41.54% to close Tuesday's trading at $46.

News: No news

Recent events:

Privately-held Innovate Biopharmaceuticals Inc. acquired Monster Digital Inc. (MSDI) in a reverse merger transaction in January of this year.

Innovate Biopharmaceuticals shares commenced trading on Nasdaq with the new ticker INNT, reflecting the 1 for 10 reverse split in trading on January 31, 2018.


The lead drug candidate is Larazotide acetate (INN-202), which has successfully met its primary endpoint in a phase 2b efficacy clinical trial for celiac disease. Also in the pipeline is INN-108, indicated for mild to moderate ulcerative colitis, which is entering Phase II trials this year, and INN-329, entering phase III trial for Magnetic Resonance Cholangiopancreatography (MRCP).

Near-term Catalyst:

-- Larazotide acetate is expected to move into phase III clinical trials in celiac disease in Q2 2018.

3. MYnd Analytics Inc. (MYND)

Gained 36.51% to close Tuesday's trading at $1.72.

News: The Company announced that it completed a private placement for gross proceeds of $2.1 million on March 29, 2018.

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:

-- 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.

4. Allena Pharmaceuticals Inc. (ALNA)

Gained 26.17% to close Tuesday's trading at $16.49.

News: No news


The Company's drug candidates include ALLN-177, under a phase III trial in patients with enteric hyperoxaluria, dubbed URIROX-1, and a Phase 2 basket trial in adolescents and adults with primary hyperoxaluria or enteric hyperoxaluria and hyperoxalemia, dubbed Study 206; ALLN-346, intended for patients with hyperuricemia and moderate to severe chronic kidney disease, under a preclinical program.

Near-term Catalysts:

-- The interim data from Study 206 is expected to be announced in the second half of 2018.
-- The top line data from URIROX-1 is expected to be announced in the second half of 2019.

Recent event:

The Company went public on the NASDAQ Global Select Market on November 2, 2017, offering its shares at a price of $14.00 each.

5. Cellectis S.A. (CLLS)

Gained 25.38% to close Tuesday's trading at $38.53.

News: Allogene intends to assume from Pfizer the global strategic collaboration agreement originally formed with Cellectis in 2014.

The global strategic collaboration is related to developing "off-the-shelf" CAR T immunotherapies for oncology.

Cellectis will remain eligible to receive clinical and commercial milestone payments of up to $2.8 billion, or $185 million per target for 15 targets and tiered royalties in the high single digits on net sales of any products that are commercialized by Allogene under the agreement.

6. Urogen Pharma Ltd. (URGN)

Gained 23.68% to close Tuesday's trading at $59.80.

News: The Company presented results from an interim analysis of its ongoing pivotal phase III clinical trial of UGN-101 for the non-surgical treatment of low-grade upper tract urothelial cancer, dubbed OLYMPUS.

According to the results, which were available online through the Journal of Urology website, 33 patients were evaluated for the report - with 28 having undergone primary disease evaluation. The complete response rate in the intent to treat cohort is 57%, and 6 patients who have undergone 3-month follow-up, remain in complete response.

Near-term Catalysts:

-- The full interim analysis of the OLYMPUS trial is scheduled to be presented on May 21, 2018 in an oral presentation during the plenary session at the 113th American Urological Association's (AUA) Annual Meeting in San Francisco.
-- The top-line results from the OLYMPUS study are expected in the third quarter of 2018.

7. Myomo Inc. (MYO)

Gained 21.33% to close Tuesday's trading at $3.47.

News: No news

Myomo is a commercial stage medical robotics company.

Recent event:

-- On March 7, 2018, the Company announced Q4 and full year 2017 financial results.

Net loss for the recent fourth quarter was $1.9 million or $0.25 per share compared to a net loss of $1.40 million or $1.25 per share in the year-ago quarter. Total revenue for the fourth quarter of 2017 rose to $547 thousand from $448 thousand in the comparable prior year quarter.

The Company had cash of $12.96 million at year-end 2017.

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