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ECYT Has VISION, LPCN Up 50% In 5 Days, MYO On Watch, FDA Nod Boosts SRNE

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

1. Endocyte Inc. (ECYT)

Gained 41.19% to close Wednesday's (Feb.28) trading at $5.93.

News: The Company has offered to sell 17.85 million shares of its common stock at a price to the public of $4.20 per share.

The aggregate net proceeds from the offering are expected to be approximately $70.0 million. The offering is slated to close on or about March 2, 2018, subject to the satisfaction of customary closing conditions.

Clinical Trials & Near-term Catalysts:

-- The lead program is a prostate specific membrane antigen (PSMA)-targeted radioligand therapy, 177Lu-PSMA-617, whose phase III trial design has been finalized.

Enrollment in the trial, dubbed VISION, is expected to begin in the second quarter of 2018 and is expected to be completed in 18-24 months. The first interim assessment of overall survival could occur as early as the second half of 2019.

-- Updated results from Peter MacCallum Cancer Center-sponsored 177Lu-PSMA-617 trial in metastatic castration-resistant prostate cancer (mCRPC) patients are expected in the second half of 2018.

2. Lipocine Inc. (LPCN)

Gained 25% to close Wednesday's trading at $1.90. This is the second straight day of gain for the stock.

News: No news

Recent event:

On February 27, 2018, Empire Asset Management upgraded Lipocine to Buy from Hold, setting a price target of $21.00.

Pipeline:

TLANDO, an oral product candidate for Testosterone Replacement Therapy, under FDA review; LPCN 1111, a novel testosterone replacement therapy product candidate, which has completed a phase IIb dose finding study in hypogonadal men, and LPCN 1107, an oral product candidate for the indication of prevention of recurrent preterm birth, which has completed phase II studies, are the drug candidates in the pipeline.

Near-term Catalysts:

-- TLANDO was voted down by an FDA panel in January of this year. The FDA's final decision is expected on May 8, 2018.
-- Meet with the FDA in Q1, 2018 to discuss a phase III clinical protocol for LPCN 1111.
-- Conduct Food/Fat Effect clinical study for LPCN 1107 in 2H, 2018.

3. Invuity Inc. (IVTY)

Gained 23.88% to close Wednesday's trading at $4.15.

News: Philip Sawyer has stepped down as President and Chief Executive Officer of the Company. Scott D. Flora has been appointed interim President and CEO.

Recent event:

On February 13, 2018, the Company announced financial results for the fourth quarter and year ended December 31, 2017.

The net loss for the fourth quarter of 2017 was $7.4 million or $0.43 per share on revenue of $11.2 million. This compared to a net loss of $9.6 million or $0.56 loss per share and revenue of $9.4 million in the fourth quarter of 2016.

For fiscal 2018, Invuity expects revenue to exceed $46 million. Revenue in full-year 2017 was $39.6 million.

4. Myomo Inc. (MYO)

Myomo is a commercial stage medical device company in the medical robotics industry, specializing in myoelectric braces, or orthotics, for people with neuromuscular disorders.

Gained 20.05% to close Wednesday's trading at $4.61.

News: No news

Recent event:

-- On November 6, 2017, the Company reported financial results for the three and nine months ended September 30, 2017.

The Company's net loss for the quarter ended September 30, 2017, widened to $1.26 million from $1.02 million for the corresponding 2016 period. Total revenue for the third quarter of 2017 was $489,000, up from $184,194 in the year-ago comparable quarter.

The third quarter of 2017 marked Myomo's first full quarter as a publicly traded company.

Near-term Catalyst:

The Company is slated to release its financial results for the fourth quarter and year end December 31, 2017 results on Wednesday, March 7, 2018, after the US markets close.

5. Sorrento Therapeutics Inc. (SRNE)

Gained 17.75% to close Wednesday's trading at $9.95.

News: The FDA has approved the Company's ZTlido, a next-generation non-opioid, lidocaine patch proposed for the relief of pain associated with post-herpetic neuralgia.

ZTlido is a major advancement in analgesics because of its proprietary adhesion technology demonstrating 12-hour wear with efficient lidocaine delivery, even during exercise, according to the Company.

The product will be commercially available to patients sometime in 2018.

6. Five Prime Therapeutics Inc. (FPRX)

Gained 14.42% to close Wednesday's trading at $21.26.

News: The Company's clinical pipeline is on track to more than double to five products in 2018.

Clinical Trials & Near-term Catalysts:

-- A phase 1a/1b trial of Cabiralizumab in combination with Opdivo in patients with late-line pancreatic cancer is ongoing. Updates from this trial are expected in the second half of this year.
-- A phase II trial evaluating Cabiralizumab and Opdivo with and without chemotherapy compared to chemotherapy alone in patients with advanced pancreatic cancer, initiated by Bristol Myers is underway.
-- A phase 1/2 trial of Cabiralizumab in patients with pigmented villonodular synovitis (PVNS) is underway. Whether or not Cabiralizumab advances into a pivotal trial will be known by the end of 2018.
-- Complete Phase 1 portion of FIGHT chemo combo trial in gastric cancer, and transition to global phase III portion in mid-2018.

FIGHT is a global phase I/III trial of FPA144 in combo with chemo in first-line gastric cancer.

-- Complete phase I safety trial of FPA144 monotherapy in unselected patients with gastric cancer in Japan in 2018.

7. Aeglea Bio Therapeutics Inc. (AGLE)

Gained 12.23% to close Wednesday's trading at $7.25.

News: No news

Clinical Trials & Near-term Catalysts:

The lead compound is Pegzilarginase (AEB1102), under a phase 1/2 clinical trial in patients with Arginase 1 Deficiency.

The trial is designed to enroll approximately 10 patients, adult and pediatric, with Arginase 1 Deficiency in the United States, Canada, and Europe. The trial investigates both single ascending doses (Part 1) and repeated dosing (Part 2).

-- The phase 1/2 Adult Repeat Dose Data is expected in 2Q, 2018.
-- The Pediatric phase 1/2 Repeat Dose Data is anticipated in 3Q, 2018.
-- A phase Ib study of Pegzilarginase in combination with Merck's Keytruda for Small Cell Lung Cancer is expected to be initiated this month.

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