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GERN Turning Heads, ARQL To Present Data In Apr., Mark Your Calendar For PTN


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(RTTNews.com) - The following are some of today's top gainers in the pharma/biotech sector.

1. Geron Corp. (GERN)

Gained 19.09% to close Wednesday's (Mar.21) trading at $4.99.

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 Catalyst:

-- 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.

2. ArQule Inc. (ARQL)

Gained 18.11% to close Wednesday's trading at $2.87.

News: No news

Clinical Trials:

-- ARQ 087 (Derazantinib), under phase III trial in Intrahepatic Cholangiocarcinoma (iCCA), is ongoing. -- ARQ 531, proposed for heme malignancies, is under phase 1a/b testing. -- Miransertib (ARQ 092), for Proteus syndrome, is under Phase I/II trial. -- ARQ 751, for solid tumors, is under Phase 1a study.

Upcoming event:

The Company will make a presentation at the 17th Annual Needham Healthcare Conference on March 27th, 2018, at 3:30 p.m. ET at the Westin Grand Central Hotel in New York.

Near-term Catalysts:

-- Data from a phase 1b trial for Miransertib in combination with Anastrozole in PIK3CA or AKT1-mutant endometrial and ovarian cancers will be presented on April 15, 2018. -- Results of a phase I dose escalation study of ARQ 751 in adult subjects with advanced solid tumors will be presented on April 15, 2018.

3. Prothena Corporation plc (PRTA)

Gained 14.39% to close Wednesday's trading at $38.72.

News: The Company has inked a global collaboration with Celgene Corp. (CELG) to develop new therapies for a broad range of neurodegenerative diseases.

The collaboration focuses on preclinical programs targeting proteins implicated in several neurodegenerative diseases, including tau, TDP-43 and an undisclosed third target.

Under the terms of the deal, Prothena will receive a $100 million upfront payment and a $50 million equity investment by Celgene, plus future potential exercise payments and regulatory and commercial milestones for each licensed program. Prothena will also receive additional royalties on net sales of any resulting marketed products.

4. KemPharm Inc. (KMPH)

Gained 14.29% to close Wednesday's trading at $8.00.

News: The Company announced positive top line results from its ongoing pediatric and adolescent pharmacokinetic (PK) study with KP415/d-methylphenidate (d-MPH) capsules in children 6-12 years and adolescents 13-17 years old with ADHD.

The results suggest that following oral administration of KP415 product candidate, exposure to d-methylphenidate is predictable in patients with attention-deficit/hyperactivity disorder (ADHD) between the ages of 6 and 17 years.

Near-term Catalyst:

-- Top line results from an on-going pivotal efficacy laboratory classroom study with KP415 in children with Attention-Deficit/Hyperactivity Disorder are expected by mid-year.

Upcoming event:

-- The Company is slated to host a conference call and live audio webcast on Thursday, March 29, 2018, at 4:30 p.m. ET, to discuss its corporate and financial results for the fourth quarter and year end 2017.

5. Achaogen Inc. (AKAO)

Gained 13.45% to close Wednesday's trading at $12.48.

News: The Company's NDA for Plazomicin is scheduled to be reviewed by an FDA panel on May 2, 2018.

Plazomicin is proposed for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, and bloodstream infections (BSI) due to certain Enterobacteriaceae in patients who have limited or no alternative treatment option. As previously announced, the FDA's final decision on Plazomicin is expected on June 25, 2018.

6. Palatin Technologies Inc. (PTN)

Gained 10.89% to close Wednesday's trading at $1.12.

News: No news

Near-term Catalyst:

The NDA for Rekynda (Bremelanotide), which is proposed for Hypoactive Sexual Desire Disorder, is expected to be filed with the FDA by March 31, 2018.

The Company has an agreement with AMAG Pharmaceuticals (AMAG), under which AMAG has exclusive North American commercial rights to Rekynda.

7. Arena Pharmaceuticals Inc. (ARNA)

Gained 10.69% to close Wednesday's trading at $44.00.

News: The Company has priced its underwritten public offering of 8.5 million shares of its common stock at $41.50 each.

Recent event:

-- On Mar.20, 2018, the Company announced positive results from its phase II trial of Etrasimod in ulcerative colitis.

In the trial, dubbed OASIS, patients receiving the 2 mg dose of Etrasimod achieved statistically significant improvements compared to placebo in the primary, all secondary, and clinical remission endpoints.

Near-term Catalysts:

-- Data from a phase II trial of APD371 for the potential treatment of visceral pain, specifically pain associated with Crohn's disease is expected in Q2, 2018. -- Initiate a phase III clinical program consisting of 3 studies with oral Ralinepag intended for the treatment of pulmonary arterial hypertension (PAH) in the second half of this year.

8. Harvard Bioscience Inc. (HBIO)

Gained 10.34% to close Wednesday's trading at $4.80.

News: No news

Recent event:

-- On Mar.1, 2018, the Company reported its financial results for the fourth quarter and full year ended December 31, 2017.

On a non-GAAP basis, net income for the recent fourth quarter increased to $1.7 million or $0.05 per share from $1.3 million or $0.04 per share in the year-ago quarter.

Revenues for the fourth quarter of 2017 were $27.5 million, an increase of 4%, compared $26.4 million in the year-ago quarter.

Looking ahead, the Company continues to expect 2018 revenues to be between $118 million and $123 million. Revenues were $101.9 million in 2017.

9. Adaptimmune Therapeutics plc ( ADAP )

Gained 10.04% to close Wednesday's trading at $11.40.

News: No news

To know ADAP's pipeline details, please visit our Company Spotlight column.


Read the original article on RTTNews (http://www.rttnews.com/2874873/gern-turning-heads-arql-to-present-data-in-apr-mark-your-calendar-for-ptn.aspx)


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