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ECYT On Fire After ABX Deal, Rigel's ITP Drug Skips Panel Review, MCRB On Watch

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The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of October 2, 2017.

GAINERS

1. Endocyte Inc. (ECYT)

Gained 157.45% to close Monday's (Oct.2nd) trading at $3.63.

News: The Company announced the completion of an exclusive worldwide license of PSMA-617 from ABX GmbH.

The transaction provides Endocyte with 177Lu-PSMA-617, the most advanced targeted radioligand therapy in development for prostate cancer, addressing a greater than $1 billion market opportunity.

Endocyte plans to seek regulatory approval to initiate a phase III registration trial of 177Lu-PSMA-617 in early 2018. If all goes well as planned, the Company expects to complete the trial as early as 2020.

2. Rigel Pharmaceuticals Inc. (RIGL)

Gained 32.68% to close Monday's trading at $3.37.

News: The Company has been notified that an FDA panel review is not required to discuss its New Drug Application for Tavalisse (fostamatinib) in patients with chronic or persistent immune thrombocytopenia.

immune thrombocytopenia, or ITP, is an autoimmune disease where the immune system attacks and destroys platelets in the blood. The result is abnormally low platelet counts.

The FDA decision on Tavalisse is expected by April 17, 2018.

3. Catabasis Pharmaceuticals, Inc. (CATB)

Gained 24.53% to close Monday's trading at $2.64.

News: No news

Near-term catalyst:

-- The Company will present results from joint research collaboration with Sarepta Therapeutics at the 22nd International Congress of the World Muscle Society on October 5, 2017.

The poster presentation is titled "Edasalonexent (CAT-1004), an NF-kB inhibitor, enhances myotube formation in vitro, and increases exon-skipped sarcolemmal dystrophin in muscle of mdx mice".

Edasalonexent is Catabasis' lead drug candidate for Duchenne muscular dystrophy.

A three-part phase I/II clinical trial investigating the safety and efficacy of Edasalonexent in boys ages 4-7 affected with Duchenne muscular dystrophy (any confirmed mutation), dubbed MoveDMD, is underway.

Part A of the MoveDMD trial evaluated the safety, tolerability and pharmacokinetics of Edasalonexent and showed positive results. Sixteen of the 17 boys enrolled in Part A continued to Part B of the trial, which is a phase II trial that evaluated the safety and efficacy of Edasalonexent in DMD over a 12-week period in approximately 30 boys.

On January 31, 2017, after the market close, the Company reported that Part B of the MoveDMD trial did not meet the primary efficacy endpoint. The news sent the stock tumbling more than 70% to $1.18 the following day.

Part C, which is an open-label extension that includes dosing with Edasalonexent for 36 weeks beyond the 12-week placebo-controlled portion of the trial (Part B), is ongoing. Part C is evaluating longer term safety and efficacy with the same clinical end points as Part B.

4. AcelRx Pharmaceuticals Inc. (ACRX)

Gained 19.57% to close Monday's trading at $5.50.

News: No news

Near-term catalyst:

-- The FDA decision on the Company's investigational product Dsuvia for the treatment of moderate-to-severe acute pain in a medically supervised setting is expected to be announced on October 12, 2017.

Dsuvia, formerly known as ARX-04, consists of 30 mcg sufentanil in very small sublingually absorbed tablets that are delivered via a disposable, pre-filled, single-dose applicator.

AcelRx estimates that the market potential of Dsuvia in the U.S. will be roughly $1.1 billion.

5. Arbutus Biopharma Corp. (ABUS)

Gained 16.94% to close Monday's trading at $7.25.

News: The Company has signed a share purchase agreement with Roivant Sciences for the sale of convertible preferred shares for gross proceeds of $116.4 million. Roivant is Arbutus' largest existing shareholder.

Mark Murray, President and CEO of Arbutus said, "This financing meaningfully extends Arbutus' operating runway to enable the generation of important clinical data for multiple pipeline programs. I look forward to leveraging Roivant's infrastructure and capabilities to complement Arbutus and to accelerate our mission of developing a curative therapy for HBV."

6. Presbia PLC (LENS)

Gained 16.63% to close Monday's trading at $5.26.

News: No news

Pipeline:

The Company's lead product candidate is Presbia Flexivue Microlens, a revolutionary optical lens implant for treating presbyopia, the age-related loss of near vision. The Presbia Flexivue Microlens is currently approved for sale in 42 countries around the world.

Near-term catalyst:

-- The Company is planning to make its final submission to the FDA seeking approval of Presbia Flexivue Microlens before the end of 2017 in anticipation of approval in 2018.

7. Mersana Therapeutics Inc. (MRSN)

Gained 14.75% to close Monday's trading at $19.84.

News: No news

Recent event:

The Company went public on the NASDAQ Global Select Market on June 28, 2017 at an offering price of 15.00 per share.

Near-term catalysts:

-- Interim results from phase I trial of lead oncology drug candidate XMT-1522 in patients with advanced tumors expressing HER2, including breast cancer, non-small-cell-lung-cancer (NSCLC) and gastric cancer are expected around the end of this year.
-- File the second IND shortly and begin clinical studies in early 2018 for XMT-1536, a potential first-in-class Dolaflexin ADC targeting NaPi2b-expressing tumors.

8. Ardelyx Inc. (ARDX)

Gained 14.29% to close Monday's trading at $6.40.

News: No news

Near-term catalysts:

-- Results from T3MPO-2, the ongoing six-month phase III trial of Tenapanor in patients with IBS-C, are expected early in the fourth quarter of 2017.
-- Completion of T3MPO-3, the long-term safety extension study of Tenapanor in patients with IBS-C, is expected by late 2017.

9. Synergy Pharmaceuticals Inc. (SGYP)

Gained 12.07% to close Monday's trading at $3.25.

News: No news

Near-term catalyst:

-- The Company's supplemental New Drug Application for TRULANCE for the treatment of adults with irritable bowel syndrome with constipation is under FDA review - with a decision date set for January 24, 2018.

LOSERS

1. Seres Therapeutics Inc. (MCRB)

Lost 23.32% to close Monday's trading at $12.30.

News: The Company reported positive topline results from SER-287 phase 1b study in patients with Ulcerative Colitis. But looks like investors are not all that impressed with the results.

2. Rockwell Medical Inc. (RMTI)

Lost 8.29% to close Monday's trading at $7.85.

News: No news

Recent event:

On September 28, 2017, the Company announced that it has submitted its chemistry, manufacturing and controls (CMC) post-approval drug manufacturing supplement of Calcitriol to the FDA.

Calcitriol is Rockwell's FDA approved active Vitamin D injection for the management of hypocalcemia in patients undergoing chronic renal dialysis.

The Company anticipates Calcitriol to be commercially available in the U.S. approximately 30 days after the CMC submission, provided the FDA has no further requests.

3. OncoMed Pharmaceuticals Inc. (OMED)

Lost 6.19% to close Monday's trading at $4.24.

News: No news

Pipeline:

Enrollment is underway in the following trials...

-- Two phase Ib trials of Navicixizumab in combination with standard of care chemotherapies - one in patients with 2nd line metastatic colorectal cancer and a second in patients with platinum-resistant ovarian cancer.
-- A phase 1a/b study of Rosmantuzumab in advanced solid tumors (Phase 1a) and in patients with previously treated metastatic colorectal or gastric cancer (Phase 1b).
-- A Phase 1a study of anti-TIGIT antibody in patients with advanced or metastatic solid tumors.
-- A phase Ia single agent study of GITRL-Fc in solid tumors was initiated as recently as last month.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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