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FDA Nod For AVGR, EOLS Is All Smiles, GERN Up 30% In 3 Days, IMMP On Watch

pharma daily 052218 lt

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

1. Avinger Inc. (AVGR)

Gained 73.54% to close Wednesday's trading at $2.23.

Avinger is a commercial-stage medical device company that designs, manufactures and sells image-guided, catheter-based systems that are used by physicians to treat patients with peripheral arterial disease, or PAD.

News: The Company's next generation Pantheris Lumivascular atherectomy system with extended nosecone has been granted clearance by the FDA. It is the first-ever image-guided atherectomy device for the treatment of peripheral artery disease, and is expected to be launched immediately in the U.S.

This version of the device received CE Mark approval last December.

2. Cara Therapeutics Inc. (CARA)

Gained 42.76% to close Wednesday's trading at $16.56.

News: The Company announced that it has licensed worldwide rights, except in the U.S., Japan and South Korea, to commercialize KORSUVA injection for the treatment of chronic kidney disease-associated pruritus in dialysis patients to Vifor Fresenius Medical Care Renal Pharma Ltd.

The deal entitles Cara to receive an upfront payment of $50 million in cash, an equity investment of $20 million, and up to $470 million in regulatory and commercial milestones.

KORSUVA is under a pivotal phase III trial in hemodialysis patients suffering from moderate-to-severe chronic kidney disease-associated pruritus in the United States, dubbed KALM-1.

Near-term Catalysts:

-- Preliminary results from the KALM-1 trial are expected in February 2019.
-- Initiate a global phase III clinical trial of KORSUVA injection for the treatment of chronic kidney disease-associated pruritus in hemodialysis patients in multiple countries later this year.

3. Oragenics Inc. (OGEN)

Gained 19.66% to close Wednesday's trading at $1.40.

News: Oragenics and Texas A&M University System have been granted U.S. patent for Lantibiotic MU1140.

MU1140, proposed for the treatment of Clostridium-difficile-infections, is in pre-clinical development.

4. Geron Corp. (GERN)

Gained 14.99% to close Wednesday's trading at $4.68.

News: No news


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:

-- Updated data (as of January 2018) from the first 32 patients enrolled in Part 1 of IMerge, the ongoing Phase 2/3 clinical trial of Imetelstat in patients with lower risk myelodysplastic syndromes (MDS), will be presented at the 23rd Congress of the European Hematology Association (EHA) to be held in Stockholm, Sweden, on June 17, 2018.
-- 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.

5. Evolus Inc. (EOLS)

Gained 14.62% to close Wednesday's trading at $19.36. The stock touched an all-time high of $19.70 in intraday trading.

News: No news

Recent event:

-- On May 16, 2018, the FDA rejected the Company's Biologics License Application for DWP-450 for the treatment of glabellar lines, also known as frown lines, in adult patients.

There were deficiencies in items related to Chemistry, Manufacturing, and Controls ("CMC") processes that led to the rejection. However, no deficiencies were related to clinical or non-clinical matters.

The same day, the Company also announced good news related to favorable completion of FDA's pre-approval inspection of Daewoong's manufacturing facility in South Korea which was purpose built for production of DWP-450.

6. Immutep Limited (IMMP)

Gained 12.95% to close Wednesday's trading at $2.53.

News: No news


The Company's lead drug candidate is Eftilagimod alpha. A phase IIb clinical study of Eftilagimod alpha in metastatic breast cancer, dubbed AIPAC, and a phase I clinical trial. in patients with unresectable or metastatic melanoma, dubbed TACTI-mel, are underway.

Near-term Catalysts:

-- Interim results from the three initial patient cohorts of its ongoing TACTI-mel Phase I clinical trial will be presented in a global webcast on Tuesday, May 29, 2018, 6:00pm US Eastern Daylight Time.
-- A subset of the interim results from TACTI-mel Phase I clinical trial will be presented at the 3rd Annual Advances in ImmunoOncology Congress, on 25 May 2018 in London, UK.

7. MiMedx Group Inc. (MDXG)

Gained 11.17% to close Wednesday's trading at $8.96.

News: No news

Recent events:

-- On March 2, 2018, NASDAQ notified MiMedx that it was not in compliance with the NASDAQ Listing Rules since the Company had not yet filed its Form 10-K for the year ended December 31, 2017.
-- On April 26, 2018, the Company announced that its first quarter 2018 revenue exceeded the $92 million high end of its previously released guidance. Based upon the strong first quarter performance, the Company raised its full year revenue guidance from a previous range of $383 million to $387 million to a revised range of $389 million to $394 million.
-- On May 18, 2018, the Company has been notified of being noncompliant with the NASDAQ Listing Rules since it has not yet filed its Form 10-Q for the period ended March 31, 2018.

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