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CDNA, ALNA Up On Analyst Coverage, LIFE Goes Ahead, GLYC Gearing Up For ASH

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The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of November 27, 2017.

GAINERS

1. GlycoMimetics Inc. (GLYC)

Gained 11.92% to close Monday's (Nov.27) trading at $14.18.

News: No news

Near-term catalysts:

--Next data read-out from the ongoing phase I/II clinical trial of product candidate GMI-1271 for the treatment of acute myeloid leukemia is expected to be presented at the ASH meeting in December.
-- Initiation of a phase III study of GMI-1271 for the treatment of acute myeloid leukemia in mid-2018.
-- A phase III trial of Rivipansel in patients hospitalized for vaso-occlusive crisis of sickle cell disease is being conducted by the Company's partner Pfizer. This study remains on track for completion in the second half of 2018.

2. Tocagen Inc. (TOCA)

Gained 11.71% to close Monday's trading at $11.54.

News: No news

The Company went public on the NASDAQ Global Select Market on April 13, 2017, offering its shares at a price of $10.00 each.

Pipeline:

Tocagen's lead product candidate is a combination of an investigational biologic, Toca 511, and an investigational small molecule, Toca FC, designed to be used together.

Near-term catalysts:

-- A phase III clinical trial of Toca 511 & Toca FC, for the treatment of patients with recurrent brain cancer, dubbed Toca 5, is underway. A planned interim analyses of the study at 50% and 75% of events, are estimated to occur in the second half of 2018 and first half of 2019, respectively.
-- Initiation of Phase 1b trial, called Toca 7, evaluating Toca 511 & Toca FC combined with standard of care in patients with newly diagnosed high grade glioma expected in the second half of 2018.
--Report activity/safety data from a phase 1b study of Toca 511 in combination with Toca FC in patients with metastatic cancers in 2018.

3. CareDx Inc (CDNA)

Gained 10% to close Monday's trading at $7.37.

News: H.C. Wainwright analyst Ram Selvaraju has initiated coverage on CareDx with a "Buy" rating on the stock and a target price $12.00.

Recent events:

-- The Company launched AlloSure, its proprietary next-generation sequencing test for measuring the percentage of donor-derived cell-free DNA (dd-cfDNA) in solid organ transplant recipients, last month.

4. Allena Pharmaceuticals Inc. (ALNA)

Gained 9.52% to close Monday's trading at $14.38.

News: Wedbush has initiated coverage on Allena with "Outperform" rating on the stock and a target price $30.00.

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.

Pipeline:

The Company's lead product candidate is ALLN-177 for the treatment of hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, CKD and other serious kidney diseases.
ALLN-177 has been studied in three phase II clinical trials.

Near-term catalysts:

-- Initiate the first of two planned pivotal phase III clinical trials for ALLN-177 in the first quarter of 2018.

5. InflaRx N.V. (IFRX)

Gained 9.15% to close Monday's trading at $16.70.

News: No news

Recent event:

-- The Company went public on the NASDAQ Global Select Market on November 8, 2017, offering its shares at a price of $15.00 each.

Pipeline:

The Company's lead compound is IFX-1, under phase II clinical trial in patients suffering from moderate to severe Hidradenitis Suppurativa (HS), a painful, chronic and debilitating inflammatory skin disease. Positive top line data from an exploratory Phase IIa trial of IFX-1 in Hidradenitis Suppurativa were reported in September of 2017.

Near-term catalyst:

-- Initiation of an international, multi-center, randomized, placebo-controlled Phase IIb trial in Hidradenitis Suppurativa is being planned.

6. Seres Therapeutics Inc. (MCRB)

Gained 8.81% to close Monday's trading at $10.38.

News: No news

Recent event:

-- On October 2, 2017, the Company reported positive top line results from SER-287 phase 1b study in patients with Ulcerative Colitis. However, investors were not that impressed with the results, and the stock fell 23% that day to $12.30.

Near-term catalysts:

-- Microbiome data, a co-primary endpoint of the phase 1b study of SER-287 in patients with Ulcerative Colitis study, are expected in the coming months.
-- Results from Phase 1b study of SER-262 in primary C. difficile infection are expected in early 2018.

7. aTyr Pharma Inc. (LIFE)

Gained 8.75% to close Monday's trading at $4.35.

News: The Company has dosed the first subjects in a phase I trial of iMod.Fc (ATYR1923), its first engineered Physiocrine and second therapeutic candidate, in development for the treatment of interstitial lung diseases (ILDs). Top-line data from the study are expected in the second quarter of 2018.

LOSERS

1. ANI Pharmaceuticals Inc. (ANIP)

Lost 10.57% to close Monday's trading at $66.68.

News: No news

Recent event:

-- On November 2, 2017, the Company reported Q3, 2017 financial results.

Net income rose to $4.7 million or $1.11 per share in the recent third quarter from $2.5 million or $0.77 per share in the prior year period. Net revenue in the third quarter of 2017 was $48.2 million, an increase of 25% from $38.5 million in the prior year period.

Looking ahead to full year 2017, the Company expects non GAAP EPS in the range of $3.83 to $4.00, and revenue in the range of $181 million to $183 million.

2. Ocular Therapeutix Inc. (OCUL)

Lost 10.12% to close Monday's trading at $3.73.

News: No news

Near-term catalysts:

-- Meet with the FDA in early 2018 to review plans to resubmit its NDA for DEXTENZA for the treatment of post-surgical ocular pain.
--Resubmit its NDA for DEXTENZA in the first half of 2018.
--A phase III clinical trial for OTX-TP (travoprost insert) for the treatment of glaucoma and ocular hypertension is underway - with top line efficacy data expected in the second half of 2018.
-- A pilot human clinical trial with an intracameral product candidate, OTX-TIC, which is a bioresorbable travoprost-containing hydrogel depot delivered via a fine-gauge needle injection for patients who have moderate to severe glaucoma, initiated in Q3, 2017, is underway.
-- Advance OTX-TKI into phase I testing outside the United States in the first half of 2018.

3. Novan Inc. (NOVN)

Lost 9.48% to close Monday's trading at $4.87.

News: No news

Pipeline:

The Company's pipeline includes:

-- SB206, which is under phase II trial for genital warts; under phase I study for Molluscum and under phase I study for HPV -associated sexually transmitted infections.
-- NVN3100, which is under pre-clinical testing for anal neoplasia and cervical neoplasia.
-- SB414, which is under phase I study for psoriasis, and under preclinical testing for atopic dermatitis.
-- SB204, under late-stage development for acne, and
-- SB208, under phase II study for Onychomycosis Tinea Pedis

Upcoming event:

-- The Company is slated to make a presentation at the Piper Jaffray 29th Annual Healthcare Conference, Wednesday, Nov. 29, 2017.

4. Quidel Corporation (QDEL)

Lost 8.97% to close Monday's trading at $36.33.

News: Beckman Coulter is taking legal recourse to enforce its rights to sell B-type Naturietic Peptide assay for the diagnosis of heart failure directly to its customers, contrary to its agreement with Quidel.

Although developed and manufactured by Beckman Coulter, this assay is now being sold exclusively by Quidel and its designated distributors, following Quidel's acquisition of the B-type Naturietic Peptide (BNP) assay business run on Beckman Coulter analyzers from Alere Inc. recently.

Quidel plans to vigorously defend the validity of the agreement and is confident in its legal position.

5. KalVista Pharmaceuticals Inc. (KALV)

Lost 8.88% to close Monday's trading at $9.75.

News: No news

Near-term catalyst:

-- Initiate Phase 2 proof-of-concept trial of intravitreal KVD001 for Diabetic Macular Edema later this year.

6. Immune Design Corp. (IMDZ)

Lost 8.60% to close Monday's trading at $4.25.

News: No news

Pipeline:

The Company plans to initiate a pivotal phase III trial of CMB305 monotherapy in synovial sarcoma patients. Data from interim analysis of phase II trial of CMB305 combination therapy were presented at ESMO 2017, and it showed greater benefit in sarcoma patients receiving the combination.

Updated data from a randomized phase II study evaluating G100 and low-dose radiation (XRT), versus G100 and XRT with the systemic administration of Merck's Keytruda in follicular NHL patients will be presented at the American Society of Hematology next month.

7. Aileron Therapeutics Inc. (ALRN)

Lost 8.07% to close Monday's trading at $10.94.

News: No news

Aileron's common stock made its debut on the NASDAQ Global Market on June 29, 2017 at an offering price of $15.00 per share.

Pipeline:

The Company's lead product candidate is ALRN-6924. Multiple clinical studies of ALRN-6924 are underway, including a Phase 1 All-comers trial in advanced solid tumors or lymphomas, a Phase 2a trial in peripheral T-cell lymphoma (PTCL), a Phase 1 trial in acute myeloid leukemia (AML) and advanced myelodysplastic syndrome (MDS) as a monotherapy, and a Phase 1b trial in AML/MDS in combination with cytosine arabinoside (Ara-C).

Near-term catalysts:

--Preclinical reports from two studies of ALRN-6924 in PTCL and AML will be presented at the American Society of Hematology (ASH) Annual Meeting in December.
-- Interim data from the ongoing trials are expected to be reported during the first half of 2018.

8. Juniper Pharmaceuticals (JNP)

Lost 7.69% to close Monday's trading at $4.80.

News: No news

Near-term catalyst:

-- The top line preclinical data for IVR formulations, JNP-0101, JNP-0201 and JNP-0301, remain on track for by the end of 2017.

JNP-0101 is an oxybutynin IVR for the treatment of overactive bladder in women; JNP-0201 is a combination estradiol + progesterone IVR for hormone replacement therapy and JNP-0301 is a natural progesterone IVR for the prevention of preterm birth.

(IVR: intravaginal ring technology).

9. Collegium Pharmaceutical Inc. (COLL)

Lost 7.67% to close Monday's trading at $15.52.

News: The FDA has outlined steps to promote development of generic versions of opioids formulated to deter abuse. Generic versions pose competition to branded drugs like Xtampza ER.

The Company's lead product Xtampza ER is an opioid with abuse-deterrent formulation. Net product revenues for Xtampza ER in the third quarter of 2017 were $12.0 million compared to $408,000 in the year-ago quarter.

by RTTNews Staff Writer

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