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APEN Gains Steam, SGRY Starting To Heal, AZRX Catches Eyes, No Stopping CPRX


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(RTTNews.com) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of November 28, 2017.

GAINERS

1. Apollo Endosurgery Inc. (APEN)

Gained 33% to close Tuesday's (Nov.28) trading at $5.40.

The Company deals with less invasive medical devices for bariatric and gastrointestinal procedures.

On November 27, 2017, the Company received FDA Clearance for OverStitch Sx endoscopic suturing system. It will be introduced in the US and Europe in the first half of 2018.

Commenting on the news, Christopher Gostout, MD, Chief Medical Officer at Apollo Endosurgery said, "The launch of OverStitch Sx will allow suturing technology to be available to nearly any physician with access to an endoscope. Broader physician access to endoscopic suturing allows for greater patient access to a variety of minimally invasive endoscopic treatments."

2. InflaRx N.V. (IFRX)

Gained 13.77% to close Tuesday's trading at $19.00.

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.

3. Surgery Partners Inc. (SGRY)

Gained 11.63% to close Tuesday's trading at $9.60.

News: No news

Recent event:

On November 8, 2017, the Company reported Q3, 2017 results, and presented an optimistic picture of its business for the next year.

For the third quarter of 2017, the Company's net loss was $13.6 million or $0.66 per share compared to $2.3 million or $0.05 per share for the same period last year. Revenue for the recent third quarter increased 8.4% to $306.3 million from $282.7 million for the third quarter of 2016.

Analysts polled by Thomson Reuters expected the Company to incur a loss of $0.02 per share on revenue of $302.87 million.

Looking ahead to full-year 2017, the Company trimmed its revenue outlook to a range of $1.30 billion to $1.33 billion, from its prior outlook of $1.34 billion to $1.36 billion range. The continuation of broader industry softness related to residual effects of the hurricanes as well as the ongoing impact of slower volumes and a less favorable payor mix are the reasons for the tapered outlook.

However, given the integration with National Surgical Healthcare, or NSH, progressing as planned, the Company is confident of entering 2018 with a stronger business capable of delivering improved, sustainable long-term financial performance.

Surgery partners acquired NSH from Irving Place Capital for roughly $760 million in May of this year.

4. AzurRx BioPharma Inc. (AZRX)

Gained 11.50% to close Tuesday's trading at $3.20.

News: No news

The Company's current product pipeline consists of two therapeutic proteins under development - MS1819 for exocrine pancreatic insufficiency associated with chronic pancreatitis and cystic fibrosis, under phase II development, and AZ1101, for the prevention of hospital-acquired infections and antibiotic-associated diarrhea, under pre-clinical testing.

Recent event:

-- On September 27, 2017, the Company reported positive results from the first six treated patients in its ongoing phase IIa trial of MS1819-SD for the treatment of exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis.

Near-term catalysts:

The preliminary results from phase II studies of MS1819 are expected in the first quarter of 2018.

5. Catalyst Pharmaceuticals Inc. (CPRX)

Gained 10.25% to close Tuesday's trading at $3.98.

News: The Company announced that it is selling 14.28 million shares of its common stock in the public offering at a price of $3.50 per share.

Recent event:

-- On November 27, 2017, the Company announced positive top-line results from a second phase III trial of Firdapse for the symptomatic treatment of Lambert-Eaton myasthenic syndrome. The Company is planning to submit its NDA for Firdapse to the FDA in the first quarter of 2018.

To know more about CPRX, please visit our Company Spotlight column.

6. MannKind Corp. (MNKD)

Gained 9.72% to close Tuesday's trading at $3.16.

News: No news

Recent event:

-- On November 7, 2017, the Company reported third quarter financial results.

The net loss for the third quarter of 2017 was $32.9 million or $0.31 per share compared to net income of $126.5 million or $1.32 per share in the year-ago quarter. Included in the year-ago quarterly net income was collaboration revenue of $161.8 million related to the termination of the Sanofi agreement.

For the third quarter of 2017, Afrezza net revenue of $2.0 million, up 28% over the second quarter of 2017 and 246% over the third quarter of 2016.

The positive label update on inhaled insulin Afrezza, the marketed product of MannKind, in late September, and Afrezza T.V. commercial market expansion are expected to further accelerate its growth.

7. Ocular Therapeutix Inc. (OCUL)

Gained 9.12% to close Tuesday's trading at $4.07.

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.

8. Sierra Oncology Inc. (SRRA)

Gained 8.98% to close Tuesday's trading at $2.79.

News: No news

Near-term catalyst:

-- An update on the Company's SRA737 program is expected in February 2018.

SRA737 is under two phase I trials - a phase I trial of SRA737 administered orally in subjects with advanced cancer, and a phase I trial of oral SRA737 given in combination with Gemcitabine plus Cisplatin or Gemcitabine alone in subjects with advanced cancer.

9. Ardelyx Inc. (ARDX)

Gained 8.40% to close Tuesday's trading at $6.45.

News: The Company has provided Kyowa Hakko Kirin Co., Ltd. exclusive rights to develop and commercialize Tenapanor for the treatment of cardiorenal diseases, including hyperphosphatemia, in Japan.

Tenapanor is Ardelyx's lead product candidate that is in phase III development in the United States for the treatment of hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis.

Ardelyx stands to receive a $30 million upfront payment from Kyowa Hakko and is eligible to receive additional development and commercialization milestones worth up to $130 million. Ardelyx is also entitled for high-teen royalties throughout the term of the agreement.

LOSERS

1. Aratana Therapeutics Inc. (PETX)

Lost 18.95% to close Tuesday's trading at $5.86.

News: The Company announced it is commencing an underwritten registered public offering of $35 million of shares of its common stock. The underwriters may have a 30-day option to purchase up to an additional $5.25 million of shares of common stock. The pricing is yet to be announced.

2. Arbutus Biopharma Corp (ABUS)

Lost 7.81% to close Tuesday's trading at $5.90.

News: No news

To know more about ABUS, please visit our Company Spotlight column.

3. Cytokinetics Incorporated (CYTK)

Lost 7.05% to close Tuesday's trading at $7.25.

News: No news

Recent event:

-- On November 21, 2017, the Company announced that its phase III clinical trial of Tirasemtiv in patients with amyotrophic lateral sclerosis did not meet the study goals. The news sent the stock plunging 25.68% to $8.25 that day.

The trial, dubbed VITALITY-ALS, did not meet the primary endpoint of change from baseline in slow vital capacity (SVC) which was evaluated at 24 weeks or any of the secondary endpoints in the trial which were evaluated at 48 weeks.

4. vTv Therapeutics Inc. (VTVT)

Lost 6.61% to close Tuesday's trading at $4.38.

News: No news

Near-term catalyst:

-- The Company's lead product candidate is Azeliragon, under phase III trial in patients with mild Alzheimer's disease, dubbed STEADFAST.

The STEADFAST trial has 2 parts - Part A and Part B. Part A enrolled patients in the United States and Canada. Part B included study sites in the United Kingdom, Ireland, Australia, New Zealand and South Africa.

Top-line results from Part A of the study are expected to be in early 2018 and that from Part B in late 2018.

5. Immune Design Corp. (IMDZ)

Lost 5.88% to close Tuesday's trading at $4.25. This is the second straight day of loss for the stock.


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.

For comments and feedback: contact editorial@rttnews.com

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