DXCM Falls On CGM Rivalry, ZYNE Firms Up, SPPI In Limelight, Big Day Awaits MNKD

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

GAINERS

1. Zynerba Pharmaceuticals Inc. (ZYNE)

Gained 52.50% to close Thursday's (Sep.28) trading at $9.44.

News: The Company reported positive top line results from its phase II trial of ZYN002 cannabidiol (CBD) gel in pediatric and adolescent patients with Fragile X syndrome.

In the trial, dubbed FAB-C, ZYN002 cannabidiol gel in pediatric and adolescent patients with Fragile X syndrome met its primary endpoint, achieving a 46% improvement in the total score of Anxiety, Depression, and Mood Scale (ADAMS) at week twelve compared to baseline.

2. Spectrum Pharmaceuticals Inc. (SPPI)

Gained 22.97% to close Thursday's trading at $13.49.

News: The Company announced that additional interim data from its ongoing phase II study of Poziotinib in EGFR Exon 20 Mutant Non-Small Cell Lung Cancer will be released on October 18, 2017.

In a recent presentation about Poziotinib compassionate use in Non-Small Cell Lung Cancer at MD Anderson Cancer Center, the Company revealed that for a 65 year old non smoking female suffering from Stage IV adenocarcinoma with HER2 exon 20 insertion mutation, treatment with Poziotinib 16mg orally daily for a week improved cough and pain in multiple bone sites. PET/CT scans of the patient taken after 4 weeks of therapy showed significant radiolological response while after 9 weeks of therapy, the patient is stable.

3. Catabasis Pharmaceuticals Inc. (CATB)

Gained 21.86% to close Thursday's trading at $2.23.

News: 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. MannKind Corp. (MNKD)

Gained 20% to close Thursday's trading at $2.22.

News: No news

Near-term catalyst:

-- The FDA decision on the label change of Afrezza Inhaled Insulin, highlighting its unique PK: PD profile is expected to be announced by September 30, 2017.

5. Editas Medicine Inc. (EDIT)

Gained 16.11% to close Thursday's trading at $23.14.

News: No news

Recent event:

-- On September 26, 2017, the European Medicines Agency granted Orphan Medicinal Product designation to EDIT-101, the Company's pre-clinical, CRISPR-based medicinal product to treat Leber Congenital Amaurosis type 10 (LCA10).

Near-term catalyst:

-- An Investigational New Drug (IND) application for EDIT-101 is expected to be submitted in mid-2018.

6. Proteon Therapeutics Inc. (PRTO)

Gained 13.16% to close Thursday's trading at $2.15.

News: No news

Near-term catalysts:

-- Enroll 24 patients in phase I trial of Vonapanitase in patients with peripheral artery disease before the end of 2017. -- Complete enrollment of 600 patients in PATENCY-2 in the first quarter of 2018.

PATENCY-2 is Proteon's ongoing pivotal Phase 3 clinical trial of Vonapanitase in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis.

7. Syros Pharmaceuticals Inc. (SYRS)

Gained 12.57% to close Thursday's trading at $15.22.

News: No news

Pipeline:

The Company's lead drug candidates are SY-1425, in a Phase 2 clinical trial for genomically defined subsets of patients with acute myeloid leukemia and myelodysplastic syndrome, and SY-1365, in a Phase 1 clinical trial for patients with advanced solid tumors, including transcriptionally dependent cancers such as triple negative breast, small cell lung and ovarian cancers.

Near-term catalysts:

-- Initial clinical data from phase II clinical trial of SY-1425 are expected to be reported in the fourth quarter of 2017. -- Preliminary clinical data from phase I clinical trial of SY-1365 is expected in 2018.

LOSERS

1. DexCom Inc. (DXCM)

Lost 32.65% to close Thursday's trading at $45.44.

News: Dexcom shares took a hit following FDA approval of Abbott's FreeStyle Libre Flash Glucose Monitoring System.

The FreeStyle Libre system enables the user to get accurate glucose readings anytime, without the need to routinely finger prick. A small sensor automatically measures and continuously stores glucose readings day and night. This system allows people with diabetes to avoid the additional step of fingerstick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes—with a wave of the mobile reader.

Dexcom's G5 Mobile CGM System, approved by the FDA last December, also lets one to make diabetes treatment decisions without pricking the finger. But it still requires calibration with two daily fingersticks.

2. AngioDynamics Inc. (ANGO)

Lost 13.17% to close Thursday's trading at $16.29.

News: The Company reported first quarter financial results for the 2018 fiscal year ended August 31, 2017.

The Company recorded a net loss of less than one hundred thousand dollars, or $0.00 per share in the first quarter of fiscal 2018 compared to a net income of $1.3 million or $0.04 per share in the first quarter of fiscal 2017. Net sales for the fiscal first quarter were $85.4 million, down 3 percent compared to $88.1 million a year ago primarily related to our Core/Angiographic Catheter business.

3. Endo International plc (ENDP)

Lost 9.85% to close Thursday's trading at $8.15.

News: No news

Recent event:

-- On August 8, 2017, the Company reported second-quarter 2017 financial results.

Adjusted income from continuing operations for the recent second quarter rose to $207 million or $0.93 per share from $192 million or $0.86 per share in the year-ago quarter. Revenues for the second quarter of 2017 were $876 million, a 5 percent decrease compared to second-quarter 2016 revenues of $921 million.

Looking ahead to full year 2017, the Company expects total revenues to be between $3.38 billion to $3.53 billion. The Company generated revenues of $4.01 billion in 2016. The GAAP loss per share from continuing operations for 2017 is expected to be between $4.76 and $4.46 and adjusted EPS from continuing operations are forecast to range between $3.35 and $3.65.

4. Zogenix Inc. (ZGNX)

Lost 8.36% to close Thursday's trading at $12.88.

News: No news

Near-term catalysts:

-- The top-line data from Study 1 of phase III program of ZX008 in Dravet Syndrome, scheduled to be reported in the third quarter of 2017, are pending. The phase III program consists of two studies 1501 and 1502. The results from the combined patient population of studies 1501 and 1502 would be reported as "Study 1".