Gainers & Losers Of May 17: SNDX, PULM, PBYI, CNCE, XLRN...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of May 17, 2017.

GAINERS

1. Syndax Pharmaceuticals Inc. (SNDX)

Gained 44.62% to close Wednesday's (May 17) trading at $13.58.

News: The Company reported results from melanoma cohort of its ongoing phase II trial of Entinostat in combination with Merck's KEYTRUDA.

The results have shown that the addition of Entinostat can result in meaningful responses in patients who have progressed on an anti-PD-1 or anti-PD-1/anti-CTLA-4 regimen like KEYTRUDA, which is an area of very high unmet medical need, according to the Company.

2. Pulmatrix Inc. (PULM)

Gained 18.88% to close Wednesday's trading at $2.77.

News: In an interview to Stock-Sector.com, Pulmatrix CFO William Duke spoke about the market potential of his Company's investigational inhaled therapy PUR1900.

PUR1900 that targets fungal infections for severe asthma and cystic fibrosis patients is under non clinical development, and according to the CFO, PUR1900 has a blockbuster potential.

Near-term catalysts:

-- The Company expects pre-clinical data on PUR1900 targeting fungal infections for severe asthma and cystic fibrosis patients in the first half of 2017 -- Secure a strategic partner(s) on PUR0200, the company's most-advanced drug candidate, in the first half of 2017. PUR0200 is a novel dry powder formulation of a currently marketed once daily LAMA bronchodilator Spiriva HandiHaler, for the treatment of chronic obstructive pulmonary disease. PUR0200 is currently being developed in Europe based on PK bioequivalence, and the US development program is being planned. -- Pulmatrix intends to seek a pre-IND meeting with the FDA to inform the US clinical development path for PUR0200 in the second half of 2017. -- Continue CMC development work in the first half of 2017 to support a future European pivotal pharmacokinetic bioequivalence approval study as well as the US development path.

3. Puma Biotechnology Inc. (PBYI)

Gained 13.46% to close Wednesday's trading at $36.25

News: The Company made a presentation at the Bank of America Merrill Lynch 20th Annual Health Care Conference on May 16, 2017.

Near-term catalyst:

The Company's NDA for Neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer is scheduled to be reviewed by an FDA panel on May 24, 2017.

4. Mirati Therapeutics Inc. (MRTX)

Gained 8.96% to close Wednesday's trading at $3.65.

News: No news

The company's clinical programs include Glesatinib, under phase II study in non-small cell lung cancer; Sitravatinib, under phase 1b trial for the treatment of genetically-selected non-small cell lung cancer and other solid tumors, and Mocetinostat, under a phase 1b/2 trial in patients with advanced solid tumors and NSCLC.

Near-term catalysts:

-- Additional update on the Glesatinib program is expected in the second half of 2017 -- Additional update on the Sitravatinib program is anticipated in Q3 2017 and -- -- Additional update on the Mocetinostat program is expected in mid-year 2017.

5. Omeros Corp. (OMER)

Gained 8.70% to close Wednesday's trading at $16.25.

News: The Company reported additional positive results from the first stage of its phase II clinical trial of OMS721 for the treatment of serious kidney disorders.

The first stage in the phase 2 trial includes four different types of complement-associated kidney diseases: IgA nephropathy, membranous nephropathy, lupus nephritis, and complement component 3 (C3) glomerulopathy.

The additional results reported today were that of the IgA nephropathy patients, expanding on the data reported earlier this year and further demonstrating marked and statistically significant improvement in urine protein levels (proteinuria).

The Company is preparing for its Phase 3 clinical trial in IgA nephropathy, and is continuing to conduct the second stage of its ongoing Phase 2 clinical trial in which OMS721 is evaluated in non-steroid-treated patients with IgA nephropathy.

6. Titan Pharmaceuticals Inc. (TTNP)

Gained 8.51% to close Wednesday's trading at $2.55, continuing its rally for the second straight day.

News: No news

Recent event: The Company reported financial results for the first quarter 2017 on May 10th.

Net loss applicable to common shareholders in the first quarter of 2017 widened to $3.0 million or $0.14 per share from $1.8 million or $0.09 per share in the same quarter in 2016. Titan's revenue was approximately $40,000 in the first quarter of 2017 compared with no revenue in the same period of a year ago.

Near-term catalyst:

The Company has sought FDA's permission to begin clinical trial of Ropinirole implant for Parkinson's disease. The regulatory agency has requested additional information, which the Company plans to submit by the end of the second quarter.

If all goes well as planned, the Company will initiate a phase I/II pharmacokinetic study in the third quarter.

7. Coherus Biosciences Inc. (CHRS)

Gained 7.94% to close Wednesday's trading at $23.80.

News: The Company has scored a victory in inter partes review with the Patent Trial and Appeal Board invalidating a key patent covering AbbVie's (ABBV) autoimmune disease drug Humira.

Coherus filed an inter partes review petition against AbbVie's patents related to a 40 mg biweekly dosing regimen for treating rheumatoid arthritis with Humira in November 2015.

Coherus' investigational drug CHS-1420, which is a biosimilar candidate to Humira, successfully completed phase III testing in January of this year.

Near-term catalystS:

-- Anticipate a 351(k) Biologics License Application submission of CHS-1420 in the U.S. at or near the end of second quarter of 2017. -- FDA decision on CHS-1701, a proposed biosimilar to Amgen's (AMGN) blockbuster Neulasta, is expected on June 9, 2017.

LOSERS

1. Acceleron Pharma Inc. (XLRN)

Lost 12.31% to close Wednesday's trading at $26.57.

News: No news

Recent event: On May 8, the Company reported financial results for the first quarter ended March 31, 2017, which fell short of analysts' expectations.

Net loss for Q1, 2017 was $25.41 million or $0.66 per share on collaboration revenue of $3.71 million. Analysts polled by Thomson Reuters expected the Company to incur a loss of $0.60 per share on revenue of $4.13 million.

In the year-ago first quarter, the Company had reported a net income of $5.06 million or $0.13 per share and collaboration revenue of $18.20 million.

2. Concert Pharmaceuticals Inc. (CNCE)

Lost 7.48% to close Wednesday's trading at $14.85.

News: The FDA has placed a clinical hold on the Company's Phase 2a clinical trial of CTP-543 for alopecia areata, also known as spot baldness.

The regulatory agency has informed the Company that a review of certain recently completed non-clinical toxicology studies is required before CTP-543 can advance to phase IIa trial. Safety concerns are not the reason for the FDA's decision to impose the clinical hold, the Company noted.