Gainers & Losers Of May 23: GLYC, PBYI, SGMO, CERS, AGLE...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of May 23, 2017.

GAINERS

1. GlycoMimetics Inc. (GLYC)

Gained 20.35% to close Tuesday's (May 23) trading at $13.25, gaining more than what it lost yesterday.

News: No news

Recent event: On May 23, the Company announced that it intends to offer and sell, subject to market conditions, 6 million shares of its common stock in an underwritten public offering. The stock fell nearly 14% on the stock offering.

Read more about GlycoMimetics at our Company Spotlight column.

2. Sangamo Therapeutics Inc. (SGMO)

Gained 10.07% to close Tuesday's trading at $8.20.

News: No news

Recent events:

On May 16, the Company's cDNA gene therapy candidate for hemophilia A, SB-525, was granted Fast Track designation by the FDA. SB-525 is being developed as part of an exclusive, global collaboration and license agreement with Pfizer Inc. that was signed on May 10, 2017.

Near-term catalysts:

A phase 1/2 clinical trial of SB-525 in adults with hemophilia A is expected to open and begin screening subjects for enrollment by the end of the second quarter 2017.

The Company's other three lead programs are SB-318 for Mucopolysaccharidosis (MPS) I; SB-913 for MPS II and SB-FIX for Hemophilia B, all of which are under phase 1/2 clinical trials.

3. Puma Biotechnology Inc. (PBYI)

Gained 9.89% to close Tuesday's trading at $57.80.

Near-term catalyst:

-- The Company's breast cancer drug Neratinib is all set to be reviewed by an FDA panel on May 24, 2017.

Neratinib is an investigational therapy for the extended adjuvant treatment of early stage HER2-positive breast cancer that has previously been treated with a trastuzumab (Herceptin) containing regimen.

No specific PDUFA (decision) date has been notified for Neratinib. However, the U.S. regulatory agency's decision is expected to be announced in the third quarter of 2017.

4. Collegium Pharmaceutical Inc. (COLL)

Gained 8.77% to close Tuesday's trading at $9.18.

News: No news

The Company currently has one marketed product Xtampza ER, an abuse-deterrent, extended-release, oral formulation of oxycodone approved by the FDA for the management of pain.

Upcoming events:

The Company is scheduled to make a presentation at

-- The Jefferies 2017 Global Healthcare Conference on Tuesday, June 6th at 9:00 a.m. ET in New York City -- The 37th Annual William Blair Growth Stock Conference on Wednesday, June 14th at 2:40 p.m. CT at The Four Seasons Hotel Chicago.

LOSERS

1. Cerus Corp. (CERS)

Lost 25% to close Tuesday's trading at $2.25.

News: The Company has lowered its 2017 product revenue guidance due to expected impact of Platelet Additive Solution supply disruption on INTERCEPT platelet production.

The INTERCEPT Blood System, marketed by Cerus, is designed to reduce the risk of transfusion-transmitted infections.

The U.S. supply shortage of the platelet additive solution (PAS) manufactured and sold by Fresenius Kabi is due to an unanticipated delay in FDA approval of a plastic component used in the manufacture of the PAS container following discontinuation of the original component by Fresenius Kabi's supplier.

The Company now expects 2017 product revenue to range between $38 million and $46 million compared to the prior range of $43 million to $48 million.

2. Fluidigm Corp. (FLDM)

Lost 10.35% to close Tuesday's trading at $4.89.

News: No news

Recent event: On May 4, the Company reported financial results for the first quarter ended March 31, 2017.

Total revenue for Q1, 2017 was $25.5 million, a decrease of 12% from $29.0 million in the first quarter of 2016 and an increase of 2% from $25.1 million in the fourth quarter of 2016.

Non-GAAP net loss for the first quarter of 2017 narrowed to $9.6 million or $0.33 per share from $11.5 million or $0.40 per share for the first quarter of 2016.

For the second quarter of 2017, the total revenue is projected to be in the range of $22 million to $24 million.

3. Aeglea Biotherapeutics Inc. (AGLE)

Lost 10.16% to close Tuesday's trading at $5.57.

News: Dosing in pediatric patients in the ongoing Phase 1/2 trial of AEB1102 in Arginase 1 Deficiency is likely to be delayed.

In March 2017, the Company was informed by the FDA that additional data might be needed to support the inclusion of pediatric patients in the ongoing Phase 1/2 trial of AEB1102 in Arginase 1 Deficiency.

The Company recently received written feedback from the FDA based on supporting data provided in March and a follow-up meeting with the Agency in late April.

Aeglea noted that it is unable to resolve a difference in opinion at this time on the data needed to support inclusion of pediatric patients.

4. Alexion Pharmaceuticals, Inc. (ALXN)

Lost 9.34% to close Tuesday's trading at $104.64.

New: The Company has announced changes to its executive leadership team

The Company's CFO, Dave Anderson, will resign at the end of August, and a search for a new CFO is underway.

Martin Mackay, Executive Vice President, Head of Research & Development will be retiring from Alexion, and search for a replacement is already underway.

Clare Carmichael, Executive Vice President, Chief Human Resources Officer, will be leaving the Company to pursue new opportunities effective June 1, 2017. Search is underway for replacement.

Brian Goff is joining Alexion as Chief Commercial Officer, effective June 1, 2017.