Gainers & Losers Of The Day: PULM, FWP, TNDM, ADHD, CNCE…

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

GAINERS

1. Pulmatrix Inc. (PULM)

Gained 127.97% to close Tuesday's (Jan.17) trading at $1.55.

News: The company's drug candidate PUR1900, for treating fungal infections in the lungs of cystic fibrosis patients, has been designated as a "Qualified Infectious Disease Product" by the FDA. PUR1900 is under preclinical testing.

2. Benitec Biopharma Limited (BNTC)

Gained 62.16% to close Tuesday's trading at $3.00.

News: The company's BB-301, a ddRNAi therapeutic in development for the treatment of oculopharyngeal muscular dystrophy, has been granted Orphan Drug Designation by the European Medicines Agency.

BB-301 is currently in preclinical development and Benitec plans to initiate IND-enabling studies later this year.

3. Forward Pharma A/S (FWP)

Gained 48.23% to close Tuesday's trading at $27.20.

News: The company has entered into a Settlement and License Agreement with Biogen over multiple sclerosis drug Tecfidera.

Biogen will pay Forward Pharma a non-refundable cash fee of $1.25 billion, 10% of net sales of Tecfidera beginning in 2021, and 20% of net sales beginning in 2029, as part of the Settlement and License Agreement. Tecfidera is one of Biogen's key drugs and it brought home sales of $1.03 billion in Q3, 2016.

In 2014, Forward Pharma had sued Biogen seeking damages for Biogen's unlawful sales of Tecfidera in Germany.

However, the License agreement does not resolve the other patent suits between the two companies.

4. BiondVax Pharmaceuticals Ltd. (BVXV)

Gained 41.73% to close Tuesday's trading at $5.23.

News: No news

Last week, a study published in Vaccine Journal indicated that BiondVax's universal flu vaccine candidate M-001 may cover strains which don't yet exist.

The company reported positive preliminary safety results from its European Phase 2b clinical trial of M-001 last November.

5. Pernix Therapeutics Holdings Inc. (PTX)

Gained 15.77% to close Tuesday's trading at $3.23.

News: No news

Anticipated event: Q4 and Full-year 2016 financial results to be reported on March 8, 2017.

6. Tandem Diabetes Care Inc. (TNDM)

Gained 14.58% to close Tuesday's trading at $2.75.

News: No news

Anticipated event: Q4 and Full-year 2016 financial results to be reported on February 22, 2017.

The non-GAAP sales of the company are expected to be in the range of $85 million to $90 million. The consensus forecast amongst analysts covering Thomson Reuters is $86.55 million.

7. Aeterna Zentaris Inc. (AEZS)

Gained 13.73% to close Tuesday's trading at $2.90

News: No news

Near-term catalyst: Top-line results from phase III trial of Zoptrex in endometrial cancer are expected to be released this quarter (Q1, 2017).

8. Infinity Pharmaceuticals, Inc. (INFI)

Gained 10.67% to close Tuesday's trading at $1.66.

News: No news

Near-term catalysts: The company has set itself a couple of goals to be achieved this year.

- Present preclinical and clinical data from a Phase 1 study of IPI-549 in patients with advanced solid tumors at the upcoming PI3K Keystone Symposia Conference in January 2017 - Report Phase 1 data from the monotherapy dose-escalation phase as well as the IPI-549 plus Opdivo dose-escalation phase in 2017 - Complete the dose-escalation phase evaluating IPI-549 monotherapy in the first half of 2017 - Begin enrolling patients with advanced solid tumors in the monotherapy expansion cohort during the second half of 2017 - Complete the dose-escalation combination phase evaluating IPI-549 plus Opdivo in the second half of 2017 - Begin enrolling patients with non-small cell lung cancer (NSCLC), melanoma and squamous cell carcinoma of the head and neck (SCCHN) in combination expansion cohorts evaluating IPI-549 plus Opdivo in the second half of 2017.

9. Tenax Therapeutics Inc. (TENX)

Gained 10.63% to close Tuesday's trading at $2.29.

News: No news

Near-term catalyst: The top-line data from the company's phase III LEVO-CTS trial in cardiac surgery is anticipated this month.

The LEVO-CTS trial is a double-blind, randomized, placebo-controlled study that is evaluating the use of Levosimendan administered before and during cardiac surgery to reduce the incidence of low cardiac output syndrome (LCOS) and associated morbidity and mortality.

LOSERS

1. Alcobra Ltd. (ADHD)

Lost 50.66% to close Tuesday's trading at $0.94.

News: The company's second phase III clinical trial of investigational product Metadoxine Extended Release (MDX) for the treatment of ADHD in adult patients did not meet the primary endpoint.

The trial, dubbed MEASURE, did not demonstrate a statistically significant difference from placebo in the change from baseline of the investigator rating of the Conners' Adult ADHD Rating Scales (CAARS).

2. EnteroMedics Inc. (ETRM)

Lost 35.04% to close Tuesday's trading at $8.90.

News: No news

The stock has been on the decline since touching a high of $30.41 on January 10, 2017.

3. Pfenex Inc. (PFNX)

Lost 15.52% to close Tuesday's trading at $7.62.

News: No news

Near-term catalyst: A pivotal trial of PF708 is pending initiation. PF708 is being developed through the 505(b)(2) regulatory development pathway, and the clinical program is expected to include an immunogenicity/pharmacokinetic study in subjects with osteoporosis.

4. Concert Pharmaceuticals Inc. (CNCE)

Lost 13.94% to close Tuesday's trading at $9.01.

News: The company provided further details on the development plan in the U.S. and Europe for CTP-656.

Near-term catalysts:

- A phase II trial of CTP-656 in cystic fibrosis patients in Europe is expected to be initiated in the second quarter of 2017. - The top-line results from an ongoing Phase 2 trial of CTP-656 in cystic fibrosis patients being conducted at multiple U.S. are expected by year-end 2017.