OTTAWA (dpa-AFX) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of March 20, 2017.
1. Esperion Therapeutics Inc. (ESPR)
Gained 74.14% to close Monday's (Mar.20) trading at $41.22.
News: The Company said it has achieved clarity from the FDA regarding its LDL-C lowering development program, Bempedoic acid.
On June 28, 2016, the Company said that the FDA did not provide clarity on a regulatory pathway for an LDL-C lowering indication in the U.S. in statin intolerant patients. The news sent the stock plunging 40%.
Bempedoic acid is an inhibitor of ATP Citrate Lyase, and is under phase III testing, which comprises of 4 studies. The company expects top-line results from its long-term safety and tolerability study by Q2 2018 and top-line results from its ongoing Phase 3 LDL-C lowering efficacy studies by mid-2018.
A global cardiovascular outcomes trial for Bempedoic acid, known as CLEAR Outcomes CVOT, was initiated by the company in January of this year.
Esperion plans to submit a NDA by 1H 2019 for an LDL-C lowering indication based on the successful completion of the global pivotal Phase 3 program. The NDA for a cardiovascular disease risk reduction indication is planned for submission to the FDA by 2022, on the basis of a successful completion of the CLEAR Outcomes CVOT.
2. Nektar Therapeutics (NKTR)
Gained 42.65% to close Monday's trading at $22.11.
News: The Company reported positive results from its Phase 3 efficacy study of NKTR-181, a first-in-class opioid analgesic.
The study, dubbed SUMMIT-07, compared twice-daily dosing of NKTR-181 tablets to placebo in the treatment of over 600 patients with moderate to severe chronic low back pain who were new to opioid therapy (opioid-naïve).
The trial met the primary efficacy endpoint in demonstrating significantly improved chronic back pain relief with NKTR-181 compared to placebo. Key secondary endpoints of the study were also met with high statistical significance.
3. Bellerophon Therapeutics Inc. (BLPH)
Gained 34.95% to close Monday's trading at $1.39. The stock has fully recovered its Friday's loss.
News: No news
Results of phase II trials for INOpulse therapy to treat significant unmet needs in pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (PH-COPD) and idiopathic pulmonary fibrosis (PH-IPF) are expected to be reported during the middle of 2017.
4. CytomX Therapeutics Inc. (CTMX)
Gained 24.44% to close Monday's trading at $18.89.
News: The Company has announced a strategic collaboration with Bristol-Myers Squibb Co. (BMY), building upon its initial 2014 alliance in oncology.
Under the original collaboration signed in May 2014, Bristol-Myers Squibb selected four oncology targets. Under the expanded collaboration, CytomX will grant Bristol-Myers Squibb exclusive worldwide rights to develop and commercialize Probody therapeutics for up to six additional oncology targets and two non-oncology targets.
Bristol-Myers Squibb will make an upfront payment of $200 million to CytomX and, in addition, will provide research funding over the course of the research term. CytomX will also be eligible to receive up to $448 million in future development, regulatory and sales milestone payments for each collaboration target, as well as tiered royalties from the mid-single digits to low-double digits on net sales of each product commercialized by Bristol-Myers Squibb.
5. Moleculin Biotech Inc. (MBRX)
Gained 14.71% to close Monday's trading at $1.17.
News: No news
-- Report data from phase II trial evaluating Annamycin as a potential treatment for relapsed or refractory acute myeloid leukemia by the second half of 2017.
6. Aurinia Pharmaceuticals Inc. (AUPH)
Gained 14.03% to close Monday's trading at $8.78.
News: The Company has closed its US$173.1 million public offering of common shares and full exercise of underwriters' option to purchase additional common shares.
The company priced its underwritten public offering of 22.3 million common shares on Mar.14, 2017. The shares were priced at US$6.75 each.
The company's investigational drug in focus is Voclosporin, a novel calcineurin inhibitor, which has the potential to improve near- and long-term outcomes in lupus nephritis when added to standard of care CellCept, also known as mycophenolate mofetil (MMF).
A phase IIb trial of Voclosporin for lupus nephritis, dubbed AURA, has been successfully completed.
A phase III trial with low dose Voclosporin (23.7mg twice daily), dubbed AURORA, is expected to commence in Q2 2017.
1. Cerulean Pharma Inc. (CERU)
Lost 62.35% to close Monday's trading at $1.25.
News: The Company is reducing its workforce by 11 people, or approximately 58%, to a total of eight full-time equivalent employees, which is expected to be completed during the second quarter of 2017.
Cerulean has also entered into a definitive stock purchase agreement with privately held Daré Bioscience Inc., under which the equity holders of Daré Bioscience will become the majority owners of Cerulean.
The Company also announced the sale of its clinical product candidates, CRLX101 and CRLX301, for $1.5 million to BlueLink Pharmaceuticals, a subsidiary of NewLink Genetics Corp.
Additionally, Cerulean announced that it has entered into an agreement with Novartis, its existing collaborator, pursuant to which Novartis will acquire all rights to Cerulean's Dynamic Tumor Targeting Platform for $6 million.
2. Aevi Genomic Medicine Inc. (GNMX)
Lost 59.38% to close Monday's trading at $2.21.
News: The Company's phase 2/3 efficacy study of AEVI-001 in adolescent patients with ADHD (attention-deficit/hyperactivity disorder) who have genetic disorders impacting the mGluR network did not meet primary endpoint.
The study, dubbed SAGA, did not meet the primary endpoint of reduction on the ADHD rating scale (ADHD-RS) compared to placebo.
3. Ritter Pharmaceuticals Inc. (RTTR)
Lost 17.70% to close Monday's trading at $1.86.
News: No news
The company's lead product candidate is RP-G28, under a phase 2b/3 clinical trial for the treatment of lactose intolerance.
Data readout from the phase 2b/3 trial of RP-G28 is expected this month (Q1, 2017).
4. Tandem Diabetes Care Inc. (TNDM)
Lost 10.98% to close Monday's trading at $1.82.
News: No news
On March 9th, the Company announced that it has filed a registration statement on Form S-1 with the Securities and Exchange Commission relating to a proposed follow-on public offering of approximately $50 million of its common stock.
5. Caladrius Biosciences Inc. (CLBS)
Lost 10.82% to close Monday's trading at $5.11. The stock has given back most of its Friday's gain.
News: No news
On March 17, 2017, the Company reported narrower loss and higher revenue for the fourth quarter and full-year of 2016 compared to the year-ago periods. The news sent the stock up over 12% that day.
6. Innocoll Holdings plc (INNL)
Lost 10.40% to close Monday's trading at $1.12.
News: No news
After having gained 135% in the first 4 trading days of last week, the stock has started to give back its gains.
Recent event: Last week, Innocoll confirmed that it is in discussions which may or may not lead to an offer for the entire issued share capital of the Company.
7. Pulmatrix Inc. (PULM)
Lost 10.03% to close Monday's trading at $2.78.
News: No news
-- 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.
Copyright RTT News/dpa-AFX, source International Compact