BEIJING (dpa-AFX) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of June 26, 2017.
1. AVEO Pharmaceuticals Inc. (AVEO)
Gained 56% to close Monday's (June 26) trading at $1.95.
News: The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has recommended the Company's FOTIVDA for approval as a treatment for patients with advanced renal cell carcinoma.
The European Commission, which typically adheres to the recommendation of the CHMP, but is not obligated to do so, is expected to make its final decision in about 67 days.
2. Moleculin Biotech Inc. (MBRX)
Gained 38.18% to close Monday's trading at $1.52.
News: The Company has entered into an agreement with a physician at the Mayo Clinic to enable additional research on Moleculin's WP1066 molecule for the possible treatment of a rare form of pediatric brain tumor.
The sponsoring physician has submitted an IND to the FDA and the IND is on hold until documentation of Good Manufacturing Process or GMP production of WP1066 can be presented to the FDA, which Moleculin has agreed to provide.
The Company's lead candidate, Annamycin, is under phase II trial as a potential treatment for relapsed or refractory acute myeloid leukemia - with top line data expected to be reported by the second half of 2017.
3. ContraFect Corp. (CFRX)
Gained 20.83% to close Monday's trading at $1.45.
News: No news
An international phase II study of CF-301 as a potential treatment of Staphylococcus aureus bacteremia was initiated last month. The company expects to announce top line results in Q4 2018.
4. Sorrento Therapeutics Inc. (SRNE)
Gained 13.51% to close Monday's trading at $2.10.
News: No news
Sorrento's subsidiary SCILEX Pharmaceuticals Inc. plans to resubmit the NDA for ZTlido to the FDA and the MAA to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, and other member states (EU countries) in the second half of 2017.
The investigational medicated plaster ZTlido is intended for the treatment of postherpetic neuralgia.
5. ImmunoGen Inc. (IMGN)
Gained 12.54% to close Monday's trading at $6.82.
News: The Company presented data from its ongoing phase I study of single agent IMGN779 in patients with relapsed or refractory adult acute myeloid leukemia whose tumors express CD33.
The phase 1 trial is designed to establish the maximum tolerated dose and determine the recommended Phase 2 dose for IMGN779 administered as monotherapy. The trial is also intended to evaluate safety and tolerability and characterize PK, PD, and preliminary anti-leukemia activity in relapsed or refractory AML.
The results demonstrate favorable safety profile with repeat dosing and no dose-limiting toxicities.
6. Sinovac Biotech Ltd. (SVA)
Gained 12.46% to close Monday's trading at $6.41.
News: The Company has entered into a definitive agreement for going-private transaction.
As per the agreement, Sinovac Biotech will be acquired by Sinovac (Cayman) Ltd in a transaction valued at approximately $1.8 million.
The purchase price represents a premium of 32.1% and 30%, respectively, over the Company's 30- and 60-trading day volume-weighted average price as quoted by NASDAQ prior to the Company's announcement on February 1, 2016 that it had received a non-binding 'going-private' proposal from Weidong Yin, the chairman, president and chief executive officer of the Company, and SAIF Partners IV L.P. ('SAIF') and/or its affiliates to acquire all of the outstanding Shares not already owned by them.
7. Selecta Biosciences (SELB)
Gained 12.20% to close Monday's trading at $19.87.
News: The Company has announced a $50 million private placement.
Certain new and existing institutional investors have agreed to purchase an aggregate of 2.75 million shares of the Company's common stock at a price of $16.00 per share. Additionally, a member of the company's Board of Directors has agreed to purchase, for an aggregate purchase price of approximately $6 million, 338,791 shares of common stock and warrants to purchase 79,130 shares of common stock at an exercise price of $17.71.
The closing of the offering is subject to certain conditions and is expected to occur on June 27, 2017.
The Company's lead drug candidate is SEL-212, under phase II testing to treat severe gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. This trial is expected to be completed in 2017. If all goes well, a phase III program will commence in 2018.
8. Cara Therapeutics Inc. (CARA)
Gained 12.19% to close Monday's trading at $25.40.
News: The FDA has granted Breakthrough Therapy designation to the Company's I.V. CR845 for the treatment of moderate-to-severe uremic pruritus (UP) in chronic kidney disease patients undergoing hemodialysis.
I.V. CR845 is under phase 2/3 testing in uremic pruritus and under phase III trial for the treatment of postoperative pain.
Top-line results from Part A of the phase 2/3 clinical trial of I.V. CR845 in patients with uremic pruritus were announced in March of this year. The trial met its primary endpoint, with a 68 percent reduction in worst itching scores versus placebo after an eight-week treatment period, and its secondary endpoint, with a 100 percent improvement in quality of life domains versus placebo.
Completion of phase III trial of I.V. CR845 in postoperative pain is expected in the fourth quarter of 2017.
9. Urogen Pharma Ltd. (URGN)
Gained 11.67% to close Monday's trading at $19.43.
News: No news
The Company made its debut on the NASDAQ as recently as May 4, 2017, offering its shares at a price of $13.00 each.
The lead drug candidate of Urogen is MitoGel, a novel sustained release formulation of Mitomycin C, for the treatment of non-muscle invasive, low-grade upper tract urothelial carcinoma (UTUC).
A phase III trial of MitoGel for the treatment of low-grade upper tract urothelial carcinoma, dubbed OLYMPUS, is underway.
10. Proteostasis Therapeutics Inc. (PTI)
Gained 11.66% to close Monday's trading at $4.79.
News: The Company has filed an Investigational New Drug application with the FDA for PTI-808, its cystic fibrosis transmembrane conductance regulator (CFTR) potentiator.
A phase I study of PTI-808 in healthy volunteers is expected to be initiated in July.
Preliminary phase I data from at least 8 cystic fibrosis subjects from a cohort of stable Orkambi patients dosed with PTI-428 for 7 days followed by a 7-day follow-up period were reported on June 9, 2017. The treatment was well tolerated, and no safety concerns were identified.
By the end of June, Proteostasis expects to report preliminary data, including lung function, from multiple ascending dose (MAD) cohorts of two different CF patient populations: at least eight CF subjects receiving PTI-428 or placebo in addition to Orkambi as their background for seven days and up to eight CF subjects receiving PTI-428 as their sole CFTR modulator therapy or placebo for seven days.
Data from the 28-day dosing cohort in phase I clinical trial of PTI-428 are expected in the second half of 2017.
1. Neothetics Inc. (NEOT)
Lost 69.52% to close Monday's trading at $0.70.
News: The Company's phase 2 proof-of-concept trial of LIPO-202 for the reduction of submental subcutaneous fat did not meet the endpoints.
In the trial, LIPO-202 did not demonstrate improvement on any efficacy measurements or separation from placebo.
2. Matinas BioPharma Holdings Inc. (MTNB)
Lost 27.80% to close Monday's trading at $2.00.
News: The Company reported top line data from its phase II study of orally-administered MAT2203 for the treatment of Vulvovaginal Candidiasis, or VVC.
Although the phase II study achieved its primary endpoint in demonstrating MAT2203 is safe and well tolerated, both the clinical and mycological responses for MAT2203 did not meet the Company's expectations, and were below that of Fluconazole, the guideline recommended therapy for the treatment of VVC.
3. HealthStream Inc. (HSTM)
Lost 16.90% to close Monday's trading at $25.67.
News: Laerdal Medical A/S, a Norwegian company, has ended renewal negotiations for the agreements with HealthStream regarding the HeartCode and Resuscitation Quality Improvement (RQI) products.
The current agreements expire on December 31, 2018.
The Company noted that the announcement of the expected conclusion of its agreements with Laerdal does not affect its previously stated financial guidance for 2017.
For 2017, HealthStream anticipates that consolidated revenues will grow 10 to 14 percent compared to 2016. The Company had revenues of $226.0 million for 2016.
4. InVivo Therapeutics Holdings Corp. (NVIV)
Lost 10.53% to close Monday's trading at $2.55.
News: No news
The Company's lead product candidate is Neuro-Spinal Scaffold, an investigational device, currently being evaluated in a pivotal study for the treatment of patients with spinal cord injury, dubbed INSPIRE.
The Company expects to complete enrollment in the INSPIRE study during the third quarter of this year.
5. Vital Therapies Inc. (VTL)
Lost 9.23% to close Monday's trading at $2.95.
News: No news
-- The top line data from a phase III study of ELAD System in subjects with severe alcoholic hepatitis, dubbed VTL-308, are anticipated around mid-2018.
6. Acceleron Pharma Inc. (XLRN)
Lost 9.06% to close Monday's trading at $31.01.
News: No news
-- On June 12, 2017, the Company announced that its phase II study of Dalantercept in advanced renal cell carcinoma, dubbed DART, failed to meet the primary endpoint. Due to lack of efficacy, the development of Dalantercept has been discontinued. -- On June 23, 2017, the Company reported preliminary results from the ongoing Phase 2 study of Luspatercept in patients with beta-thalassemia. Results from the ongoing study demonstrated increases in hemoglobin and decreases in red blood cell transfusion burden sustained for up to 24 months, with patients still active on treatment.
A global Phase 3 study of Luspatercept in transfusion-dependent beta-thalassemia patients, dubbed BELIEVE, is fully enrolled and top-line results are expected in mid-2018.
7. Seattle Genetics Inc. (SGEN)
Lost 8.41% to close Monday's trading at $56.55.
News: The Company reported positive results from phase III study of ADCETRIS in frontline advanced Hodgkin Lymphoma.
The phase III study, dubbed ECHELON-1, met its primary endpoint of a statistically significant improvement in modified progression-free survival (PFS) versus the control arm.
However, investors were not very happy as the two-year modified PFS rate for patients in the ADCETRIS arm was 82.1 percent compared to 77.2 percent in the control arm.
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