31.10.2017 02:52:38
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ADMS Draws Attention, AAAP Buyout Rumor Becomes Real, GBT Exudes HOPE
(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of October 30, 2017.
GAINERS
1. Adamas Pharmaceuticals Inc. (ADMS)
Gained 21.01% to close Monday's (Oct.30th) trading at $23.61.
News: A 13G filing dated October 27, 2017 reveals that hedge fund Point72 Asset Management L.P has a 5.1% passive stake in Adamas.
Recent event:
-- On August 24, 2017, the Company received approval for GOCOVRI, the first and only medication for the treatment of Dyskinesia in Parkinson's disease patients.
GOCOVRI, with a list price is $28,500/year or $2,375/month, is expected to be available this quarter, and formally launched with the full deployment of Adamas' sales force in January 2018.
Near-term catalyst:
-- The Company is slated to report third quarter 2017 financial results on Thursday, November 2, 2017 after market close.
2. Mustang Bio Inc. (MBIO)
Gained 13.14% to close Monday's trading at $9.99.
News: The Company has entered into a lease agreement with the UMass Medicine Science Park in Worcester, Massachusetts, for a manufacturing facility to support the clinical development and commercialization of its CAR T product candidates.
Pipeline:
Mustang Bio is focused on developing CAR T-cell therapies to cure cancer, and its lead CAR T therapies include MB-101 in glioblastoma and MB-102 in acute myeloid leukemia.
Near-term catalyst:
-- Read out phase I data of MB-101 in glioblastoma and MB-102 in acute myeloid leukemia in early 2018.
3. Global Blood Therapeutics Inc. (GBT)
Gained 12.52% to close Monday's trading at $38.65.
News: On October 28, 2017, the Company presented the positive effect of Voxelotor, its drug candidate for sickle cell disease, by citing the case study of a 67-year-old male with HbSS sickle cell genotype who was ineligible to participate in the ongoing HOPE trial.
HOPE is the Company's ongoing pivotal phase III trial of Voxelotor in people with sickle cell disease.
According to the Company, the patient, after receiving Voxelotor 900 mg orally once daily, showed a rapid response (in 1 to 2 weeks), with an improvement in pain, fatigue, and overall mental health. His hemoglobin levels rose quickly to approximately 1.5 g/dL above baseline with a sustained increase over 66 weeks in range of 1 to 1.5 g/Dl, added the Company.
The top-line clinical trial results from HOPE are expected in the first half of 2019.
4. Immune Design (IMDZ)
Gained 12.20% to close Monday's trading at $4.60.
News: No news
Near-term catalyst:
-- The Company is slated to report third quarter 2017 financial results and provide a corporate update after the close of U.S. financial markets on Wednesday, November 1, 2017.
5. Advanced Accelerator Application SA(ADR) (AAAP)
Gained 10.41% to close Monday's trading at $80.50.
News: Novartis has proposed to acquire the Company's American Depositary Shares for $41 per ordinary share and $82 per ADS (each representing 2 ordinary shares), in a transaction that is valued at approximately $3.9 billion. Rumors of Novartis eyeing Advanced Accelerator have been doing the rounds since late September.
Advanced Accelerator is an innovative radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicine products. The lead compound in development is Lutathera for the treatment of neuroendocrine tumors.
Lutathera is under FDA review, for the second time, with a decision expected on January 26, 2018. The drug was approved by the European Commission last month.
6. Vanda Pharmaceuticals Inc. (VNDA)
Gained 8.16% to close Monday's trading at $15.90.
News: No news
Near-term catalyst:
-- The Company is slated to release results for the third quarter of 2017 on Tuesday, November 7, 2017, after the market closes.
7. Urogen Pharma Ltd. (URGN)
Gained 7.88% to close Monday's trading at $30.66.
News: No news
The Company made its debut on the NASDAQ on May 4, 2017, offering its shares at a price of $13.00 each.
Pipeline:
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. Also in the pipeline is VesiGel, under phase IIa trial for low grade bladder cancer.
8. TRACON Pharmaceuticals (TCON)
Gained 7.55% to close Monday's trading at $2.85.
News: No news
Near-term catalyst:
-- Top-line progression-free survival data from phase IIb study of TRC105 and Inlyta in patients with advanced or metastatic renal cell carcinoma, dubbed TRAXAR, are expected later this year.
LOSERS
1. Pain Therapeutics Inc. (PTIE)
Lost 10.34% to close Monday's trading at $3.47.
News: A pre-NDA guidance meeting to discuss the Company's New Drug Application resubmission for REMOXY ER as a treatment for severe chronic pain is planned for November 14, 2017.
REMOXY ER is a proprietary, abuse-deterrent, extended-release oral formulation of oxycodone. The proposed indication for this drug candidate is for "the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. REMOXY ER was issued a Complete Response Letter by the FDA last September.
Near-term catalysts:
-- Top line results from abuse potential study via the nasal route of abuse with REMOXY ER expected by year-end 2017. -- Resubmission of the New Drug Application for REMOXY ER in Q1 2018.
2. Achaogen Inc. (AKAO)
Lost 8.36% to close Monday's trading at $12.49.
News: No news
Near-term catalyst:
--The Company is slated to report its third quarter financial results on Wednesday, November 8, 2017 after the close of financial markets.
Recent event:
-- On October 26, 2017, the Company submitted its New Drug Application for Plazomicin to the FDA for treatment of complicated urinary tract infections and bloodstream infections.
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Vanda Pharmaceuticals IncShs | 4,86 | 0,00% |