(RTTNews.com) - The following are some of today's top gainers in the pharma/biotech sector.
1. Verastem Inc. (VSTM)
Gained 31.39% to close Monday's (June 18) trading at $8.58.
News: The latest data from a Phase Ib/II study evaluating Duvelisib in combination with FCR (dFCR) as a frontline treatment in younger patients with chronic lymphocytic leukemia (CLL) were presented at the 23rd Congress of the European Hematology Association on June 16, 2018.
In the study, the combination regimen achieved an overall response rate (ORR) of 94%, including 26% of patients experiencing a complete response or complete response with incomplete blood count recovery (CR/CRi), and 68% achieving a partial response.
In addition, patients also experienced a high rate of bone marrow MRD negativity of 76%, which is significantly higher than historical data with FCR. Importantly, the results from this study demonstrated that Duvelisib can be combined with a triple chemo-immunotherapy in the front-line setting with an acceptable safety profile, added the Company.
Duvelisib NDA is under priority review by the FDA, with a decision expected on October 5, 2018.
The Company is seeking full approval for Duvelisib for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma.
2. PTC Therapeutics Inc. (PTCT)
Gained 27.51% to close Monday's trading at $47.88.
News: The Company presented encouraging updated interim clinical data from Part 1 of the FIREFISH study investigating Risdiplam (RG7916) in babies with Type 1 Spinal Muscular Atrophy (SMA), at the 22nd Annual SMA Researcher Meeting on June 16, 2018.
FIREFISH is a two-part study in infants with Type I Spinal Muscular Atrophy (SMA). Part one is an open-label, dose escalation study in at least 8 infants for a minimum of 4 weeks. The primary objective of part one is to assess the safety profile of RG7916 in infants and determine the dose for part two. Part two is an open-label, single-arm study in approximately 40 infants with Type I SMA for 24 months, followed by an open-label extension. The primary objective of part two is to assess the efficacy of RG7916 at the selected dose over a 12-month treatment period.
According to the updated data, at Day 182, over 90% of the babies achieved a greater than 4-point increase in CHOP-INTEND score compared to baseline. The CHOP-INTEND is a test designed to measure motor milestone development of patients with SMA Type 1.
Up to 6.5-fold increase of protein production translated into clinical impact for the babies in the FIREFISH study," said Stuart Peltz, CEO of PTC Therapeutics.
3. Arrowhead Pharmaceuticals Inc. ( ARWR )
Gained 24.03% to close Monday's trading at $13.73.
News: The Company announced that it has completed enrollment of a Phase 1 clinical study of ARO-AAT for the treatment of a rare genetic liver disease associated with alpha-1 antitrypsin deficiency. Two planned cohorts at a dose of 400 mg were eliminated because maximal activity appeared to occur at lower doses than expected.
The study now has 7 cohorts in which 16 subjects receive placebo and 28 subjects receive single or multiple doses of ARO-AAT at doses of 35, 100, 200, or 300 mg.
-- Initial data from the Phase 1 clinical study of ARO-AAT will be presented in November.
-- Initial data from the ongoing Phase 1/2 study of ARO-HBV, being developed for patients with chronic hepatitis B virus infection, will also be presented in November.
4. ObsEva SA (OBSV)
Gained 22.82% to close Monday's trading at $17.87.
News: The Company's Phase 2b clinical trial of Linzagolix for the treatment of endometriosis-associated pain, dubbed EDELWEISS, met the primary and secondary endpoints.
Linzagolix will advance into phase III testing by the end of the year.
The Company has launched a proposed underwritten public offering of 4.75 million common shares. The underwriters have been granted a 30-day option to purchase up to an additional 712,500 common shares.
5. China Biologic Products Holdings Inc. (CBPO)
Gained 21.15% to close Monday's trading at $99.39.
News: CITIC Capital Holdings Limited, an alternative investment management and advisory company, has offered to acquire all outstanding shares of China Biologic Products not already owned for US$110 in cash per Ordinary Share.
The proposal was submitted to the Board of Directors of China Biologic Products on June 11, 2018.
6. TapImmune Inc. (TPIV)
Gained 17.43% to close Monday's trading at $12.33. The stock has gained 134% so far this month.
News: No news
-- On May 15, 2018, the Company announced that it has entered into a definitive merger agreement to acquire Marker Therapeutics Inc., a privately-held clinical-stage developer of a transformative, non-genetically engineered, multi-antigen T cell therapy platform.
-- On June 8, 2018, the Company announced pricing of $70 million private placement. The closing of the transaction, which is subject to the closing of the merger with Marker, the approval by TapImmune's stockholders as required by NASDAQ Stock Market Rules, and other customary closing conditions, is anticipated to occur by the end of the third quarter of 2018.
7. Quotient Limited (QTNT)
Gained 16.95% to close Monday's trading at $8.35.
Quotient is a commercial-stage diagnostics company.
News: The Company reported positive European field trial data for the initial MosaiQ IH Microarray, which exceeded the targeted criteria for submission for CE marking.
The Company also announced that it planned to issue an additional $36 million of notes with funding to occur within 10 business days.
-- File for European regulatory approvals for its initial MosaiQ IH microarray in the second half of calendar 2018 and for the initial Serological Disease Screening (SDS) microarray in the first half of calendar 2019.
-- Expand IH antigen testing menu during the second half of calendar 2018.
-- Commence U.S. field trials with the expanded antigen testing menu in the first half of calendar 2019.
-- File for U.S. and European regulatory approval for the expanded IH microarray in the second half of calendar 2019.
8. Scholar Rock Holding Corp. (SRRK)
Gained 10.43% to close Monday's trading at $20.76.
News: No news
The Company's most advanced product candidate is SRK-015, being developed for the treatment of patients with Spinal Muscular Atrophy (SMA), which is under phase I testing.
The Company went public on the Nasdaq Global Select Market on May 24, 2018, offering its shares at a price of 14.00 each.
Clinical trials & Near-term Catalysts:
-- The ongoing Phase 1 clinical trial is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of intravenous SRK-015 in healthy adult volunteers.
-- Upon successful completion of the Phase 1 trial, the Company plans to initiate a Phase 2 proof-of-concept trial of SRK-015 in patients with later-onset Spinal Muscular Atrophy in the first quarter of 2019.
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