11.01.2018 03:37:02
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D-Day For ARDM Today, ALRN To Report Data In 1H18, DFFN On Watch
(RTTNews) - The following are some of the stocks that lost the largest percentage in price today in the pharma/biotech sector.
1. AmpliPhi Biosciences Corp. (APHB)
Lost 25.33% to close Wednesday's trading at $1.12.
News: The Company has priced its public offering of 4 million shares of its common stock at $1.00 per share.
The gross proceeds from the offering are expected to be about $4.0 million. The offering is expected to close on or about January 12, 2018.
Recent event:
-- On January 3, 2018, the Company reported positive interim results from its single-patient expanded access program of its lead product candidates, AB-SA01, for Staphylococcus aureus infections, and AB-PA01, for Pseudomonas aeruginosa infections. The news sent the stock soaring more than 20% that day.
2. Diffusion Pharmaceuticals Inc. (DFFN)
Lost 13.87% to close Wednesday's trading at $1.48.
News: No news
Clinical Trials & Near-term Catalyst:
-- Late last month, the Company announced that its phase III clinical trial of trans sodium crocetinate ("TSC") in patients with newly-diagnosed inoperable glioblastoma multiforme ("GBM") brain cancer, dubbed INTACT, was open for enrollment.
-- The first patient enrollment in INTACT is targeted for January 2018. Enrollment is expected to be completed by early 2019, with interim safety and efficacy data possible in 2020 and trial completion in 2021.
3. Aradigm Corp (ARDM)
Lost 7.57% to close Wednesday's trading at $3.42. The stock is down 47% year-to-date.
Near-term Catalyst:
-- A panel of outside experts convened by the FDA will meet on January 11, 2018, to vote on the Linhaliq NDA.
The Company is seeking approval of Linhaliq (formerly known as Pulmaquin) for the treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa.
The FDA panel will discuss whether or not the Company has provided substantial evidence of safety and effectiveness of the 28-day Linhaliq regimen in delaying the time to first exacerbation after starting treatment.
The FDA's final decision on Linhaliq is expected on January 26, 2018. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.
4. Apellis Pharmaceuticals Inc. (APLS)
Lost 7.02% to close Wednesday's trading at $20.26.
News: No news
Recent event:
The Company debuted on the NASDAQ Global Select Market on November 9, 2017, offering its shares at a price of $14.00 each.
Clinical Trials & Near-term Catalysts:
-- APL-2 has been successfully studied in a phase II clinical trial (FILLY) in patients with geographic atrophy associated with age-related macular degeneration. -- APL-2 is also under two phase Ib trials in paroxysmal nocturnal hemoglobinuria - one as monotherapy and the other as add-on to Soliris. -- A phase III program of APL-2 for the treatment of patients with geographic atrophy (GA) associated with age-related macular degeneration (AMD) is planned to begin in the second half of 2018.
5. Aileron Therapeutics Inc. (ALRN)
Lost 6.40% to close Wednesday's trading at $9.65.
News: No news
Aileron's common stock made its debut on the NASDAQ Global Market on June 29, 2017 at an offering price of $15.00 per share.
Pipeline:
The Company's lead product candidate is ALRN-6924. Multiple clinical studies of ALRN-6924 are underway, including a Phase 1 All-comers trial in advanced solid tumors or lymphomas, a Phase 2a trial in peripheral T-cell lymphoma (PTCL), a Phase 1 trial in acute myeloid leukemia (AML) and advanced myelodysplastic syndrome (MDS) as a monotherapy, and a Phase 1b trial in AML/MDS in combination with cytosine arabinoside (Ara-C).
Near-term Catalysts:
-- Interim data from the Phase 2a trial of ALRN-6924 for the treatment of patients with peripheral T-cell lymphoma are expected to be reported in the first half of 2018.
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