Here's a roundup of top developments in the biotech space over the last 24 hours:
Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs Sept. 15)
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Sept. 15)
Stocks In Focus
Aerie Announces Mixed Results For Phase 2b Study Of AR-15512 In Dry Eye Disease
Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) reported topline results from a Phase 2b clinical study of AR-15512 ophthalmic solution for the treatment of patients with dry eye disease, showing greatest efficacy in the higher concentration, 0.003% BID, which Aerie said will be advanced to Phase 3 studies.
The study achieved statistical significance for multiple pre-specified symptom endpoints and multiple pre-specified sign endpoints. It also showed statistically significant improvement in both symptoms and signs as early as day 14 and continuous improvement through day 84. Both formulations of AR-15512 were safe and well-tolerated, the company said.
The study did not achieve statistical significance at the pre-determined primary endpoints at day 28, according to Aerie.
Aerie said it expects to have an end of Phase 2 meeting with the Food and Drug Administration in the first quarter of 2022. In order to complete development of AR-15512, the company plans to conduct two additional three-month Phase 3 efficacy studies and an additional safety study.
The stock was slumping 15.29% to $13.30 premarket Thursday.
Travere Out-Licenses Rights To Kidney Disorder Drug In Europe, Australia, New Zealand To Vifor
Travere Therapeutics, Inc. (NASDAQ:TVTX) and Vifor Pharma announced the companies have entered into a joint collaboration and licensing agreement for the commercialization of sparsentan in Europe, Australia and New Zealand.
Sparsentan is a novel investigational product candidate currently being evaluated in pivotal Phase 3 clinical studies for the treatment of focal segmental glomerulosclerosis and IgA nephropathy, two rare progressive kidney disorders and leading causes of end-stage kidney disease.
Travere shares were down 5.44% to $22.25 in premarket trading.
Axsome Commences Late-Stage Study Of AXS-12 As Treatment Option For Chronic Sleep Disorder
Axsome Therapeutics, Inc. (NASDAQ:AXSM) said it has enrolled the first patient in SYMPHONY, a Phase 3 study of AXS-12 in patients with narcolepsy. AXS-12 is a novel, oral, potent, and highly selective norepinephrine reuptake inhibitor. Topline results from the SYMPHONY trial are anticipated in the first half of 2023.
The stock was gaining 2.92% to $28.53 in premarket trading.
Thermo Fisher Companion Diagnostic Tests For Takeda's Lung Cancer Drug Approved By FDA
Crinetics Reports Positive Early Stage Results For Congenital Hyperinsulism Drug
Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) announced positive preliminary findings from the single ascending dose cohorts of a first-in-human Phase 1 clinical study with CRN04777, demonstrating pharmacologic proof-of-concept for treating congenital hyperinsulinism.
Offerings
The stock was slipping 0.86% to $11.48 in premarket trading.
aTyr Pharma, Inc. (NASDAQ:LIFE) announced that it has commenced an underwritten public offering of shares of its common stock. All of the shares to be sold in the offering are to be sold by aTyr.
The shares were losing 4.58% to $8.13 in premarket trading.
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On The Radar
Clinical Readouts/Presentations
European Society for Medical Oncology 2021 Congress Presentations
The combo as first-line therapy was well-tolerated with compelling activity.
Leap shares were jumping 41.45% to $2.73 in premarket trading.
As a monotherapy and in combination with pembrolizumab, SBT6050 was generally well-tolerated, with an adverse event profile that is consistent with immune system activation and considered on-mechanism.
The stock was down 13.85% at $14 in premarket trading.
Phio Pharmaceuticals Corp. (NASDAQ:PHIO) announced results of a new study showing that local treatment in vivo with INTASYL can cure tumors and generate systemic tumor immunity that is both durable and tumor-specific.
The results show that up to 83% of the animals treated with PH-3861 had a complete response when treated at low doses, namely doses suboptimal for monotherapy. Moreover, this treatment induced a durable and specific systemic anti-tumor immune response, without requiring further treatment.
The stock was advancing 10.66% to $2.18 in premarket trading.
Related Link: Attention Biotech Investors: Mark Your Calendar For September PDUFA Dates
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