The following is a roundup of top developments in the biotech space over the last 24 hours:
Scaling The Peaks
(Biotech stocks that hit 52-week highs Dec. 2.)
- Aquestive Therapeutics Inc AQST (completed rolling NDA submission for libervant buccal film for the management of seizure clusters)
- Arvinas Inc ARVN
- ASLAN PHARMACEU/ADR ASLN (reported positive results for proof-of-concept study of atopic dermatitis drug)
- Aurinia Pharmaceuticals Inc AUPH
- Axsome Therapeutics Inc AXSM
- Bausch Health Companies Inc BHC
- BioDelivery Sciences International, Inc. BDSI
- Cassava Sciences Inc SAVA
- Collegium Pharmaceutical Inc COLL
- Cue Biopharma Inc CUE
- Dicerna Pharmaceuticals Inc DRNA
- Evofem Biosciences Inc EVFM (reported positive results for Phase 2 study for investigational asset to treat chlamydia and gonorrhea in women)
- GALAPAGOS NV/S ADR GLPG
- Incyte Corporation INCY
- Kodiak Sciences Inc KOD
- Kadmon Holdings Inc KDMN
- Krystal Biotech Inc KRYS
- Merck & Co., Inc. MRK (FDA accepted Merck's NDA for Keytruda in non-muscle invasive bladder cancer, according the application Priority Review designation)
- Neubase Therapeutics Inc NBSE (H.C. Wainwright analyst Ram Selvaraju reiterated a Buy rating and $14 price target on the shares)
- Ovid Therapeutics Inc OVID
- Oramed Pharmaceuticals, Inc. ORMP
- Recro Pharma Inc REPH
- Qiagen NV QGEN
- Xenon Pharmaceuticals Inc XENE — announced a deal with Neurocrine Biosciences, Inc. NBIX to license its epilepsy drug to the latter
Down In The Dumps
(Biotech stocks that hit 52-week lows Dec. 2.)
- Evelo Biosciences Inc EVLO
- Evogene Ltd EVGN
- KemPharm Inc KMPH
- KITOV PHARMA LT/S ADR KTOV
- Midatech Pharma PLC-ADR MTP
- Predictive Oncology Inc POAI
- X4 Pharmaceuticals Inc XFOR
Stocks In Focus
Astellas To Buy Audentes For $3B In Cash
ASTELLAS PHARMA/ADR ALPMY announced a definitive agreement to buy Audentes Therapeutics Inc BOLD for $60 per share in cash, representing a total equity value of $3 billion.
"By joining together with Audentes' talented team, we are establishing a leading position in the field of gene therapy with the goal of addressing the unmet needs of patients living with serious, rare diseases," Astellas CEO Kenji Yasukawa said in a statement.
Audentes shares were ripping 105.91% higher to $58.91 in Tuesday's premarket session.
Axsome's Narcolepsy Drug Meets Aces Midstage Trial
Axsome announced its AXS-12 met the pre-specified primary endpoint and significantly reduced cataplexy attacks as compared to placebo in patients with narcolepsy in the Phase 2 CONCERT trial. The asset also significantly reduced excessive daytime sleepiness and improved cognitive function, sleep quality and sleep-related symptoms.
The shares were advancing 15.04% to $45.58 in Tuesday's premarket session.
Aldeyra Reports Mixed Late-Stage Results For Dry Eye Drug
Aldeyra Therapeutics Inc ALDX announced positive top-line results from Part 1 of the adaptive Phase 3 study dubbed RENEW, which evaluated ADX-102 (topical ocular reproxalap) for dry eye syndrome.
ADX-102 was found statistically superior to vehicle in Ocular Discomfort & 4-Symptom Questionnaire ocular endpoints for dryness, discomfort, burning, grittiness and stinging.
For the co-primary endpoint of fluorescein nasal region ocular staining, it did not reach statistical significance.
The company said it expects to initiate the Part 2 portion of the RENEW study in the first half of 2020.
The stock was adding 1.87% to $7.63 in Tuesday's premarket session.
Applied Genetic's Chief Medical Officer Departs Ahead Of Key Data Releases
Gene therapy company Applied Genetic Technologies Corp AGTC said its chief medical officer Theresa Heah has resigned to pursue other opportunities. The resignation has nothing to do with pending data releases, the company said.
Applied Genetic also said the departure does not affect its previously announced guidance on the timing of data reporting from the Phase 1/2 trials in patients with X-linked retinitis pigmentosa and achromatopsia, with the interim six-month data for the former due in January and the interim six-month data from the dose escalation group of both the achromatopsia B3 and A3 Phase 1/2 studies also due in January.
The stock was 9.09% at $2.50.
FDA Approves 2 Of Amneal's Generics
Amneal Pharmaceuticals Inc AMRX said it has received FDA approval for its ANDAs for the generic versions of Revatio for oral suspension 10 mg/ml and Amicar tablets USP, 400 mg. The company said it has initiated commercialization activities.
Revatio is Pfizer Inc.'s PFE FDA-approved product for treating adult patients with pulmonary arterial hypertension. Amicar acts as an inhibitor for fibrinolysis.
The stock added 4.17% to $4 in after-hours trading.
Puma's Breast Cancer Drug Receives Regulatory Nod In Singapore
Puma Biotechnology Inc PBYI said its licensing partner Specialized Therapeutics Asia has received marketing approval for Nerlynx in Singapore.
Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant Herceptin-based therapy.
The stock was trading 1.12% higher at $10.85 in Tuesday's premarket session.
NantKwest Reports Promising Safety Data From Early Sage Study Of Cell Therapy Candidate
Nantkwest Inc NK announced results from six patients evaluated in the Phase 1 QUILT-3.064 study that showed promising safety data. The study evaluated the safety and preliminary efficacy of its first-in-class, tumor-targeting PD-L1. t-haNK cell therapy in patients with locally advanced or metastatic solid tumors.
The stock was trading 15.89% higher at $1.75 in Tuesday's premarket session.
ASLAN PHARMA said it has priced its previously announced underwritten public offering of 5.125 million ADSs at $2.50 each. Each ADS represent five shares of Aslan. The company expects to raise gross proceeds of $12.8 million from the offering. The offering is set to close on or about Dec. 5.
The stock was crashing by 43.46% to $2.94 in Tuesday's premarket session.
Kodiak Sciences said it has commenced an underwritten public offering of $250 million worth of its common shares. All the shares are to be sold by the company.
The stock was down 11.3% at $45.28 premarket Tuesday.
Arrowhead Pharmaceuticals Inc ARWR said it intends to offer 4 million shares of its common stock in an underwritten public offering. All the shares earmarked for the offering are to be sold by the company. The company said it would use the net proceeds for general corporate purposes, including working capital, capex, R&D and clinical trial expenditures.
The stock was down 3.99% at $60.80 at the time of publication Tuesday.
On The Radar
Clinical Trial Readouts
Ardelyx Inc ARDX will present Phase 3 data for tenapanor for treating hyperphosphatemia in end-stage renal disease patients.
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