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 Sept. 23.)
- Applied Therapeutics Inc APLT
- Avadel Pharmaceuticals PLC AVDL (announced a communication from the FDA allowing it to proceed with a reduced sample size in a Phase 3 study of its drug to treat excessive daytime sleepiness)
- Bioanalytical Systems, Inc. BASI
- Bio-Rad Laboratories, Inc. Class A Common Stock BIO
- Celgene Corporation CELG
- Cesca Therapeutics Inc KOOL
- DURECT Corporation DRRX
- Enlivex Therapeutics Ltd ENLV
- Sanofi SA SNY
- SpringWorks Therapeutics Inc SWTX
- ZEALAND PHARMA/S ADR ZEAL
Down In The Dumps
(Biotech stocks that hit 52-week lows Sept. 23)
- Aduro BioTech Inc ADRO
- AEterna Zentaris Inc. AEZS
- Akcea Therapeutics Inc AKCA (announced departures of CEO, president and COO, and the appointment of board member Damien McDevitt as interim CEO)
- BioNano Genomics Inc BNGO
- Catalyst Biosciences Inc CBIO
- Cellectis SA CLLS
- Clovis Oncology Inc CLVS (announced acquisition of rights to FAP-targeted radiopharmaceuticals from 3B Pharmaceuticals for $12 million)
- Erytech Pharma SA ERYP
- Invivo Therapeutics Holdings Corp NVIV
- Kalvista Pharmaceuticals Inc KALV
- KITOV PHARMA LT/S ADR KTOV
- Mersana Therapeutics Inc MRSN
- Neon Therapeutics Inc NTGN
- Onconova Therapeutics Inc ONTX (announced $3.4-million registered direct offering of common shares)
- Plus Therapeutics Inc PSTV (priced its common stock offering)
- ProQR Therapeutics NV PRQR
- Sarepta Therapeutics Inc SRPT
- Satsuma Pharmaceuticals Inc STSA (priced its IPO Sept. 13)
- Sienna Biopharmaceuticals Inc SNNA
- Sophiris Bio Inc SPHS
- Stealth BioTherapeutics Corp MITO
- Titan Pharmaceuticals, Inc. TTNP
- Vaxart Inc VXRT
Stocks In Focus
Novartis' Sandoz Unit Recalls Ulcer Medicine
Novartis AG NVS's Sandoz unit said it is voluntarily recalling all quantities and lots of ranitidine hydrochloride capsules in the U.S. to the consumer levels due to confirmed contamination with N-Nitrosodimethylamine, or NDMA, above the levels established by the FDA.
NDMA is considered a probable carcinogen based on lab tests.
Ranitidine hydrochloride capsules are an oral product indicated to treat ulcers.
To date, the company said it has not received any reports of adverse events related to use of the product as part of this recall.
See also: The Week Ahead In Biotech: Spotlight On ESMO Conference
Anchiano Enters Agreement With ADT PharmaÂ
ANCHIANO THERAP/S ADR ANCN said its U.S. subsidiary has entered into an exclusive worldwide collaboration and option to license agreement with ADT Pharma to develop novel small-molecule inhibitors of RAS and PDE10/β-catenin.
Under the terms of the agreement, Anchiano will be granted an exclusive option to license the RAS and PDE10/β-catenin inhibitors in exchange for a $3-million upfront payment.
Anchiano will have the option to exclusively license the compounds worldwide at any time by obtaining an IND designation.
If Anchiano exercises its option, it will be responsible for development and commercialization and will incur additional payment obligations, including milestone and royalty payments to ADT.
The stock gained 6.74% to $2.85 in after-hours trading.
Proteon To Reverse Merge With ArTara
Proteon Therapeutics Inc PRTO, which focuses on treatments for kidney and vascular diseases, announced an agreement to merge with privately held biopharma ArTara Therapeutics, which develops treatments for rare and specialty diseases.
The merged company will focus on advancing ArTara's pipeline of transformative late-stage, de-risked, rare and specialty disease assets. Upon stockholder approval, the combined company is expected to operate under the name ArTara Therapeutics, Inc. and trade on the Nasdaq Capital Market under the ticker symbol "TARA."
The stock rallied 18.98% to 40 cents in after-hours trading.
Takeda Licenses Evotec's Platform For Drug Discovery
German pharma company Evotec SE EVTCY and Japan's Takeda Pharmaceutical Co Ltd TAK announced a strategic, multiyear drug discovery collaboration, under which the companies aim to establish at least five drug discovery programs. Evotec will deliver clinical candidates for Takeda to pursue into clinical development.
Under the terms, Takeda will pay Evotec a one-time, upfront fee to access its platforms. Additionally, Evotec is eligible to receive pre-clinical, clinical and commercial milestones that can total in excess of $170 million per program as well as tiered royalties on future sales.
On The Radar
Clinical Trial Readout
Urogen Pharma Ltd URGN will present initial Phase 2b data for its UGN-102 in low-grade, non-muscle invasive bladder cancer.
Related Link: Axsome Shares Flirt With Record High: How Much Upside Is Left?
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