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 (NASDAQ: APLT)
- Avadel Pharmaceuticals PLC (NASDAQ: 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. (NASDAQ: BASI)
- Bio-Rad Laboratories, Inc. Class A Common Stock (NYSE: BIO)
- Celgene Corporation (NASDAQ: CELG)
- Cesca Therapeutics Inc (NASDAQ: KOOL)
- DURECT Corporation (NASDAQ: DRRX)
- Enlivex Therapeutics Ltd (NASDAQ: ENLV)
- Sanofi SA (NASDAQ: SNY)
- SpringWorks Therapeutics Inc (NASDAQ: SWTX)
- ZEALAND PHARMA/S ADR (NASDAQ: ZEAL)
Down In The Dumps
(Biotech stocks that hit 52-week lows Sept. 23)
- Aduro BioTech Inc (NASDAQ: ADRO)
- AEterna Zentaris Inc. (NASDAQ: AEZS)
- Akcea Therapeutics Inc (NASDAQ: AKCA) (announced departures of CEO, president and COO, and the appointment of board member Damien McDevitt as interim CEO)
- BioNano Genomics Inc (NASDAQ: BNGO)
- Catalyst Biosciences Inc (NASDAQ: CBIO)
- Cellectis SA (NASDAQ: CLLS)
- Clovis Oncology Inc (NASDAQ: CLVS) (announced acquisition of rights to FAP-targeted radiopharmaceuticals from 3B Pharmaceuticals for $12 million)
- Erytech Pharma SA (NASDAQ: ERYP)
- Invivo Therapeutics Holdings Corp (NASDAQ: NVIV)
- Kalvista Pharmaceuticals Inc (NASDAQ: KALV)
- KITOV PHARMA LT/S ADR (NASDAQ: KTOV)
- Mersana Therapeutics Inc (NASDAQ: MRSN)
- Neon Therapeutics Inc (NASDAQ: NTGN)
- Onconova Therapeutics Inc (NASDAQ: ONTX) (announced $3.4-million registered direct offering of common shares)
- Plus Therapeutics Inc (NASDAQ: PSTV) (priced its common stock offering)
- ProQR Therapeutics NV (NASDAQ: PRQR)
- Sarepta Therapeutics Inc (NASDAQ: SRPT)
- Satsuma Pharmaceuticals Inc (NASDAQ: STSA) (priced its IPO Sept. 13)
- Sienna Biopharmaceuticals Inc (NASDAQ: SNNA)
- Sophiris Bio Inc (NASDAQ: SPHS)
- Stealth BioTherapeutics Corp (NASDAQ: MITO)
- Titan Pharmaceuticals, Inc. (NASDAQ: TTNP)
- Vaxart Inc (NASDAQ: VXRT)
Stocks In Focus Novartis' Sandoz Unit Recalls Ulcer Medicine
Novartis AG (NYSE: 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.
Anchiano Enters Agreement With ADT Pharma
ANCHIANO THERAP/S ADR (NASDAQ: 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 (NASDAQ: 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 (OTC: EVTCY) and Japan's Takeda Pharmaceutical Co Ltd (NYSE: 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 (NASDAQ: URGN) will present initial Phase 2b data for its UGN-102 in low-grade, non-muscle invasive bladder cancer.
See more from Benzinga
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