Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling The Peaks
(Biotech stocks that hit 52-week highs on Nov. 21.)
- ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD)
- Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY)
- Amgen, Inc. (NASDAQ: AMGN) (raised full-year guidance following completion of Otezla purchase from Celgene)
- Antares Pharma Inc (NASDAQ: ATRS)
- Arvinas Inc (NASDAQ: ARVN)
- Axsome Therapeutics Inc (NASDAQ: AXSM)
- Beigene Ltd (NASDAQ: BGNE)
- BIO-TECHNE Corp (NASDAQ: TECH)
- BridgeBio Pharma Inc (NASDAQ: BBIO)
- Cue Biopharma Inc (NASDAQ: CUE)
- Epizyme Inc (NASDAQ: EPZM)
- Kamada Ltd. (NASDAQ: KMDA)
- Kodiak Sciences Inc (NASDAQ: KOD)
- Molecular Templates Inc (NASDAQ: MTEM)
- Recro Pharma Inc (NASDAQ: REPH) (completed spin-off of Baudax Bio in a bid to a become a pure play CDMO)
Down In The Dumps
(Biotech stocks that hit 52-week lows on Nov. 21.)
- AcelRx Pharmaceuticals Inc (NASDAQ: ACRX)
- Aerie Pharmaceuticals Inc (NASDAQ: AERI) (received European approval for its Rhokiinsa 0.02% for the reduction of elevated intraocular pressure)
- Affimed NV (NASDAQ: AFMD)
- Anixa Biosciences Inc (NASDAQ: ANIX)
- CareDx Inc (NASDAQ: CDNA)
- Cumberland Pharmaceuticals, Inc. (NASDAQ: CPIX)
- ENDRA Life Sciences Inc (NASDAQ: NDRA)
- Genprex Inc (NASDAQ: GNPX)
- Idera Pharmaceuticals Inc (NASDAQ: IDRA)
- Interpace Biosciences Inc (NASDAQ: IDXG)
- Invivo Therapeutics Holdings Corp (NASDAQ: NVIV) (priced its previously announced common stock offering)
- Iterum Therapeutics PLC (NASDAQ: ITRM)
- Jaguar Health Inc (NASDAQ: JAGX)
- MacroGenics Inc (NASDAQ: MGNX)
- Merrimack Pharmaceuticals Inc (NASDAQ: MACK)
- Neon Therapeutics Inc (NASDAQ: NTGN) (announced a changed focus and the elimination of 24% of workforce)
- Novavax, Inc. (NASDAQ: NVAX)
- Nuvectra Corp (NASDAQ: NVTR)
- Onconova Therapeutics Inc (NASDAQ: ONTX)
- Sellas Life Sciences Group Inc (NASDAQ: SLS)
- Sierra Oncology Inc (NASDAQ: SRRA)
- Syros Pharmaceuticals Inc (NASDAQ: SYRS)
- Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) (announced plans to commence Phase 2 proof-of-concept study of alcohol use disorder drug)
- Unum Therapeutics Inc (NASDAQ: UMRX)
- Viveve Medical Inc (NASDAQ: VIVE)
Stocks In Focus Aslan Reports Publication Of Positive Pre-Clinical Data For Blood Cancer Drug
ASLAN PHARMACEU/ADR (NASDAQ: ASLN) said new preclinical data for ASLAN003 as a potential treatment of acute myeloid leukemia has been published in the November issue of the Haematological Journal.
"The findings support ASLAN003's potential as a potent human dihydroorotate dehydrogenase (DHODH) inhibitor and novel target for differentiation therapy with a favourable toxicity profile," the company said.
Celyad Receives Funding From Belgium's Walloon Region
CELYAD SA/ADR (NASDAQ: CYAD) said it has received 8.5 million euros ($9.3 million) in grants and non-dilutive funding from the Walloon Region of Belgium. The company said the funds will support the development of its CAR-T candidates, including CYAD-01 and CYAD-02 for the treatment of relapsed/refractory acute myeloid leukemia, as well as next-gen approaches in clinical development.
The stock was trading 11.06% higher at $12.65 in Friday's premarket session.
Roche Extends Tender Offer To Buy Spark To Dec. 10
Roche Holdings AG Basel ADR (OTC: RHHBY) announced yet another extension in the offering period for its previously announced tender offer to buy all outstanding shares of Spark Therapeutics Inc (NASDAQ: ONCE) for $114.50 per share.
The offer period has been extended from the earlier schedule of 5 p.m. on Monday, Nov. 25 until 5 p.m. Tuesday, Dec. 10.
The extension provides additional time for the U.S. FTC and U.K. Competition and Markets Authority to complete their previously disclosed review of the deal, the companies said.
Zymeworks Reports Positive Phase 1 Readout For Solid Tumor Drug
Zymeworks Inc (NYSE: ZYME) announced updated Phase 1 data for single agent ZW25 in heavily pretreated patients with HER-2 expressing solid tumors at the ESMO Asia Congress.
The disease control rate was 70%, comprising 44% partial responses and 26% stable disease, while 32% patients experienced disease control for greater than six months.
Out of the nine evaluable biliary duct cancer patients, the disease control rate was 78% and the objective response rate was 67%, while in the 13 colorectal cancer patients and 23 gastroesophageal adenocarcinoma patients, the overall response rates were 46% and 39%, respectively.
Along with its collaborator BeiGene, Zymeworks said it intends to advance ZW25 into potentially registration-enabling global studies in HER2-expressing biliary tract cancer and gastroesophageal adenocarcinoma.
Enanta Pharmaceuticals Inc (NASDAQ: ENTA) reported fourth-quarter revenue of $51.3 million versus $67.2 million in the year-ago period. The revenues comprised royalty revenue from worldwide net sales of AbbVie Inc (NYSE: ABBV)'s hepatitis C virus regimen Mavyret/Maviret. The net income per share declined from $1.30 to 44 cents. Analysts expected earnings per share of 53 cents per share.
The stock was down 5.84% at $59.80 in the premarket session.
On The Radar Clinical Trial Readouts
Society For Neuro-Oncology Presentations
VBI Vaccines Inc (NASDAQ: VBIV): Phase 1/2 data for VBI-1901 in recurrent glioblastoma multiforme.
DelMar Pharmaceuticals Inc (NASDAQ: DMPI): Updated Phase 2 data for VAL-083 in unmethylated newly diagnosed glioblastoma multiforme as well as in unmethylated recurrent glioblastoma multiforme.
strong>Agios Pharmaceuticals Inc (NASDAQ: AGIO): updated Phase 1 data for ivosidenib and vorasidenib in IDHm low-grade glioma.
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